1、 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON,D.C.20549 FORM 10-Q QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31,2025 OR TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d)OF THE SECURITIES EXCHANGE ACT OF 1

2、934 Commission file number 001-16174 TEVA PHARMACEUTICAL INDUSTRIES LIMITED(Exact name of registrant as specified in its charter)Israel(State or other jurisdiction of incorporation or organization)124 Dvora HaNevia St.,Tel Aviv,ISRAEL(Address of principal executive offices)Not Applicable(IRS Employe

3、r Identification Number)6944020(Zip code)+972(3)914-8213(Registrants telephone number,including area code)Securities registered pursuant to Section 12(b)of the Act:Title of each class Trading Symbol(s)Name of each exchange on which registered American Depositary Shares,each representing one Ordinary

4、 Share TEVA New York Stock Exchange Indicate by check mark whether the registrant(1)has filed all reports required to be filed by Section 13 or 15(d)of the Securities Exchange Act of 1934 during the preceding 12 months(or for such shorter period that the registrant was required to file such reports)

5、,and(2)has been subject to such filing requirements for the past 90 days.Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T(232.405 of this chapter)during the preceding 12 month

6、s(or for such shorter period that the registrant was required to submit such files).Yes No Indicate by check mark whether the registrant is a large accelerated filer,an accelerated filer,a non-accelerated filer,smaller reporting company,or an emerging growth company.See the definitions of“large acce

7、lerated filer,”“accelerated filer,”“smaller reporting company,”and“emerging growth company”in Rule 12b-2 of the Exchange Act.Large accelerated filer Non-accelerated filer Emerging growth company Accelerated filer Smaller reporting company If an emerging growth company,indicate by check mark if the r

8、egistrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a)of the Exchange Act.Indicate by check mark whether the registrant is a shell company(as defined in Rule 12b-2 of the Act).Yes No As o

9、f March 31,2025,the registrant had 1,146,959,855 ordinary shares outstanding.For an accessible version of this Quarterly Report on Form 10-Q,please visit TEVA PHARMACEUTICAL INDUSTRIES LIMITED INDEX PART I.Financial Statements(unaudited)Item 1.Financial Statements(unaudited)Consolidated Balance Shee

10、ts 3 Consolidated Statements of Income(loss)4 Consolidated Statements of Comprehensive Income(loss)5 Consolidated statements of changes in equity 6 Consolidated Statements of Cash Flows 7 Notes to Consolidated Financial Statements 8 Item 2.Managements Discussion and Analysis of Financial Condition a

11、nd Results of Operations 44 Item 3.Quantitative and Qualitative Disclosures about Market Risk 63 Item 4.Controls and Procedures 63 PART II.OTHER INFORMATION Item 1.Legal Proceedings 64 Item 1A.Risk Factors 64 Item 2.Unregistered Sales of Equity Securities and Use of Proceeds 64 Item 3.Defaults Upon

12、Senior Securities 64 Item 4.Mine Safety Disclosures 64 Item 5.Other Information 64 Item 6.Exhibits 65 Signatures 66 TEVA PHARMACEUTICAL INDUSTRIES LIMITED INTRODUCTION AND USE OF CERTAIN TERMS Unless otherwise indicated,all references to the“Company,”“we,”“our”and“Teva”refer to Teva Pharmaceutical I

13、ndustries Limited and its subsidiaries,and references to“revenues”refer to net revenues.References to“U.S.dollars,”“dollars,”“U.S.$”and“$”are to the lawful currency of the United States of America,and references to“NIS”are to new Israeli shekels.References to“ADS(s)”are to Tevas American Depositary

14、Share(s).References to“MS”are to multiple sclerosis.Market data,including both sales and share data,is based on information provided by IQVIA,a provider of market research to the pharmaceutical industry(“IQVIA”),unless otherwise stated.References to“R&D”are to Research and Development,references to“

15、IPR&D”are to in-process R&D,references to“S&M”are to Selling and Marketing and references to“G&A”are to General and Administrative.Some amounts in this report may not add up due to rounding.All percentages have been calculated using unrounded amounts.This report on Form 10-Q contains many of the tra

16、demarks and trade names used by Teva in the United States and internationally to distinguish its products and services.Any third-party trademarks mentioned in this report are the property of their respective owners.CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS In addition to historical inform

17、ation,this Quarterly Report on Form 10-Q,and the reports and documents incorporated by reference in this Quarterly Report on Form 10-Q,may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995,which are based on managements current beliefs and

18、expectations and are subject to substantial risks and uncertainties,both known and unknown,that could cause our future results,performance or achievements to differ significantly from that expressed or implied by such forward-looking statements.These forward-looking statements include statements con

19、cerning our plans,strategies,objectives,future performance and financial and operating targets,and any other information that is not historical information.You can identify these forward-looking statements by the use of words such as“should,”“expect,”“anticipate,”“estimate,”“target,”“may,”“project,”

20、“guidance,”“intend,”“plan,”“believe”and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance.Important factors that could cause or contribute to such differences include risks relating to:our ability to successfully co

21、mpete in the marketplace,including:that we are substantially dependent on our generic products;concentration of our customer base and commercial alliances among our customers;competition faced by our generic medicines from other pharmaceutical companies and changes in regulatory policy that may resu

22、lt in additional costs and delays;delays in launches of new generic products;our ability to develop and commercialize additional pharmaceutical products;competition for our innovative medicines;our ability to achieve expected results from investments in our product pipeline;our ability to successful

23、ly execute our Pivot to Growth strategy,including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio,whether organically or through business development,to sustain and focus our portfolio of generic medicines,and

24、to execute on our organizational transformation and to achieve expected cost savings;and the effectiveness of our patents and other measures to protect our intellectual property rights,including any potential challenges to our Orange Book patent listings in the U.S.;our significant indebtedness,whic

25、h may limit our ability to incur additional indebtedness,engage in additional transactions or make new investments;and our potential need to raise additional funds in the future,which may not be available on acceptable terms or at all;our business and operations in general,including:the impact of gl

26、obal economic conditions and other macroeconomic developments and the governmental and societal responses thereto;the widespread outbreak of an illness or any other communicable disease,or any other public health crisis;effectiveness of our optimization efforts;significant disruptions of information

27、 technology systems,including cybersecurity attacks and breaches of our data security;interruptions in our supply chain or problems with internal or third party manufacturing;challenges associated with conducting business globally,including political or economic instability,major hostilities or terr

28、orism,such as the ongoing conflict between Russia and Ukraine and the state of war declared in Israel;our ability to attract,hire,integrate and retain highly skilled personnel;our ability to successfully bid for suitable acquisition targets or licensing opportunities,or to consummate and integrate a

29、cquisitions;and our prospects and opportunities for growth if we sell assets or business units and close or divest plants and facilities,as well as our ability to successfully and cost-effectively consummate such sales and divestitures,including our planned divestiture of our API business;compliance

30、,regulatory and litigation matters,including:failure to comply with complex legal and regulatory environments;the effects of governmental and civil proceedings and litigation which we are,or in the future become,party to;the effects of reforms in healthcare regulation and reductions in pharmaceutica

31、l pricing,reimbursement and coverage;increased legal and regulatory action in connection with public concern over the abuse of opioid medications;our ability to timely make payments required under our nationwide opioids settlement agreement and provide our generic version of Narcan(naloxone hydrochl

32、oride nasal spray)in the amounts and at the times required under the terms of such agreement;scrutiny from competition and pricing authorities around the world,including our ability to comply with and operate under our deferred prosecution agreement(“DPA”)with the U.S.Department of Justice(“DOJ”);po

33、tential liability for intellectual property right infringement;product liability claims;failure to comply with complex Medicare,Medicaid and other governmental programs reporting and payment obligations;compliance with sanctions and trade control laws;environmental risks;and the impact of ESG issues

34、;1 TEVA PHARMACEUTICAL INDUSTRIES LIMITED the impact of the state of war declared in Israel and the military activity in the region,including the risk of disruptions to our operations and facilities,such as our manufacturing and R&D facilities,located in Israel,the impact of our employees who are mi

35、litary reservists being called to active military duty,and the impact of the war on the economic,social and political stability of Israel;other financial and economic risks,including:our exposure to currency fluctuations and restrictions as well as credit risks;potential impairments of our long-live

36、d assets;the impact of geopolitical conflicts including the state of war declared in Israel and the conflict between Russia and Ukraine;potential significant increases in tax liabilities;the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax ben

37、efits,or of a change in our business;our exposure to changes in international trade policies,including the imposition of tariffs in the jurisdictions in which we operate,and the effects of such developments on sales of our products and the pricing and availability of our raw materials;and the impact

38、 of any future failure to establish and maintain effective internal control over our financial reporting;and other factors discussed in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31,2024,including in the sections captioned“Risk Factors”and“Fo

39、rward-Looking Statements.”Forward-looking statements speak only as of the date on which they are made,and we assume no obligation to update or revise any forward-looking statements or other information contained herein,whether as a result of new information,future events or otherwise.You are caution

40、ed not to put undue reliance on these forward-looking statements.2 PART I FINANCIAL INFORMATION ITEM 1.FINANCIAL STATEMENTS TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED BALANCE SHEETS(U.S.dollars in millions,except for share data)(Unaudited)March 31,2025 December 31,2024 ASSETS Current assets

41、:Cash and cash equivalents$1,697$3,300 Accounts receivables,net of allowance for credit losses of$80 million and$78 million as of March 31,2025 and December 31,2024,respectively 3,384 3,059 Inventories 3,247 3,007 Prepaid expenses 1,018 1,006 Other current assets 368 409 Assets held for sale 1,814 1

42、,771 Total current assets 11,528 12,552 Deferred income taxes 1,762 1,799 Other non-current assets 464 462 Property,plant and equipment,net 4,631 4,581 Operating lease right-of-use assets,net 363 367 Identifiable intangible assets,net 4,189 4,418 Goodwill 15,477 15,147 Total assets$38,415$39,326 LIA

43、BILITIES AND EQUITY Current liabilities:Short-term debt$421$1,781 Sales reserves and allowances 3,696 3,678 Accounts payables 2,290 2,203 Employee-related obligations 474 624 Accrued expenses 2,952 2,792 Other current liabilities 964 1,020 Liabilities held for sale 358 698 Total current liabilities

44、11,157 12,796 Long-term liabilities:Deferred income taxes 461 483 Other taxes and long-term liabilities 4,011 4,028 Senior notes and loans 16,230 16,002 Operating lease liabilities 288 296 Total long-term liabilities 20,990 20,809 Commitments and contingencies,see note 10 Total liabilities 32,146 33

45、,606 Redeemable non-controlling interests 340 Equity:Teva shareholders equity:Ordinary shares of NIS 0.10 par value per share;March 31,2025 and December 31,2024:authorized 2,495 million shares;issued 1,253 million shares and 1,240 million shares,respectively 58 58 Additional paid-in capital 27,965 2

46、7,764 Accumulated deficit(14,958)(15,173)Accumulated other comprehensive loss(2,675)(3,148)Treasury shares as of March 31,2025 and December 31,2024:106 million ordinary shares(4,128)(4,128)6,262 5,373 Non-controlling interests 7 7 Total equity 6,269 5,380 Total liabilities,redeemable non-controlling

47、 interests and equity$38,415$39,326 Amounts may not add up due to rounding.The accompanying notes are an integral part of the financial statements.3 TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF INCOME(LOSS)(U.S.dollars in millions,except share and per share data)(Unaudited)Three

48、 months ended March 31,2025 2024 Net revenues$3,891$3,819 Cost of sales 2,014 2,048 Gross profit 1,877 1,771 Research and development expenses 247 242 Selling and marketing expenses 622 608 General and administrative expenses 297 278 Intangible assets impairments 121 80 Other assets impairments,rest

49、ructuring and other items(22)673 Legal settlements and loss contingencies 86 106 Other loss(income)5 1 Operating income(loss)519 (218)Financial expenses,net 225 250 Income(loss)before income taxes 294 (467)Income taxes(benefit)74 (52)Share in(profits)losses of associated companies,net*4 Net income(l

50、oss)220 (419)Net income(loss)attributable to redeemable and non-redeemable non-controlling interests 6 (280)Net income(loss)attributable to Teva 214 (139)Earnings(loss)per share attributable to ordinary shareholders:Basic$0.19$(0.12)Diluted$0.18$(0.12)Weighted average number of shares(in millions):B

51、asic 1,138 1,123 Diluted 1,159 1,123 *Represents an amount less than$0.5 million.Amounts may not add up due to rounding.The accompanying notes are an integral part of the financial statements.4 TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME(LOSS)(U.S.dollars i

52、n millions)(Unaudited)Three months ended March 31,2025 2024 Net income(loss)$220$(419)Other comprehensive income(loss),net of tax:Currency translation adjustment 494 (123)Unrealized gain(loss)from derivative financial instruments,net 7 7 Unrealized loss on defined benefit plans(1)(1)Total other comp

53、rehensive income(loss)500 (117)Total comprehensive income(loss)720 (536)Comprehensive income(loss)attributable to redeemable and non-redeemable non-controlling interests 33 (322)Comprehensive income(loss)attributable to Teva$687$(214)Amounts may not add up due to rounding.The accompanying notes are

54、an integral part of the financial statements.5 TEVA PHARMACEUTICAL INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY Teva shareholders equity Ordinary shares Number of shares(in millions)Stated value Additional paid-in capital Retained earnings(accumulated deficit)Accumulated other com

55、prehensive income(loss)Treasury shares Total Teva shareholders equity Non-controlling interests Total equity(U.S.dollars in millions)Balance at December 31,2024 1,240 58 27,764 (15,173)(3,148)(4,128)5,373 7 5,380 Net Income(loss)214 214 *214 Other comprehensive income(loss)473 473 *473 Issuance of S

56、hares 13 *Proceeds from exercise of options 3 3 3 Stock-based compensation expense 34 34 34 Purchase of shares from redeemable non-controlling interests*165 165 165 Balance at March 31,2025 1,253$58$27,965$(14,958)$(2,675)$(4,128)$6,262$7$6,269 *Represents an amount less than$0.5 million.*In connect

57、ion with the sale of Tevas business venture in Japan.See note 17.Teva shareholders equity Ordinary shares Number of shares(in millions)Stated value Additional paid-in capital Retained earnings(accumulated deficit)Accumulated other comprehensive income(loss)Treasury shares Total Teva shareholders equ

58、ity Non-controlling interests Total equity(U.S.dollars in millions)Balance at December 31,2023 1,227 57 27,807(13,534)(2,697)(4,128)7,506 620 8,126 Net Income(loss)(139)(139)(280)(419)Other comprehensive income(loss)(75)(75)(42)(117)Issuance of shares 11 1 *1 1 Stock-based compensation expense 28 28

59、 28 Proceeds from exercise of options 6 6 6 Dividend to non-controlling interests*(18)(18)Purchase of shares from non-controlling interests*(45)(3)(48)(16)(64)Balance at March 31,2024 1,238$58$27,796$(13,673)$(2,775)$(4,128)$7,279$265$7,543 *Represents an amount less than$0.5 million.*In connection

60、with the dividend to non-controlling interest in Tevas business venture in Japan.*Purchase of shares from non-controlling interests in Tevas subsidiary in Switzerland.Amounts may not add up due to rounding.The accompanying notes are an integral part of the financial statements.6 TEVA PHARMACEUTICAL

61、INDUSTRIES LIMITED CONSOLIDATED STATEMENTS OF CASH FLOWS(U.S.dollars in millions)(Unaudited)Three months ended March 31,2025 2024 Operating activities:Net income(loss)$220 (419)Adjustments to reconcile net income(loss)to net cash provided by operations:Depreciation and amortization 244 272 Impairmen

62、t of long-lived assets and assets held for sale 77 679 Net change in operating assets and liabilities(700)(497)Deferred income taxes net and uncertain tax positions 28 (189)Stock-based compensation 34 28 Other items(8)2 Net cash provided by(used in)operating activities(105)(124)Investing activities:

63、Beneficial interest collected in exchange for securitized trade receivables 322 295 Purchases of property,plant and equipment and intangible assets(127)(124)Proceeds from sale of business and long-lived assets,net 17 Acquisition of businesses,net of cash acquired (15)Purchases of investments and oth

64、er assets(11)(12)Net cash provided by(used in)investing activities 201 144 Financing activities:Repayment of senior notes and loans and other long-term liabilities(1,368)Purchase of shares from redeemable and non-redeemable non-controlling interests(38)(64)Dividends paid to redeemable and non-redeem

65、able non-controlling interests(340)(78)Other financing activities 3 (9)(1,744)Net cash provided by(used in)financing activities (151)Translation adjustment on cash and cash equivalents 45 (104)Net change in cash,cash equivalents and restricted cash(1,603)(236)Balance of cash,cash equivalents at begi

66、nning of period 3,300 3,227 Balance of cash,cash equivalents at end of period$1,697 2,991 Non-cash financing and investing activities:Beneficial interest obtained in exchange for securitized accounts receivables$311 312 Amounts may not add up due to rounding The accompanying notes are an integral pa

67、rt of the financial statements.7 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)Note 1 Basis of presentation:a.Basis of presentation The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidat

68、ed financial statements.In the opinion of management,the financial statements reflect all normal and recurring adjustments necessary for a fair statement of the financial position and results of operations of Teva.The information included in this Quarterly Report on Form 10-Q should be read in conju

69、nction with the consolidated financial statements and accompanying notes included in the Companys Annual Report on Form 10-K for the year ended December 31,2024,as filed with the Securities and Exchange Commission(“SEC”).The year-end balance sheet data was derived from the audited consolidated finan

70、cial statements as of December 31,2024,but not all disclosures required by generally accepted accounting principles in the United States(“U.S.GAAP”)are included.In preparing the Companys consolidated financial statements,management is required to make estimates and assumptions that affect the report

71、ed amounts of assets,liabilities,equity and disclosure of contingent liabilities and assets at the dates of the financial statements and the reported amounts of revenues and expenses during the reported years.Actual results could differ from those estimates.In preparing the Companys consolidated fin

72、ancial statements,management also considered the economic implications of inflation expectations on its critical and significant accounting estimates.Government actions taken to address macroeconomic developments,as well as their economic impact on Tevas third-party manufacturers and suppliers,custo

73、mers and markets,could also impact such estimates and may change in future periods.As applicable to these consolidated financial statements,the most significant estimates and assumptions relate to determining the valuation and recoverability of IPR&D assets,marketed product rights,contingent conside

74、ration and goodwill,assessing sales reserves and allowances in the United States,uncertain tax positions,valuation allowances and contingencies.Some of these estimates could be impacted by higher costs and the ability to pass on such higher costs to customers,which is highly uncertain.As of the date

75、 of these consolidated financial statements,sustained conflict between Russia and Ukraine and disruption in the region is ongoing.The Russia and Ukraine markets are included in Tevas International Markets segment results.Teva has no manufacturing or R&D facilities in these markets.During the three m

76、onths ended March 31,2025,the impact of this conflict on Tevas results of operation and financial condition continues to be immaterial.In October 2023,Israel was attacked by a terrorist organization and entered a state of war on several fronts.As of the date of these consolidated financial statement

77、s,sustained conflict in the region is ongoing.Israel is included in Tevas International Markets segment results.Tevas global headquarters and several manufacturing and R&D facilities are located in Israel.Currently,such activities in Israel remain largely unaffected.Teva continues to maintain contin

78、gency plans with backup production locations for key products.During the three months ended March 31,2025,the impact of this war on Tevas results of operations and financial condition is immaterial,but such impact may increase,which could be material,as a result of the continuation,escalation or exp

79、ansion of such war.Tevas results of operations for the three months ended March 31,2025,are not necessarily indicative of results that could be expected for the entire fiscal year.Certain amounts in the consolidated financial statements and associated notes may not add up due to rounding.All percent

80、ages have been calculated using unrounded amounts.b.Significant accounting policies Recently adopted accounting pronouncements None.Recently issued accounting pronouncements,not yet adopted In November 2024,the FASB issued ASU 2024-03“Income Statement:Reporting Comprehensive IncomeExpense Disaggrega

81、tion Disclosures,”which requires more detailed information about specified categories of expenses(purchases of inventory,employee compensation,depreciation,amortization,and depletion)included in certain expense captions presented on the face of the income statement,as well as disclosures about selli

82、ng expenses.Additionally,in January 2025,the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03.ASU 2024-03 is effective for fiscal years beginning after December 15,2026 and for interim periods within fiscal years beginning after December 15,2027.Early adoption is permitted.The am

83、endments may be applied either(1)prospectively to financial statements issued for reporting periods after the effective date of this ASU or(2)retrospectively to all prior periods presented in the financial statements.The Company is currently evaluating this guidance to determine the impact it may ha

84、ve on its consolidated financial statements disclosures.8 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)In December 2023,the FASB issued ASU 2023-09“Income Taxes(Topic 7 40):Improvements to Income Tax Disclosures”.This guidance is intended to enhance the

85、 transparency and decision-usefulness of income tax disclosures.The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S.and in foreign jurisdictions.ASU 202

86、3-09 is effective for fiscal years beginning after December 15,2024 on a prospective basis,with the option to apply the standard retrospectively.The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.In October 2023,

87、the FASB issued ASU 2023-06“Disclosure Improvements:Codification Amendments in Response to the SECs Disclosure Update and Simplification Initiative,”which incorporates certain SEC disclosure requirements into the FASB Accounting Standards Codification(“Codification”).The amendments in the ASU are ex

88、pected to clarify or improve disclosure and presentation requirements of a variety of Codification topics,allow investors to more easily compare entities subject to the SECs existing disclosures with those entities that were not previously subject to the requirements,and align the requirements in th

89、e Codification with the SECs regulations.The effective date for each amendment will be the date on which the SECs removal of that related disclosure from Regulation S-X or Regulation S-K becomes effective,with early adoption prohibited.The amendments in this ASU should be applied prospectively.The C

90、ompany does not expect ASU 2023-06 will have a material impact to its consolidated financial statements.NOTE 2 Certain transactions:The Company has entered into alliances and other arrangements with third parties to acquire rights to products it does not have,to access markets it does not operate in

91、 and to otherwise share development costs or business risks.The Companys most significant agreements of this nature are summariz ed below.mAbxience In April 2024,Teva announced it entered into a strategic licensing agreement with mAbxience for a biosimilar candidate currently in development for the

92、treatment of multiple oncology indications.Under the terms of the licensing agreement,mAbxience will develop and produce the biosimilar product and Teva will lead the regulatory processes and commercializ ation in multiple global markets,including Europe and the U.S.In September 2024,Teva and mAbxie

93、nce entered into an amendment to the licensing agreement whereby,similar to the initial licensing agreement,mAbxience will lead the development and production of an anti-PD-1 oncology biosimilar candidate and Teva will manage regulatory approvals and oversee commercializ ation in the designated mark

94、ets.Under the initial agreement,Teva paid mAbxience an aggregate of$20 million in upfront and milestone payments in 2024,which were recorded as R&D expenses.Pursuant to the amendment of the licensing agreement,in the fourth quarter of 2024,Teva paid mAbxience further upfront and milestone payments i

95、n a total amount of$15 million,which were recorded as R&D expenses.mAbxience may be eligible for additional future development,regulatory and commercial milestone payments,in an aggregate amount of up to$320 million.Launch Therapeutics and Abingworth On March 28,2024,Teva and Launch Therapeutics,Inc

96、.(“Launch Therapeutics”)entered into a clinical collaboration agreement to further accelerate the clinical research program of Tevas Dual-Action Asthma Rescue Inhaler(“DARI”)(ICS-SABA;TEV-248).As part of this clinical collaboration agreement Teva also entered into a development funding agreement wit

97、h funds affiliated with Abingworth LLP(“Abingworth”).Under the clinical collaboration agreement,Launch Therapeutics,a clinical development company backed by Abingworth and Carlyle,the global investment firm,will have the lead role in the operational execution and management of the planned clinical t

98、rials.Teva will retain primary responsibility for manufacturing,regulatory interactions in the U.S.,and commercializ ation.DARI(ICS-SABA)is currently in Phase 3 for the treatment of asthma symptoms addressing both immediate symptoms and long-term inflammation.9 TEVA PHARMACEUTICAL INDUSTRIES LIMITED

99、 Notes to Consolidated Financial Statements(Unaudited)Under the development funding agreement,Abingworth will provide Teva up to$150 million to fund ongoing development costs for DARI(ICS-SABA).In exchange and subject to regulatory approval,Teva will pay Abingworth a milestone payment in the amount

100、actually funded by Abingworth up to$150 million,as well as success payments based on DARI(ICS-SABA)sales.During the first quarter of 2025 and during 2024,Teva recorded$30 million and$42 million,respectively,as reimbursement for R&D expenses incurred in connection with this agreement.Biolojic Design

101、On November 26,2023,Teva entered into a license agreement with Biolojic Design Ltd.(“Biolojic”),pursuant to which Teva received exclusive rights to develop,manufacture and globally commercializ e a BD9 multibody for the potential treatment of atopic dermatitis and asthma.In exchange,Teva paid an upf

102、ront payment in an amount of$10 million in January 2024,which was recorded as an R&D expense in the fourth quarter of 2023.In the first quarter of 2025,Teva recogniz ed a milestone payment in an amount of$5 million as R&D expenses,which will be paid during the second quarter of 2025.Biolojic may be

103、eligible to receive additional development and commercial milestone payments of up to approximately$500 million,over the next several years,based on the achievement of certain pre-clinical,clinical and regulatory milestones,with the majority of the payments based on future sales achievements.Royalty

104、 Pharma On November 9,2023,Teva entered into a funding agreement with Royalty Pharma plc.(“Royalty Pharma”)to further accelerate the clinical research program for Tevas olanz apine LAI(TEV-7 49).Under the terms of the funding agreement,Royalty Pharma will provide Teva up to$100 million to fund ongoi

105、ng development costs for olanz apine LAI(TEV-7 49).In exchange and subject to regulatory approval,Teva will pay Royalty Pharma a milestone payment in the amount actually funded by Royalty Pharma,paid over 5 years,in addition to royalties upon commercializ ation.Teva will continue to lead the develop

106、ment and commercializ ation of the product globally.During 2023 and 2024,Teva recorded$100 million as reimbursement for R&D expenses incurred in connection with this agreement,which collectively amounted to the total funding Royalty Pharma was to provide Teva.Olanz apine LAI(TEV-7 49)is currently in

107、 Phase 3 for the treatment of schiz ophrenia(see also MedinCell transaction below).Sanofi On October 3,2023,Teva entered into an exclusive collaboration with Sanofi to co-develop and co-commercializ e Tevas duvakitug(anti-TL1A,TEV-57 4)asset,a novel anti-TL1A therapy for the treatment of ulcerative

108、colitis and Crohns disease,two types of inflammatory bowel disease.Under the terms of the collaboration agreement,in partial consideration of the licenses granted to Sanofi,Teva received an upfront payment of$500 million in the fourth quarter of 2023,which was recogniz ed as revenue.Additionally,Tev

109、a may receive up to$1 billion in development and launch milestones.Each company will equally share the remaining development costs globally and net profits and losses in major markets,with other markets subject to a royalty arrangement,and Sanofi will lead the development of the Phase 3 program.Teva

110、 will lead commercializ ation of the product in Europe,Israel and specified other countries,and Sanofi will lead commercializ ation in North America,Japan,other parts of Asia and the rest of the world.On December 17,2024,Teva and Sanofi announced that the Phase 2b study for duvakitug met its primary

111、 endpoints in patients with ulcerative colitis and Crohns disease.Sanofi and Teva plan to initiate Phase 3 development in inflammatory bowel disease in the second half of 2025,pending regulatory discussions.MODAG In October 2021,Teva announced a license agreement with MODAG GmbH(“Modag”)providing Te

112、va with an exclusive global license to develop,manufacture and commercializ e Modags lead compound,emrusolmin(TEV-286)and a related compound(TEV-287).Teva made an upfront payment of$10 million to Modag in the fourth quarter of 2021,recorded as an R&D expense.Emrusolmin(TEV-286)was developed for the

113、treatment of Multiple System Atrophy(“MSA”)and Parkinsons disease.In the third quarter of 2024,Teva initiated a Phase 2 clinical trial for Emrusolmin(TEV-286).TEV-287 is being developed for Parkinsons disease.In the second quarter of 2025 Teva initiated a Phase 1 clinical trial for TEV-287,and in co

114、nnection with that trial,recorded a$10 million milestone payment to Modag as an R&D expense,which is expected to be paid in the third quarter of 2025.Modag may be eligible for additional future development milestone payments,in an aggregate amount of up to$20 million,as well as future commercial mil

115、estones and royalties.10 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)Alvotech In August 2020,Teva entered into an agreement with biopharmaceutical company Alvotech for the exclusive commercializ ation in the U.S.of five biosimilar product candidates.Th

116、e initial pipeline for this collaboration contained biosimilar candidates addressing multiple therapeutic areas,including proposed biosimilars to Humira(adalimumab)and Stelara(ustekinumab).Under the terms of the agreement,Alvotech is responsible for the development,registration and supply of the bio

117、similar product candidates and Teva will exclusively commercializ e the products in the U.S.In July 2023,Alvotech and Teva amended their collaboration agreement,adding two new biosimilar candidates as well as line extensions of two current biosimilar candidates to their partnership.Teva made upfront

118、 and milestone payments in an aggregate amount of$124 million between the years 2020 and 2024.Teva made an additional milestone payment of$5 million in the first quarter of 2025,which was recogniz ed as R&D expenses in the fourth quarter of 2024.Additional development and commercial milestone paymen

119、ts of up to approximately$37 5 million,in addition to royalty and milestone payments related to the amendment of the collaboration agreement entered into in July 2023,may be payable by Teva over the next few years.Teva and Alvotech will share revenue from the commercializ ation of these biosimilars.

120、The amendment of the collaboration agreement entered into in July 2023 includes increased involvement by Teva regarding manufacturing and quality at Alvotechs manufacturing facility.Additionally,pursuant to another amendment to the collaboration agreement entered into on September 29,2023,Teva purch

121、ased$40 million of subordinated convertible bonds of Alvotech.Alvotech redeemed the convertible bonds for$44 million,including accrued interest,which was paid to Teva in July 2024.On February 24,2024,Alvotech and Teva announced that the FDA approved SIMLANDI(adalimumab-ryvk)injection,as an interchan

122、geable biosimilar to Humira,for the treatment of adult rheumatoid arthritis,juvenile idiopathic arthritis,adult psoriatic arthritis,adult ankylosing spondylitis,Crohns disease,adult ulcerative colitis,adult plaque psoriasis,adult hidradenitis suppurativa and adult uveitis.On April 17,2024,Alvotech a

123、nd Teva amended their collaboration agreement to enable the purchase by Quallent of a private label adalimumab-ryvk injection from Alvotech for the U.S.market,with Alvotech sharing profits with Teva on the private label sales.On May 20,2024,Alvotech and Teva announced that SIMLANDI is available in t

124、he United States.On April 16,2024,Alvotech and Teva announced that the FDA approved SELARSDITM(ustekinumab-aekn)injection for subcutaneous use,as a biosimilar to Stelara,for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients six y

125、ears and older,and on October 22,2024,announced that the FDA approved SELARSDI in a new presentation,130 mg/26 mL(5 mg/mL)solution in a single-dose vial for intravenous infusion,expanding its label to include treatment of adults with Crohns disease and ulcerative colitis.On February 21,2025,Alvotech

126、 and Teva announced that SELARSDI is available in the United States.On May 5,2025,Teva and Alvotech announced that the FDA has approved SELARSDI(ustekinumab-aekn)injection as interchangeable with the reference biologic Stelara(ustekinumab)in all presentations matching the reference product,effective

127、 as of April 30,2025.In January 2025,Teva and Alvotech announced that the FDA had accepted for review Biologic License Applications(“BLA”)for Alvotechs proposed biosimilars to Simponi and Simponi Aria(golimumab).In February 2025,Teva and Alvotech announced that the FDA had accepted for review a BLA

128、for Alvotechs proposed biosimilar to Eylea(aflibercept).Takeda In December 2016,Teva entered into a license agreement with a subsidiary of Takeda Pharmaceutical Company Ltd.(“Takeda”),for the research,development,manufacture and commercializ ation of ATTENUKINETM technology.Teva received a$30 millio

129、n upfront payment and a milestone payment of$20 million in 2017.During the second quarter of 2022,Takeda initiated its Phase 2 study of modakafusp alfa(formerly TAK-57 3 or TEV 57 3)and as a result paid Teva a milestone payment of$25 million,which was recogniz ed as revenue in the second quarter of

130、2022.In April 2024,Takeda informed Teva of its intent to terminate the agreement with respect to such product candidate,and its product rights were reverted back to Teva in the first quarter of 2025.In December 2024,Takeda informed Teva of its intent to terminate the license agreement in its entiret

131、y,and all rights to the ATTENUKINETM technology will revert back to Teva in the first half of 2025.MedinCell In November 2013,Teva entered into an agreement with MedinCell for the development and commercializ ation of multiple long-acting injectable(“LAI”)products.Teva leads the clinical development

132、 and regulatory process and is responsible for the commercializ ation of these products.The lead product is risperidone LAI(formerly known as TV-46000).On April 28,2023,the FDA approved UZEDY(risperidone)extended-release injectable suspension for the treatment of schiz ophrenia in adults,which was l

133、aunched in the U.S.in May 2023.On February 25,2025,Teva and MedinCell announced that the supplemental New Drug Application(sNDA)for UZEDY extended-release injectable suspension for the maintenance treatment of the Bipolar I disorder in adults has been accepted for filing by the FDA.MedinCell may be

134、eligible for future sales-based milestones of up to$105 million with respect to UZEDY.Teva also pays MedinCell royalties on net sales.11 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)The second selected product candidate is olanz apine LAI(TEV-7 49)for t

135、he treatment of schiz ophrenia.In the third quarter of 2022,Teva decided to progress development of the product to Phase 3 and,as a result,paid a$3 million milestone payment to MedinCell,which was recogniz ed as R&D expenses.On May 8,2024,Teva and MedinCell announced positive Phase 3 efficacy result

136、s from a trial evaluating olanz apine LAI as a once-monthly subcutaneous long-acting injectable in adults with schiz ophrenia and on March 31,2025,Teva announced survey results demonstrating patient and healthcare satisfaction with olanz apine LAI.Additional safety and efficacy results are planned i

137、n the first half of 2025.Teva paid a further$5 million milestone payment to MedinCell in the first quarter of 2025,which was recogniz ed as R&D expenses.MedinCell may become eligible for further development and commercial milestones of up to$112 million,as well as royalties on sales of olanz apine L

138、AI(TEV-7 49).Assets and Liabilities Held for Sale:General Assets and liabilities held for sale as of March 31,2025,mainly included Tevas API business.Assets held for sale as of December 31,2024 included mainly Tevas API business and Tevas business venture in Japan.On December 31,2024,Teva classified

139、 its API business(including its R&D,manufacturing and commercial activities)as held for sale.The intention to divest is in alignment with Tevas Pivot to Growth strategy.However,there can be no assurance regarding the ultimate timing or structure of a potential divestiture or whether a divestiture wi

140、ll be agreed or completed at all.In connection with the held for sale classification of Tevas API business,in the first quarter of 2025,Teva recorded a favorable adjustment of$46 million in other assets impairments,restructuring and other items.See note 12.On March 31,2025,Teva divested its business

141、 venture in Japan,pursuant to which,in the first quarter of 2025,Teva recorded a marginal gain.Teva has elected the policy to include the currency translation adjustment related to the disposal group as part of the asset carrying amount.The table below summariz es all of Tevas assets and liabilities

142、 included as held for sale as of March 31,2025 and December 31,2024:March 31,December 31,2025 2024 (U.S.$in millions)Accounts receivables$7 3$222 Inventories 502 647 Property,plant and equipment,net and others 930 913 Identifiable intangible assets,net 22 83 Goodwill 207 255 Other current assets 107

143、 99 Other non-current assets 201 236 Expected loss on sale*(228)(684)Total assets of the disposal group classified as held for sale in the consolidated balance sheets$1,814$1,7 7 1 Accounts payables(243)(283)Other current liabilities(40)(49)Other non-current liabilities(7 5)(85)Expected loss on sale

144、*(281)Total liabilities of the disposal group classified as held for sale in the consolidated balance sheets$(358)$(698)12*Includes an expected loss from reclassification of currency translation adjustments to the consolidated statements of income(loss)upon sale.TEVA PHARMACEUTICAL INDUSTRIES LIMITE

145、D Notes to Consolidated Financial Statements(Unaudited)NOTE 3 Revenue from contracts with customers:Disaggregation of revenue The following table disaggregates Tevas revenues by major revenue streams.For additional information on disaggregation of revenues,see note 15.Three months ended March 31,202

146、5 United States Europe International Markets Other activities Total (U.S.$in millions)Sale of goods 1,514 1,198 553 129 3,395 Licensing arrangements 22 7 6 1 36 Distribution 37 3 11 384 Other 1 (12)12 7 6 7 6$1,910$1,194$582$206$3,891 Represents an amount less than$0.5 million.Three months ended Mar

147、ch 31,2024 United States Europe International Markets Other activities Total (U.S.$in millions)Sale of goods 1,321 1,252 566 128 3,267 Licensing arrangements 23 11 5 40 Distribution 381 9 391 Other 9 16 97 121$1,7 25$1,27 2$597$225$3,819 Represents an amount less than$0.5 million.Variable considerat

148、ion Variable consideration mainly includes sales reserves and allowances(“SR&A”),comprised of rebates(including Medicaid and other governmental program discounts),chargebacks,returns and other promotional(including shelf stock adjustments)items.Provisions for prompt payment discounts are netted agai

149、nst accounts receivables.The Company recogniz es these provisions at the time of sale and adjusts them if the actual amounts differ from the estimated provisions.13 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)SR&A to U.S.customers comprised approximate

150、ly 68%of the Companys total SR&A as of March 31,2025,with the remaining balance primarily related to customers in Canada and Germany.The changes in SR&A for third-party sales for the three months ended March 31,2025 and 2024 were as follows:Sales Reserves and Allowances Reserves included in Accounts

151、 Receivable,net Rebates Medicaid and other governmental allowances Chargebacks Returns Other Total reserves included in Sales Reserves and Allowances Total(U.S.$in millions)Balance at January 1,2025$56$1,67 4$561$936$399$108$3,67 8$3,7 34 Provisions related to sales made in current year period 99 1,

152、250 219 1,988 69 30 3,556 3,655 Provisions related to sales made in prior periods (37)9(20)(3)(4)(55)(55)Credits and payments(83)(1,224)(193)(2,035)(55)(16)(3,523)(3,606)Translation differences 19 5 6 2 8 40 40 Balance at March 31,2025$7 2$1,682$601$87 5$412$126$3,696$3,7 68 Sales Reserves and Allow

153、ances Reserves included in Accounts Receivable,net Rebates Medicaid and other governmental allowances Chargebacks Returns Other Total reserves included in Sales Reserves and Allowances Total(U.S.$in millions)Balance at January 1,2024$61$1,603$540$859$436$97$3,535$3,596 Provisions related to sales ma

154、de in current year period 93 1,118 181 1,942 7 3 40 3,354 3,447 Provisions related to sales made in prior periods 10 20(11)(6)(1)12 12 Credits and payments(87)(1,086)(17 1)(1,935)(67)(18)(3,27 7)(3,364)Translation differences (17)(3)(5)(3)(2)(30)(30)Balance at March 31,2024$67$1,628$567$850$433$116$

155、3,594$3,661 14 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)NOTE 4 Inventories:Inventories,net of reserves,consisted of the following:March 31,December 31,2025 2024 (U.S.$in millions)Finished products$1,895$1,7 83 Raw and packaging materials 7 16 67 1 P

156、roducts in process 37 7 353 Materials in transit and payments on account 259 199$3,247$3,007 NOTE 5 Identifiable intangible assets:Identifiable intangible assets consisted of the following:Gross carrying amount net of impairment Accumulated amortization Net carrying amount March 31,December 31,March

157、 31,December 31,March 31,December 31,2025 2024 2025 2024 2025 2024 (U.S.$in millions)Product rights$15,97 3$15,915$12,265$11,998$3,7 08$3,917 Trade names 57 9 568 310 300 269 268 In process research and development 212 233 212 233 Total$16,7 64$16,7 16$12,57 5$12,298$4,189$4,418 Product rights and t

158、rade names Product rights and trade names are assets presented at amortiz ed cost.Product rights and trade names represent a portfolio of pharmaceutical products in various therapeutic categories from various acquisitions with a weighted average life period of approximately 8 years.Amortiz ation of

159、intangible assets was$145 million and$152 million in the three months ended March 31,2025 and 2024,respectively.IPR&D Tevas IPR&D are assets that have not yet been approved in its major markets.IPR&D carries intrinsic risks that the asset might not succeed in advanced phases and may be impaired in f

160、uture periods.Intangible assets impairments Impairments of long-lived intangible assets for the three months ended March 31,2025 and 2024 were$121 million and$80 million,respectively.The fair value measurement of the impaired intangible assets in the three months ended March 31,2025 is based on sign

161、ificant unobservable inputs in the market and thus represents a Level 3 measurement within the fair value hierarchy.The discount rate applied ranged from 8.25%to 9.25%.A probability of success factor of 90%was used in the fair value calculation to reflect inherent regulatory and commercial risk of I

162、PR&D.15 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)Impairments in the first quarter of 2025 consisted of:(a)Identifiable product rights of$112 million due to:(i)$7 2 million mainly related to a change in Tevas commercial plan regarding certain product

163、s as part of its optimiz ation efforts,mainly in the U.S.,and(ii)$40 million mainly related to updated market assumptions regarding price and volume of products in Europe;and (b)IPR&D assets of$9 million,mainly related to generic pipeline products resulting from development progress and changes in o

164、ther key valuation indications mainly in the U.S.(e.g.,market siz e,competition assumptions,legal landscape and launch date).Impairments in the first quarter of 2024 consisted of:(a)Identifiable product rights of$57 million,mainly due to updated market assumptions regarding price and volume of produ

165、cts mainly in the U.S.;and (b)IPR&D assets of$23 million,mainly related to generic pipeline products resulting from development progress and changes in other key valuation indications mainly in the U.S.(e.g.,market siz e,competition assumptions,legal landscape and launch date).NOTE 6 Goodwill:Change

166、s in the carrying amount of goodwill for the period ended March 31,2025,were as follows:United States Europe International Markets Other Total Tevas API Medis(U.S.$in millions)Balance as of December 31,2024(1)$5,7 32$8,07 5$1,110$232$15,147 Other changes during the period:Translation differences and

167、 other 241 64 24 330 Balance as of March 31,2025(1)$5,7 32$8,316$1,17 4$256$15,47 7 (1)Cumulative goodwill impairment as of March 31,2025 and December 31,2024,was each approximately$29.6 billion.Teva operates its business through three reporting segments:United States,Europe and International Market

168、s.Each of these business segments is a reporting unit.Additional reporting units include Tevas production and sale of APIs to third parties(“Teva API”)and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.Tevas API and Medis repo

169、rting units are included under“Other”in the table above.See note 15 for additional segment information.Teva determines the fair value of its reporting units using the income approach.The income approach is a forward-looking approach for estimating fair value.Within the income approach,the method use

170、d is the discounted cash flow method.Teva begins with a forecast of all the expected net cash flows associated with the reporting unit,which includes the application of a terminal value,and then applies a discount rate to arrive at a net present value amount.Cash flow projections are based on Tevas

171、estimates of revenue growth rates and operating margins,taking into consideration industry and market conditions.The discount rate used is based on the weighted average cost of capital(“WACC”),adjusted for the relevant risk associated with country-specific and business-specific characteristics.If an

172、y of these expectations were to vary materially from Tevas assumptions,Teva may record an impairment of goodwill allocated to these reporting units in the future.First Quarter Developments During the first quarter of 2025,management evaluated whether there were any developments that occurred during

173、the quarter to determine if it was more likely than not that the fair value of any of its reporting units was below its carrying amount as of March 31,2025.Management concluded that no triggering event had occurred and,therefore,no quantitative assessment was performed.16 TEVA PHARMACEUTICAL INDUSTR

174、IES LIMITED Notes to Consolidated Financial Statements(Unaudited)NOTE 7 Debt obligations:a.Short-term debt:March 31,December 31,Interest rate as of March 31,2025 Maturity 2025 2024 (U.S.$in millions)Convertible senior debentures 0.25%2026 23 23 Current maturities of long-term liabilities 398 1,7 58

175、Total short-term debt$421$1,7 81 Convertible senior debentures The principal amount of Tevas 0.25%convertible senior debentures due in 2026 was$23 million as of March 31,2025 and as of December 31,2024.These convertible senior debentures include a“net share settlement”feature according to which the

176、principal amount will be paid in cash and in case of conversion,only the residual conversion value above the principal amount will be paid in Teva shares.Due to the“net share settlement”feature,exercisable at any time,these convertible senior debentures are classified in the Balance Sheet under shor

177、t-term debt.17 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)b.Long-term debt:Interest rate as of March 31,2025 Maturity March 31,2025 December 31,2024 (U.S.$in millions)Senior notes EUR 1,000 million(4)6.00%2025 429 Senior notes USD 1,000 million(5)7.13

178、%2025 427 Senior notes EUR 900 million(6)4.50%2025 515 Senior notes CHF 350 million 1.00%2025 398 387 Senior notes USD 3,500 million 3.15%2026 3,37 4 3,37 4 Senior notes EUR 7 00 million 1.88%2027 7 57 7 30 Sustainability-linked senior notes USD 1,000 million(1)(*)4.7 5%2027 1,000 1,000 Sustainabili

179、ty-linked senior notes EUR 1,100 million(1)(*)3.7 5%2027 1,193 1,144 Senior notes USD 1,250 million 6.7 5%2028 1,250 1,250 Senior notes EUR 7 50 million 1.63%2028 812 7 7 8 Sustainability-linked senior notes USD 1,000 million(2)(*)5.13%2029 1,000 1,000 Sustainability-linked senior notes USD 600 mill

180、ion(3)(*)7.88%2029 600 600 Sustainability-linked senior notes EUR 800 million(3)(*)7.38%2029 866 835 Sustainability-linked senior notes EUR 1,500 million(2)(*)4.38%2030 1,626 1,562 Sustainability-linked senior notes USD 500 million(3)(*)8.13%2031 500 500 Sustainability-linked senior notes EUR 500 mi

181、llion(3)(*)7.88%2031 542 521 Senior notes USD 7 89 million 6.15%2036 7 83 7 83 Senior notes USD 2,000 million 4.10%2046 1,986 1,986 Total senior notes 16,687 17,821 Less current maturities (398)(1,7 58)Less debt issuance costs (59)(61)Total senior notes and loans$16,230$16,002 (1)If Teva fails to ac

182、hieve certain sustainability performance targets,a one-time premium payment of 0.15%-0.45%out of the principal amount will be paid at maturity or upon earlier redemption,if such redemption is on or after May 9,2026.(2)If Teva fails to achieve certain sustainability performance targets,the interest r

183、ate shall increase by 0.125%-0.37 5%per annum,from and including May 9,2026.(3)If Teva fails to achieve certain sustainability performance targets,the interest rate shall increase by 0.100%-0.300%per annum,from and including September 15,2026.(4)In January 2025,Teva repaid$426 million of its 6.00%se

184、nior notes due 2025 at maturity.(5)In January 2025,Teva repaid$427 million of its 7.13%senior notes due 2025 at maturity.(6)In March 2025,Teva repaid$515 million of its 4.50%senior notes due 2025 at maturity.*Interest rate adjustments and a potential one-time premium payment related to the sustainab

185、ility-linked bonds are treated as bifurcated embedded derivatives.See note 8c.Long-term debt was issued by several indirect wholly-owned subsidiaries of the Company and is fully and unconditionally guaranteed by the Company as to payment of all principal,interest,discount and additional amounts,if a

186、ny.The long-term debt outlined in the above table is generally redeemable at any time at varying redemption prices plus accrued and unpaid interest.Tevas debt as of March 31,2025 was effectively denominated in the following currencies:63%in U.S.dollars,35%in euro and 2%in Swiss franc.18 TEVA PHARMAC

187、EUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)Tevas principal sources of short-term liquidity are its cash on hand,existing cash investments,liquid securities and available credit facilities,primarily its$1.8 billion unsecured syndicated sustainability-linked revolv

188、ing credit facility entered into in April 2022,as amended in February 2023 and in May 2024(“RCF”).The RCF had an initial maturity date of April 2026 with two one-year extension options.In April 2024,an extension option was exercised and the RCF maturity date was extended to April 2027.The RCF contai

189、ns certain covenants,including certain limitations on incurring liens and indebtedness and maintenance of certain financial ratios,including a maximum leverage ratio,which becomes more restrictive over time.On May 3,2024,the terms of the RCF were amended to update the Companys maximum permitted leve

190、rage ratio under the RCF for certain periods.Under the terms of the RCF,as amended,the Companys leverage ratio shall not exceed(i)4.00 x in 2025 and in the first quarter of 2026,(ii)3.75x in the second,third and fourth quarters of 2026 and(iii)3.50 x in the first quarter of 2027 and onwards.The RCF

191、permits the Company to increase the maximum leverage ratio if it consummates or commences certain material transactions.Under the RCF,as amended,the applicable margin used to calculate the interest rate under the RCF is linked to one sustainability performance target,the number of new regulatory sub

192、missions in low and middle-income countries.Proceeds from borrowings under the RCF can be used for general corporate purposes,including repaying existing debt.As of March 31,2025,and as of the date of this Quarterly Report on Form 10-Q,no amounts were outstanding under the RCF.Based on current and f

193、orecasted results,the Company expects that it will not exceed the financial covenant thresholds set forth in the RCF within one year from the date the financial statements are issued.Under specified circumstances,including non-compliance with any of the covenants described above and the unavailabili

194、ty of any waiver,amendment or other modification thereto,the Company will not be able to borrow under the RCF.Additionally,violations of the covenants,under the circumstances referred to above,would result in an event of default in all borrowings under the RCF and,when greater than a specified thres

195、hold amount as set forth in each series of senior notes and sustainability-linked senior notes is outstanding,could lead to an event of default under the Companys senior notes and sustainability-linked senior notes due to cross-acceleration provisions.Teva expects that it will continue to have suffi

196、cient cash resources to support its debt service payments and all other financial obligations within one year from the date that the financial statements are issued.NOTE 8 Derivative instruments and hedging activities:a.Foreign exchange risk management:In the first three months of 2025,approximately

197、 48%of Tevas revenues were denominated in currencies other than the U.S.dollar.As a result,Teva is subject to significant foreign currency risks.The Company enters into forward exchange contracts and purchases and writes options in order to hedge the currency exposure on balance sheet items,revenues

198、 and expenses.In addition,the Company takes measures to reduce its exposure by using natural hedging.The Company also acts to offset risks in opposite directions among the subsidiaries within Teva.The currency hedged items are usually denominated in the following main currencies:euro,Swiss franc,Bri

199、tish pound,Russian ruble,Canadian dollar,Polish zloty,Japanese yen,new Israeli shekel,Indian rupee and other currencies.Depending on market conditions,foreign currency risk is also managed through the use of foreign currency debt.The Company may choose to hedge against possible fluctuations in forei

200、gn subsidiaries net assets(“net investment hedge”)and has entered into cross-currency swaps and forward-contracts in the past in order to hedge such an exposure.Most of the counterparties to the derivatives are major banks and the Company is monitoring the associated inherent credit risks.The Compan

201、y enters into derivative transactions for hedging purposes only.b.Interest risk management:The Company raises capital through various debt instruments,including senior notes,sustainability-linked senior notes,bank loans and convertible debentures that bear fixed or variable interest rates,as well as

202、 a syndicated sustainability-linked revolving credit facility and securitization programs that bear a variable interest rate.In some cases,the Company has swapped from a fixed to a variable interest rate(“fair value hedge”)and from a fixed to a fixed interest rate with an exchange from a currency ot

203、her than the functional currency(“cash flow hedge”),thereby reducing overall interest expenses or hedging risks associated with interest rate fluctuations.As of March 31,2025,all outstanding senior notes,sustainability-linked senior notes and convertible debentures bear a fixed interest rate.19 TEVA

204、 PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)c.Bifurcated embedded derivatives:Upon the issuance of its sustainability-linked senior notes,Teva recognized embedded derivatives related to interest rate adjustments and a potential one-time premium payment upo

205、n failure to achieve certain sustainability performance targets,such as access to medicines in low-to-middle-income countries and reduction of absolute greenhouse gas emissions,which were bifurcated and are accounted for separately as derivative financial instruments.As of March 31,2025,the fair val

206、ue of these derivative instruments is negligible.d.Derivative instruments outstanding:The following table summarizes the classification and fair values of derivative instruments:Fair value Not designated as hedging instruments March 31,2025 December 31,2024 Reported under(U.S.$in millions)Asset deri

207、vatives:Other current assets:Option and forward contracts$27$71 Liability derivatives:Other current liabilities:Option and forward contracts(72)(24)The table below provides information regarding the location and amount of pre-tax(gains)losses from derivatives designated in cash flow hedging relation

208、ships:Financial expenses,net Other comprehensive income(loss)Three months ended,Three months ended,March 31,2025 March 31,2024 March 31,2025 March 31,2024 Reported under(U.S.$in millions)Line items in which effects of hedges are recorded$225$250$500$(117)Cross-currency swaps-cash flow hedge(1)(8)1 2

209、0 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)The table below provides information regarding the location and amount of pre-tax(gains)losses from derivatives not designated as hedging instruments:Financial expenses,net Net revenues Three months ended,T

210、hree months ended,March 31,2025 March 31,2024 March 31,2025 March 31,2024 Reported under(U.S.$in millions)Line items in which effects of hedges are recorded$225$250$(3,891)$(3,819)Option and forward contracts(2)62 (10)Option and forward contracts economic hedge(3)27(13)(1)On March 31,2023,Teva enter

211、ed into a cross-currency interest rate swap agreement,designated as cash flow hedge for accounting purposes with respect to an intercompany loan due October 2026,denominated in Japanese yen.The agreement was terminated in the first quarter of 2024 and resulted in cash proceeds of$16 million.(2)Teva

212、uses foreign exchange contracts(mainly option and forward contracts)to hedge balance sheet items from currency exposure.These foreign exchange contracts are not designated as hedging instruments for accounting purposes.In connection with these foreign exchange contracts,Teva recognizes gains or loss

213、es that offset the revaluation of the balance sheet items also recorded under financial expenses,net.(3)Teva entered into option and forward contracts designed to limit the exposure of foreign exchange fluctuations on projected revenues and expenses recorded in euro,Swiss franc,British pound,Russian

214、 ruble,Canadian dollar,Polish zloty,Japanese yen,new Israeli shekel,Indian rupee and some other currencies to protect its projected operating results for 2025.These derivative instruments do not meet the criteria for hedge accounting,however,they are accounted for as an economic hedge.These derivati

215、ve instruments,which may include hedging transactions against future projected revenues and expenses,are recognized on the balance sheet at their fair value on a quarterly basis,while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters.In the three mo

216、nths ended March 31,2025,the negative impact from these derivatives recognized under revenues was$27 million.In the three months ended March 31,2024,the positive impact from these derivatives recognized under revenues was$13 million.Changes in the fair value of the derivative instruments are recogni

217、zed in the same line item in the statements of income as the underlying exposure being hedged.Cash flows associated with these derivatives are reflected as cash flows from operating activities in the consolidated statements of cash flows.e.Amortizations due to terminated derivative instruments:Forwa

218、rd-starting interest rate swaps and treasury lock agreements In 2015,Teva entered into forward-starting interest rate swaps and treasury lock agreements to protect the Company from interest rate fluctuations in connection with a future debt issuance the Company was planning.These forward-starting in

219、terest rate swaps and treasury lock agreements were terminated in July 2016 upon the debt issuance.Termination of these transactions resulted in a loss position of$493 million,which was recorded as other comprehensive income(loss)and is amortized under financial expenses,net over the life of the deb

220、t.With respect to these forward-starting interest rate swaps and treasury lock agreements,losses of$7 million were recognized under financial expenses,net,for each of the three months ended March 31,2025 and 2024.f.Securitization:U.S.securitization program On November 7,2022,Teva and a bankruptcy-re

221、mote special purpose vehicle(“SPV”)entered into an accounts receivable securitization facility(“AR Facility”)with PNC Bank,National Association(“PNC”)with a three-year term.The AR Facility provided for purchases of accounts receivable by PNC in an amount of up to$1 billion through November 2023,and

222、up to$500 million from November 2023 through November 2025.On June 30,2023,the AR Facility agreement was amended to include an additional receivables purchaser under the agreement,in an amount of up to$250 million through November 2025.As a result,the total commitment of PNC was reduced to an amount

223、 of up to$750 million,effective June 30,2023.Under the terms of the AR facility agreement,in November 2023,the total commitment of PNC was further reduced to an amount of up to$500 million through November 2025.On November 7,2023,the SPV amended the agreement and increased the commitment amount to a

224、 maximum of$1 billion by including an additional receivables purchaser in an amount of up to$250 million through March 2024,which was then reduced by$125 million through November 2025.As a result,the commitment amount was reduced to a maximum of$875 million without any additional purchasers particip

225、ating in the AR facility.On October 29,2024,the SPV amended the agreement and increased the commitment amount to a maximum amount of$950 million by an existing receivables purchaser increasing its commitment by$75 million.21 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Stat

226、ements(Unaudited)Pledged accounts receivables In connection with the U.S.securitization program,accounts receivables,net of allowance for credit losses,include$370 million and$558 million as of March 31,2025 and December 31,2024,respectively,which are pledged by the SPV to PNC.g.Supplier Finance Pro

227、gram Obligation Teva maintains supply chain finance agreements with participating financial institutions.Under these agreements,participating suppliers may voluntarily elect to sell their accounts receivable with Teva to these financial institutions.Tevas suppliers negotiate their financing agreemen

228、ts directly with the respective financial institutions and Teva is not a party to these agreements.Teva has no economic interest in its suppliers decisions to participate in the program and Teva pays the financial institutions the stated amount of confirmed invoices on the maturity dates,which is ge

229、nerally within 120 days from the date the invoice was received.The agreements with the financial institutions do not require Teva to provide assets pledged as security or other forms of guarantees for the supplier finance program.All outstanding amounts related to suppliers participating in the supp

230、lier finance program are recorded under accounts payables in Tevas consolidated balance sheets.As of March 31,2025 and December 31,2024,the outstanding accounts payables to suppliers participating in these supplier finance programs were$189 million and$158 million,respectively.NOTE 9 Legal settlemen

231、ts and loss contingencies:In the first quarter of 2025,Teva recorded expenses of$86 million in legal settlements and loss contingencies,compared to expenses of$106 million in the first quarter of 2024.Expenses in the first quarter of 2025 were mainly related to an update to the estimated settlement

232、provision for the opioid cases(mainly the effect of the passage of time on the net present value of the discounted payments).Expenses in the first quarter of 2024 were mainly related to an update to the estimated settlement provision of the opioid cases(mainly the effect of the passage of time on th

233、e net present value of the discounted payments),as well as an update to the estimated provision for the U.S.DOJ patient assistance program litigation.See note 10.As of March 31,2025 and December 31,2024,Tevas provision for legal settlements and loss contingencies recorded under accrued expenses and

234、other taxes and long-term liabilities was$4,877 million and$4,881 million,respectively.NOTE 10 Commitments and contingencies:General From time to time,Teva and/or its subsidiaries are subject to claims for damages and/or equitable relief arising in the ordinary course of business.In addition,as desc

235、ribed below,in large part as a result of the nature of its business,Teva is frequently subject to litigation.Teva generally believes that it has meritorious defenses to the actions brought against it and vigorously pursues the defense or settlement of each such action.Teva records a provision in its

236、 consolidated financial statements to the extent that it concludes that a contingent liability is probable and the amount thereof is reasonably estimable.Based upon the status of the cases described below,managements assessments of the likelihood of damages,and the advice of legal counsel,no materia

237、l provisions have been made regarding the matters disclosed in this note,except as noted below.Litigation outcomes and contingencies are unpredictable,and substantial damages or other relief may be awarded.Accordingly,managements assessments involve complex judgments about future events and often re

238、ly heavily on estimates and assumptions.Teva continuously reviews the matters described below and may,from time to time,remove previously disclosed matters where the exposures were fully resolved in the prior year,or determined to no longer meet the materiality threshold for disclosure,or were subst

239、antially resolved.If one or more of such proceedings described below were to result in final judgments against Teva,such judgments could be material to its results of operations and cash flows in a given period.In addition,Teva incurs significant legal fees and related expenses in the course of defe

240、nding its positions even if the facts and circumstances of a particular litigation do not give rise to a provision in the consolidated financial statements.22 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)In connection with third-party agreements,Teva ma

241、y under certain circumstances be required to indemnify,and may be indemnified by,in unspecified amounts,the parties to such agreements against third-party claims.Among other things,Tevas agreements with third parties may require Teva to indemnify them,or require them to indemnify Teva,for the costs

242、and damages incurred in connection with product liability claims,in specified or unspecified amounts.Except as otherwise noted,all of the litigation matters disclosed below involve claims arising in the United States.Except as otherwise noted,all third-party sales figures given below are based on IQ

243、VIA data.Intellectual Property Litigation From time to time,Teva seeks to develop generic and biosimilar versions of patent-protected pharmaceuticals and biopharmaceuticals for sale prior to patent expiration in various markets.In the United States,to obtain approval for most generics prior to the e

244、xpiration of the originators patents,Teva must challenge the patents under the procedures set forth in the Hatch-Waxman Act of 1984,as amended.For many biosimilar products that are covered by patents,Teva participates in the“patent dance”procedures of the Biologics Price Competition and Innovation A

245、ct(“BPCIA”),which allow for the challenge to originator patents prior to obtaining biosimilar product approval.To the extent that Teva seeks to utilize such patent challenge procedures,Teva is and expects to be involved in patent litigation regarding the validity,enforceability or infringement of th

246、e originators patents.Teva may also be involved in patent litigation involving the extent to which its product or manufacturing process techniques may infringe other originator or third-party patents.Additionally,depending upon a complex analysis of a variety of legal and commercial factors,Teva may

247、,in certain circumstances,elect to market a generic or biosimilar version of the product even though litigation is still pending.To the extent Teva elects to proceed in this manner,it could face substantial liability for patent infringement if the final court decision is adverse to Teva,which could

248、be material to its results of operations and cash flows in a given period.Teva could also be sued for patent infringement outside of the context of the Hatch-Waxman Act or BPCIA.For example,Teva could be sued for patent infringement after commencing sales of a product.This type of litigation can inv

249、olve any of Tevas pharmaceutical products,not just its generic and biosimilar products.The general rule for damages in patent infringement cases in the United States is that the patentee should be compensated by no less than a reasonable royalty and it may also be able,in certain circumstances,to be

250、 compensated for its lost profits.The amount of a reasonable royalty award would generally be calculated based on the sales of Tevas product.The amount of lost profits would generally be based on the lost sales of the patentees product.In addition,the patentee may seek consequential damages as well

251、as enhanced damages of up to three times the profits lost by the patent holder for willful infringement,although courts have typically awarded much lower multiples.Teva is also involved in litigation regarding patents in other countries where it does business,particularly in Europe.The laws concerni

252、ng generic pharmaceuticals and patents differ from country to country.Damages for patent infringement in Europe may include lost profits or a reasonable royalty,but enhanced damages for willful infringement are generally not available.In July 2014,GlaxoSmithKline(“GSK”)filed claims against Teva in t

253、he U.S.District Court for the District of Delaware for infringement of a patent directed to using carvedilol in a specified manner to decrease the risk of mortality in patients with congestive heart failure.Teva began selling its carvedilol tablets(the generic version of GSKs Coreg)in September 2007

254、.A jury returned a verdict in GSKs favor,which was initially overturned by the U.S.District Court.The Court of Appeals for the Federal Circuit reinstated the$235.5 million jury verdict,not including pre-or post-judgment interest,finding Teva liable for patent infringement.The U.S.Supreme Court denie

255、d Tevas appeal for a rehearing.On December 12,2024,the U.S.District Court for the District of Delaware set a schedule for briefing on legal issues that remain in the case,and the briefings were completed on March 26,2025.In addition to those legal issues,there will need to be a trial regarding certa

256、in equitable issues that were never presented in the 2017 jury trial.Teva recognized a provision based on its offer to settle the matter.Product Liability Litigation Tevas business inherently exposes it to potential product liability claims.Teva maintains a program of insurance,which may include com

257、mercial insurance,self-insurance(including direct risk retention),or a combination of both types of insurance,in amounts and on terms that it believes are reasonable and prudent in light of its business and related risks.However,Teva sells,and will continue to sell,pharmaceuticals that are not cover

258、ed by its product liability insurance;in addition,it may be subject to claims for which insurance coverage is denied,as well as claims that exceed its policy limits.Product liability coverage for pharmaceutical companies is becoming more expensive and increasingly difficult to obtain.As a result,Tev

259、a may not be able to obtain the type and amount of insurance it desires,or any insurance on reasonable terms,in certain or all of its markets.23 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)Since July 2018,Teva and its subsidiaries have been parties to

260、litigation relating to previously unknown nitrosamine impurities discovered in certain products.The nitrosamine impurities were allegedly found in the active pharmaceutical ingredient(“API”)supplied to Teva by multiple API manufacturers.Subsequently,Teva initiated recalls of losartan(April 2019)and

261、metformin(June 2020),due to the presence of nitrosamine impurities.Various nitrosamine litigations remain pending in the United States related to Tevas valsartan,losartan,metformin and ranitidine products.There are currently two Multi-District Litigations(“MDL”)pending against Teva and other manufac

262、turers,including one MDL in the U.S.District Court for the District of New Jersey with respect to Tevas valsartan and losartan products,and another MDL in the U.S.District Court for the Southern District of Florida related to ranitidine.The claims against Teva and other generic manufacturers in the

263、ranitidine MDL have been dismissed on preemption and other grounds,and are currently on appeal in the Eleventh Circuit Court of Appeals.Teva was dismissed from all ranitidine claims pending in Illinois based on preemption grounds,which plaintiffs have appealed.State court ranitidine cases naming Tev

264、a are also pending in coordinated proceedings in California and Pennsylvania.The district court in the valsartan MDL originally scheduled the first trial to commence in the fourth quarter of 2024,but that trial has been postponed indefinitely.Bellwether trial workup based on personal injury claims i

265、nvolving Tevas valsartan product is underway,and Tevas first trial may occur no earlier than in the fourth quarter of 2025.Discovery is ongoing in the MDL with respect to the losartan claims against Teva.Certain generic manufacturers,including Teva,have also been named in a small number of state cou

266、rt actions asserting allegations similar to those in the aforementioned valsartan MDL brought by single plaintiffs.All of these state court matters are stayed,aside from a single case pending in New Jersey.Similar lawsuits are pending in Canada.Teva was also named in a consolidated proceeding pendin

267、g in the U.S.District Court for the District of New Jersey brought by individuals and end payors seeking economic damages on behalf of purported classes of consumers and end payors who purchased Tevas and other generic manufacturers metformin products.In December 2024,Teva reached a settlement of th

268、is matter that resolved all of the plaintiffs claims against Teva and the settlement agreement will be presented to the court for approval.Competition Matters As part of its generic pharmaceuticals business,Teva has challenged a number of patents covering branded pharmaceuticals,some of which are am

269、ong the most widely-prescribed and well-known drugs on the market.Many of Tevas patent challenges have resulted in litigation relating to Tevas attempts to market generic versions of such pharmaceuticals under the federal Hatch-Waxman Act.Some of this litigation has been resolved through settlement

270、agreements in which Teva obtained a license to market a generic version of the drug,often years before the patents expire.Teva and its subsidiaries have been named as defendants in cases that allege antitrust violations arising from such settlement agreements.The plaintiffs in these cases are usuall

271、y direct and indirect purchasers of pharmaceutical products,some of whom assert claims on behalf of classes of all direct and indirect purchasers,and they typically allege that(i)Teva received something of value from the innovator in exchange for an agreement to delay generic entry,and(ii)significan

272、t savings could have been realized if there had been no settlement agreement and generic competition had commenced earlier.These plaintiffs seek various forms of injunctive and monetary relief,including damages based on the difference between the brand price and what the generic price allegedly woul

273、d have been and disgorgement of profits,which are often automatically tripled under the relevant statutes,plus attorneys fees and costs.The alleged damages generally depend on the size of the branded market and the length of the alleged delay,and can be substantial,potentially measured in multiples

274、of the annual brand sales,particularly where the alleged delays are lengthy or branded drugs with annual sales in the billions of dollars are involved.Teva believes that its settlement agreements are lawful and serve to increase competition,and has defended them vigorously.In Tevas experience to dat

275、e,these cases have typically settled for a fraction of the high end of the damages sought,although there can be no assurance that such outcomes will continue.24 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)In June 2013,the U.S.Supreme Court held,in Fede

276、ral Trade Commission(“FTC”)v.Actavis,Inc.,that a rule of reason test should be applied in analyzing whether such settlements potentially violate the federal antitrust laws.The Supreme Court held that a trial court must analyze each agreement in its entirety in order to determine whether it violates

277、the U.S.antitrust laws.This test has resulted in increased scrutiny of Tevas patent settlements,additional action by the FTC and state and local authorities,and an increased risk of liability in Tevas currently pending antitrust litigations.In December 2011,three groups of plaintiffs filed claims ag

278、ainst Wyeth and Teva for alleged violations of the U.S.antitrust laws in connection with their November 2005 settlement of patent litigation involving extended-release venlafaxine(generic Effexor XR).The cases were filed by a purported class of direct purchasers,a purported class of indirect purchas

279、ers and certain chain pharmacies in the U.S.District Court for the District of New Jersey.The plaintiffs claim that the settlement agreement between Wyeth and Teva unlawfully delayed generic entry.On September 18,2024,the district court lifted its stay of discovery and the case is now proceeding.Tev

280、a and one group of plaintiffs(the“Indirect Purchaser Plaintiffs”or“IPPs”)reached an agreement to resolve the IPPs claims against Teva,and on March 19,2025,that settlement was granted preliminary approval by the court.Annual sales of Effexor XR were approximately$2.6 billion at the time of settlement

281、 and at the time Teva launched its generic version of Effexor XR in July 2010.In February 2012,two purported classes of direct-purchaser plaintiffs filed claims against GSK and Teva in the U.S.District Court for the District of New Jersey for alleged violations of the antitrust laws in connection wi

282、th their February 2005 settlement of patent litigation involving lamotrigine(generic Lamictal).The plaintiffs claimed that the settlement agreement unlawfully delayed generic entry and sought unspecified damages.During February 2023,a number of direct purchasers who were denied class certification f

283、iled suit as individual plaintiffs,which action was transferred to the U.S.District Court for the District of New Jersey.Discovery of the newly added individual plaintiffs is ongoing.Annual sales of Lamictal were approximately$950 million at the time of the settlement and approximately$2.3 billion a

284、t the time Teva launched its generic version of Lamictal in July 2008.In April 2013,purported classes of direct purchasers of,and end payers for,Niaspan(extended release niacin)filed claims against Teva and Abbott for violating the antitrust laws by entering into a settlement agreement in April 2005

285、 to resolve patent litigation over the product.A multidistrict litigation has been established in the U.S.District Court for the Eastern District of Pennsylvania.Throughout 2015 and in January 2016,several individual direct-purchaser opt-out plaintiffs filed complaints with allegations nearly identi

286、cal to those of the direct purchasers class.On April 24,2023,the U.S.District Courts denial of the indirect purchasers motion for class certification was affirmed by the Court of Appeals for the Third Circuit,and on June 5,2023,the Court of Appeals denied the indirect purchasers petition for re-hear

287、ing.In October 2016,the District Attorney for Orange County,California,filed a similar complaint in California state court,alleging violations of state law and seeking restitution and civil penalties.The California state court case is temporarily stayed.Annual sales of Niaspan were approximately$416

288、 million at the time of the settlement and approximately$1.1 billion at the time Teva launched its generic version of Niaspan in September 2013.In November 2020,the European Commission issued a final decision in its proceedings against both Cephalon and Teva,finding that the 2005 settlement agreemen

289、t between the parties had the object and effect of hindering the entry of generic modafinil,and imposed fines totaling euro 60.5 million on Teva and Cephalon.Teva and Cephalon filed an appeal against the decision in February 2021,and a judgment was issued on October 18,2023 rejecting Tevas grounds o

290、f appeal.A provision for this matter was included in the financial statements.In lieu of posting a cash bond,Teva has provided the European Commission with a bank guarantee in the amount of the imposed fines.On January 4,2024,Teva appealed the October 2023 judgment to the European Court of Justice.O

291、n March 27,2025,the advocate general to the European Court of Justice issued a non-binding opinion,recommending that Tevas appeal be dismissed.The appeal otherwise remains pending.In February 2021,the State of New Mexico filed a lawsuit against Teva and certain other defendants related to various me

292、dicines used to treat HIV(the“New Mexico litigation”).Between September 2021 and April 2022,several private plaintiffs including retailers and health insurance providers filed similar claims in various courts,which were all removed and/or consolidated into the U.S.District Court for the Northern Dis

293、trict of California(the“California litigation”).As they relate to Teva,the lawsuits challenged settlement agreements Teva entered into with Gilead in 2013 and/or 2014 to resolve patent litigation relating to Tevas generic versions of Viread and/or Truvada and Atripla,although plaintiffs in the Calif

294、ornia litigation abandoned any claim for damages relating to the Viread settlement.In May 2023,Teva and Gilead reached a settlement agreement with the retailer plaintiffs in the California litigation and Teva recognized a provision for this matter based on such settlement.On June 30,2023,the jury in

295、 the trial against the 25 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)remaining plaintiffs in the California litigation issued a verdict in favor of Teva and Gilead,rejecting all of the remaining plaintiffs claims.On February 12,2024,the court entered

296、a judgment as to all claims against Teva in the California litigation.The plaintiffs appealed to the U.S.Court of Appeals for the Ninth Circuit,and the appeal is fully briefed.In the New Mexico litigation,on June 27,2024,Teva and the State of New Mexico finalized their settlement agreement,and the N

297、ew Mexico court entered a consent judgment resolving the New Mexico litigation.Teva recognized a provision for the settlement with New Mexico.Annual sales in the United States at the time of the settlement of Viread,Truvada and Atripla were approximately$582 million,$2.4 billion,and$2.9 billion,resp

298、ectively.Annual sales in the United States at the time Teva launched its generic version of Viread in 2017,Truvada in 2020 and Atripla in 2020 were approximately$728 million,$2.1 billion and$444 million,respectively.In March 2021,the European Commission opened a formal antitrust investigation to ass

299、ess whether Teva may have abused a dominant position by delaying the market entry and uptake of medicines that compete with COPAXONE.On October 10,2022,the European Commission issued a Statement of Objections,which sets forth its preliminary allegations that Teva had engaged in anti-competitive prac

300、tices.On October 31,2024,the European Commission announced its final decision,alleging that Teva had abused a dominant position in certain European member states by(i)filing and withdrawing certain divisional patents,and(ii)raising concerns about competitors follow-on versions of COPAXONE.The decisi

301、on also includes a fine of euro 462.6 million,potentially subject to post-decision interest.Teva filed an appeal against the decision with the General Court of the European Union in January 2025,and that appeal remains pending.In accordance with Accounting Standards Codification 450“Accounting for C

302、ontingencies,”Teva recognized a provision in its financial statements in the third quarter of 2024,based on managements current best estimate of the outcome within a range of outcomes for the final resolution of this case.Teva has provided the European Commission surety underwritten guarantees in an

303、 amount of euro 462.6 million,together with specified post-decision interest,to cover the fine amount.Certain generic competitors in Europe have also brought similar antitrust claims against Teva in Germany and the Netherlands,which have been stayed.Teva could face additional claims from generic com

304、petitors,payors,or other private plaintiffs in Europe related to this matter.On June 29,2021,Mylan Pharmaceuticals(“Mylan”)filed claims against Teva in the U.S.District Court for the District of New Jersey.On March 11,2022 and March 15,2022,purported purchasers of COPAXONE filed claims against Teva

305、in the U.S.District Court for the District of New Jersey on behalf of themselves and similarly situated direct and indirect purchasers of COPAXONE.On August 22,2022,additional purported purchasers of COPAXONE sued Teva in the U.S.District Court for the District of Vermont on behalf of themselves and

306、 similarly situated indirect purchasers of COPAXONE.The complaints variously assert claims for alleged violations of the Lanham Act,state and federal unfair competition and monopolization laws,tortious interference,trade libel,and a violation of the Racketeer Influenced and Corrupt Organizations Act

307、(“RICO Act”).Additionally,plaintiffs claim Teva was involved in an unlawful scheme to delay and hinder generic competition concerning COPAXONE sales.Plaintiffs seek damages for lost profits and expenses,disgorgement,restitution,treble damages,attorneys fees and costs,and injunctive relief.Teva moved

308、 to dismiss all of the complaints,and on January 22,2024,Tevas motion to dismiss the complaint in the District of Vermont was granted as to certain state law claims but was otherwise denied.On February 27,2025,the Special Master in the District of New Jersey issued reports and recommendations on Tev

309、as motions to dismiss the direct purchaser plaintiffs(“DPP”)complaint and the Mylan complaint,recommending dismissal of several aspects of the plaintiffs respective claims and allowing others to proceed.Mylan filed an objection with the District Court to certain of the Special Masters recommendation

310、s for dismissal but not others.The objection remains pending.The DPPs have sought clarification from the Special Master on one aspect of her recommendation but have waived any other objection.On April 30,2025,the Special Master granted DPPs leave to replead one aspect of their claim but also granted

311、 Teva leave to file a renewed motion to dismiss the amended complaint.A decision on Tevas remaining motions to dismiss the third party payors complaint in the District of New Jersey remains pending.On April 3,2025,Walgreen Co.,The Kroger Co.,Albertsons Companies,Inc.,and H-E-B,L.P.(“Retailers”),as o

312、pt-outs of the purported DPP class in the District of New Jersey,filed a complaint against Teva in the District of Vermont alleging claims similar to those filed by other plaintiffs and asserting a claim under the Sherman Act.On April 21,2025,Teva filed a motion for partial judgment on the pleadings

313、 in the Vermont purchaser action,based on the reasoning of the recommendations by the Special Master in the New Jersey actions.On April 23,2025,Teva filed a motion for a partial stay of discovery in the Vermont purchaser action in light of its pending motion for partial judgment on the pleadings,and

314、 also filed a motion to dismiss or transfer the Retailers action from the District of Vermont to the District of New Jersey.All three of those motions are still being briefed.26 TEVA PHARMACEUTICAL INDUSTRIES LIMITED Notes to Consolidated Financial Statements(Unaudited)On July 15,2021,the U.K.Compet

315、ition and Markets Authority(“CMA”)issued a decision imposing fines for breaches of U.K.competition law by Allergan,Actavis UK,Auden Mckenzie and a number of other companies in connection with the supply of 10mg and 20mg hydrocortisone tablets in the U.K.The decision combines the CMAs three prior inv

316、estigations into the supply of hydrocortisone tablets in the U.K.,as well as the CMAs subsequent investigation relating to an alleged anticompetitive agreement with Waymade.On January 9,2017,Teva completed the sale of Actavis UK to Accord Healthcare Limited,in connection with which Teva agreed to in

317、demnify Accord Healthcare for potential fines imposed by the CMA and/or damages awarded by a court against Actavis UK in relation to two of the three statements of objection from the CMA(dated December 16,2016 and March 3,2017),and resulting from conduct prior to the closing date of the sale.In addi

318、tion,Teva agreed to indemnify Allergan against losses arising from this matter in the event of any such fines or damages.On October 6,2021,Accord UK(previously Actavis UK)and Auden Mckenzie appealed to the U.K.Competition Appeal Tribunal(the“Tribunal”)the CMAs decisions that the prices of hydrocorti

319、sone were unfair and excessive and that the agreements amounted to infringements of the U.K.s Competition Act as so-called pay-for-delay arrangements.The hearing for the appeal concluded in the first quarter of 2023,with partial judgments handed down by the Tribunal on September 18,2023(judgment on

320、unfair pricing),March 8,2024(judgments on pay-for-delay and due process)and April 29,2024(judgment on fines).The CMA appealed to the U.K.Court of Appeals on an expedited basis against certain elements of the pay-for-delay and due process judgments that it had lost,and on September 6,2024,the U.K.Cou

321、rt of Appeal overturned the Tribunals judgment on due process and,as a result,the Tribunal will now consider and issue a further judgment on fines.Accord UK and Auden Mckenzie requested permission to appeal the U.K.Court of Appeals ruling(overturning the Tribunals judgment on due process)to the U.K.

322、Supreme Court,but that request was denied in January 2025.In March 2025,the Tribunal gave Accord UK and Auden Mckenzie permission to appeal to the Court of Appeal certain other issues relating to unfair pricing and fines.Those appeals have been filed and remain pending.A provision for the estimated

323、exposure for Teva related to the fines and/or damages has been recorded in the financial statements.In November 2022,two complaints filed by plaintiffs purporting to represent retailer purchasers and a putative class of end-payor purchasers were filed in the U.S.District Court for the District of Ne

324、w Jersey against Teva and its marketing partner,Natco Pharma Limited(“Natco”),alleging violations of the antitrust laws in connection with their December 2015 settlement of patent litigation with Celgene Corporation(which was subsequently acquired by BMS)involving the drug Revlimid(lenalidomide).The

325、 complaints also name Celgene and BMS as defendants.On January 24,2023,the complaints were consolidated for pre-trial purposes only with an earlier-filed,already consolidated Insurer Opt-Out Action filed against BMS and Celgene.On February 16,2023,plaintiffs filed amended complaints adding additiona

326、l plaintiffs.On May 16,2023,Teva and Natco,along with Celgene,moved to dismiss the complaints against them.Additionally,on October 6,2023,two individual payor plaintiffs brought claims similar to those described above in the U.S.District Court for the Northern District of California,which actions we

327、re consolidated with the pending consolidated actions and transferred to the U.S.District Court for the District of New Jersey.On June 6,2024,the court granted in full Celgenes motion to dismiss the Insurer Opt-Out Action,but allowed plaintiffs leave to amend most of their claims.The Court had previ

328、ously administratively terminated Tevas,Natcos,and Celgenes motions to dismiss the retailer and end-payor complaints pending the decision on the Insurer Opt-Out Action.The plaintiffs filed amended complaints on August 5,2024,and the defendants subsequently filed motions to dismiss,which remain pendi

329、ng.On December 16,2024,five individual Insurer Opt Out plaintiffs,each of whom had added Teva and Natco as defendants in the Insurer Amended Complaint filed on August 5,2024,filed new standalone complaints adding no new substantive allegations and naming Teva,Natco and other defendants as defendants

330、.Annual sales of Revlimid in the United States were approximately$3.5 billion at the time of the settlement.On December 2,2022,plaintiffs purporting to represent putative classes of indirect purchasers of EpiPen(epinephrine injection)and NUVIGIL(armodafinil)filed a complaint in the U.S.District Cour

331、t for the District of Kansas against Teva,Cephalon,and a former Teva executive.Teva owns the New Drug Application(“NDA”)for NUVIGIL and sold the brand product,for which generic entry occurred in 2016.Teva filed an ANDA to sell generic EpiPen,which Teva launched in 2018,following receipt of FDA appro

332、val.The complaint alleges,among other things,that the defendants violated federal antitrust laws,the RICO Act,and various state laws in connection with settlements resolving patent litigation relating to those products.Plaintiffs seek injunctive relief,compensatory and punitive damages,interest,atto

333、rneys fees and costs.On September 26,2023,plaintiffs filed a brief in opposition to Tevas motion to dismiss the amended complaint,in which plaintiffs limited their claims only to those relating to the alleged delay of generic NUVIGIL.On March 26,2024,the court issued its decision,which granted Tevas motion in part,dismissing plaintiffs RICO claims and certain state law claims,but denied Tevas moti