目录
错误Q30000818686--12-3100-0000000伊利诺伊州利率调整和与可持续发展相关的一次性保费支付被视为分离的嵌入式衍生工具。请参阅8c注。如果Teva未能达到特定可持续性绩效目标,利率将从2026年9月15日开始每年增加0.100%至0.300%。如果Teva未能达到特定可持续性绩效目标,将在2026年5月9日或之后的赎回日(如果赎回日期在此日期之后)到期时,从本金金额中支付0.15%-0.45%的一次性保费。2024年10月,Teva按到期日偿还了其到期日为2024年的1.13%优先票据,金额为68500万美元。如果Teva未能达到特定可持续性绩效目标,利率将从2026年5月9日开始每年增加0.125%至0.375%。2024年4月,Teva按到期日偿还了其到期日为2024年的6%优先票据,金额为95600万美元。包括与退出和处置活动有关的减值。上述表格中截至2023年9月30日结束的三个月和九个月的待定考量已根据第1c条讨论进行了修订。包括外币换算调整。2024年前九个月的其他营收包括某些产品权利的出售。2024年第三季度的其他营收包括某些产品权利的出售。2023年9月29日,Teva购买了Alvotech的4000万美元次级可转债。2024年6月26日,Alvotech宣布打算行使赎回权,并在2024年7月向Teva赎回了可转债(见第2条)。该计划包括出售股份以仅用于支付应缴税款。为反映在合并财务报表中对这些项目呈现的修订,先前期间呈现的数据已进行修订。有关更多信息,请参阅第1c条。金额不包括8000万美元的外币翻译调整损失,归属于非控制利益。金额不包括600万美元的外币翻译调整损失,归属于非控制权益。2023年3月31日,泰瓦与一项跨货币利率互换协议,指定为属于关于2026年10月到期的以日元计价的公司间贷款的资金流量套期交易进行了会计处理。该协议于2024年第一季度终止,导致1600万美元的现金收益。附带条件的交易代表与收购相关的公允价值记录的负债。上表所呈现的截至2023年9月30日九个月的涉及Allergan的有关按揭占款调整的财务数据已按照1c条款讨论进行了修订。公允价值是基于报价市场价格估算的。2024年9月30日和2023年12月31日的累积商誉减值分别约为290亿美元和283亿美元。 0000818686 2024-01-01 2024-09-30 0000818686 2024-09-30 0000818686 2023-12-31 0000818686 2024-07-01 2024-09-30 0000818686 2023-07-01 2023-09-30 0000818686 2023-01-01 2023-09-30 0000818686 2023-01-01 2023-12-31 0000818686 2019-08-31 0000818686 2024-06-30 0000818686 2018-08-21 2022-08-21 0000818686 2008-07-31 0000818686 2005-02-28 0000818686 2013-04-01 2013-04-30 0000818686 2013-09-01 2013-09-30 0000818686 2023-06-01 2023-06-30 0000818686 2024-04-01 2024-06-30 0000818686 2023-09-30 0000818686 2023-12-31 2023-12-31 0000818686 2021-07-08 0000818686 2024-01-01 2024-03-31 0000818686 2024-03-28 0000818686 2024-03-31 0000818686 2023-11-07 2023-11-07 0000818686 2022-11-09 2022-11-09 0000818686 2022-12-31 0000818686 2023-06-30 0000818686 泰瓦: 受限现金成员 美国通用会计准则: 公允价值输入一级成员 2023-12-31 0000818686 teva:限制性现金会员 2023-12-31 0000818686 teva:高级票据和可持续发展联系票据成员 2023-12-31 0000818686 teva:高级票据和可转换高级债务会员 2023-12-31 0000818686 teva:产品权利会员 2023-12-31 0000818686 us-gaap:研发和开发过程中的成员 2023-12-31 0000818686 us-gaap:商标成员 2023-12-31 0000818686 美国会计原则:可转换债券成员 2023-12-31 0000818686 us-gaap:公允价值输入二级成员 2023-12-31 0000818686 1. 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us-gaap:后续事件会员 2024-01-01 2024-12-31 0000818686 us-gaap: 循环信贷设施成员 teva:修订后的循环信贷业务成员 us-gaap:后续事件会员 2026-01-01 2026-03-31 0000818686 us-gaap: 循环信贷设施成员 teva:修订后的循环信贷业务成员 us-gaap:后续事件会员 2026-04-01 2026-06-30 0000818686 us-gaap: 循环信贷设施成员 Teva:修订后的循环信贷设施成员 us-gaap:后续事件会员 2026-10-01 2026-12-31 0000818686 Teva:特殊用途载体修正协议2024年10月成员 Teva:应收账款证券化设施成员 Teva:PNC银行成员 us-gaap:后续事件会员 2024-10-29 0000818686 teva:AndroGel一%折扣率会员 2019-08-31 0000818686 Teva:与美国司法部达成延期起诉协议会员 Teva:因违反反托拉斯法被罚款会员 2023-08-21 0000818686 Teva:与美国司法部达成延期起诉协议会员 Teva:捐赠克霉唑和托布拉霉素会员 2023-08-21 0000818686 Teva:因美国司法部民事调查要求被发出民事诉讼传票会员 us-gaap:后续事件会员 2024-10-10 2024-10-10 0000818686 Teva:关于向患者援助计划员捐赠的民事诉讼会员 us-gaap:后续事件会员 2024-10-10 0000818686 teva:美国司法部民事诉讼部门的民事调查要求 us-gaap:后续事件会员 2024-10-10 0000818686 teva:美国司法部民事诉讼部门的民事调查要求 teva:2024年会员 us-gaap:后续事件会员 2024-10-10 0000818686 teva:美国司法部民事诉讼部门的民事调查要求 teva:2025年会员 us-gaap:后续事件会员 2024-10-10 0000818686 teva:与美国医院和其他医疗保健提供者的诉讼成员 2023-07-01 2023-07-31 0000818686 teva:安大略省教师证券诉讼成员 4,923,731 2022-06-02 2022-06-02 0000818686 srt:欧洲成员 2021-01-01 2021-09-30 0000818686 teva:嗜酸性食管炎会员 国家:美国 2021-01-01 2021-09-30 0000818686 teva:嗜酸性食管炎成员 2021-01-01 2021-09-30 0000818686 teva:员工终止成员 2022-12-31 0000818686 teva:其他退出与处置成员 2022-12-31 0000818686 us-gaap:其他综合收益的累计成员 2022-12-31 0000818686 us-gaap:母公司成员 2022-12-31 0000818686 美元指数:非控股权成员 2022-12-31 0000818686 US-GAAP:普通股成员 2022-12-31 0000818686 美元指数: 应付股本会员 2022-12-31 0000818686 us-gaap:留存收益成员 2022-12-31 0000818686 us-gaap:TreasuryStockCommonMember 2022-12-31 0000818686 teva:员工解雇成员 2023-09-30 0000818686 teva:其他退出和处置成员 2023-09-30 0000818686 teva:计入销售准备和准许的总准备成员 2022-12-31 0000818686 teva:含于应收账款净额的准备成员 2022-12-31 0000818686 teva:回扣成员 2022-12-31 0000818686 teva:医疗补助成员 2022-12-31 0000818686 teva:退款成员 2022-12-31 0000818686 teva:退货成员 2022-12-31 0000818686 teva:其他销售准备成员 2022-12-31 0000818686 teva:医疗补助及其他政府津贴成员 2023-09-30 0000818686 teva:退款成员 2023-09-30 0000818686 teva:退货成员 2023-09-30 0000818686 teva:其他销售储备和折让成员 2023-09-30 0000818686 teva:包含在销售储备和折让中的总储备成员 2023-09-30 0000818686 teva:包含在应收账款净额中的储备成员 2023-09-30 0000818686 teva : Rebates Member 2023-09-30 0000818686 us-gaap:已实现的累计换算调整成员 2022-12-31 0000818686 us-gaap:累计定义利益计划调整会员 2022-12-31 0000818686 us-gaap:累计收益/损失-现金流套期保值母公司会员 2022-12-31 0000818686 us-gaap:其他综合收益的累计成员 2023-09-30 0000818686 us-gaap:累计定义利益计划调整会员 2023-09-30 0000818686 us-gaap:累计收益/损失-现金流套期保值母公司会员 2023-09-30 0000818686 us-gaap:已实现的累计换算调整成员 2023-09-30 0000818686 美元指数:非控股权成员 2023-09-30 0000818686 US-GAAP:普通股成员 2023-09-30 0000818686 美元指数: 应付股本会员 2023-09-30 0000818686 us-gaap:留存收益成员 2023-09-30 0000818686 us-gaap:TreasuryStockCommonMember 2023-09-30 0000818686 us-gaap:母公司成员 2023-09-30 0000818686 美元指数: 应付股本会员 2023-06-30 0000818686 us-gaap:留存收益成员 2023-06-30 0000818686 us-gaap:其他综合收益的累计成员 2023-06-30 0000818686 us-gaap:TreasuryStockCommonMember 2023-06-30 0000818686 us-gaap:母公司成员 2023-06-30 0000818686 美元指数:非控股权成员 2023-06-30 0000818686 US-GAAP:普通股成员 2023-06-30 0000818686 teva:员工终止成员 2023-12-31 0000818686 teva:其他退出和处置成员 2023-12-31 0000818686 US-GAAP:普通股成员 2023-12-31 0000818686 美元指数: 应付股本会员 2023-12-31 0000818686 us-gaap:留存收益成员 2023-12-31 0000818686 us-gaap:其他综合收益的累计成员 2023-12-31 0000818686 us-gaap:TreasuryStockCommonMember 2023-12-31 0000818686 us-gaap:母公司成员 2023-12-31 0000818686 美元指数:非控股权成员 2023-12-31 0000818686 teva:员工终止成员 2024-09-30 0000818686 teva:其他退出和处置成员 2024-09-30 0000818686 Teva:将储备资金包含在应收账款净额会员 2023-12-31 0000818686 Teva:折扣会员 2023-12-31 0000818686 Teva:医疗补助和其他政府津贴会员 2023-12-31 0000818686 Teva:返点会员 2023-12-31 0000818686 Teva:退货会员 2023-12-31 0000818686 Teva:其他销售储备和津贴会员 2023-12-31 0000818686 Teva:销售储备和津贴中总共包括的储备会员 2023-12-31 0000818686 Teva:将储备资金包含在应收账款净额会员 2024-09-30 0000818686 teva:折扣会员 2024-09-30 0000818686 teva:医疗补助和其他政府津贴会员 2024-09-30 0000818686 teva:退款会员 2024-09-30 0000818686 teva:回报会员 2024-09-30 0000818686 teva:其他销售储备和折扣会员 2024-09-30 0000818686 teva:销售储备和折扣中包括的总准备金会员 2024-09-30 0000818686 us-gaap:累计收益/损失-现金流套期保值母公司会员 2023-12-31 0000818686 us-gaap:已实现的累计换算调整成员 2023-12-31 0000818686 us-gaap:累计定义利益计划调整会员 2023-12-31 0000818686 us-gaap:累计定义利益计划调整会员 2024-09-30 0000818686 us-gaap:累计收益/损失-现金流套期保值母公司会员 2024-09-30 0000818686 us-gaap:已实现的累计换算调整成员 2024-09-30 0000818686 us-gaap:其他综合收益的累计成员 2024-09-30 0000818686 us-gaap:留存收益成员 2024-09-30 0000818686 us-gaap:TreasuryStockCommonMember 2024-09-30 0000818686 us-gaap:母公司成员 2024-09-30 0000818686 美元指数:非控股权成员 2024-09-30 0000818686 US-GAAP:普通股成员 2024-09-30 0000818686 美元指数: 应付股本会员 2024-09-30 0000818686 teva:其他国家成员 teva:Medis报告单位成员 2024-09-30 0000818686 teva:其他国家成员 teva:Teva的Api报告单位成员 2024-09-30 0000818686 teva:国际市场成员 2024-09-30 0000818686 srt:欧洲成员 2024-09-30 0000818686 国家:美国 2024-09-30 0000818686 srt:北美会员 2024-09-30 0000818686 us-gaap:其他综合收益的累计成员 2024-06-30 0000818686 us-gaap:母公司成员 2024-06-30 0000818686 美元指数:非控股权成员 2024-06-30 0000818686 US-GAAP:普通股成员 2024-06-30 0000818686 美元指数: 应付股本会员 2024-06-30 0000818686 us-gaap:留存收益成员 2024-06-30 0000818686 us-gaap:TreasuryStockCommonMember 2024-06-30 0000818686 国家:美国 2022-12-31 0000818686 srt:欧洲成员 2022-12-31 0000818686 teva:国际市场成员 2022-12-31 0000818686 teva:其他国家成员 teva:Teva的Api报告单位成员 2022-12-31 0000818686 teva:其他国家成员 teva:Medis基本报表成员 2022-12-31 0000818686 srt:北美会员 2022-12-31 0000818686 srt:北美会员 2023-12-31 0000818686 国家:美国 2023-12-31 0000818686 srt:欧洲成员 2023-12-31 0000818686 teva:国际市场成员 2023-12-31 0000818686 teva:其他国家成员 teva:Teva的Api基本报表成员 2023-12-31 0000818686 teva:其他国家会员 teva:Medis报告单位会员 2023-12-31 iso4217:USD xbrli:股份 xbrli:纯形 iso4217:eur iso4217:CHF teva:Segment iso4217:USD xbrli:股份
 
 
美国
证券交易委员会
华盛顿特区 20549
 
 
表格
10-Q
 
 
 
根据1934年证券交易法第13或15(d)条款的季度报告
截至2024年6月30日季度结束 九月三十日, 2024
 
根据1934年证券交易法第13或15(d)条款的过渡报告
委员会文件编号
001-16174
 
 
梯瓦制药有限公司
(根据其章程指定的注册人正式名称)
 
 
 
以色列
 
不适用
(依据所在地或其他管辖区)
的注册地或组织地点)
 
(IRS雇主
识别号码)
124 Dvora HaNevi’a St., 特拉维夫,
以色列
 
6944020
(总部办公地址)
 
(邮递区号)
+972
(3)
 914-8213
(注册人的电话号码,包括区号)
 
 
根据该法案第12(b)条规定注册的证券:
 
每种类别的名称
 
交易
标的
 
每个交易所的名称
注册在哪里的
美国存托股份,每一份代表一份普通股
 
梯瓦制药
 
纽约证券交易所
请勾选该注册者是否(1)在过去12个月内(或注册者必须提交此类报告的较短期间内)提交了证券交易法第13或15(d)条要求提交的所有报告,以及(2)过去90天一直受到该提交要求的影响。 ☒ 不 ☐
选择“X”表示
S-T
☒否 ☐  ☒ 否 ☐
请打勾表示申报人是一家大型快速文件提交者,加速提交者,
非加速文件提交者,还是一家较小的报告公司,或一家新兴成长企业。有关“大型快速文件提交者”,“加速文件提交者”,“较小的报告公司”
提交者,小型报告公司或新兴增长公司。请参阅《规则》中对「大型加速提交者」、「加速提交者」、「小型报告公司」和「新兴增长公司」的定义
12b-2
条款。
 
大型加速归档人      加速档案提交者  
非加速公司
文件处理器
     较小报告公司  
新兴成长型企业       
如果是新兴增长型企业,请勾选是否选择不使用根据交易所法第13(a)条所提供的任何新的或修改后的财务会计准则的延长过渡期。 ☐
请勾选符号以指示公司是否为壳公司(根据交易所法令第○○规范定义)。 ☐ 是 ☐ 否
12b-2
《法案》(the Act)生效? 是 ☐ 否 ☐
截至2024年9月30日,登记人持有 1,133,050,214 普通股流通中。
 
 
 


目录
http://fasb.org/us-gaap/2024#IncomeLossFromContinuingOperationsBeforeIncomeTaxesMinorityInterestAndIncomeLossFromEquityMethodInvestments2026-04-30http://fasb.org/us-gaap/2024#Liabilitieshttp://www.tevapharm.com/20240930#ImpairmentsRestructuringAndOthershttp://fasb.org/us-gaap/2024#OtherAssetsCurrenthttp://fasb.org/us-gaap/2024#OtherAssetsCurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesCurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesCurrent
梯瓦制药工业有限公司
欲阅览本季度报告的无障碍版
第10-Q表格,
请造访 www.tevapharm.com
指数
 
第一部分。
    
项目1。
  基本报表 (未经审计)   
  合并资产负债表      5  
  综合损益表      6  
  综合损益表      7  
  综合损益表变动表      8  
  综合现金流量表      10  
  基本报表注      11  
项目2。
  管理层对财务状况和业绩的讨论与分析      57  
项目3。
  有关市场风险的定量和定性披露      85  
项目 4。
  控制项和程序      85  
第二部分。
    
项目1。
  法律诉讼      87  
项目1A。
  风险因素      87  
项目2。
  股票权益的未注册销售和资金用途      87  
项目3。
  优先证券违约      87  
项目 4。
  矿业安全披露      87  
项目5。
  其他信息      88  
第6项。
  附件      89  
  签名      90  
 
2

目录
梯瓦制药有限公司
 
介绍和使用某些术语
除非另有说明,“公司”、“我们”、“我们的”和“梯瓦”均指梯瓦制药工业有限公司及其子公司,提到“收入”指净收入。 提到“美元”,“美元”,“美元”和“$”指美利坚合众国的法定货币,提到“以色列新谢克尔”指新以色列舍克尔。 提到“ADS”指梯瓦的美国存托股份。 “MS”指多发性硬化症。 市场数据,包括销售数据和份额数据,基于提供给药品行业的市场研究者IQVIA(“IQVIA”)提供的信息,除非另有说明。 提到“研发”是指研究与开发,提到“知识产权研发”是指&D,提到“销售与市场营销”是指销售与市场营销,提到“总部与行政部门”是指总部与行政部门。本报告中的某些金额可能不符合,因为取整。 所有百分比均是使用未取整的金额计算的。 这份根据表格的报告包含了梯瓦在美国和国际上用来区分其产品和服务的许多商标和商标。 本报告提及的任何第三方商标均为其各自所有者的财产。
收购中
研发,提到“销售与营销”是指销售与市场营销,提到“总部与行政部门”是指总部与行政部门。本报告中的某些金额可能不符合,因为取整。 所有百分比均是使用未取整的金额计算的。 这份根据表格的报告包含了梯瓦在美国和国际上用来区分其产品和服务的许多商标和商标。 本报告提及的任何第三方商标均为其各自所有者的财产。
10-Q
此报告中包含了梯瓦在美国和国际上用来区分其产品和服务的许多商标和商标。 本报告提及的任何第三方商标均为其各自所有者的财产。
关于前瞻性声明的警示
除了历史信息,这份表格第...季度报告
10-Q,
以及本季度报告中引用的报告和文件
10-Q,
可能包含根据1995年《私人证券诉讼改革法案》的定义的前瞻性声明,这些声明基于管理层当前的信仰和期望,并受到实质性风险和不确定性的影响,无论是已知还是未知,这些风险和不确定性可能导致我们未来的结果、绩效或成就与这些前瞻性声明所表达或暗示的结果显著不同。您可以通过使用诸如“应该”、“期待”、“预计”、“估计”、“目标”、“可能”、“项目”、“指导”、“打算”、“计划”、“相信”等词语来识别这些前瞻性声明,并在与未来运营或财务绩效的任何讨论中表达类似含义和表达的词语和术语。可能导致或有助于产生这种差异的重要因素包括与之相关的风险:
 
   
我们在市场上成功竞争的能力,包括:我们在很大程度上依赖我们的仿制产品;我们的客户群体和商业联盟对我们的依赖程度很高;新仿制产品推出的延迟;我们开发和商业化生物制药产品的能力;我们创新药品的竞争;我们从产品管线投资中实现预期结果的能力;我们开发和商业化其他药品的能力;我们成功执行“转型增长”战略的能力,包括扩展我们的创新和仿制生物药品管线并盈利地商业化创新药品和仿制生物药品组合,无论是通过有机扩张还是通过业务发展,并维持和集中我们的仿制药品组合;以及我们专利和其他措施保护我们的知识产权的有效性,包括在美国对我们的《橙皮书》专利清单可能存在的挑战;
 
   
我们的巨额负债,可能限制我们增加额外负债、进行额外交易或进行新投资的能力,可能会导致我们的信贷评级未来下调;以及我们无法以有利于我们的金额或条件筹集债务或借款资金;
 
   
我们的业务和运营总体情况,包括:全球经济形势和其他宏观经济发展以及政府和社会对此的回应的影响;疾病的广泛爆发或其他传染病,或其他公共卫生危机;我们优化努力的有效性;吸引、招聘、整合和留住高技能人员的能力;我们供应链中断或内部或第三方制造问题;信息技术系统中断;我们数据安全挑战的违约,包括在全球范围内开展业务时面临的政治或经济不稳定、重大冲突或恐怖主义活动,比如俄罗斯和乌克兰之间的持续冲突以及以色列宣布的战争状态;因我们所受制药监管的广泛性导致的成本和延误;我们成功买盘适当的收购目标或许可机会,或完成和整合收购;以及我们如果卖出资产或业务部门,并关闭或出售工厂和设施,在此如果我们能够成功,以及高效率地完成此类出售和出售,包括我们计划出售API业务的出售;
 
   
合规、监管和诉讼事项,包括:未能遵守复杂的法律和监管环境的影响;政府和民事诉讼以及我们是或将来成为当事人的影响;卫生法规改革及药品定价、报销和覆盖范围的影响;与公众对滥用阿片药物的关注相关的增加的法律和监管行动;我们及时根据全国阿片类药物和按照协议的条款所需的支付且提供Narcan的仿制版本
®
(纳洛酮盐酸盐鼻喷剂)按协议的要求时间和数量达到的能力;受到全球竞争和定价机构的审查,包括我们遵守和执行与美国司法部(DOJ)达成的推诿起诉协议(“DPA”)的能力;知识产权侵权的潜在责任;产品责任索赔;未能遵守复杂的医疗保险、医疗补助和其他政府计划的报告和付款义务;遵守反腐败、制裁和贸易控制法律;环境风险;以及可持续性问题的影响;
 
3

目录
梯瓦制药有限公司
 
   
以色列宣布战争状态及该地域的军事活动对我们的业务和设施产生影响,例如位于以色列的制造和研发设施,以及我们的员工因为是军事预备役士兵而被召入军队的影响,还有战争对以色列的经济、社会和政治稳定造成的影响;
 
   
其他金融和经济风险,包括:我们对货币波动和限制的敞口以及信用风险;我们长期资产的潜在减值;地缘政治冲突的影响,包括以色列宣布的战争状态和俄乌冲突;潜在重大增加的税务责任;政府计划或税收优惠终止或到期,或业务发生变化对我们整体有效税率的影响;以及我们纠正现有财务报告内部控制方面重大缺陷的能力;
以及在本季度报告的表格中讨论的其他因素
10-Q
和我们截至2023年12月31日年度报告的表格中
10-K
包括“风险因素”一节。前瞻性声明仅于其发布之日起生效,我们不承担更新或修订任何前瞻性声明或此处包含的其他信息的义务,无论是因新信息、未来事件还是其他原因。请谨慎对待这些前瞻性声明。
 
4

目录
第I部分—财务信息
 
项目1。
基本报表
梯瓦制药工业有限公司
汇编表格
(以百万美元为单位,除股票数据外)
(未经审计)
 
    
2022年9月30日
   
12月31日,
 
    
2024
   
2023
 
资产
    
流动资产:
    
现金及现金等价物
   $ 3,319     $ 3,226  
应收账款,扣除信用损失准备911百万美元和95截至2024年9月30日和2023年12月31日,资产总额为xx百万美元。
     3,462       3,408  
存货
     3,959       4,021  
预付费用
     1,127       1,255  
其他资产
     445       504  
待售资产
     2       70  
  
 
 
   
 
 
 
总流动资产
     12,314       12,485  
延迟所得税
     2,070       1,812  
其他
非流动性
资产
     459       470  
物业、厂房和设备,净值
     5,672       5,750  
保险业
租赁权
净资产
     364       397  
可识别无形资产净值
     4,756       5,387  
商誉
     16,124       17,177  
  
 
 
   
 
 
 
资产总额
   $ 41,758     $ 43,479  
  
 
 
   
 
 
 
负债和股东权益
    
流动负债:
    
短期债务
   $ 2,580     $ 1,672  
销售准备金和折扣
     3,785       3,535  
应付账款
     2,371       2,602  
与雇员相关的义务
     619       611  
应计费用
     2,984       2,771  
其他流动负债
     1,241       1,044  
待售负债
     216       13  
  
 
 
   
 
 
 
流动负债合计
     13,797       12,247  
长期负债:
    
延迟所得税
     538       606  
其他税收和长期负债
     4,344       4,019  
优先票据和贷款
     16,400       18,161  
经营租赁负债
     295       320  
  
 
 
   
 
 
 
长期负债总额
     21,578       23,106  
  
 
 
   
 
 
 
承诺和 contingencies
,查看备注10
    
负债合计
     35,375       35,353  
  
 
 
   
 
 
 
股东权益:
    
梯瓦股东权益:
    
以新以色列谢克尔的普通股为名义金额-0.10 每股面值;2024年9月30日和2023年12月31日:授权 2,495百万股;已发行 1,240百万股1,227各自有2,697,690万和2,071,289万股
     58       57  
共计
实收资本
资本金
     27,860       27,807  
累积赤字
     (14,956 )     (13,534
累计其他综合损失
     (2,769     (2,697
2024年9月30日和2023年12月31日的库藏股: 106百万普通股
     (4,128     (4,128
  
 
 
   
 
 
 
     6,065       7,506  
  
 
 
   
 
 
 
非控制权益
其他权益
     319       620  
  
 
 
   
 
 
 
股东权益总计
     6,383       8,126  
  
 
 
   
 
 
 
负债和所有者权益总额
   $ 41,758     $ 43,479  
  
 
 
   
 
 
 
金额可能因四舍五入而不匹配。
财务报表的附注是其组成部分。
 
5

目录
梯瓦制药工业有限公司
综合损益表
(以百万美元计算,除每股和每股数据外)
(未经审计)
 
    
截止

2022年9月30日
   
九个月结束

2022年9月30日
 
    
2024
   
2023
   
2024
   
2023
 
净利润
   $ 4,332     $ 3,850     $ 12,315     $ 11,389  
销售成本
     2,183       1,999       6,372       6,159  
毛利润
     2,148       1,851       5,943       5,230  
研发费用
     240       253       751       726  
销售和市场费用
     626       576       1,891       1,726  
一般及管理费用
     298       268       859       870  
无形资产减值
     28       47       169       289  
商誉减值
     600             1,000       700  
其他资产减值、重组及其他项目
     (23     57       931       276  
法律和损失准备金
     450       314       638       1,009  
其他
损失
(收益)
     (21     (9     (22     (43
  
 
 
   
 
 
   
 
 
   
 
 
 
业务利润(亏损)
     (51 )     344       (274 )     (323
财务费用,净额
     272       280       763       808  
  
 
 
   
 
 
   
 
 
   
 
 
 
税前收益(亏损)
     (324 )     64       (1,037 )     (1,131
所得税(利益)
     69       (12     648       (48
分享关联公司的净利润损失
     (3     §       (1     (1
  
 
 
   
 
 
   
 
 
   
 
 
 
     (390 )     77       (1,684 )     (1,082
归属于净利润(损失)
非控制股权
其他权益
     47       8       (262     (60
  
 
 
   
 
 
   
 
 
   
 
 
 
归属梯瓦的净利润(亏损)
     (437 )     69       (1,422 )     (1,022
  
 
 
   
 
 
   
 
 
   
 
 
 
每股盈利(亏损)归属于普通股股东:
        
基础
   $ (0.39 )   $ 0.06     $ (1.26 )   $ (0.91
  
 
 
   
 
 
   
 
 
   
 
 
 
摊薄后
   $ (0.39 )   $ 0.06     $ (1.26 )   $ (0.91
  
 
 
   
 
 
   
 
 
   
 
 
 
每股加权平均股数(以百万计):
        
基础
     1,133       1,121       1,130       1,119  
  
 
 
   
 
 
   
 
 
   
 
 
 
摊薄后
     1,133       1,135       1,130       1,119  
  
 
 
   
 
 
   
 
 
   
 
 
 
 
§
代表少于$的金额
0.5
截至2021年3月27日,未偿还本金总额为$。
金额可能因四舍五入而不相符。
财务报表的附注是其组成部分。
 
6

目录
梯瓦制药工业有限公司
综合损益表
(单位:百万美元)
(未经审计)
 
    
截止

2022年9月30日
   
九个月结束

2022年9月30日
 
    
2024
   
2023
   
2024
   
2023
 
   $ (390 )   $ 77     $ (1,684 )   $ (1,082
其他综合收益(损失), 净额(税后):
        
货币翻译调整
     174       (255     (94     (173
金融工具衍生物未实现收益(损失),净额
     7       7       21       19  
企业年金计划未实现损失
     (1     (1     (2     (2
  
 
 
   
 
 
   
 
 
   
 
 
 
其他综合收益(损失)总额
     180       (249     (75     (156
  
 
 
   
 
 
   
 
 
   
 
 
 
总综合收益(损失)
     (210 )     (172 )     (1,759 )     (1,238
归属于的综合收益(损失)
非控制股权
其他权益
     114       (8     (268     (144
  
 
 
   
 
 
   
 
 
   
 
 
 
归属梯瓦的综合收益(损失)
   $ (324 )   $ (164 )   $ (1,491 )   $ (1,094
  
 
 
   
 
 
   
 
 
   
 
 
 
金额可能因四舍五入而不相符。
财务报表的附注是其组成部分。
 
7

目录
梯瓦制药有限公司
股东权益变动表
 
   
梯瓦制药股东权益
             
   
普通股
                                           
   
股数
股份(在
(以百万计)
   
说明
价值
   
额外的
实收资本

资本金
   
留存收益
盈余
(累积的
deficit)
   
累积的
其他
综合
(亏损)
   
国库
   
梯瓦总额
股东的
股东权益
   
非控制权益

其他权益
   
总计
股东权益
 
                                                       
   
(以百万美元计)
 
                                                       
2024年6月30日余额
    1,239       58       27,829       (14,519     (2,881     (4,128     6,359       204       6,563  
净利润
          (437 )         (437 )     47       (390 )
其他综合收益(损失)
            113         113       67       180  
股份发行
    1       *       *             *         *  
股票补偿费用
        29             29         29  
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
2024年9月30日余额
    1,240     $ 58     $ 27,860      $ (14,956 )   $ (2,769   $ (4,128   $ 6,065      $ 319      $ 6,383   
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
*
表示小于某一金额 0.5截至2021年3月27日,未偿还本金总额为$。
 
   
梯瓦制药股东权益
             
   
普通股
                                           
   
股数
shares (in
millions)
   
说明
价值
   
额外的
实收资本

资本金
   
留存收益
盈余
(累积
赤字)
   
累积的
其他
综合
(损失)
   
国库
   
梯瓦制药
股东的
股东权益
   
非控制权益

其他权益
   
总计
股东权益
 
                                                       
   
(以百万美元计)
 
                                                       
2023年12月31日的余额
    1,227       57       27,807       (13,534     (2,697     (4,128     7,506       620       8,126  
净利润
          (1,422 )         (1,422 )     (262     (1,684 )
其他综合收益(损失)
            (69       (69     (6     (75
股份发行
    13       1       *             1         1  
股票补偿费用
        89             89       —        89  
期权行使所得
        7             7         7  
应分配的股息
非控制股权
interests**
                  (18     (18
Purchase of shares from
非控制股权
interests***
        (45       (3       (48     (16     (64
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
2024年9月30日余额
    1,240     $ 58     $ 27,860     $ (14,956 )   $ (2,769   $ (4,128   $ 6,065     $ 319     $ 6,383  
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
*
代表少于$的金额0.5截至2021年3月27日,未偿还本金总额为$。
**
关于分红派息给
非控制股权
日本梯瓦制药合资企业中的股份。
***
从 购买公司股份
非控制股权
瑞士的梯瓦制药子公司中的股份。
 
8

目录
   
梯瓦股东权益
             
   
普通股
                                           
   
股数
股份数(以
百万计)
   
说明
价值
   
额外的
实收资本

资本金
   
留存收益
盈余
(累积
亏损)
   
累积的
其他
综合的
(亏损)
   
国库
   
梯瓦总额
股东的
股东权益
   
非控制权益

其他权益
   
总计
股东权益
 
                                                       
   
(以百万美元计)
 
                                                       
2023年6月30日余额 **
    1,227       57       27,748       (14,066     (2,677     (4,128     6,936       656       7,592  
净利润(亏损)**
          69           69       8       77  
其他综合收益(损失)
            (233       (233     (16     (249 )
股份发行
        *             *         *  
股票补偿费用
        31             31         31  
应分配的股息
非控制股权
interest ***
                  (67     (67
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance at September 30, 2023 **
    1,227     $ 57     $ 27,780     $ (13,995   $ (2,910   $ (4,128   $ 6,804     $ 582     $ 7,387  
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
*
代表少于$的金额0.5截至2021年3月27日,未偿还本金总额为$。
**
The data presented for prior periods has been revised to reflect a revision in relation to a contingent consideration liability and related expenses in the consolidated financial statements. For additional information, see note 1c.
***
关于分红派息声明
非控制股权
对梯瓦制药在日本的合资企业的利益。
 
   
梯瓦制药股东权益
             
   
普通股
                                           
   
股数
股份(以百万美元计)
   
说明
价值
   
额外的
实收资本

资本金
   
留存收益
盈余
(accumulated
亏损)
   
累积的
其他
全面
(损失)
   
国库
   
梯瓦总额
股东的
股东权益
   
非控制权益

其他权益
   
总计
股东权益
 
                                                       
   
(以百万美元计)
 
                                                       
2022年12月31日的余额 **
    1,217       57       27,688       (12,975     (2,838     (4,128     7,804       794       8,598  
净利润
          (1,022 )         (1,022 )     (60     (1,082
其他综合收益(损失)
            (72       (72     (84     (156
股份发行
    10       *       *             *         *  
股票补偿费用
        93             93       —        93  
应分配的股息
非控制股权
利息 ***
                  (67     (67
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
2023年9月30日结余 **
    1,227     $ 57     $ 27,780     $ (13,995   $ (2,910   $ (4,128   $ 6,804     $ 582     $ 7,387  
 
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
*
代表少于$的金额0.5截至2021年3月27日,未偿还本金总额为$。
**
过往时期呈现的数据已经修订,以反映综合财务报表中与相关费用相关的应收待摊负债的修订。有关更多信息,请参阅附注1c。
***
关于对股息的宣布
非控制股权
在日本梯瓦制药的合资公司的权益。
金额可能因四舍五入而不相符。
财务报表的附注是其组成部分。
 
9

目录
梯瓦制药有限公司
综合现金流量表
(单位:百万美元)
(未经审计)
 
    
截止

2022年9月30日
   
九个月结束
9月30日,
 
    
2024
   
2023
   
2024
   
2023
 
经营活动:
        
   $ (390 )     77     $ (1,684 )     (1,082
调整以重新计算净利润(亏损)为经营活动提供的净现金:
        
折旧和摊销
     259       283       790       887  
商誉减值
     600             1,000       700  
长期资产和待售资产减值
     (51 )     48       758       310  
经营性资产和负债净变动额
     317       (227     (190 )     (364
递延所得税-净额和不确定税务立场
     (53     (199     (666     (349
股票补偿
     29       31       89       93  
其他项目 *
     2       (5     597       18  
出售业务和长期资产的净亏损(盈利)
     (21     (3     (22     (29
  
 
 
   
 
 
   
 
 
   
 
 
 
经营活动产生的净现金流量
     693       5       672       184  
  
 
 
   
 
 
   
 
 
   
 
 
 
投资活动:
        
收集的有益权益,以换取证券化的应收账款
     339       362       951       1,056  
购买固定资产、厂房和设备以及无形资产
     (148     (149     (369     (407
出售业务和长期资产的收益
     38       10       39       68  
收购企业,扣除现金净额
                 (15      
购买投资和其他资产
     (1     (38     (56     (44
出售投资所得款
     40             40    
其他投资活动
           (1           (6
  
 
 
   
 
 
   
 
 
   
 
 
 
投资活动产生的净现金流量
     268       184       590       667  
  
 
 
   
 
 
   
 
 
   
 
 
 
筹资活动:
        
偿还优先票据、贷款和其他长期负债
           (1,000     (956     (4,152
从 购买公司股份
非控制股权
其他权益
                 (64      
Others
非控制股权
其他权益
                 (78      
优先票据净额,扣除发行成本
                       2,451  
短期债务收入
           700             700  
短期债务偿还
           (200           (200
其他融资活动
           (76     (19     (136
  
 
 
   
 
 
   
 
 
   
 
 
 
筹集资金的净现金流量
           (576     (1,117     (1,337
  
 
 
   
 
 
   
 
 
   
 
 
 
现金及现金等价物的翻译调整
     100       (33     (53     (98
  
 
 
   
 
 
   
 
 
   
 
 
 
经营性现金流净额
     1,061       (420     — 92       (584
期初现金、现金等价物和受限现金余额
     2,258       2,670       3,227       2,834  
  
 
 
   
 
 
   
 
 
   
 
 
 
期末现金、现金等价物和受限现金余额
   $ 3,319       2,250       3,319       2,250  
  
 
 
   
 
 
   
 
 
   
 
 
 
现金及现金等价物
     3,319       2,249       3,319       2,249  
其他流动资产中包含的受限制现金
           1             1  
  
 
 
   
 
 
   
 
 
   
 
 
 
现金、现金等价物及限制性现金的总额(见现金流量表)
     3,319       2,250       3,319       2,250  
  
 
 
   
 
 
   
 
 
   
 
 
 
非现金
融资和投资活动:
        
交换账户应收账款获得的有利权益
   $ 332       376     $ 964       1,090  
向股东分红的
非控制股权
其他权益
   $       67     $       67  

*
2024年9月30日结束的九个月期间的调整主要涉及与以色列税务当局达成协议,解决了某些诉讼,涉及金额为$495与2008年至2020年应缴税款相关的数额高达百万美元。
由于四舍五入,金额可能不合计。
财务报表的附注是其组成部分。
 
10

目录
梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
注释1 – 呈现的基础:
 
 
a.
报表基础
随附的未经审计的合并基本报表是以与年度合并基本报表相同的基础编制的。管理层认为,这些基本报表反映了所有必要的正常和经常性调整,以公正地表述梯瓦的财务状况和经营业绩。本季度报告中的信息应与公司在年度报告中的合并基本报表及附带说明一起阅读
10-Q
截至2023年12月31日的财年,已提交给证券交易委员会(“SEC”)的表格
10-K
的基本报表。
年末
资产负债表数据来源于截至2023年12月31日的经审计合并基本报表,但并未包括美国公认会计原则(“U.S. GAAP”)要求的所有披露。
在编制公司的合并基本报表时,管理层需做出影响资产、负债、股权及在基本报表日期披露或有负债和资产的报告金额的估算和假设。实际结果可能与这些估算有所不同。
在编制公司的合并基本报表时,管理层还考虑了通货膨胀预期对其关键和重要会计估算的经济影响。就这些合并基本报表而言,最重要的估算和假设与判断IPR&D资产、销售产品权和商誉的估值及可回收性,评估在美国的销售准备金和折扣,不确定的税务情况,估值准备金和或有事项相关。这些估算可能会受到更高成本和将这些更高成本传递给客户能力的不确定性影响。政府采取的措施以应对宏观经济发展及其对梯瓦制药第三方制造商、供应商、客户和市场的经济影响,也可能影响这些估算,并可能在未来时期发生变化。
2022年2月,俄罗斯对乌克兰发起了侵略。截至这些合并基本报表的日期,该地区持续冲突和动荡仍在进行。俄罗斯和乌克兰市场包含在梯瓦制药的国际市场分部成果中。梯瓦制药在这些市场没有制造或研发设施。在截至2024年9月30日的三个月和九个月期间,这场冲突对梯瓦制药的事件经营和财务状况的影响仍然不重要。
在2023年10月,以色列遭到恐怖组织攻击,进入战争状态
o
截至本合并财务报表的日期,在多个方面持续冲突正在进行中。以色列被纳入梯瓦制药的国际市场部门业绩中。梯瓦制药的全球总部和若干制造业-半导体及研发设施位于以色列。目前,以色列的这些活动基本上未受到影响。梯瓦制药持续维护关键产品的后备生产地点应急计划。至2024年9月30日的三个月和九个月期间,该战争对梯瓦制药的运营结果和财务状况的影响不大,但由于战争的继续、升级或扩大,此影响可能增加,可能会变得重大。
截至2024年9月30日的三个月和九个月期间,梯瓦制药的运营结果并不一定代表整个财政年度可以预期的结果。
合并财务报表及相关附注中的某些金额可能因四舍五入而不相加。所有百分比均使用未四舍五入的金额计算。
 
 
b.
重大会计政策
最近采用的会计 pronouncement
无。
最近发布的会计 pronouncement,尚未采用
在2023年12月,FASB发布了ASU
2023-09
“所得税(话题740):对所得税披露的改进”。该指引旨在提高所得税披露的透明度和决策价值。ASU中的修订
2023-09
满足投资者对增强所得税信息的要求,主要通过对美国及外国管辖区的税率调节和已支付所得税的披露进行变更。ASU
2023-09
适用于2024年12月15日后开始的财政年度,采用前瞻性基础,提供追溯性应用标准的选项。允许提前采用。公司正在评估该指引,以判断其可能对合并的基本报表披露产生的影响。
 
 
11

梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
 
在2023年11月,FASB发布了ASU
2023-07
“细分报告:可报告细分信息的改进”。该指南主要通过要求披露定期提供给首席运营决策者的重大细分费用、包含在每一项报告的细分利润或亏损的测量中的金额及其组成的描述、其他细分项目的金额和描述,以及可报告细分的利润或亏损及资产的临时披露,扩大了公共实体的细分披露。该指南自2023年12月15日后开始的财政年度起生效,自2024年12月15日后开始的财政年度内的临时期间适用,允许提前采用。这些修改要求对在实体的财务报表中呈现的所有前期进行追溯适用。公司预计ASU的采用不会对其合并财务报表相关的披露产生重大影响。
在2023年10月,FASB发布了ASU
2023-06
“披露改进:针对SEC的披露更新和简化倡议的编纂修订”,该修订将某些SEC的披露要求纳入FASB会计标准编纂(“编纂”)。ASU中的修订预计将澄清或改善多种编纂主题的披露和呈现要求,使投资者更容易将受SEC现有披露要求的实体与未以前受该要求的实体进行比较,并使编纂中的要求与SEC的规定保持一致。每项修订的生效日期为SEC解除相关披露所适用的《条例》
S-X
或《条例》
S-K
生效的日期,禁止提前采用。该ASU中的修订应当前瞻性地适用。公司预计ASU
2023-06
将对其综合基本报表产生重大影响。
 
 
c.
修订之前报告的综合基本报表
在编制截至2023年12月31日的综合基本报表时,公司发现存在一个应付款项的错误,以及与未来预计的版税支付相关的费用,同时还有对应的递延税项调整,这些错误导致应付款项的低估,约为$132百万,其中$98百万,涉及2022年,以及$34百万,涉及2023年。这些错误源于未将应包括在公允价值
重新计量
的应付款项计算中,截止到2022年12月31日,以及季度和
截至10月份
截至2022年6月30日、9月30日和12月31日,以及2023年3月31日、6月30日和9月30日的期间。这些错误没有影响到公司的实际特许权使用费支付,以及上述期间的经营活动、融资活动和投资活动的总现金流。
公司对这些错误进行了评估,分别考虑了定性和定量因素,并得出结论认为这些错误对上述所有先前期间没有重大影响。然而,2022年先前期间错误的总金额对2023财政年度的合并财务报表将是重大影响。因此,公司已经修订了受此错误影响的先前期间。
下表展示了修订对公司相关期间合并财务报表中每项项目的影响:
 
     截至三个月     截至九个月  
     2023年9月30日     2023年9月30日  
     以百万美元计(每股金额除外)  
     (未经审计)  
     调整后
之前
报告
    调整     修订后     此前
报告了
    调整     经修订  
其他资产减值、重组及其他事项
   $ 46       11       57     $ 241       34       276  
营业收入(亏损)
     355       (11     344       (289     (34     (323
税前收入(亏损)
     75       (11     64       (1,097     (34     (1,131
所得税(收益)
     (12     §       (12     (48     §       (48
净利润(亏损)
     88       (11     77       (1,048     (34     (1,082
归属于梯瓦制药的净利润(亏损)
     80       (11     69       (988     (34     (1,022
归属于普通股股东的每股收益(亏损):
            
基本和稀释后的每股亏损
   $ 0.07       (0.01     0.06     $ (0.88     (0.04     (0.91
 
§
代表少于 $ 的金额0.5百万。
 
 
 
12

梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
     2023年9月30日  
     调整后
之前
报告过
     调整      如修订  
     (未经审计)  
递延所得税
   $ 1,748        7        1,755  
总资产
     42,088        7        42,095  
其他税收和长期负债
     3,818        132        3,950  
长期负债总额
     23,182        132        23,314  
总负债
     34,576        132        34,708  
梯瓦制药股东权益:
        
累计亏损
     (13,870      (125      (13,995
总权益
     7,512        (125      7,387  
总负债及权益
   $ 42,088        7        42,095  
 
 
13

目录
梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
注释2 – 某些交易:
The Company has entered into alliances and other arrangements with third parties to acquire rights to products it does not have, to access
市场
it does not operate in and to otherwise share development costs or business risks. The Company’s most significant agreements of this nature are summarized 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 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 commercialization in multiple global markets, including Europe and the U.S. In September 2024, Teva and mAbxience entered into an amendment to the licensing agreement whereby, similar to the initial licensing agreement, mAbxience will lead the development and production of an
抗PD-1
oncology biosimilar candidate and Teva will manage regulatory approvals and oversee commercialization in the designated markets.
Under the initial agreement, in the second quarter of 2024, Teva paid mAbxience upfront and milestone payments in a total amount of $20百万,作为研发费用记录。根据许可协议的修订,2024年第三季度,梯瓦制药确认了总额为$的预付款和里程碑付款。15百万作为研发费用,其中$5百万于2024年10月支付,剩余款项需在2024年底前支付。mAbxience可能有资格获得额外的未来开发、监管和商业里程碑付款,总额可达$320百万。
Launch Therapeutics和Abingworth
2024年3月28日,梯瓦制药与Launch Therapeutics, Inc.(“Launch Therapeutics”)签署了一项临床合作协议,以进一步加速梯瓦制药的临床研究计划
ICS-SABA
(TEV-‘248)。
作为此次临床合作协议的一部分,梯瓦还与与Abingworth LLP(“Abingworth”)相关的资金达成了开发融资协议。根据临床合作协议,Launch Therapeutics,这是一家由Abingworth和全球投资公司Carlyle支持的临床开发公司,将在计划的临床试验的操作执行和管理中发挥主导作用。梯瓦将保留在美国的制造、监管互动和商业化的主要责任。
ICS-SABA
(TEV-’248)
目前正在进行Ⅲ期临床试验,以治疗哮喘症状,解决即时症状和长期炎症。
根据开发融资协议,Abingworth将向梯瓦提供高达$150百万美元,以资助
ICS-SABA
(TEV-‘248)。
在交易所中,并且根据监管批准,梯瓦制药将向Abingworth支付一笔里程碑付款,金额为实际由Abingworth提供的资金,最高达$150百万,以及基于
ICS-SABA
(TEV-‘248)
销售。在2024年第三季度,梯瓦制药记录了$20百万作为研发费用的报销
发生的
与本协议相关。
生物设计
2023年11月26日,梯瓦与生物设计有限公司(“生物设计”)签署了许可协议,根据该协议,梯瓦获得了开发、制造和全球商业化BD9多抗体的独占权,以潜在治疗特应性皮炎和哮喘。作为交换,梯瓦于2024年1月支付了一笔金额为$的预付款,记作2023年第四季度的研发费用。10生物设计可能有资格根据某些500临床和监管里程碑的达成,在接下来的几年中,收到最多约$的额外开发和商业里程碑付款。
前临床,
大部分付款将基于未来的
销售
成就。
royalty pharma
2023年11月9日,梯瓦制药与Royalty Pharma plc("Royalty Pharma")签署了一项资金协议,以进一步加速梯瓦药品的奥氮平长效注射剂临床研究计划
(TEV-’749)。
根据资金协议的条款,Royalty Pharma将向梯瓦提供最高可达$100百万美元,以资助奥氮平长效注射剂
(TEV-‘749),
并有选项将总资金金额增加至$125百万美元,该选项将于2024年第二季度到期。作为交换,并受到监管机构批准的条件,梯瓦将根据Royalty Pharma实际提供的资金向Royalty Pharma支付里程碑付款,分期支付 5 年,除了商业化后获得的版权费。梯瓦制药将继续主导该产品的全球开发和商业化。在2023年第四季度,以及2024年的第一、第二和第三季度,梯瓦制药记录了$35百万,$27百万,$19百万和$18百万,作为对研发费用的补偿
与本协议相关的费用,总计金额为Royalty Pharma将提供给梯瓦制药的
 
$
100
百万。奥氮平LAI
(TEV-’749)
目前正在进行第3期临床试验,以治疗精神分裂症(另见下文MedinCell交易)。
 
 
14

梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
赛诺菲安万特
在2023年10月3日,梯瓦与赛诺菲安万特达成了独家合作协议,
共同开发
共同-
商业化梯瓦的duvakitug(抗TL1A,
TEV-’574)
资产,这是一种新型的抗TL1A疗法,用于治疗溃疡性结肠炎和克罗恩病,这两种都是炎症性肠病,目前正在进行阶段20亿的临床试验。根据合作协议的条款,作为赛诺菲授予的许可证的部分对价,梯瓦在2023年第四季度收到了$500 百万的预付款,确认作为营业收入。此外,梯瓦可能会获得高达$1 十亿的开发和启动里程碑。每家公司将在全球范围内平等分担剩余的开发费用以及主要市场的净利润和亏损,其他市场将受制于特许权使用费安排,赛诺菲将主导阶段3项目的开发。梯瓦将领导该产品在欧洲、以色列和其他指定国家的商业化,而赛诺菲将在北美、日本、其他亚洲地区以及世界其他地区领导商业化。
MODAG
在2021年10月,梯瓦宣布与MODAG GmbH(“Modag”)签署了一项许可协议,授予梯瓦独家全球许可,以开发、制造和商业化Modag的主要化合物emrusolmin
(TEV-’286)
及相关化合物
(TEV-’287)。
Emrusolmin
(TEV-’286)
最初开发用于治疗多系统萎缩(“MSA”)和帕金森病,并有潜力应用于其他神经退行性疾病的治疗,如阿尔茨海默病。梯瓦制药已启动第二阶段临床试验。在2021年第四季度,梯瓦制药向Modag支付了$10百万作为研发费用。Modag可能有资格获得未来额外的开发里程碑付款,总金额高达$30百万,以及未来的商业里程碑和版税。
Alvotech
在2020年8月,梯瓦与生物制药公司ALVAOTECH签订了协议,独家在美国商业化五种生物仿制药产品候选者。此次合作的初步管道包含了针对多个治疗领域的生物仿制药候选者,包括拟商业化的Humira(阿达木单抗)和Stelara(乌司他丁)。
®
(阿达木单抗)和Stelara(乌司他丁)。
®
根据协议条款,ALVAOTECH负责生物仿制药产品候选者的开发、注册和供应,而梯瓦将在美国独家商业化这些产品。2023年7月,ALVAOTECH和梯瓦修改了他们的合作协议,增加了两个新的生物仿制药候选者以及两个当前生物仿制药候选者的延伸。
梯瓦在2020年、2021年和2023年共计支付了总额为$的前期及里程碑付款。78梯瓦在2024年第二季度额外支付了$的里程碑付款,以及$27192024年第三季度达到百万。额外的开发和商业里程碑付款可能高达约$380百万,以及与2023年7月签订的合作协议修订相关的特许权使用费和里程碑付款,可能在未来几年由梯瓦制药支付。梯瓦制药与ALFA将分享这些生物仿制药的营业收入。
2023年7月签订的合作协议修订包括梯瓦制药在ALFA的制造设施中对制造和质量的更大参与。此外,根据该修订,2023年9月29日,梯瓦制药购买了$40 百万的ALFA的次级可转债。2024年6月26日,ALFA宣布其行使赎回权的意图,并以$44 百万(包括应计利息)赎回该可转债,并于2024年7月支付给梯瓦制药。
2024年2月24日,ALFA和梯瓦制药宣布FDA批准了SIMLANDI
®
(阿达木单抗-ryvk)注射液,作为Humira的可互换生物仿制药
®
用于治疗成人类风湿关节炎、青少年特发性关节炎、成人银屑病关节炎、成人强直性脊柱炎、克罗恩病、成人溃疡性结肠炎、成人斑块状银屑病、成人腋下脓皮病和成人葡萄膜炎。2024年4月17日,Alvotech与梯瓦制药修订了合作协议,允许Quallent从Alvotech购买用于美国市场的私标adalimumab-ryvk注射剂,Alvotech将与梯瓦分享私标销售的利润。2024年5月20日,Alvotech与梯瓦制药宣布SIMLANDI在美国上市。
 
15

梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
 
关于拟议的Stelara生物仿制药
®
2023年6月12日,Alvotech和梯瓦制药与强生达成了和解和许可协议,允许在美国的许可进入日期不晚于 2025年2月21日.
2024年4月16日,Alvotech和梯瓦制药宣布FDA批准了SELARSDI
TM
(ustekinumab-aekn)注射液用于皮下使用,作为Stelara的生物类似药
®
, 用于治疗中度至重度斑块型牛皮癣以及适用于6岁及以上的成年人和儿童患者的活动性银屑病关节炎,并于2024年10月22日宣布FDA批准在新的剂型中销售SELARSDI,130 mg/26 mL (5 mg/mL) 单剂量小瓶的静脉输注溶液,扩大其标签以包括对克罗恩病和溃疡性结肠炎成年患者的治疗。
武田制药
2016年12月,梯瓦制药与武田制药有限公司的子公司(“武田”)签署了许可证协议,用于ATTENUKINE的研究、开发、制造和商业化技术。
TM
梯瓦收到了$30百万的预付款和2017年$20百万的里程碑付款。在2022年第二季度,武田启动了modakafusp alfa(以前称为
TAk-573
或TEV '573)的2期研究,并因此向梯瓦支付了$25百万的里程碑付款,该款项在2022年第二季度确认作为营业收入。2024年4月,武田通知梯瓦其打算终止与该产品候选人的协议,该产品权利将在2025年初归还给梯瓦。武田继续在许可证协议下拥有其他产品候选人的权利。
MedinCell
2013年11月,梯瓦与MedinCell达成协议,开发和商业化多种长效注射剂(“LAI”)产品。梯瓦负责临床开发和监管流程,并负责这些产品的商业化。主要产品是利斯吡坦长效注射剂(原名为
TV-46000)。
2023年4月28日,美国FDA批准了UZEDY
®
(利斯吡坦)缓释注射悬液,用于治疗成年人的精神分裂症,该产品于2023年5月在美国上市。MedinCell可能有资格获得未来基于销售额的里程碑奖励,最高可达$105 百万,关于UZEDY的销售。梯瓦还向MedinCell支付净销售的版税。
第二个选定的产品候选是奥氮平LAI
(TEV-’749)
用于治疗精神分裂症。2022年第三季度,梯瓦决定将该产品的开发推进到第三阶段,因此向MedinCell支付了$3百万的里程碑付款,这被视为研发费用。2024年5月8日,梯瓦和MedinCell宣布了评估氟哌啶醇长效注射剂在成年精神分裂症患者中作为每月一次的皮下长效注射剂的第3阶段积极效果结果。预计在2025年上半年将发布额外的安全性和有效性结果。MedinCell可能有资格获得进一步的开发和商业里程碑,总额可达$108百万,以及氟哌啶醇长效注射剂的销售版税
(TEV-’749)
待出售的资产和负债:
一般
截至2024年9月30日和2023年12月31日的待出售资产和负债,包括梯瓦国际市场部门的一些业务,预计将在明年内出售,主要是日本的业务创业公司。
关于
出售分类中,在2024年第一季度,梯瓦制药录得费用$577百万由于预计出售损失,包括$369百万来自于出售时将货币翻译调整重新分类到收入报表的预计损失,以及其他资产减值、重组和其他项目。在2024年第二季度,梯瓦制药又记录了$67百万与上述提到的货币翻译调整重新分类的预计损失相关。在2024年第三季度,梯瓦制药录得了$83百万的有利调整,主要与上述提到的货币翻译调整重新分类的预计损失变动有关。请参阅第12条。
 
16

梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
下表总结了截至2024年9月30日和2023年12月31日,所有梯瓦的资产和负债(作为待售资产):
 
    
9月30日,
    
12月31日,
 
    
2024
    
2023
 
    
(以百万美元计算)
 
存货
     169        12  
应收账款
     123         
商誉
     48        30  
可识别的无形资产净值
     67         
物业、厂房及设备,净值
     10        5  
其他流动和
非流动
资产
     40        23  
预计销售损失*
     (455       
  
 
 
    
 
 
 
合并资产负债表中分类为待售的处置组的总资产
   $ 2      $ 70  
  
 
 
    
 
 
 
应付账款
     (76       
其他负债
     (34      (13
预计销售损失*
     (106       
  
 
 
    
 
 
 
合并资产负债表中分类为待售的处置组的总负债
   $ (216    $ (13
  
 
 
    
 
 
 

*
包括由于销售而将货币折算调整重新分类至合并损益表的预计损失。
 
17

目录
梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
注释 3 – 来自客户合同的营业收入:
报告对营收的分解不同服务类型,主要行业板块,合同类型和地理分布进行了分解。
下表将梯瓦的营业收入按主要营业收入来源进行了细分。有关营业收入细分的更多信息,请参见注释 15。
 
 
  
截至2024年9月30日的三个月
 
 
  
美国
 
  
欧洲
 
  
国际
市场
 
  
其他活动
 
  
总计
 
 
  
(百万美元)
 
商品销售
     1,822        1,214       568        121        3,794  
许可安排
     23        9       6        8        45  
分配
     380        §       10               390  
其他
     §        42       29        100        102  
  
 
 
    
 
 
   
 
 
    
 
 
    
 
 
 
   $ 2,225      $ 1,265     $   613      $ 229      $ 4,332  
  
 
 
    
 
 
   
 
 
    
 
 
    
 
 
 

§
代表小于50万美元的金额。
 
    
截至2023年9月30日的三个月
 
    
美国
    
欧洲
   
国际
市场
    
其他活动
    
总计
 
    
(百万美元)
 
商品销售
     1,500        1,117       556        130        3,303  
许可安排
     30        13       9        1        53  
分配
     366        §       11               377  
其他
     §        15        15        86        117  
  
 
 
    
 
 
   
 
 
    
 
 
    
 
 
 
   $ 1,896      $ 1,146     $   591      $ 217      $ 3,850  
  
 
 
    
 
 
   
 
 
    
 
 
    
 
 
 

§
代表低于50万美元的金额。
 
    
截至2024年9月30日的九个月
 
    
美国
    
欧洲
   
国际
市场
    
其他活动
    
总计
 
    
(以百万美元计)
 
商品销售
     4,857        3,668       1,708        399        10,701  
许可协议
     68        26       17        10        121  
分配
     1,134        §       28               1,163  
其他
     §        54        49        295        330  
  
 
 
    
 
 
   
 
 
    
 
 
    
 
 
 
   $ 6,060      $ 3,749     $ 1,802      $ 703      $ 12,315  
  
 
 
    
 
 
   
 
 
    
 
 
    
 
 
 

§
表示金额少于50万美元。
 
18

梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
    
截至2023年9月30日的九个月
 
    
美国
    
欧洲
    
国际
市场
    
其他活动
    
总计
 
    
(以百万美元计)
 
商品销售
     4,210        3,446        1,656        412        9,724  
许可安排
     72        38        21        4        134  
分配
     1,183        §        29               1,212  
其他
     §        8        44        265        318  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
   $ 5,465      $ 3,493      $ 1,750      $ 681      $ 11,389  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
 
§
表示金额低于50万美元。 
变量考虑
变量考虑主要包括销售准备金和减免(“SR&A”),包括折扣(包括医疗补助和其他政府计划折扣)、回扣、退货和其他促销(包括货架库存调整)项目。及时付款折扣的准备金从应收账款中抵消。
公司在销售时确认这些准备金,并在实际数额与估计准备金不同的情况下进行调整。
截至2024年9月30日,SR&A对美国客户的占比约为 67%,其余的余额主要与加拿大和德国的客户有关。2024年和2023年截至9月30日的第三方销售SR&A变动如下:
 
    
销售准备金和减免
 
    
储备
包含在内
账户
应收账款净额
   
折扣
   
医疗补助和
其他
政府的
津贴
   
退款
   
收益
   
其他
   
总储备
包含于
销售储备
和减免
   
总计
 
    
(以百万美元计算)
 
2024年1月1日的余额
   $ 61     $ 1,603     $ 540     $ 859     $ 436     $ 97     $ 3,535     $ 3,596  
与本年度销售相关的准备金
     294       3,436       579       5,925       191       146       10,277       10,571  
与以前年度销售相关的准备金
           16       26       (11     (28     (2     1       1  
信用和支付
     (292     (3,269     (556     (5,877     (209     (121     (10,032     (10,324
翻译差异
           1       3       1       (1           4       4  
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
截至2024年9月30日的余额
   $ 63     $ 1,787     $ 592     $ 897     $ 389     $ 120     $ 3,785     $ 3,848  
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
19

梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
 
    
销售准备金和补助
 
    
储备
包含在
账户
应收款,净额
   
折扣
   
医疗补助和
其他
政府的
津贴
   
扣款
   
收益
   
其他
   
总储备
包括在
销售准备金
和让步
   
总计
 
                                                  
    
(以百万美元计)
 
截至2023年1月1日的余额
   $ 67     $ 1,575     $ 663     $ 991     $ 455     $ 66     $ 3,750     $ 3,817  
与当前年度内销售有关的准备金
     262       2,968       468       5,636       205       73       9,350       9,612  
与以前期间销售有关的准备金
           (22     (33     (21     24             (52     (52
信用和付款
     (268     (2,989     (617     (5,768     (251     (53     (9,678     (9,946
翻译差异
           (8     (2     (3           (6     (19     (19
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
截至2023年9月30日的余额
   $ 61     $ 1,524     $ 479     $ 835     $ 433     $ 80     $ 3,351     $ 3,412  
  
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
20

目录
梯瓦制药有限公司
合并财务报表注释
(未经审核)
 
注释 4 - 库存:
库存净额由以下部分组成:
 
    
9月30日,
    
12月31日,
 
    
2024
    
2023
 
    
(以百万美元计)
 
成品
   $ 2,314      $ 2,346  
原材料和封装材料
     926        993  
在制品
     524        500  
在途材料和账户支付
     195        183  
  
 
 
    
 
 
 
   $ 3,959      $ 4,021  
  
 
 
    
 
 
 
注释5 - 可识别的无形资产:
可识别的无形资产包括以下内容:
 
    
毛额净额
减值
    
累计摊销
    
净账面价值
 
    
9月30日,
    
12月31日,
    
9月30日,
    
12月31日,
    
9月30日,
    
12月31日,
 
    
2024
    
2023
    
2024
    
2023
    
2024
    
2023
 
    
(以百万美元计)
 
产品权益
   $ 16,408      $ 17,981      $ 12,235      $ 13,274      $ 4,173      $ 4,707  
商标名称
     586        583        296        269        290        314  
在研开发
     294        366                      294        366  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
总计
   $ 17,287      $ 18,930      $ 12,531      $ 13,543      $ 4,756      $ 5,387  
  
 
 
    
 
 
    
 
 
    
 
 
    
 
 
    
 
 
 
产品权益和商标
产品权益和商标作为资产按摊销成本呈现。产品权益和商标代表了来自多项收购的多种治疗类别的药品组合,平均使用寿命约为 9 年。
无形资产的摊销为$146百万和$145截至2024年和2023年9月30日的三个月内,金额为百万。
无形资产的摊销为$444百万和$471截至2024年和2023年9月30日的九个月内,金额为百万。
药品研发
梯瓦的药品研发是尚未在其主要市场获得批准的资产。药品研发存在固有风险,资产可能无法在爱文思控股阶段成功,并可能在未来期间受损。
无形资产减值
截至2024年9月30日和2023年9月30日的三个月内,长期无形资产减值为$28百万和$47百万,分别为。
2024年第三季度的减值包括:
可识别的产品权利为$28百万,主要由于对主要在美国市场产品的价格和成交量的市场假设更新。
 
21

梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
 
2023年第三季度的减值包括:
 
  (a)
知识产权与研发资产为$29百万,主要是由于来自于开发进展的仿制药管线产品以及其他关键估值指标的变化(例如:市场规模、竞争假设、法律环境和上市日期);以及
 
  (b)
可识别的产品权利为$18百万,主要是由于对产品价格和成交量的市场假设更新。
截至2024年9月30日和2023年的九个月内,长期无形资产减值为$169百万和$289百万,分别为。
2024年前九个月的减值包括:
 
  (a)
可识别的产品权利为$136百万,由于关于美国市场主要产品的价格和成交量的市场假设更新所致;以及
 
  (b)
知识产权与研发资产为$33百万,主要由于来自开发进展的仿制药管线产品和美国市场中其他关键估值指标的变化(例如,市场规模、竞争假设、法律环境和上市日期)。
2023年前九个月的减值包括:
 
  (a)
可识别的产品权利为$206百万,原因包括:(i)$112百万,主要由于日本的监管价格降低;以及(ii)$94百万,涉及对产品价格和成交量的更新市场假设;以及
 
  (b)
知识产权与研发资产为$83百万,主要由于来自于开发进展的仿制药管线产品及其他关键估值指标(如市场规模、竞争假设、法律环境和上市日期)的变化。
截至2024年9月30日的九个月内,减值无形资产的公允价值计量基于市场中显著不可观察的输入,因此在公允价值层次结构中代表了水平3计量。所应用的折现率范围为 8.5% 到 10%. 成功概率因素为 90% 被用于公允价值计算,以反映IPR&D固有的监管和商业风险。
 
22

目录
梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
 
注意事项 6 – 商誉:
截至2024年9月30日的期间内,商誉的账面价值变动情况如下:
 
 
  
北部
美国
 
 
联合
 
  
欧洲
 
  
国际
市场
 
 
其他
 
  
总计
 
 
 
梯瓦的
API
 
 
美迪斯
 
 
  
 
 
 
(以百万美元计算)
 
 
 
 
截至2023年12月31日的余额(1)
   $ 6,459     $      $ 8,466      $ 675     $ 1,313     $ 265      $ 17,177  
与加拿大转向国际市场相关的商誉分配
     (6,459     5,813               646                     
  
 
 
   
 
 
    
 
 
    
 
 
   
 
 
   
 
 
    
 
 
 
截至2024年1月1日的余额
   $     $ 5,813      $ 8,466      $ 1,321     $ 1,313     $ 265      $ 17,177  
  
 
 
   
 
 
    
 
 
    
 
 
   
 
 
   
 
 
    
 
 
 
期间的其他变动:
                 
商誉减值
                               (1,000 )
 
           (1,000 )
重分类为待售资产的商誉
                         (29                  (29
翻译差异及其他
                  97        (131     5       4        (25
  
 
 
   
 
 
    
 
 
    
 
 
   
 
 
   
 
 
    
 
 
 
截至2024年9月30日的余额(1)
   $     $ 5,813      $ 8,563      $ 1,161     $ 318     $ 269      $ 16,124  
  
 
 
   
 
 
    
 
 
    
 
 
   
 
 
   
 
 
    
 
 
 

(1)
截至2024年9月30日和2023年12月31日累计的商誉减值约为$29.3十亿美元,以及$28.3十亿,分别为。
梯瓦通过三个报告板块运营其业务:美国、欧洲和国际市场。每个业务板块都是一个报告单元。其他报告单元包括梯瓦向第三方生产和销售的原料药(“梯瓦 API”)以及一个
外许可
通过其附属公司Medis向其他药品公司提供产品组合的平台。梯瓦的API和Medis报告单元在上表中的“其他”下列出。有关其他板块信息,请参见附注15。
梯瓦制药使用收入法来判断其报告单位的公允价值。收入法是一种前瞻性的方法,用于估算公允价值。在收入法中,采用的方法是折现现金流法。梯瓦制药从预测与报告单位相关的所有预期净现金流开始,包括终值的应用,然后应用折现率得出净现值。现金流预测基于梯瓦制药对营业收入增长率和经营利润率的估算,考虑了行业和市场条件。使用的折现率基于加权平均资本成本(“WACC”),并为与特定国家和特定业务相关的风险进行了调整。如果这些预期中的任何一项与梯瓦的假设存在实质性差异,梯瓦可能会在未来记录分配给这些报告单位的商誉减值。
第一季度的发展
如第15注进一步讨论的,截至2024年1月1日,加拿大被报告为梯瓦的国际市场板块的一部分,而不再作为梯瓦的北美板块的一部分,该板块已更名为梯瓦的美国板块。因此,梯瓦根据这一变化调整了其分部报告及其报告单位,并使用相对公允价值分配重新分配了其商誉。与商誉重新分配一起,梯瓦对调整后的美国和国际市场报告单位的余额进行了商誉减值测试,并得出结论认为每个报告单位的公允价值超过其账面价值。
在2024年第一季度,管理层评估了该季度是否发生了任何发展,以判断其任何报告单位的公允价值是否在2024年3月31日低于其账面金额。管理层得出结论认为没有触发事件发生,因此没有进行定量评估。
第二季度动态
在2024年第二季度,梯瓦完成了其长期规划(“LRP”)过程。LRP是梯瓦内部财务规划和预算过程的一部分,并由梯瓦管理层及董事会讨论和审核。
 
23

梯瓦制药工业有限公司
合并财务报表注释
(未经审核)
 
此外,梯瓦在进行年度商誉减值测试时,借助独立评估专家对所有报告单位进行了定量分析。
如之前所披露的,截止到2023年12月31日和2024年3月31日,梯瓦的API报告单位的估计公允价值超过其估计账面价值的部分微不足道。2024年第二季度进行的更新定量分析,基于上述LRP过程和梯瓦的增长转型策略假设,确认了商誉减值费用为$400与梯瓦制药的API报告单位相关的百万。
在与梯瓦制药的API报告单位相关的商誉减值费用记录后,截止2024年6月30日,该报告单位的账面价值等于其公允价值。因此,如果商业环境或预期发生重大变化,可能需要在未来对梯瓦制药的API报告单位记录进一步的减值费用(见下方“第三季度发展”)。
梯瓦制药的美国、欧洲、国际市场和Medis报告单位的公允价值超过了 10%,截至2024年6月30日,其账面价值。
在2023年第二季度,梯瓦制药记录了与其国际市场报告单位相关的商誉减值费用,金额为$700与其国际市场报告单位相关的百万,主要由于由于与多个国家特定特征相关的风险增加,折现率上升。
第三季度发展
在2024年第三季度,管理层评估在该季度是否发生了任何发展,以判断截至2024年9月30日其任何报告单位的公允价值是否低于其账面金额的可能性。
作为此次评估的一部分,管理层注意到与梯瓦制药的API报告单元相关的触发事件,这源于对梯瓦制药意图通过出售剥离其API业务的假设更新。
梯瓦制药在2024年第三季度进行了定量评估,导致录得一项关于商誉减值的费用,金额为$600 百万美元,与梯瓦制药的API报告单元相关。
在这项商誉减值费用之后,截至2024年9月30日,梯瓦制药的API报告单元的账面价值与公允价值相等。因此,如果商业条件或预期,包括与梯瓦制药意图剥离其API业务相关的预期,发生实质性变化,可能需要在未来对梯瓦制药的API报告单元记录进一步的减值费用。
关于剩余的报告单元,管理层得出结论,截至2024年9月30日,任何报告单元的公允价值低于其账面价值的可能性并不大,因此没有进行定量评估。
备注7 – 债务义务:
 
a.
短期债务:
 
    
截至的利率
2024年9月30日
   
到期
    
9月30日,
    
12月31日,
 
    
2024
    
2023
 
                 
(以百万美元计算)
 
可转换高级债券
     0.25     2026        23        23  
长期负债的当前到期部分
 
     2,557        1,649  
  
 
 
    
 
 
 
所有短期债务
 
   $ 2,580      $ 1,672  
  
 
 
    
 
 
 
可转换高级债券
梯瓦制药的本金金额为 0.25到期于2026年的可转换高级债券的本金金额为$23截至2024年9月30日和2023年12月31日的金额为 百万。这些可转换高级债券包括一个“净股权结算”功能,根据该功能,将以现金支付本金金额,并且在转换的情况下,只有超过本金金额的剩余转换价值会以梯瓦制药的股票支付。由于“净股权结算”功能,这些可转换高级债券可以在任何时候行使,因此在资产负债表中被归类为‘短期债务’。
 
24

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
b.
Long-term debt:
 
    
Interest rate as of
September 30, 2024
   
Maturity
    
September 30,
2024
   
December 31,
2023
 
                 
(U.S. $ in millions)
 
Senior notes USD 1,250 million (4)
     6.00     2024              956  
Senior notes EUR 1,500 million (5)
     1.13     2024        700       693  
Senior notes EUR 1,000 million
     6.00     2025        459       453  
Senior notes USD 1,000 million
     7.13     2025        427       427  
Senior notes EUR 900 million
     4.50     2025        554       547  
Senior notes CHF 350 million
     1.00     2025        417       416  
Senior notes USD 3,500 million
     3.15     2026        3,374       3,374  
Senior notes EUR 700 million
     1.88     2027        781       771  
Sustainability-linked senior notes USD 1,000 million (1)(*)
     4.75     2027        1,000       1,000  
Sustainability-linked senior notes EUR 1,100 million (1)(*)
     3.75     2027        1,229       1,215  
Senior notes USD 1,250 million
     6.75     2028        1,250       1,250  
Senior notes EUR 750 million
     1.63     2028        834       826  
Sustainability-linked senior notes USD 1,000 million (2)(*)
     5.13     2029        1,000       1,000  
Sustainability-linked senior notes USD 600 million (3)(*)
     7.88     2029        600       600  
Sustainability-linked senior notes EUR 800 million (3)(*)
     7.38     2029        895       884  
Sustainability-linked senior notes EUR 1,500 million (2)(*)
     4.38     2030        1,676       1,656  
Sustainability-linked senior notes USD 500 million (3)(*)
     8.13     2031        500       500  
Sustainability-linked senior notes EUR 500 million (3)(*)
     7.88     2031        558       552  
Senior notes USD 789 million
     6.15     2036        783       783  
Senior notes USD 2,000 million
     4.10     2046        1,986       1,986  
       
 
 
   
 
 
 
Total senior notes
          19,023       19,889  
Other long-term debt
          2       1  
Less current maturities
          (2,557     (1,649
Less debt issuance costs
          (68     (80
       
 
 
   
 
 
 
Total senior notes and loans
        $ 16,400     $ 18,161  
       
 
 
   
 
 
 
 
(1)
If Teva fails to achieve 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 rate shall increase by
0.125%-0.375%
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 April 2024, Teva repaid $956 million of its 6% senior notes due 2024 at maturity.
(5)
In October 2024, Teva repaid $685 million of its 1.13% senior notes due 2024 at maturity.
*
Interest rate adjustments and a potential
one-time
premium payment related to the sustainability-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 any. The long-term debt outlined in the above table is generally redeemable at any time at varying redemption prices plus accrued and unpaid interest.
 
25

TEVA
PHARMACEUTICAL
INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
Teva’s debt as of September 30, 2024 was effectively denominated in the following currencies: 58% in U.S. dollars, 40% in euro and 2% in Swiss franc.
Teva’s 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 revolving credit facility entered into in April 2022, as amended on February 6, 2023 and on May 3, 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 contains 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 Company’s maximum permitted leverage ratio under the RCF for certain periods. Under the terms of the RCF, as amended, the Company’s leverage ratio shall not exceed (i) 4.00x in 2024, 2025 and in the first quarter of 2026, (ii) 3.75x in the second, third and fourth quarters of 2026 and (iii) 3.50x in the first quarter of 2027 and onwards. The RCF 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 submissions 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 September 30,
2024
, and as of the date of this Quarterly Report on Form
10-Q,
no amounts were outstanding under the RCF. Based on current and forecasted 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 unavailability 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 threshold 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 Company’s senior notes and sustainability-linked senior notes due to cross-acceleration provisions.
Teva expects that it will continue to have sufficient 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 nine months of 2024, approximately 47% of Teva’s 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 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, Japanese yen, British pound, Russian ruble, Canadian dollar, Polish zloty, 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 foreign subsidiaries net assets (“net investment hedge”) and has in the past entered into cross-currency swaps and forward-contracts 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 Company does not enter into derivative transactions for trading purposes.
 
26

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
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 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 other than the functional currency (“cash flow hedge”), thereby reducing overall interest expenses or hedging risks associated with interest rate fluctuations. As of September 30, 2024, all outstanding senior notes, sustainability-linked senior notes and convertible debentures bear a fixed interest rate.
 
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 upon 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 September 30, 2024, the fair value of these derivative instruments is negligible.
d. Derivative instruments outstanding:
The following table summarizes the notional amounts for hedged items, when transactions are designated as hedge accounting:
 
    
September 30,
    
December 31,
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Cross-currency swap - cash flow hedge (1)
   $      $ 169  
  
 
 
    
 
 
 
The following table summarizes the classification and fair values of derivative instruments:
 
    
Fair value
 
    
Designated as hedging

instruments
    
Not designated as hedging

instruments
 
    
September 30,

2024
    
December 31,

2023
    
September 30,

2024
    
December 31,

2023
 
Reported under
  
(U.S. $ in millions)
    
(U.S. $ in millions)
 
Asset derivatives:
           
Other current assets:
           
Option and forward contracts
   $      $      $ 32      $ 38  
Other
non-current
assets:
           
Cross-currency swap-cash flow hedge (1)
            8                
Liability derivatives:
           
Other current liabilities:
           
Option and forward contracts
                   (33      (39
 
27

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 designated in cash flow hedging relationships:
 
    
Financial expenses, net
    
Other comprehensive income
(loss)
 
    
Three months ended,
    
Three months ended,
 
    
September 30,

2024
    
September 30,
2023
    
September 30,

2024
    
September 30,
2023
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
   $ 272      $ 280      $ 180      $ (249
Cross-currency swaps - cash flow hedge (1)
            (7             1  
    
Financial expenses, net
    
Other comprehensive income
(loss)
 
    
Nine months ended,
    
Nine months ended,
 
    
September 30,

2024
    
September 30,
2023
    
September 30,

2024
    
September 30,
2023
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
   $ 763      $ 808      $ (75    $ (156
Cross-currency swaps - cash flow hedge (1)
     (8      (22      1        (4
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,
    
Three months ended,
 
    
September 30,
2024
    
September 30,
2023
    
September 30,
2024
    
September 30,
2023
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
   $ 272      $ 280      $ (4,332    $ (3,850
Option and forward contracts (2)
     4        4                
Option and forward contracts economic hedge (3)
                   9        (22
    
Financial expenses, net
    
Net revenues
 
    
Nine months ended,
    
Nine months ended,
 
    
September 30,
2024
    
September 30,
2023
    
September 30,
2024
    
September 30,
2023
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
   $ 763      $ 808      $ (12,315    $ (11,389
Option and forward contracts (2)
     (33      (46              
Option and forward contracts economic hedge (3)
                   (1      (20
 
28

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 

(1)
On March 31, 2023, Teva entered 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 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 losses 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, Japanese yen, British pound, Russian ruble, Canadian dollar, Polish zloty and some other currencies to protect its projected operating results for 2024. These derivative instruments do not meet the criteria for hedge accounting, however, they are accounted for as an economic hedge. These derivative 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 months ended September 30, 2024, the negative impact from these derivatives recognized under revenues was $9 million. In the nine months ended September 30, 2024, the positive impact from these derivatives recognized under
revenues
was $1 million. In the three months ended September 30, 2023, the positive impact from these derivatives recognized under
revenues
was $22 million. In the nine months ended September 30, 2023, the positive impact from these derivatives recognized under revenues was $20 million. Changes in the fair value of the derivative instruments are recognized 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:
Forward-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 interest 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 debt.
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 September 30, 2024 and 2023, and losses of $21 million and $25 million were recognized under financial expenses, net for each of the nine months ended September 30, 2024 and 2023, respectively.
 
 
f.
Securitization:
U.S. securitization program
On November 7, 2022, Teva and a bankruptcy-remote 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 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 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 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 participating 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.
 
29

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
Pledged accounts receivables
In connection with the U.S. securitization program, accounts receivables, net of allowance for credit losses, include $934 million and $437 million as of September 30, 2024 and December 31, 2023, respectively, which are pledged by the SPV to PNC.
 
 
g.
Supplier Finance Program 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. Teva’s suppliers negotiate their financing agreements 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 generally 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 supplier finance program are recorded under accounts
payables
in Teva’s consolidated balance sheets. As of September 30, 2024 and December 31, 2023, respectively, $163 million and $108 million of
accounts payables to suppliers participating
 in these supplier finance programs were outstanding.
NOTE 9 – Legal settlements and loss contingencies:
In the third quarter of 2024, Teva recorded expenses of $450 million in legal settlements and loss contingencies, compared to expenses of $314 million in the third quarter of 2023. Expenses in the third quarter of 2024 were mainly related to
a decision by the European Commission in its antitrust investigation into COPAXONE
®
, and
an update to the estimated settlement provision for the opioid cases (mainly related to the settlement agreement with the city of Baltimore and the effect of the passage of time on the net present value of the discounted payments). Expenses in the third quarter of 2023 were mainly related to an update to the provision for the DOJ patient assistance program litigation, as well as an update to the estimated settlement provision of the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments). See note 10.
In the first nine months of 2024, Teva recorded expenses of $638 million in legal settlements and loss contingencies, compared to $1,009 million in the first nine months of 2023. Expenses in the first nine months of 2024 were mainly related to a decision by the European Commission in its antitrust investigation into COPAXONE, and an update to the estimated settlement provision for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments and the settlement agreement with the city of Baltimore). Expenses in the first nine months of 2023 were mainly related to an estimated provision for the DOJ patient assistance program litigation, an update to the estimated settlement provision of the opioid cases, the provision for the settlement of the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products, as well as the provision for the settlement of the reverse-payment antitrust litigation over certain HIV medicines.
As of September 30, 2024 and December 31, 2023, Teva’s provision for legal settlements and loss contingencies recorded under accrued expenses and other taxes and long-term liabilities was $4,915 million and $4,771 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 described 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 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, management’s assessments of the likelihood of damages, and the advice of legal counsel, no material 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, management’s assessments involve complex judgments about future events and often rely 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 substantially resolved.
 
30

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
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 defending its positions even if the facts and circumstances of a particular litigation do not give rise to a provision in the consolidated financial statements.
In connection with third-party agreements, Teva may 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, Teva’s agreements with third parties may require Teva to indemnify them, or require them to indemnify Teva, for the costs 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 IQVIA 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 expiration of the originator’s 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 Act (“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 the originator’s 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, 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 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 involve any of Teva’s 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 compensated for its lost profits. The amount of a reasonable royalty award would generally be calculated based on the sales of Teva’s product. The amount of lost profits would generally be based on the lost sales of the patentee’s product. In addition, the patentee may seek consequential damages as well 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 concerning 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 the 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 GSK’s Coreg
®
) in September 2007. A jury returned a verdict in GSK’s 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 denied Teva’s appeal for a rehearing. The case has been remanded to the district court for further proceedings on Teva’s other legal and equitable defenses that have not yet been considered by the district court. Teva recognized a provision based on its offer to settle the matter.
 
31

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
In January 2021, Teva initiated a patent invalidity action against the compound patent and Supplementary Protection Certificate (“SPC”) asserted to cover Bristol-Myers Squibb Company’s (“BMS”) Eliquis
®
(apixaban). In May 2022, the U.K. High Court held that the compound patent and SPC are invalid and Teva began selling its generic version of Eliquis
®
(apixaban). In May 2023, the U.K. Court of Appeal upheld this decision and denied BMS’s request to appeal to the U.K. Supreme Court. On October 31, 2023, the U.K. Supreme Court denied BMS’s application for further review, making the decision to revoke the compound patent and SPC final. Separately, in February 2021, Teva initiated a patent invalidity action against the formulation patents, which are also under opposition at the European Patent Office (“EPO”). On July 15, 2022, the U.K. High Court held that these formulation patents were invalid but granted permission to appeal, which was subsequently stayed pending the outcome of the opposition at the EPO to one of the formulation patents. On December 21, 2023, the EPO’s Technical Board of Appeal held its hearing on the opposition, and on March 13, 2024, it issued a written decision revoking the patent. On May 13, 2024, BMS filed a submission to the Enlarged Board of Appeal seeking its permission to review the Technical Board of Appeal’s decision, a hearing for which is scheduled for December 3, 2024.
Product Liability Litigation
Teva’s business inherently exposes it to potential product liability claims. Teva maintains a program of insurance, which may include commercial 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 covered 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, Teva 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.
Teva and its subsidiaries are parties to litigation relating to previously unknown nitrosamine impurities discovered in certain products. The discovery led to a global recall of single and combination valsartan medicines around the world starting in July 2018 and to subsequent recalls on other products. The nitrosamine impurities in valsartan were allegedly found in the active pharmaceutical ingredient (“API”) supplied to Teva by multiple API manufacturers, including by Zhejiang Huahai Pharmaceuticals Co. Ltd. Since July 2018, Teva has been actively engaged with global regulatory authorities in reviewing its sartan and other products to determine whether NDMA and/or other related nitrosamine impurities are present in specific products. Where necessary, Teva has initiated additional voluntary recalls.
Multiple lawsuits have been filed in connection with this matter. Teva’s products allegedly at issue in the various nitrosamine-related litigations pending in the United States include valsartan, losartan, metformin and ranitidine. There are currently two Multi-District Litigations (“MDL”) pending against Teva and other manufacturers, including one MDL in the U.S. District Court for the District of New Jersey related to, with respect to Teva, valsartan and losartan, and another MDL in the U.S. District Court for the Southern District of Florida related to ranitidine. The claims against Teva in these MDLs include individual personal injury and/or product liability claims, economic damages claims brought by consumers and end payors as putative class actions, and medical monitoring class claims. The district court in the valsartan MDL certified a series of subclasses on plaintiffs’ economic loss claims as well as a medical monitoring class and originally scheduled the first trial to commence in the fourth quarter of 2024, but that trial has been postponed indefinitely by the court. Discovery is ongoing in the MDL with respect to the losartan claims against Teva. The claims against Teva and other generic manufacturers in the ranitidine MDL have been dismissed on preemption grounds but are subject to appeal. The district court in the ranitidine MDL also excluded all of plaintiffs’ general causation experts and granted summary judgment to the brand defendants on preemption grounds and later applied that general causation ruling to all defendants. This ruling is on appeal in the Eleventh Circuit Court of Appeals.
Certain generic manufacturers, including Teva, have also been named in state court actions asserting allegations similar to those in the aforementioned MDLs. In particular, state court valsartan and losartan actions are pending but currently stayed in New Jersey and Delaware, with the exception of a single-plaintiff case that was later refiled in a New Jersey state court in October 2022 and is in the very initial stages of discovery. State court ranitidine cases naming Teva are also pending in coordinated proceedings in California and Pennsylvania. Teva was dismissed from all ranitidine claims pending in Illinois based on preemption grounds, which plaintiffs have appealed for final judgments as to all remaining defendants. Teva was also dismissed on preliminary objections in Pennsylvania for plaintiffs whose cases are governed by Pennsylvania law, but further motion practice may continue. The litigation in Pennsylvania has effectively been stayed pending a decision on a motion filed by plaintiffs to recuse the presiding judge which was denied but certified for interlocutory appeal.
 
32

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
In addition to the valsartan and ranitidine MDLs and coordinated state court proceedings, Teva has been named in a consolidated proceeding pending 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 Teva’s and other generic manufacturers’ metformin products. The parties are now engaged in discovery related to the surviving metformin claims. Teva was recently named in a related proceeding pending in the same district brought by end payors also seeking economic damages on behalf of a purported class of end payors who purchased Teva’s and other generic manufacturers’ metformin products. This action was consolidated with the original proceeding for discovery and pretrial purposes only. Teva, along with the other defendants, have moved to dismiss the claims in this newly consolidated proceeding. Similar lawsuits are pending in Canada and Germany.
Competition Matters
As part of its generic pharmaceuticals business, Teva has challenged a number of patents covering branded pharmaceuticals, some of which are among the most widely-prescribed and well-known drugs on the market. Many of Teva’s patent challenges have resulted in litigation relating to Teva’s attempts to market generic versions of such pharmaceuticals under the federal Hatch-Waxman Act. Some of this litigation has been resolved through settlement 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 usually 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) significant 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 would 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 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 Teva’s experience to date, 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.
In June 2013, the U.S. Supreme Court held, in Federal 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 the antitrust laws. This test has resulted in increased scrutiny of Teva’s patent settlements, additional action by the FTC and state and local authorities, and an increased risk of liability in Teva’s currently pending antitrust litigations.
In December 2011, three groups of plaintiffs filed claims against Wyeth and Teva for alleged violations of the 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 purchasers 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. On October 16, 2024, Teva and one group of plaintiffs (the “Indirect Purchaser Plaintiffs” or “IPPs”) announced that they have reached an agreement in principle to resolve the IPPs’ claims against Teva. The parties are in the process of documenting the proposed settlement, which will be subject to court approval. Annual sales of Effexor XR
®
were approximately $2.6 billion at the time of settlement and at the time Teva launched its generic version of Effexor XR
®
in July 2010.
 
33

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
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 with 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 filed 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 at 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 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 identical to those of the direct purchasers’ class. On April 24, 2023, the U.S. District Court’s 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-hearing.
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 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 August 2019, certain direct-purchaser plaintiffs filed claims in federal court in Philadelphia against Teva and its affiliates alleging that the September 2006 patent litigation settlement relating to AndroGel
®
1% (testosterone gel) between Watson, from which Teva later acquired certain assets and liabilities, and Solvay Pharmaceuticals, Inc. (“Solvay”) violated antitrust laws. In September 2023, the plaintiffs voluntarily dismissed certain claims, and in September 2024, certain defendants, including the remaining Teva affiliates, and the plaintiffs agreed to settle the remaining claims. The litigation has been stayed pending finalization of the settlements. Annual sales of AndroGel
®
1% were approximately $350 million at the time of the earlier Watson/Solvay settlement and approximately $140 million at the time Actavis launched its generic version of AndroGel
®
1% in November 2015. A provision for this matter was previously included in the financial statements.
Between September 1, 2020 and December 20, 2020, plaintiffs purporting to represent putative classes of direct and indirect purchasers and
opt-out
retailer purchasers of Bystolic
®
(nebivolol hydrochloride) filed complaints in the U.S. District Court for the Southern District of New York against several generic manufacturers, including Teva, Actavis, and Watson, alleging, among other things, that the settlement agreements these generic manufacturers entered into with Forest Laboratories, Inc., the innovator, to resolve patent litigation over Bystolic
®
violated the antitrust laws. The cases were coordinated, and the district court granted the defendants’ motion to dismiss all claims with prejudice. The plaintiffs appealed the district court’s grant of defendants’ motion to dismiss, and on May 13, 2024, the U.S. Court of Appeals for the Second Circuit affirmed the district court’s dismissal with prejudice and issued a mandate on June 4, 2024, formally ending the appeal. The plaintiffs’ period to file a petition for a writ of certiorari to the U.S. Supreme Court expired. Annual sales of Bystolic
®
in the United States were approximately $700 million at the time of Watson’s 2013 settlement with Forest.
In November 2020, the European Commission issued a final decision in its proceedings against both Cephalon and Teva, finding that the 2005 settlement agreement 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 Teva’s grounds of appeal. A provision for this matter was included in the financial statements. 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.
In February 2021, the State of New Mexico filed a lawsuit against Teva and certain other defendants related to various medicines 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 District 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 Teva’s generic versions of Viread
®
and/or Truvada
®
and Atripla
®
, although plaintiffs in the California litigation abandoned any claim for damages relating to the Viread
®
settlement. In May
 
34

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
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 the trial against the 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 a judgment as to all claims against Teva in the California litigation and the plaintiffs have filed notices of appeal with the U.S. Court of Appeals for the Ninth Circuit, and the appeal is currently being briefed. In the New Mexico litigation, on June 27, 2024, Teva and the State of New Mexico finalized their settlement agreement, and the New 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, respectively. 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 assess 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 practices. 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 decision, which Teva intends to appeal, also includes a fine of approximately $500 million (462.6 million euros). In accordance with Accounting Standards Codification 450 “Accounting for Contingencies,” Teva recognized a provision in its financial statements in the third quarter of 2024, based on management’s current best estimate of the outcome within a range of outcomes for the final resolution of this case. Teva intends to provide the European Commission a bank guarantee to cover at least a portion of the fine.
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 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 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 (“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 to dismiss all of the complaints, and on January 22, 2024, Teva’s motion to dismiss the complaint in the District of Vermont was granted as to certain state law claims but was otherwise denied. Decisions on Teva’s remaining motions to dismiss are pending.
On July 15, 2021, the U.K. Competition 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 CMA’s three prior investigations into the supply of hydrocortisone tablets in the U.K., as well as the CMA’s 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 indemnify 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 addition, 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 CMA’s decisions that the prices of hydrocortisone 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 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. Court of Appeal overturned the Tribunal’s 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 have requested permission to appeal to the U.K. Supreme Court and have submitted to the Tribunal additional applications for permission to appeal certain other issues relating to unfair pricing and fines. A provision for the estimated exposure for Teva related to the fines and/or damages has been recorded in the financial statements.
 
35

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
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 New 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 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 additional 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 were transferred to the U.S. District Court for the District of New Jersey and consolidated with the pending consolidated actions. On June 6, 2024, the court granted in full Celgene’s motion to dismiss the Insurer
Opt-Out
Action, but allowed plaintiffs leave to amend most of their claims. The Court had previously administratively terminated Teva’s, Natco’s, and Celgene’s 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’ filed motions to dismiss on October 7, 2024. 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 Court 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 approval. 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, attorneys’ fees and costs. On September 26, 2023, plaintiffs filed a brief in opposition to Teva’s 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 Teva’s motion in part, dismissing plaintiffs’ RICO claims and certain state law claims, but denied Teva’s motion regarding plaintiffs’ antitrust claims. On April 26, 2024, Teva sought certification to seek an interlocutory appeal of the decision, which is still pending. Annual sales of NUVIGIL in the United States were approximately $300 million at the time Teva entered into the first settlement with an ANDA filer in 2012.
In May 2023, certain
end-payor
plaintiffs filed putative class action complaints in the U.S. District Court for the District of Massachusetts against Teva and a number of its affiliates, alleging that Teva engaged in anticompetitive conduct to suppress generic competition to its branded QVAR
®
asthma inhalers in violation of state and federal antitrust laws and state consumer protection laws. Teva moved to dismiss these claims, and on May 7, 2024, the court granted Teva’s motion in part and denied its motion in part. The court dismissed plaintiffs’ claim that Teva had engaged in “sham litigation” and certain of plaintiffs’ state antitrust and consumer protection claims, but permitted the case to proceed on the remainder of plaintiffs’ allegations. Following this decision, two direct purchaser plaintiffs filed similar putative class action complaints in the U.S. District Court for the District of Massachusetts. On June 18, 2024, Teva answered in all cases and simultaneously moved for judgment on the pleadings pursuant to Rule 12(c), which remains pending. Subsequently, on June 28, 2024, Teva stipulated to the dismissal of the two direct purchaser plaintiffs’ claims, with prejudice.
Government Investigations and Litigation Relating to Pricing and Marketing
Teva is involved in government investigations and litigation arising from the marketing and promotion of its pharmaceutical products in the United States.
In 2015 and 2016, Actavis and Teva USA each respectively received subpoenas from the U.S. Department of Justice (“DOJ”) Antitrust Division seeking documents and other information relating to the marketing and pricing of certain Teva USA generic products and communications with competitors about such products. On August 25, 2020, a federal grand jury in the Eastern District of Pennsylvania returned a three-count indictment charging Teva USA with criminal felony Sherman Act violations. The indictment alleged that Teva USA had participated in three separate conspiracies with other
 
36

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
generic drug manufacturers to maintain and fix prices, allocate customers, and other alleged antitrust offenses concerning the sale of generic drugs. The indictment identified the following generic drugs: pravastatin, carbamazepine, clotrimazole, etodolac (IR and ER), fluocinonide (cream,
e-cream,
gel, and ointment), warfarin, nadolol, temozolomide, and tobramycin. On August 21, 2023, Teva USA entered into a
3-year
deferred prosecution agreement (“DPA”) with the DOJ. Under the terms of the DPA, Teva USA: (i) admitted to violating the antitrust laws by agreeing with competitors, in three instances between 2013 and 2015 involving three separate customers, not to bid on an opportunity to supply a customer with a particular generic product (in the first instance pravastatin, in the second clotrimazole, and in the third tobramycin); (ii) agreed to divest the pravastatin that it sells in the United States to a third-party buyer; (iii) agreed to donate $50 million worth of clotrimazole and tobramycin, valued at wholesale acquisition cost (“WAC”), to humanitarian organizations over five years; and (iv) agreed to pay a fine in the amount of $225 million over 5 years, with $22.5 million due each year from 2024 through 2027, and $135 million due in 2028. Teva recognized a provision for the resolution of this case. 
In May 2018, Teva received a civil investigative demand from the DOJ Civil Division pursuant to the federal False Claims Act, seeking documents and information produced since January 1, 2009 relevant to the Civil Division’s investigation concerning allegations that generic pharmaceutical manufacturers, including Teva, engaged in market allocation and/or price-fixing agreements, paid illegal remuneration, and caused false claims to be submitted in violation of the False Claims Act. On October 10, 2024, Teva entered into a settlement agreement with the Civil Division to resolve these allegations. Teva will pay $25 million under the terms of the settlement – $10 million in the fourth quarter of 2024, and $15 million in 2025 – which includes no admission of wrongdoing. Teva has recognized a provision for the resolution of this matter.
In 2015 and 2016, Actavis and Teva USA each respectively received a subpoena from the Connecticut Attorney General seeking documents and other information relating to potential state antitrust law violations. On December 15, 2016, the civil action that was brought by the attorneys general of twenty states against Teva USA and several other companies asserting claims under federal antitrust law alleging price fixing of generic products in the United States was subsequently amended to include 49 states, as well as the District of Columbia and Puerto Rico as plaintiffs, and to add new allegations and state law claims against both Actavis and Teva. On May 10, 2019, most of these attorneys general filed another antitrust complaint against Actavis, Teva and other companies and individuals, which was subsequently amended on November 1, 2019, alleging that Teva was at the center of a conspiracy in the generic pharmaceutical industry and asserting that Teva and others fixed prices, rigged bids, and allocated customers and market share with respect to certain products. On June 10, 2020, most of the same states, with the addition of the U.S. Virgin Islands, filed a third complaint in the U.S. District Court for the District of Connecticut naming, among other defendants, Actavis, in a similar complaint relating to dermatological generics products, and that complaint was later amended to, among other things, add California as a plaintiff.
In the various complaints described above, which also include claims against certain former employees of Actavis and Teva USA, the states seek a finding that the defendants’ actions violated federal antitrust law and state antitrust and consumer protection laws, as well as injunctive relief, disgorgement, damages on behalf of various state and governmental entities and consumers, civil penalties and costs. All such complaints were transferred to the generic drug multidistrict litigation in the Eastern District of Pennsylvania (“Pennsylvania MDL”). On May 7, 2021, the Pennsylvania MDL court chose the attorneys general’s third complaint filed on June 10, 2020, as subsequently amended, to serve as a bellwether complaint in the Pennsylvania MDL, along with certain complaints filed by private plaintiffs. On June 7, 2022, the Court dismissed the attorneys general’s claims for monetary relief under federal law, concluding that the federal statute under which the attorneys general brought suit authorizes injunctive relief only. However, the attorneys general have pending claims for monetary relief under state law. On February 27, 2023, the Court largely denied defendants’ motions to dismiss the federal claims asserted by the attorneys general in their bellwether complaint. Another motion to dismiss related to the state law claims asserted by the attorneys general in their bellwether complaint remains pending.
Teva has settled with the states of Mississippi (in June 2021), Louisiana (in March 2022), Georgia (in September 2022), Arkansas (in October 2022), Florida (in February 2023), Kentucky (in June 2023), South Dakota (in June 2024), and New Mexico (in June 2024). Teva paid each state an amount proportional to its share of the national population (approximately $1,000,000 for each 1% share of the national population), and the states have dismissed their claims against Actavis and Teva USA, as well as certain former employees of Actavis and Teva USA, pursuant to these settlements. These settlements, in addition to the status of ongoing negotiations with several other U.S. state attorneys general to settle on comparable terms, caused management to consider settlement of the claims filed by the remaining
 
37

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
attorneys general to be probable, and management recorded an estimated provision in the third quarter of 2022. The States of Alabama (in March 2022) and Hawaii (in August 2023) and the territories of American Samoa (in July 2020) and Guam (in February 2023) have all voluntarily dismissed all of their claims in the litigation against Actavis and Teva USA. The dismissals by Alabama, Hawaii and Guam were with prejudice and the dismissal by American Samoa was without prejudice.
Beginning on March 2, 2016, and through July 2023, numerous complaints have been filed in the United States on behalf of putative classes of direct and indirect purchasers of several generic drug products, as well as several individual direct and indirect purchaser
opt-out
plaintiffs, including most recently an
opt-out
complaint filed by nine direct-action plaintiffs on April 4, 2024. These complaints, which allege that the defendants engaged in conspiracies to fix prices and/or allocate market share of generic products have been brought against various manufacturer defendants, including Teva USA and Actavis. The plaintiffs generally seek injunctive relief and damages under federal antitrust law, and damages under various state laws. The Pennsylvania MDL court scheduled potential bellwether trials for the putative classes of direct and indirect purchasers of two drugs for August 2024. From 2019 to 2021, certain individual plaintiffs commenced civil actions in the Pennsylvania Court of Common Pleas of Philadelphia County against many of the defendants in the Pennsylvania MDL, including Teva and Actavis. One plaintiff, Aetna Inc., has filed a complaint, and the defendants have moved to place all of the cases filed in the Court of Common Pleas of Philadelphia County in deferred status, which motion remains pending. Certain counties in New York and Texas have also commenced civil actions against many of the defendants in the Pennsylvania MDL, including Teva and Actavis, and the complaints have been transferred to the Pennsylvania MDL.
On January 31, 2024, the attorney generals’ motion to remand their three lawsuits to the District of Connecticut, where they were originally filed, was granted, and on March 18, 2024, the Third Circuit Court of Appeals denied defendants’ petition for
writ of mandamus
. In April 2024, all three of the attorneys general’s lawsuits have been transferred back to the U.S. District Court for the District of Connecticut, which has adopted a schedule for summary judgment in the attorneys general’s third complaint pursuant to which multiple groups of motions will be filed during 2024 and 2025. Fact discovery in the first and second complaints is ongoing.
There is also one similar complaint brought in Canada, which is in its early stages and alleges that the defendants engaged in conspiracies to fix prices and/or allocate market share of generic drug products to the detriment of a class of private payors.
In March 2017, Teva received a subpoena from the U.S. Attorney’s office in Boston, Massachusetts requesting documents related to Teva’s donations to patient assistance programs. In August 2020, the U.S. Attorney’s office in Boston, Massachusetts brought a civil action in the U.S. District Court for the District of Massachusetts alleging causes of action under the federal False Claims Act and for unjust enrichment (the “DOJ PAP Complaint”). It was alleged that Teva’s donations to certain 501(c)(3) charities that provided financial assistance to multiple sclerosis patients violated the Anti-Kickback Statute, and the DOJ sought a maximum of over $1 billion in damages, which would automatically be trebled in the event of an adverse verdict, and Teva would also be subject to mandatory statutory penalties for each false claim, the amount of which (potentially billions of U.S. dollars in additional penalties, at the high end) would be determined by the court within a statutory range. On October 10, 2024, Teva entered into a settlement agreement with the DOJ to resolve these claims. Teva will pay $425 million over 6 years under the terms of the settlement – $19 million in the fourth quarter of 2024, $34 million in 2025, $49 million in each of 2026 and 2027, $99 million in 2028, and $175 million in 2029 – which includes no admission of wrongdoing. Teva has recognized a provision for the resolution of this case. Additionally, on January 8, 2021, Humana, Inc. (“Humana”) filed an action against Teva in the U.S. District Court for the Middle District of Florida based on the allegations raised in the DOJ PAP Complaint. In June 2023, Teva filed a joint motion to dismiss the amended complaint, together with
co-defendant
Advanced Care Scripts, Inc., on the grounds that Humana lacks standing to assert RICO claims and the claims are time-barred and/or insufficiently pled, and that motion remains pending. On November 17, 2022, United Healthcare also filed an action against Teva in the U.S. District Court for the District of New Jersey based on the conduct alleged in the DOJ PAP Complaint, and on February 29, 2024, United Healthcare filed an amended complaint. On August 16, 2024, several MSP Recovery-related entities filed a putative class action against Teva and others in the U.S. District Court for the District of Kansas based on the alleged conduct in the DOJ PAP Complaint.
 
38

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
In April 2021, a city and county in Washington filed claims against Teva in the U.S. District Court for the Western District of Washington for alleged violations of the RICO Act, Washington’s Consumer Protection Act, and unjust enrichment concerning Teva’s sale of COPAXONE. Plaintiffs purport to represent a nationwide class of health plans and a subclass of Washington-based health plans that purchased and/or reimbursed health plan members for COPAXONE. Plaintiffs allege that Teva engaged in several fraudulent schemes that resulted in plaintiffs and the putative class members purchasing and/or reimbursing plan members for additional prescriptions of COPAXONE and/or at inflated COPAXONE prices. Plaintiffs seek treble damages for the excess reimbursements and inflated costs, as well as injunctive relief. On November 17, 2021, Teva moved to dismiss the suit, on the grounds that plaintiffs’ claims are barred by the applicable statutes of limitations and the direct purchaser rule, suffer from jurisdictional defects, and fail to plausibly allege fraud or other elements of their claims. On March 9, 2023, the court held a hearing on the motion to dismiss, and a decision remains pending.
On December 1, 2022, Teva received a civil subpoena from the U.S. Attorney’s office in Boston, Massachusetts requesting certain documents related to the sale and marketing of AUSTEDO
®
and risperidone LAI. Teva is cooperating with the request for documents.
In June 2024, Teva received a civil investigative demand from the Federal Trade Commission (“FTC”) seeking documents and information regarding an investigation related to patents listed in the Food and Drug Administration’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (“Orange Book”) in connection with certain inhaler products. Teva is cooperating with the request for documents and information.
On October 1, 2024, Teva received a civil investigative demand from the U.S. Attorney’s office in Boston, Massachusetts and the Civil Division of the Department of Justice requesting certain documents and information related to the manufacturing practices at its former manufacturing facility in Irvine, California, which Teva closed in 2022. Teva is cooperating with the request for documents and information.
Opioids Litigation
Since May 2014, more than 3,500 complaints have been filed by various governmental agencies and private plaintiffs in U.S. state and federal courts with respect to opioid sales and distribution against various Teva affiliates and several other pharmaceutical companies, the vast majority of which have been resolved. Cases brought by third party payers, both as individual cases and as class actions, remain. The majority of the remaining cases are consolidated in the multidistrict litigation in the Northern District of Ohio (the “MDL Opioid Proceeding”). These cases assert claims under similar provisions of different state laws and generally allege that the defendants engaged in improper marketing and distribution of Teva’s branded opioids, including ACTIQ
®
and FENTORA
®
, and also assert claims related to Teva’s generic opioid products.
In addition, over 950 personal injury plaintiffs, including various putative class actions of individuals, have asserted personal injury and wrongful death claims in over 600 complaints, nearly all of which are consolidated in the MDL Opioid Proceeding. Furthermore, approximately 100 personal injury complaints allege that Anda (in addition to naming other distributors and manufacturers) failed to develop and implement systems sufficient to identify suspicious orders of opioid products and prevent their abuse and diversion. Plaintiffs seek a variety of remedies, including restitution, civil penalties, disgorgement of profits, treble
damages, non-economic
damages, attorneys’ fees and injunctive relief. Certain plaintiffs seek damages for all costs associated with addressing the abuse of opioids and opioid addiction and certain plaintiffs specify multiple billions of dollars in the aggregate as alleged damages. In many of these cases, plaintiffs are seeking joint and several damages among all defendants. All but a handful of these cases are stayed in the MDL Opioid Proceedings.
In June 2023, Teva finalized and fully resolved its nationwide settlement agreement with the states and litigating subdivisions. Under the financial terms of the nationwide settlement agreement with the states and subdivisions, Teva will pay up to $4.25 billion (including the already settled cases), spread over 13 years. This total includes the supply of up to $1.2 billion of Teva’s generic version of Narcan
®
(naloxone hydrochloride nasal spray), valued at wholesale acquisition cost, over 10 years or cash at 20% of the wholesale acquisition cost ($240 million) in lieu of product. In September 2024, Teva reached and finalized an agreement with the City of Baltimore to settle its opioid-related claims for a total of $80 million (of which $35 million will be paid by the end of 2024 and the remainder will be paid by July 1, 2025), averting a trial that was scheduled to begin on September 16, 2024.
 
39

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
With its settlement with the City of Baltimore, Teva has settled with 100% of the U.S. states and litigating political subdivisions and the Native American tribes (the “Tribes”). Teva’s estimated cash payments between 2024 and 2028 for all opioids settlements are: $428 million payable in 2024 (of which $392 million was paid as of September 30, 2024), $423 million payable in 2025; $368 million payable in 2026; $374 million payable in 2027; and $390 million payable in 2028. These payments are subject to change based on various factors including, but not limited to, timing of payments, most favored nations clauses associated with prior settlements, and the states’ elections to take Teva’s generic version of Narcan
®
(naloxone hydrochloride nasal spray). The remaining payments, subject to adjustments, will be paid beyond 2028.
Various Teva affiliates, along with several other pharmaceutical companies, were named as defendants in opioids cases initiated by approximately 500 U.S. hospitals and other healthcare providers asserting opioid-related claims, including public nuisance. Specifically, the lawsuits brought by the hospitals allege that they have incurred financial harm from increased operating costs for treating patients whose underlying illnesses are purportedly exacerbated or complicated by opioid addiction. In September 2024, Teva and the representatives for acute care hospitals finalized the terms of a proposed settlement agreement. Under the financial terms of the proposed national settlement agreement, Teva will pay up to $126 million in cash, spread over 18 years, and supply up to $49 million of Teva’s generic version of Narcan
®
(naloxone hydrochloride nasal spray), valued at wholesale acquisition cost, over 7 years. The proposed settlement agreement is contingent upon Teva’s satisfaction, in its sole discretion, with the level of participation by acute care hospitals and health care systems in the proposed settlement agreement.
In light of the nationwide settlement agreement between Teva and the States’ Attorneys General and their subdivisions, Teva’s indemnification obligations arising from Teva’s acquisition of the Actavis Generics business for opioid-related claims, prior settlements reached with Louisiana, Texas, Rhode Island, Florida, San Francisco, West Virginia, New York, the Tribes, Nevada and the City of Baltimore, the agreement in principle with the hospitals discussed above, as well as an estimate for a number of items including, but not limited to, costs associated with administering injunctive terms, and most favored nations clauses associated with prior settlements, the Company has recorded a provision. The provision is a reasonable estimate of the ultimate costs for Teva’s opioids settlements, after discounting payments to their net present value. Opioid-related lawsuits brought against Teva by dozens of third-party payers, such as unions and welfare funds, remain pending. A reasonable upper end of a range of loss cannot be determined for the entirety of the remaining opioid-related cases. An adverse resolution of any of these lawsuits or investigations may involve large monetary penalties, damages, and/or other forms of monetary and
non-monetary
relief and could have a material and adverse effect on Teva’s reputation, business, results of operations and cash flows.
In addition, Teva, certain of its subsidiaries and other defendants, are defending claims and putative class action lawsuits in Canada related to the manufacture, sale, marketing and distribution of opioid medications. The lawsuits include a claim by the Province of British Columbia on behalf of itself and a putative class of other federal and provincial governments, and claims of municipalities, First Nations, and persons who used opioids on behalf of themselves and putative classes. In November and December 2023, the British Columbia Supreme Court held a hearing regarding preliminary motions, including plaintiffs’ certification motion, which remain pending.
Shareholder Litigation
On November 6, 2016 and December 27, 2016, two putative securities class actions were filed in the U.S. District Court for the Central District of California against Teva and certain of its current and former officers and directors. Those lawsuits subsequently were consolidated and transferred to the U.S. District Court for the District of Connecticut (the “Ontario Teachers Securities Litigation”). On December 13, 2019, the lead plaintiff filed an amended complaint, purportedly on behalf of purchasers of Teva’s securities between February 6, 2014 and May 10, 2019, asserting that Teva and certain of its current and former officers and directors violated federal securities and common laws in connection with Teva’s alleged failure to disclose pricing strategies for various drugs in its generic drug portfolio and by making allegedly false or misleading statements in certain offering materials. From July 2017 to June 2019, other putative securities class actions were filed in other federal courts based on similar allegations and claims, and were transferred to the U.S. District Court for the District of Connecticut. Between August 2017 and January 2022, twenty-three complaints were filed against Teva and certain of its current and former officers and directors on behalf of plaintiffs in various forums across the country, but many of those plaintiffs
“opted-out”
of the Ontario Teachers Securities Litigation. On January 18, 2022, Teva entered into a settlement in the Ontario Teachers Securities Litigation for $420 million, which received final approval from the court on June 2, 2022. The vast majority of the total settlement amount was covered by the Company’s insurance carriers, with a small portion contributed by Teva. Additionally, as part of the settlement, Teva admitted no liability and denied all allegations of wrongdoing. On January 22, 2021, the Court dismissed the
“opt-out”
plaintiffs’ claims arising from statements made prior to the five-year statute of repose, but denied Teva’s motion to dismiss their claims under Israeli laws. Teva has settled the majority of the
“opt-out”
claims, and one
opt-out
case remains outstanding. Teva also reached a settlement with shareholders who filed class actions in Israel with similar allegations to those raised in the Ontario Teachers Securities Litigation, which was approved by the court in Israel in November 2023.
 
40

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
On September 23, 2020, a putative securities class action was filed in the U.S. District Court for the Eastern District of Pennsylvania against Teva and certain of its former officers. On August 10, 2021, the lead plaintiff filed a corrected amended class action complaint, purportedly on behalf of persons who purchased or otherwise acquired Teva securities between October 29, 2015 and August 18, 2020. The corrected amended complaint alleges that Teva and certain of its current and former officers violated federal securities laws by allegedly making false and misleading statements regarding the commercial performance of COPAXONE, namely, by failing to disclose that Teva had allegedly caused the submission of false claims to Medicare through Teva’s donations to bona fide independent charities that provide financial assistance to patients, which allegedly impacted COPAXONE’s commercial success and the sustainability of its revenues and resulted in the DOJ PAP Complaint filed by the DOJ. The corrected amended complaint seeks unspecified damages and legal fees. On August 2, 2022, the court stayed all proceedings other than class certification proceedings pending the resolution of the DOJ PAP Complaint. On November 3, 2023, the court granted plaintiff’s motion for class certification. On November 17, 2023, Teva filed a petition with the Third Circuit Court of Appeals for leave to appeal the class certification ruling, which was denied on May 16, 2024. On August 30, 2024, the court lifted the stay. A motion to approve a securities class action was also filed in the Central District Court in Israel, which has been stayed pending the U.S. litigation, with similar allegations to those made in the above complaint filed in the U.S. District Court for the Eastern District of Pennsylvania.
Environmental Matters
Teva or its subsidiaries are party to a number of environmental proceedings, or have received claims, including under the federal Superfund law or other federal, provincial or state and local laws, imposing liability for alleged noncompliance, or for the investigation and remediation of releases of hazardous substances and for natural resource damages. Many of these proceedings and claims seek to require the generators of hazardous wastes disposed of at a third party-owned site, or the party responsible for a release of hazardous substances that impacted a site, to investigate and clean the site or to pay or reimburse others for such activities, including for oversight by governmental authorities and any related damages to natural resources. Teva or its subsidiaries have received claims, or been made a party to these proceedings, along with others, as an alleged generator of wastes that were disposed of or treated at third-party waste disposal sites, or as a result of an alleged release from one of Teva’s facilities or former facilities.
Although liability among the responsible parties, under certain circumstances, may be joint and several, these proceedings are frequently resolved so that the allocation of
clean-up
and other costs among the parties reflects the relative contributions of the parties to the site conditions and takes into account other pertinent factors. Teva’s potential liability varies greatly at each of the sites; for some sites the costs of the investigation,
clean-up
and natural resource damages have not yet been determined, and for others Teva’s allocable share of liability has not been determined. At other sites, Teva has taken an active role in identifying those costs, to the extent they are identifiable and estimable, which do not include reductions for potential recoveries of
clean-up
costs from insurers, indemnitors, former site owners or operators or other potentially responsible parties. In addition, enforcement proceedings relating to alleged violations of federal, state, commonwealth or local requirements at some of Teva’s facilities may result in the imposition of significant penalties (in amounts not expected to materially adversely affect Teva’s results of operations) and the recovery of certain costs and natural resource damages, and may require that corrective actions and enhanced compliance measures be implemented.
Item 103 of Regulation
S-K
promulgated by the SEC requires disclosure of certain environmental matters when a governmental authority is a party to the proceedings and such proceedings involve potential monetary sanctions, unless the Company reasonably believes that the matter will result in no monetary sanctions, or in monetary sanctions, exclusive of interest and costs, of less than $300,000. The following matter is disclosed in accordance with that requirement. On July 8, 2021, the National Green Tribunal Principal Bench, New Delhi, issued an order against Teva’s subsidiary in India, Teva API India Private Limited, finding
non-compliance
with environmental laws and assessed a penalty of $1.4 million. The Company disputed certain of the findings and the amount of the penalty and filed an appeal before the Supreme Court of India. On August 5, 2021, the Supreme Court of India admitted the appeal for hearing and granted an interim unconditional stay on the National Green Tribunal’s order. The Company does not believe that the eventual outcome of such matter will have a material effect on its business.
 
41

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
Other Matters
On February 1, 2018, former shareholders of Ception Therapeutics, Inc., a company that was acquired by and merged into Cephalon in 2010, prior to Cephalon’s acquisition by Teva, filed breach of contract and other related claims against the Company, Teva USA and Cephalon in the Delaware Court of Chancery. Among other things, the plaintiffs alleged that Cephalon had breached the terms of the 2010 Ception-Cephalon merger agreement by failing to exercise commercially reasonable efforts to develop and commercialize CINQAIR
®
(reslizumab) for the treatment of eosinophilic esophagitis (“EE”). The plaintiffs claimed damages of at least $200 million, an amount they alleged was equivalent to the milestones payable to the former shareholders of Ception in the event Cephalon were to obtain regulatory approval for EE in the United States ($150 million) and Europe ($50 million). On December 28, 2018, following defendants’ motion to dismiss the complaint, the court granted the motion in part and dismissed all of plaintiffs’ claims, except for their claim against Cephalon for breach of contract. In November 2021, plaintiffs moved to amend their complaint to, among other things, reassert claims against the Company and Teva USA. However, on July 12, 2022, plaintiffs filed a new amended complaint that included claims against Teva USA but not the Company, in exchange for Teva USA’s agreement to guarantee any judgment entered against Cephalon in the litigation. A bench trial for this matter was held in September 2022 and on April 30, 2024, the court issued a memorandum opinion in favor of Cephalon and Teva USA, finding that they did not breach the merger agreement as plaintiffs had alleged. Plaintiffs have appealed that ruling to the Delaware Supreme Court, and the appeal remains pending.
Gain Contingencies
From time to time, Teva may directly or indirectly pursue claims against certain parties, including but not limited to patent infringement lawsuits against other pharmaceutical companies to protect its patent rights, as well as derivative actions brought on behalf of Teva. Teva recognizes gain contingencies from the defendants in such lawsuits when they are realized or when all related contingencies have been resolved. No gain has been recognized regarding the matters disclosed below, unless mentioned otherwise.
In October 2017, Teva filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.’s (“Lilly”) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents, including three method of treatment patents and six composition of matter patents. Lilly then submitted inter partes review (“IPR”) petitions to the Patent Trial and Appeal Board (“PTAB”), challenging the validity of the nine Teva patents. The PTAB issued decisions upholding the three method of treatment patents but finding the six composition of matter patents invalid, which decisions were affirmed by the Court of Appeals for the Federal Circuit on August 16, 2021. A jury trial regarding the three method of treatment patents resulted in a verdict in Teva’s favor on November 9, 2022, in which the three method of treatment patents were determined to be valid and infringed by Lilly and Teva was awarded $176.5 million in damages. On September 26, 2023, the U.S. District Court for the District of Massachusetts issued a decision that reversed the jury’s verdict and damages award, finding Teva’s method of treatment patents to be invalid. Teva filed its opening appeal brief on February 2, 2024 and Lilly filed its responsive brief on April 19, 2024. Teva filed its responsive brief on May 29, 2024, and Lilly’s final brief was filed on July 19, 2024. No date has been set for the appeal hearing.
In March 2024, Teva filed a lawsuit in the U.S. District Court for the District of New Jersey alleging that Amarin Pharma, Inc., Amarin Pharmaceuticals Ireland Limited, and Amarin Corporation plc (collectively “Amarin”) engaged in a decade-long scheme to lock up the supply of icosapent ethyl to prevent and delay generic competition to its branded Vascepa
®
drug product. Teva’s lawsuit coincides with four other lawsuits brought by generic drug manufacturers and purchasers of branded Vascepa
®
 alleging the same or similar conduct by Amarin. Teva’s requested relief includes compensatory damages for lost sales and lost profits from generic icosapent ethyl drug sales that Teva could have made absent Amarin’s alleged interference. On May 24, 2024, Amarin filed a motion in the U.S. District Court for the District of Nevada, seeking to enforce the terms of an earlier Teva-Amarin agreement to settle patent litigation regarding Vascepa
®
, which Amarin asserts precludes Teva from filing the present antitrust action. Teva opposed this motion on June 7, 2024, and Amarin’s motion remains pending. As the lawsuit is still in its initial stages, it is not possible to predict its outcome and there is no guarantee that Teva will be granted its requested relief.
In June 2024, Teva filed a lawsuit in the U.S. District Court for the Northern District of California alleging that Corcept Therapeutics, Inc. (“Corcept”), and Optime Care Inc. (“Optime”) have engaged in a multifaceted, years-long scheme to stifle generic competition to Corcept’s branded Korlym
®
(mifepristone) drug product, which is indicated to treat endogenous Cushing’s syndrome. Teva alleges that Corcept and Optime have suppressed competition by abusing the
 
42

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
patent and judicial systems, entering a long-term, blanket exclusive-dealing agreement that has locked up a key pharmaceutical distribution channel, and making illicit payments to physicians as compensation for prescribing Korlym
®
. Teva’s requested relief includes compensatory damages for lost sales and lost profits from generic mifepristone drug sales that Teva could have made absent Corcept and Optime’s alleged interference, as well as injunctive relief to remove the unlawful barriers to generic competition created by Corcept and Optime. As the lawsuit is still in its initial stages, it is not possible to predict its outcome and there is no guarantee that Teva will be granted its requested relief.
Motions to approve derivative actions seeking monetary damages against certain past and present directors and officers have been filed in Israeli Courts alleging negligence and recklessness, as well as motions for document disclosure prior to initiating derivative actions. Motions were filed with respect to several U.S. and EU settlement agreements, opioids, allegations related to the DOJ’s complaint regarding the COPAXONE patient assistance program in the U.S., and with respect to the European Commission’s investigation relating to COPAXONE. In May 2024, Teva settled the derivative action related to the opioids litigation, and on September 16, 2024, the settlement received final approval from the Tel Aviv District Court.
 
43

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
NOTE 11 – Income taxes:
In the third quarter of 2024, Teva recognized a tax expense of $69 million, on a
pre-tax
loss
 of $324 million. In the third quarter of 2023, Teva recognized a tax benefit of $12 million, on a
pre-tax
 
income
 of $64 
million. Teva’s tax rate for the third quarter of 2024 was mainly impacted by impairment charges with no corresponding tax effects, an adjustment to the Company’s corporate tax rate in Israel on losses related to
non-qualified
tax incentive activities in Israel, legal expenses with no corresponding tax effect related to the fine issued by the European Commission in connection with its antitrust investigation into COPAXONE, and recording of valuation allowance with respect to certain carry over credits outside of Israel. Teva’s tax rate for the third quarter for 2023 was mainly affected by deferred tax benefits resulting from intellectual property related integration plans, which have been adopted, among others, in an effort of addressing the global adoption of the Organization for Economic
Co-operation
and Development (OECD) Pillar Two minimum effective corporate tax. The
pre-tax
loss in the third quarter of 2023 was revised as discussed in note 1c.
In the first nine months of 2024, Teva recognized a tax expense of $648 million, on a
pre-tax
loss of $1,037 million. In the first nine months of 2023, Teva recognized a tax benefit of $48 million, on a
pre-tax
loss of $1,131 
million. Teva’s tax rate for the first nine months of 2024 was mainly impacted by a settlement agreement with the Israeli Tax Authorities (“ITA”) as discussed below, impairment charges with no corresponding tax effects, deferred tax benefits resulting from intellectual property related integration plans, an adjustment to the Company’s corporate tax rate in Israel on losses related to
non-qualified
tax incentives activities in Israel, legal expenses with no corresponding tax effect related to the fine issued by the European Commission in connection with its antitrust investigation into COPAXONE, and recording of valuation allowance with respect to certain carry over credits outside of Israel. Teva’s tax rate for the first nine months of 2023 was mainly affected by deferred tax benefits from intellectual property related integration plans, impairments, legal settlements, and interest expense disallowances. The
pre-tax
loss in the first nine months of 2023 was revised as discussed in note 1c.
The statutory Israeli corporate tax rate is 23% in 2024. Teva’s global tax rate differs from the Israeli statutory tax rate, mainly due to generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate, tax benefits, as well as infrequent or
non-recurring
items.
Teva filed a claim seeking the refund of withholding taxes paid to the Indian tax authorities in 2012. A trial for this case is currently ongoing. A final and binding decision against Teva in this case may lead to a charge of $125 million.
On June 23, 2024, Teva entered into an agreement with the ITA to settle certain litigation with respect to taxes payable for the Company’s taxable years 2008 through 2020 (the “Agreement”). Pursuant to the terms of the Agreement, the Company will pay a total amount of approximately $750 million to the ITA spread over a
six-year
period beginning this year. The Company has the right to prepay, and amounts paid over time are subject to interest and increase for inflation. Such total amount includes: (i) $495 million in corporate taxes with respect to the Company’s historical earnings that were previously considered by the Company to be exempt from taxes under the Encouragement for Capital Investment Law; and (ii) approximately $250 million in corporate taxes, relating to additional disputed tax issues in the aforementioned taxable years. The Agreement resulted in an increase of $506 million in the Company’s total income taxes in the second quarter of 2024, as certain elements had been recognized in previous periods. Additionally, under the terms of the Agreement, it was further agreed that in the future event the Company pays dividends on, or repurchases, its equity interests, the Company will pay an additional
5%-7%
of the amount of such dividends or repurchases in corporate taxes, up to a maximum tax payment amount of approximately $500 million. Any amounts due under this provision of the Agreement will be recorded in the future as incurred.
Teva believes it has adequately provided for all of its uncertain tax positions, including items currently under dispute, however, adverse results could be material.
The OECD introduced Base Erosion and Profit Shifting (“BEPS”) Pillar Two rules that impose a global minimum tax rate of 15% for large multinational corporations. On December 12, 2022, the EU Council announced that EU member states had reached an agreement to implement the minimum taxation component of 15% of the OECD’s reform of international taxation. Other countries have also enacted or are expected to enact legislation to be effective as early as January 1, 2024, with general implementation of a global minimum tax by January 1, 2025. Teva has evaluated the potential impact on its 2024 consolidated financial statements and related disclosures and does not expect Pillar Two to have a material impact on its effective tax rate or consolidated financial statements in the foreseeable future.
 
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Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
NOTE 12 – Other assets impairments, restructuring and other items:
 
    
Three months ended
    
Nine months ended
 
    
September 30,
    
September 30,
 
    
2024
    
2023
    
2024
    
2023
 
    
(U.S. $ in millions)
    
(U.S. $ in millions)
 
Impairments
of long-lived tangible assets (1)
   $ (80    $ 1      $ 589      $ 21  
Contingent consideration (2)
     34        27        305        140  
Restructuring
     21        27        52        93  
Other
     1        2        (16      21  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ (23    $ 57      $ 931      $ 276  
  
 
 
    
 
 
    
 
 
    
 
 
 

(1)
Including impairments related to exit and disposal activities.
(2)
The contingent consideration presented in the tables above for the three and nine months ended September 30, 2023 have been revised as discussed in note 1c.
Impairments
In the three months ended September 30, 2024, Teva recorded an income of
 
$
80
 
million under impairments of tangible assets, compared to an expense of
$
1
 
million
in the three months ended September 30, 2023.
The income for the three months ended September 30, 2024 was mainly related to a favorable adjustment to the changes of the expected loss from reclassification of currency translation adjustments, partially offset by an additional impairment due to fair value update in connection with the classification of the business venture in Japan as held for sale. See note 2.
Impairments of tangible assets for the nine months ended September 30, 2024 and 2023 were $589 million and $21 million, respectively. The impairment for the nine months ended September 30, 2024 was mainly related to the classification of the business venture in Japan as held for sale (see note 2). The impairments for the nine months ended September 30, 2023 were mainly related to certain assets in the U.S. and Europe.
Teva may record additional impairments in the future, to the extent it changes its plans on any given asset and/or the assumptions underlying such plans, as a result of its ongoing network consolidation activities and its “Pivot to Growth Strategy”.
Contingent consideration
In the three months ended September 30, 2024, Teva recorded an expense of $34 million for contingent consideration, compared to an expense of $27 million in the three months ended September 30, 2023.
The expenses in the three months ended September 30, 2024 were mainly due to the effect of the passage of time on the net present value of the discounted payments. The expenses in the three months ended September 30, 2023 were mainly related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid
®
) and a change in the estimated future royalty payments to Eagle in connection with expected future bendamustine sales. The expense in the three months ended September 30, 2023 was revised as discussed in note 1c.
In the nine months ended September 30, 2024, Teva recorded an expense of $305 million for contingent consideration, compared to an expense of $140 million in the nine months ended September 30, 2023. The expenses in the first nine months of 2024 and 2023 were mainly related to a change in the estimated future royalty payments to Allergan in connection with lenalidomide capsules (the generic version of Revlimid
®
) and a change in the estimated future royalty payments to Eagle in connection with expected future bendamustine sales. The expense in the first nine months of 2023 was revised as discussed in note 1c.
Restructuring
In the three months ended September 30, 2024, Teva recorded $21 million of restructuring expenses, compared to $27 million in the three months ended September 30, 2023. Expenses for the three months ended September 30, 2024 and 2023 were primarily related to network consolidation activities.
 
45

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
In the nine months ended September 30, 2024, Teva recorded $52 million of restructuring expenses, compared to $93 million in the nine months ended September 30, 2023. The expenses for the nine months ended September 30, 2024 and 2023 were primarily related to network consolidation activities.
The following tables provide the components of the Company’s restructuring costs:
 
    
Three months ended September 30,
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Restructuring
     
Employee termination
   $ 13      $ 16  
Other
     8        12  
  
 
 
    
 
 
 
Total
   $ 21      $ 27  
  
 
 
    
 
 
 
 
    
 Nine months ended September 30, 
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Restructuring
     
Employee termination
   $ 33      $ 40  
Other
     19        53  
  
 
 
    
 
 
 
Total
   $ 52      $ 93  
  
 
 
    
 
 
 
The following table provides the components of and changes in the Company’s restructuring accruals:
 
    
Employee termination

costs
    
Other
    
Total
 
    
(U.S. $ in millions)
 
Balance as of January 1, 2024
   $ (75    $ (7    $  (82
Provision
     (33      (19      (52
Utilization and other*
     52        12        64  
  
 
 
    
 
 
    
 
 
 
Balance as of September 30, 2024
   $ (56    $ (14    $ (70
  
 
 
    
 
 
    
 
 
 
 
    
Employee termination

costs
    
Other
    
Total
 
    
(U.S. $ in millions)
 
Balance as of January 1, 2023
   $ (112    $ (7    $ (119
Provision
     (40      (53      (93
Utilization and other*
     77        53        130  
  
 
 
    
 
 
    
 
 
 
Balance as of September 30, 2023
   $ (75    $ (7    $ (82
  
 
 
    
 
 
    
 
 
 

*
Includes adjustments for foreign currency translation.
 
46

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
NOTE 13 – Earnings (Loss) per share:
Basic earnings and loss per share are computed by dividing net income (loss) attributable to Teva’s ordinary shareholders by the weighted average number of ordinary shares outstanding, including fully vested restricted share units (“RSUs”) and performance share units (“PSUs”) during the period, net of
treasury shares.
In computing diluted loss per share for the three months ended September 30, 2024, no account was taken of the potential dilution that could occur upon the exercise of options and non-vested RSUs and PSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
In computing diluted earnings per share for the three months ended September 30, 2023, basic earnings per share were adjusted to take into account the potential dilution that could occur upon the exercise of options and non-vested RSUs and PSUs granted under employee stock compensation plans. No account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
In computing diluted loss per share for the nine months ended September 30, 2024 and 2023, no account was taken of the potential dilution that could occur upon the exercise of options and
non-vested
RSUs and PSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
The weighted average diluted shares outstanding used for the fully diluted share calculations for the three months ended September 30, 2024 and 2023 were 1,133 million shares and 1,135 million shares, respectively.
The weighted average diluted shares outstanding used for the fully diluted share calculations for the nine months ended September 30, 2024 and 2023 were 1,130 million shares and 1,119 million shares, respectively.
Basic and diluted
loss
 per share w
as
 $0.39 for the three months ended September 30, 2024, compared to basic and diluted earnings per share of $0.06 for the three months ended September 30, 2023. Basic and diluted earnings per share for the three months ended September 30, 2023 w
ere
 revised as discussed in note 1c.
Basic and diluted loss per share was $1.26 for the nine months ended September 30, 2024, compared to basic and diluted loss per share of $0.91 for the nine months ended September 30, 2023. Basic and diluted loss per share for the nine months ended September 30, 2023 w
ere
 revised as discussed in note 1c.
 
47

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
NOTE 14 – Accumulated other comprehensive income (loss):
The components of, and changes within, accumulated other comprehensive income (loss) attributable to Teva are presented in the table below:
 
    
Net Unrealized Gains (Losses)
    
Benefit Plans
        
    
Foreign

currency

translation

adjustments
    
Derivative

financial

instruments
    
Actuarial gains

(losses) and

prior service

(costs) credits
    
Total
 
    
(U.S. $ in millions)
 
Balance as of December 31, 2023, net of taxes
   $ (2,384    $ (266    $ (46    $ (2,697
  
 
 
    
 
 
    
 
 
    
 
 
 
Other comprehensive income (loss) before reclassifications
     (84      —         1        (83
Amounts reclassified to the statements of income
     —         21        (3      18  
  
 
 
    
 
 
    
 
 
    
 
 
 
Net other comprehensive income (loss) before tax
     (84      21        (2      (65
  
 
 
    
 
 
    
 
 
    
 
 
 
Corresponding income tax
     (7      —         —         (7
  
 
 
    
 
 
    
 
 
    
 
 
 
Net other comprehensive income (loss) after tax*
     (91      21        (2      (72
  
 
 
    
 
 
    
 
 
    
 
 
 
Balance as of September 30, 2024, net of taxes
   $ (2,475    $ (245    $ (48    $ (2,769
  
 
 
    
 
 
    
 
 
    
 
 
 

*
Amounts do not include a $6 million loss from foreign currency translation adjustments attributable to
non-controlling
interests.
 
    
Net Unrealized Gains (Losses)
    
Benefit Plans
        
    
Foreign

currency

translation

adjustments
    
Derivative

financial

instruments
    
Actuarial gains

(losses) and

prior service

(costs) credits
    
Total
 
    
(U.S. $ in millions)
 
Balance as of December 31, 2022, net of taxes
   $ (2,514    $ (295    $ (28    $ (2,838
  
 
 
    
 
 
    
 
 
    
 
 
 
Other comprehensive income (loss) before reclassifications
     (39      (5      —         (44
Amounts reclassified to the statements of income
     —         24        (2      22  
  
 
 
    
 
 
    
 
 
    
 
 
 
Net other comprehensive income (loss) before tax
     (39      19        (2      (22
  
 
 
    
 
 
    
 
 
    
 
 
 
Corresponding income tax
     (50      —         —         (50
  
 
 
    
 
 
    
 
 
    
 
 
 
Net other comprehensive income (loss) after tax*
     (89      19        (2      (72
  
 
 
    
 
 
    
 
 
    
 
 
 
Balance as of September 30, 2023, net of taxes
   $ (2,603    $ (276    $ (30    $ (2,910
  
 
 
    
 
 
    
 
 
    
 
 
 

*
Amounts do not include a $84 million loss from foreign currency translation adjustments attributable to
non-controlling
interests.
 
48

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
NOTE 15 – Segments:
Teva operates its business and reports its financial results in three
segments
:
(a) United States segment.
(b) Europe segment, which includes the European Union, the United Kingdom and certain other European countries.
(c) International Markets segment, which includes all countries other than the United States and countries included in the Europe segment.
In addition to these three segments, Teva has other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
Teva’s Chief Executive Officer (“CEO”), who is the chief operating decision maker (“CODM”), reviews financial information prepared on a consolidated basis, accompanied by disaggregated information about revenues and contributed profit by the three identified reportable segments, namely United States, Europe and International Markets, to make decisions about resources to be allocated to the segments and assess their performance.
Segment profit is comprised of gross profit for the segment less R&D expenses, S&M expenses, G&A expenses and other income related to the segment. Segment profit does not include amortization and certain other items.
Teva manages its assets on a company basis, not by segments, as many of its assets are shared or commingled. Teva’s CODM does not regularly review asset information by reportable segment and, therefore, Teva does not report asset information by reportable segment.
Teva’s CEO may review its strategy and organizational structure from time to time. Based on such review, in May 2023 Teva launched its new Pivot to Growth strategy. Any additional changes in strategy may lead to a reevaluation of the Company’s segments and goodwill allocation to reporting units, as well as fair value attributable to its reporting units. See note 3 and note 6.
In conjunction with a recent shift in executive management responsibilities and in alignment with Teva’s Pivot to Growth strategy, Teva decided that Canada is no longer included as part of Teva’s North America segment as of January 1, 2024. From that date Canada is reported as part of the Company’s International Markets segment and Teva’s North America segment has been renamed the United States segment. Teva aligned its internal financial and segment reporting and its reporting units in accordance with this change effective January 1, 2024. Prior period amounts have been recast to conform to the reporting structure for the current year.
On January 31, 2024, Teva announced that it intends to divest its API business (including its R&D, manufacturing and commercial activities) through a sale, which divestment is expected to be completed in the first half of 2025. The intention to divest is in alignment with Teva’s Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.
 
 
a.
Segment information:
 
    
Three months ended September 30,
 
    
2024
 
    
United States
    
Europe
    
International Markets
 
    
(U.S. $ in millions)
 
Revenues
   $ 2,225      $ 1,265      $ 613  
Gross profit
     1,265        698        306  
R&D expenses
     151        55        27  
S&M expenses
     259        203        134  
G&A expenses
     107        67        36  
Other
 loss
(
income
)
     §        1        §  
  
 
 
    
 
 
    
 
 
 
Segment profit
   $ 748      $ 373      $ 109  
  
 
 
    
 
 
    
 
 
 
        
 
 
§
Represents an amount less than $0.5 million.
 
49

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
    
Three months ended September 30,
 
    
2023
 
    
United States
    
Europe
    
International Markets
 
    
(U.S. $ in millions)
 
Revenues
   $ 1,896      $ 1,146      $ 591  
Gross profit
     1,060        648        293  
R&D expenses
     156        62        30  
S&M expenses
     243        184        116  
G&A expenses
     93        66        33  
Other
 loss
(
income
)
     (2      §        (2
  
 
 
    
 
 
    
 
 
 
Segment profit
   $ 571      $ 338      $ 117  
  
 
 
    
 
 
    
 
 
 
     
 
§
Represents an amount less than $0.5 million.
 
    
Nine months ended September 30,
 
    
2024
 
    
United States
    
Europe
    
International Markets
 
    
(U.S. $ in millions)
 
Revenues
   $ 6,060      $ 3,749      $ 1,802  
Gross profit
     3,291        2,113        889  
R&D expenses
     475        173        85  
S&M expenses
     789        605        397  
G&A expenses
     300        197        109  
Other
 loss
(
income
)
     (1      1        (1
  
 
 
    
 
 
    
 
 
 
Segment profit
   $ 1,727      $ 1,137      $ 299  
  
 
 
    
 
 
    
 
 
 
    
Nine months ended September 30,
 
    
2023
 
    
United States
    
Europe
    
International Markets
 
    
(U.S. $ in millions)
 
Revenues
   $ 5,465      $ 3,493      $ 1,750  
Gross profit
     2,866        1,943        861  
R&D expenses
     460        168        81  
S&M expenses
     700        565        353  
G&A expenses
     289        196        105  
Other
loss (
income
)
     (3      (2      (34
  
 
 
    
 
 
    
 
 
 
Segment profit
   $ 1,421      $ 1,017      $ 356  
  
 
 
    
 
 
    
 
 
 
 
50

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
The following table presents a reconciliation of Teva’s segment profits to its consolidated operating income (loss) and to consolidated income (loss) before income taxes for the three and nine months ended September 30, 2024 and 2023
:

 
 
  
Three months ended
 
  
Nine months ended
 
 
  
September 30,
 
  
September 30,
 
 
  
2024
 
  
2023
 
  
2024
 
  
2023
 
 
  
(U.S. $ in millions)
 
  
(U.S. $ in millions)
 
United States profit
   $ 748      $ 571      $ 1,727      $ 1,421  
Europe profit
     373        338        1,137        1,017  
International Markets profit
     109        117        299        356  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total reportable segments profit
     1,230        1,025        3,163        2,794  
Profit (loss) of other activities
     (16      (5      (1      22  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total segments profit
     1,214        1,020        3,162        2,816  
Amounts not allocated to segments:
           
Amortization
     146        145        444        471  
Other assets impairments, restructuring and other items*
     (23 )      57        931        276  
Goodwill impairment
     600               1,000        700  
Intangible assets impairments
     28        47        169        289  
Legal settlements and loss contingencies
     450        314        638        1,009  
Other unallocated amounts
     64        112        254        394  
  
 
 
    
 
 
    
 
 
    
 
 
 
Consolidated operating income (loss) *
     (51 )      344        (274 )      (323
  
 
 
    
 
 
    
 
 
    
 
 
 
Financial expenses, net
     272        280        763        808  
  
 
 
    
 
 
    
 
 
    
 
 
 
Consolidated income (loss) before income taxes *
   $ (324 )    $ 64      $ (1,037 )    $ (1,131
  
 
 
    
 
 
    
 
 
    
 
 
 

*
The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1c.
b. Segment revenues by major products and activities:
The following tables
present
revenues by major products and activities for the three and nine months ended September 30, 2024 and 2023:
 
United States   
Three months ended

September 30,
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Generic products
   $ 1,094      $ 839  
AJOVY
®
     58        56  
AUSTEDO
     435        339  
BENDEKA
®
and TREANDA
®
     40        56  
COPAXONE
     69        98  
UZEDY
     35        2  
Anda
     380        367  
Other
     115        140  
  
 
 
    
 
 
 
Total
   $ 2,225      $ 1,896  
  
 
 
    
 
 
 
 
51

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
                                     
United States
  
Nine months ended September 30,
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Generic products
  
$
2,924
 
  
$
2,471
 
AJOVY
  
 
144
 
  
 
154
 
AUSTEDO
  
 
1,124
 
  
 
817
 
BENDEKA and TREANDA
  
 
127
 
  
 
185
 
COPAXONE
  
 
179
 
  
 
224
 
UZEDY
  
 
75
 
  
 
14
 
Anda
  
 
1,134
 
  
 
1,183
 
Other
  
 
352
 
  
 
417
 
  
 
 
    
 
 
 
Total
  
$
6,060
 
  
$
5,465
 
  
 
 
    
 
 
 
 
                                     
Europe
  
Three months ended

September 30,
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Generic products
  
$
973
 
  
$
886
 
AJOVY
  
 
56
 
  
 
41
 
COPAXONE
  
 
53
 
  
 
55
 
Respiratory products
  
 
60
 
  
 
61
 
Other*
  
 
124
 
  
 
104
 
  
 
 
    
 
 
 
Total
  
$
1,265
 
  
$
1,146
 
  
 
 
    
 
 
 

*
Other revenues in the third quarter of 2024 include the sale of certain product rights.
 
                                     
Europe
  
Nine months ended September 30,
 
    
2024
      
2023
 
    
(U.S. $ in millions)
 
Generic products
  
$
2,947
 
    
$
2,727
 
AJOVY
  
 
158
 
    
 
115
 
COPAXONE
  
 
163
 
    
 
174
 
Respiratory products
  
 
183
 
    
 
195
 
Other*
  
 
299
 
    
 
282
 
  
 
 
      
 
 
 
Total
  
$
3,749
 
    
$
3,493
 
  
 
 
      
 
 
 

*
Other revenues in the first nine months of 2024 include the sale of certain product rights.
 
52

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
               
               
International markets
  
Three months ended

September 30,
 
    
2024
    
2023
 
    
(U.S. $ in millions)
 
Generic products
  
$
477
 
  
$
470
 
AJOVY
  
 
24
 
  
 
18
 
COPAXONE
  
 
13
 
  
 
16
 
Other*
  
 
99
 
  
 
87
 
  
 
 
    
 
 
 
Total
  
$
613
 
  
$
591
 
  
 
 
    
 
 
 

*
Other revenues in the third quarter of 2024 include the sale of certain product rights.
 
               
               
International markets
  
Nine months ended
September 30,
 
    
2024
      
2023
 
    
(U.S. $ in millions)
 
Generic products
  
$
1,440
 
    
$
1,425
 
AJOVY
  
 
63
 
    
 
45
 
COPAXONE
  
 
38
 
    
 
50
 
Other*
  
 
261
 
    
 
229
 
  
 
 
      
 
 
 
Total
  
$
1,802
 
    
$
1,750
 
  
 
 
      
 
 
 

*
Other
 revenues in the first nine months of 2024 include the sale of certain product rights.
 
53

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
NOTE 16 – Fair value
measurement
:
Financial items carried at fair value on a recurring basis as of September 30, 2024 and December 31, 2023 are classified in the tables below in one of the three categories of fair value levels:
 
    
September 30, 2024
 
    
Level 1
    
Level 2
    
Level 3
    
Total
 
    
(U.S. $ in millions)
 
Cash and cash equivalents:
           
Money markets
   $ 1,822      $ —       $ —       $ 1,822  
Cash, deposits and other
     1,497        —         —         1,497  
Investment in securities:
           
Equity securities
     13        —         —         13  
Other
     3        —         —         3  
Derivatives:
           
Asset derivatives
:
           
Options and forward contracts
     —         32        —         32  
Liability derivatives
:
           
Options and forward contracts
     —         (33      —         (33
Bifurcated embedded derivatives
     —         —       §        —   
Contingent consideration*
     —         —         (552      (552
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 3,335      $ (1    $ (552    $ 2,782  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
    
December 31, 2023
 
    
Level 1
    
Level 2
    
Level 3
    
Total
 
    
(U.S. $ in millions)
 
Cash and cash equivalents:
           
Money markets
   $ 1,704      $ —       $ —       $ 1,704  
Cash, deposits and other
     1,522        —         —         1,522  
Investment in securities:
           
Investment in convertible bond security
           40        40  
Equity securities
     7        —         —         7  
Other
     1        —         —         1  
Restricted cash
     1        —         —         1  
Derivatives:
           
Asset derivatives
:
           
Options and forward contracts
     —         38        —         38  
Cross-currency interest rate swap
        8           8  
Liability derivatives
:
           
Options and forward contracts
     —         (39      —         (39
Bifurcated embedded derivatives
     —         —       §        —   
Contingent consideration*
   $ —         —         (517      (517
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
     3,235      $ 7      $ (477    $ 2,765  
  
 
 
    
 
 
    
 
 
    
 
 
 

§
Represents an amount less than $
0.5 
million.
*
Contingent consideration represents liabilities recorded at fair value in connection with acquisitions.
 
54

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
Teva determined the fair value of the liabilities for contingent consideration based on a probability-weighted discounted cash flow analysis. This fair value measurement is based on significant unobservable inputs in the market and thus represents a Level 3 measurement within the fair value hierarchy. The fair value of contingent consideration is based on several factors, such as cash flows projected from the success of unapproved product candidates; probability of success of product candidates, including risks associated with uncertainty regarding achievement and payment of milestone events; time and resources required to complete the development and approval of product candidates; life of the potential commercialized products and associated risks with obtaining regulatory approvals in the United States and Europe, and the risk adjusted discount rate for fair value measurement. The discount rate applied ranged from 8.5% to 11%. The weighted average discount rate, calculated based on the relative fair value of Teva’s contingent consideration liabilities, was 8.8%. Contingent consideration is evaluated quarterly, or more frequently, if circumstances dictate. Changes in the fair value of contingent consideration are recorded in the consolidated statements of income. Significant changes in unobservable inputs, mainly the probability of success and cash flows projected, could result in material changes to the contingent consideration liabilities. A change of the discount rate by 1% would have not resulted in material changes to the contingent consideration liabilities.
The investment in convertible bond security is accounted for as available for sale with changes in fair value reflected in other comprehensive income. See Alvotech transaction under note 2.
The following table summarizes the activity for the financial assets and liabilities where fair value measurements are estimated utilizing Level 3 inputs:
 
    
Nine months
ended September

30, 2024
    
Nine months
ended September

30, 2023
 
    
(U.S. $ in millions)
 
Fair value at the beginning of the period
   $ (477      (250
Investment in convertible bond**
     —         25  
Conversion option**
     —         15  
Redemption of convertible bond security**
     (40      —   
Bifurcated embedded derivatives
   §      §  
Adjustments to provisions for contingent consideration:
     
Allergan transaction*
     (267      (111
Eagle transaction
     (37      (35
Novetide transaction
     (1      2  
Settlement of contingent consideration:
     
Allergan transaction
     227        132  
Eagle transaction
     41        61  
Novetide transaction
     2        2  
  
 
 
    
 
 
 
Fair value at the end of the period
   $ (552    $ (159
  
 
 
    
 
 
 
 
§
Represents an amount less than $0.5 million.
*
The financial data presented in the tables above with respect to adjustments to provisions for contingent consideration related to Allergan for the nine months ended September 30, 2023 have been revised as discussed in note 1c.
**
On September 29, 2023, Teva purchased $40 million of subordinated convertible bonds of Alvotech. On June 26, 2024, Alvotech announced its intention to exercise its redemption rights and redeemed the convertible bonds, which were paid to Teva in July 2024 (see note 2).
 
55

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
Financial instruments not measured at fair value
Financial instruments measured on a basis other than fair value mostly consist of senior notes, sustainability-linked senior notes and convertible senior debentures (see note 7) and are presented in the table below in terms of fair value (level 1 inputs):
 
    
Estimated fair value*
 
    
September 30,
2024
    
December 31,
2023
 
    
(U.S. $ in millions)
 
Senior notes and sustainability-linked senior notes included under senior notes and loans
   $ 16,129      $ 17,214  
Senior notes and convertible senior debentures included under short-term debt
     2,572        1,651  
  
 
 
    
 
 
 
Total
   $ 18,701      $ 18,865  
  
 
 
    
 
 
 
 
*
The fair value was estimated based on quoted market
prices
.
 
56


Table of Contents
ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Business Overview

We are a global pharmaceutical leader, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine.

We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Today, our global network of capabilities enables our approximately 37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day.

Teva was incorporated in Israel on February 13, 1944 and is the successor to a number of Israeli corporations, the oldest of which was established in 1901.

Our Business Segments

We operate our business through three segments: United States (previously referred to as North America segment, see below “—United States Segment”), Europe and International Markets. Each business segment manages our entire product portfolio in its region, including generics, which includes biosimilars and OTC products, as well as innovative medicines. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.

In addition to these three segments, we have other activities, primarily the sale of API to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis.

Pivot to Growth Strategy

In May 2023, we introduced our Pivot to Growth strategy, which is based on four key pillars: (i) delivering on our growth engines, mainly AUSTEDO®, AJOVY®, UZEDY® and our late-stage pipeline of biosimilars; (ii) stepping up innovation through delivering on our late-stage innovative pipeline assets as well as building up our early-stage pipeline organically and potentially through business development activities; (iii) sustaining our generics medicines powerhouse with a global commercial footprint, focused portfolio, pipeline and manufacturing footprint; and (iv) focusing our business by optimizing our portfolio and global manufacturing footprint to enable strategic capital deployment to accelerate our near and long-term growth engines and reorganizing certain of our business units to a more optimal structure, while also reorganizing key business units to enhance operational efficiency.

Macroeconomic and Geopolitical Environment

In recent years, the global economy has been impacted by fluctuating foreign exchange rates. In the third quarter of 2024, approximately 45% of our revenues were denominated in currencies other than the U.S. dollar and we manufacture our products largely outside of the United States. Fluctuations in the U.S. dollar versus other currencies in which we operate may materially impact our revenues, results of operations, profits and cash flows. Additionally, high levels of inflation have recently resulted in significant economic volatility and monetary tightening by central banks through higher interest rates. Global economy has also been impacted by geopolitical tensions which have resulted in disruptions to global supply chains, including our internal supply chain. In October 2023, Israel was attacked by a terrorist organization and entered a state of war on several fronts, which as of the date of this Quarterly Report on Form 10-Q is ongoing. Our global headquarters as well as several of our manufacturing and R&D facilities are located in Israel and, while operations there currently remain largely unaffected, the impact of this war on our operations may increase, which could be material, as a result of the continuation, escalation or expansion of this war. In light of the above, supply chain disruptions could continue to result in delays in our production and distribution processes, R&D initiatives and our ability to timely respond to consumer demand. We have implemented certain measures in response to such events and are continually considering various initiatives, including price adjustments where we are not restricted contractually or regulatorily, enhanced inventory management, alternative sourcing strategies for our raw material supply and backup production plans for key products, to allow us to partially mitigate and offset the impact of these macroeconomic and geopolitical factors. However, although inflationary and other macroeconomic pressures may or have eased, the higher costs we have experienced during recent periods have already impacted our operations and will likely continue to have an effect on our financial results.

 

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Table of Contents

Highlights

Significant highlights in the third quarter of 2024 included1:

 

   

Revenues in the third quarter of 2024 were $4,332 million, an increase of 13% in U.S. dollars, or 15% in local currency terms, compared to the third quarter of 2023. This increase was mainly due to higher revenues from generic products in all our segments, from AUSTEDO in our United States segment, as well as from the sale of product rights in our Europe and International Markets segments.

 

   

Our United States segment generated revenues of $2,225 million and segment profit of $748 million in the third quarter of 2024. Revenues increased by 17% and segment profit increased by 31% compared to the third quarter of 2023.

 

   

Our Europe segment generated revenues of $1,265 million and segment profit of $373 million in the third quarter of 2024. Revenues increased by 10% in U.S. dollars, or 11% in local currency terms, compared to the third quarter of 2023. Segment profit increased by 10% compared to the third quarter of 2023.

 

   

Our International Markets segment generated revenues of $613 million and segment profit of $109 million in the third quarter of 2024. Revenues increased by 4% in U.S. dollars, or 18% in local currency terms, compared to the third quarter of 2023. Segment profit decreased by 7% compared to the third quarter of 2023.

 

   

Our revenues from other activities in the third quarter of 2024 were $229 million, an increase of 6% in U.S. dollars, or 5% local currency terms, compared to the third quarter of 2023.

 

   

Exchange rate movements during the third quarter of 2024, including hedging effects, negatively impacted overall revenues by $88 million and operating loss by $57 million, compared to the third quarter of 2023.

 

   

Gross profit margin was 49.6% in the third quarter of 2024, compared to 48.1% in the third quarter of 2023.

 

   

R&D expenses, net in the third quarter of 2024 were $240 million, a decrease of 5% compared to $253 million in the third quarter of 2023.

 

   

We recorded a goodwill impairment charge of $600 million in the third quarter of 2024, related to our Teva API reporting unit. See note 6 to our consolidated financial statements.

 

   

We recorded legal settlements and loss contingencies of $450 million in the third quarter of 2024, compared to $314 million in the third quarter of 2023. See note 9 to our consolidated financial statements.

 

   

Operating loss was $51 million in the third quarter of 2024, compared to an operating income of $344 million in the third quarter of 2023.

 

   

In the third quarter of 2024, we recognized a tax expense of $69 million, on a pre-tax loss of $324 million. In the third quarter of 2023, we recognized a tax benefit of $12 million, on a pre-tax income of $64 million. See note 11 to our consolidated financial statements.

 

   

As of September 30, 2024, our debt was $18,980 million, compared to $19,833 million as of December 31, 2023. In October 2024, we repaid at maturity $685 million of our 1.13% senior notes due in 2024. See note 7 to our consolidated financial statements.

 

   

Cash flow generated from operating activities during the third quarter of 2024 was $693 million, compared to $5 million of cash flow generated from operating activities in the third quarter of 2023. The higher cash flow generated from operating activities in the third quarter of 2024, resulted mainly from higher profit in our United States segment, as well as from changes in working capital items, including a positive impact from accounts receivables, net of SR&A, as well as from accounts payables and inventory levels, partially offset by higher legal payments during the third quarter of 2024.

 

1 

The data included in the Highlights section with respect operating income (loss), income taxes for the prior period have been revised to reflect a revision in relation to a contingent consideration and related expenses in the consolidated financial statements. For additional information, see note 1c to our consolidated financial statements.

 

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Table of Contents
   

During the third quarter of 2024, we generated free cash flow of $922 million, which we define as comprising $693 million in cash flow generated from operating activities, $339 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $38 million in divestitures of businesses and other assets, partially offset by $148 million in cash used for capital investment. During the third quarter of 2023, we generated free cash flow of $229 million. The increase in the third quarter of 2024, resulted mainly from higher cash flow generated from operating activities.

Results of Operations

Comparison of Three Months Ended September 30, 2024 to Three Months Ended September 30, 2023

Segment Information

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the three months ended September 30, 2024 and 2023:

 

     Three months ended September 30,  
     2024     2023  
     (U.S. $ in millions /
% of Segment Revenues)
 

Revenues

   $ 2,225        100   $ 1,896        100

Gross profit

     1,265        56.9     1,060        55.9

R&D expenses

     151        6.8     156        8.2

S&M expenses

     259        11.6     243        12.8

G&A expenses

     107        4.8     93        4.9

Other loss (income)

     §        §       (2      §  
  

 

 

    

 

 

   

 

 

    

 

 

 

Segment profit*

   $ 748        33.6   $ 571        30.1
  

 

 

    

 

 

   

 

 

    

 

 

 

 

*

Segment profit does not include amortization and certain other items.

§

Represents an amount less than $0.5 million or 0.5%, as applicable.

United States Revenues

As part of a recent shift in executive management responsibilities and in line with our Pivot to Growth strategy, commencing January 1, 2024, Canada is reported as part of our International Markets segment. Prior period amounts were recast to reflect this change. See note 15 to our consolidated financial statements.

Revenues from our United States segment in the third quarter of 2024 were $2,225 million, an increase of $329 million, or 17%, compared to the third quarter of 2023. This increase was mainly due to higher revenues from generic products, AUSTEDO and UZEDY, partially offset by lower revenues from certain innovative products, primarily COPAXONE and BENDEKA and TREANDA.

 

59


Table of Contents

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the three months ended September 30, 2024 and 2023:

 

     Three months ended
September 30,
     Percentage
Change
 
     2024      2023      2024-2023  
     (U.S. $ in millions)         

Generic products

   $ 1,094      $ 839        30

AJOVY

     58        56        4

AUSTEDO

     435        339        28

BENDEKA and TREANDA

     40        56        (28 %) 

COPAXONE

     69        98        (30 %) 

UZEDY

     35        2        N/A  

Anda

     380        367        3

Other

     115        140        (18 %) 
  

 

 

    

 

 

    

Total

   $ 2,225      $ 1,896        17
  

 

 

    

 

 

    

Generic products revenues in our United States segment (including biosimilars) in the third quarter of 2024 were $1,094 million, an increase of 30% compared to the third quarter of 2023, the majority of which is driven by higher revenues from lenalidomide capsules (the generic version of Revlimid®), and the remaining, primarily by the launch of liraglutide injection 1.8mg (an authorized generic of Victoza®) and higher revenues from epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®).

Among the most significant generic products we sold in the United States in the third quarter of 2024 were lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr®), Truxima® (the biosimilar to Rituxan®) and liraglutide 1.8 mg injection (an authorized generic of Victoza®). In the third quarter of 2024, our total prescriptions were approximately 292 million (based on trailing twelve months), representing 7.6% of total U.S. generic prescriptions, compared to approximately 320 million (based on trailing twelve months), representing 8.4% of total U.S. generic prescriptions in the third quarter of 2023, all according to IQVIA data.

On October 1, 2024, Teva launched octreotide acetate for injectable suspension, the first generic version of Sandostatin® LAR Depot. Octreotide acetate for injectable suspension is indicated for the treatment of acromegaly and severe diarrhea associated with carcinoid syndrome, and is available to patients in the U.S.

AJOVY revenues in our United States segment in the third quarter of 2024 were $58 million, an increase of 4% compared to the third quarter of 2023, mainly due to growth in volume. In the third quarter of 2024, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 29.1% compared to 24.9% in the third quarter of 2023.

AJOVY is indicated for the preventive treatment of migraine in adults, and was launched in the U.S. in 2018. AJOVY is the only anti-CGRP subcutaneous product indicated for quarterly treatment.

AJOVY is protected worldwide by patents expiring in 2026 at the earliest; extensions have been granted in several countries, including the United States and in Europe, until 2031. Additional patents relating to the use of AJOVY in the treatment of migraine have also been issued in the United States and will expire between 2035 and 2039. Such patents are also pending in other countries. AJOVY will also be protected by regulatory exclusivity for 12 years from marketing approval in the United States (obtained in September 2018) and 10 years from marketing approval in Europe (obtained in April 2019).

In October 2017, we filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.’s (“Lilly”) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents, including three method of treatment patents and six composition of matter patents. Lilly then submitted inter partes review (“IPR”) petitions to the Patent Trial and Appeal Board (“PTAB”), challenging the validity of the nine Teva patents. The PTAB issued decisions upholding the three method of treatment patents but finding the six composition of matter patents invalid, which decisions were affirmed by the Court of Appeals for the Federal Circuit on August 16, 2021. A jury trial regarding the three method of treatment patents resulted in a verdict in Teva’s favor on November 9, 2022, in which the three method of treatment patents were determined to be valid and infringed by Lilly, and Teva was awarded $176.5 million in damages. On September 26, 2023, the U.S. District Court for the District of Massachusetts issued a decision that reversed the jury’s verdict and damages award, finding Teva’s method of treatment patents to be invalid. Teva appealed this ruling on October 24, 2023. On February 2, 2024, Teva filed its opening appeal brief, to which Lilly filed its responding brief on April 19, 2024, which Teva responded to on May 29, 2024. Lilly’s final brief was filed on July 19, 2024. No date has been set for the appeal hearing.

 

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In addition, in 2018 we entered into separate agreements with Alder Biopharmaceuticals, Inc. and Lilly, resolving the European Patent Office oppositions that they filed against our AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.

AUSTEDO revenues in our United States segment in the third quarter of 2024 increased by 28%, to $435 million, compared to $339 million in the third quarter of 2023, mainly due to growth in volume and expanded access for patients.

AUSTEDO was launched in the U.S. in 2017. It is indicated for the treatment of chorea associated with Huntington disease and for the treatment of tardive dyskinesia in adults.

AUSTEDO is protected in the United States by 14 Orange Book patents expiring between 2031 and 2038. We received notice letters from two ANDA filers regarding the filing of their ANDAs with paragraph (IV) certifications for certain of the patents listed in the Orange Book for AUSTEDO. On July 1, 2021, we filed claims against two generic ANDA filers, Aurobindo and Lupin, in the U.S. District Court for the District of New Jersey. In addition, Apotex filed a petition for IPR by the PTAB of the patent covering the deutetrabenazine compound that expires in 2031. On March 9, 2022, the U.S. Patent and Trademark Office denied Apotex’s petition and declined to institute a review of the deutetrabenazine patent. On April 29, 2022 and June 8, 2022, we reached agreements with Lupin and Aurobindo, respectively, to sell their generic products beginning in April 2033, or earlier under certain circumstances. There are no further patent litigations pending regarding AUSTEDO.

AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023, in three doses of 6, 12 and 24 mg, and became commercially available in the U.S. in May 2023. In May 2024, the FDA approved AUSTEDO XR as a one pill, once-daily treatment option in doses of 30, 36, 42, and 48 mg. In July 2024, the FDA approved the 18 mg dosage for AUSTEDO XR making it a one pill, once-daily option for all available doses. AUSTEDO XR is a once-daily formulation indicated in adults for tardive dyskinesia and chorea associated with Huntington’s disease, which is additional to the currently marketed twice-daily AUSTEDO. AUSTEDO XR is protected by 11 Orange Book patents expiring between 2031 and 2041.

UZEDY (risperidone) extended-release injectable suspension revenues in our United States segment in the third quarter of 2024 were $35 million. UZEDY was approved by the FDA on April 28, 2023 for the treatment of schizophrenia in adults, and was launched in the U.S. in May 2023. UZEDY is a subcutaneous, long-acting formulation of risperidone that controls the steady release of risperidone. UZEDY is protected by nine Orange Book patents expiring between 2025 and 2033. We are moving forward with plans to launch UZEDY in other countries around the world. UZEDY faces competition from multiple other products.

BENDEKA and TREANDA combined revenues in our United States segment in the third quarter of 2024 were $40 million, a decrease of 28% compared to the third quarter of 2023, mainly due to competition from alternative therapies, as well as the entry of generic bendamustine products into the market. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022.

In April 2019, we signed an amendment to the license agreement with Eagle extending the royalty term applicable to the United States to the full period for which we sell BENDEKA and increased the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses.

There are 18 patents listed in the U.S. Orange Book for BENDEKA with expiration dates in 2026 and 2031. In April 2020, the U.S. District Court for the District of Delaware issued a trial decision upholding the validity of all of the asserted patents and finding that four ANDA filers for generic versions of BENDEKA infringe at least one of the patents. Teva settled with one of the three ANDA filers that appealed the district court’s decision, and on August 13, 2021, the Federal Circuit issued a Rule 36 affirmance of such decision. Litigation against the fifth ANDA filer was dismissed after withdrawal of its patent challenge, and on October 18, 2021, the case against a sixth ANDA filer was also settled.

Teva also settled litigations against three 505(b)(2) applicants, Hospira, Inc. (“Hospira”), Dr. Reddy’s Laboratories (“DRL”) and Accord Healthcare (“Accord”). Based on these settlement agreements, the three 505(b)(2) filers, Hospira, Accord and DRL can launch their products on November 17, 2027 or earlier under certain circumstances. On May 4, 2023, and June 9, 2023, Teva and Eagle also filed suit against BendaRx Corp. in the U.S. District Court for the District of Delaware, following its filing of a 505(b)(2) NDA for a bendamustine product. In addition, on June 16, 2023, Teva filed suit against BendaRx USA Corp. in the U.S. District Court for the District of Eastern Virginia, which was then stayed and has now been transferred to the U.S. District Court for the District of Delaware where it has been consolidated with the suits filed there.

 

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In addition to the settlement with Eagle regarding its bendamustine 505(b)(2) NDA, between 2015 and 2020, we reached final settlements with 22 ANDA filers for generic versions of the lyophilized form of TREANDA and one 505(b)(2) NDA filer for a generic version of the liquid form of TREANDA, providing for the launch of generic versions of TREANDA prior to patent expiration. Currently, there are multiple generic TREANDA products on the market.

COPAXONE revenues in our United States segment in the third quarter of 2024 were $69 million, a decrease of 30% compared to the third quarter of 2023, mainly due to market share erosion and competition.

The market for MS treatments continues to develop, particularly with the approval of generic versions of COPAXONE. Oral treatments for MS, such as Tecfidera®, Gilenya® and Aubagio®, continue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies, such as Ocrevus® and Kesimpta®.

Anda revenues from third-party products in our United States segment in the third quarter of 2024 increased by 3% to $380 million, compared to $367 million in the third quarter of 2023, mainly due to higher volumes. Anda, our distribution business in the United States, distributes generic and innovative medicines and OTC pharmaceutical products from Teva and various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States.

Product Launches and Pipeline

In the third quarter of 2024, we launched the generic version of the following branded products in the United States:

 

Product Name

   Brand Name     Launch
Date
     Total Annual U.S.
Branded Sales at Time
of Launch

(U.S. $ in millions
(IQVIA))*
 

Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound)

     Abraxane ®      July      $ 809  

Lisdexamfetamine Dimesylate Chewable Tablets CII - USA

     Vyvanse ®      September      $ 200  

Mesalamine Delayed-Release Tablets, USP

     N/A       August      $ 167  

Naloxone Hydrochloride Nasal Spray (OTC)

     Narcan ®      September      $ 66 ** 

Metoclopramide Injection, USP

     N/A       September      $ 12  

Sulfamethoxazole and Trimethoprim Injection, USP in the PREMIERProRx®* Label

     N/A       August      $ 1  

 

* 

The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch.

**

Represents estimated sales based on OTC sales reported through IQVIA.

As of September 30, 2024, our generic products pipeline in the United States includes 125 product applications awaiting FDA approval, including 62 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended June 30, 2024 of approximately $119 billion, according to IQVIA. Approximately 79% of pending applications include a paragraph IV patent challenge, and we believe we are first-to-file with respect to 55 of these products, or 85 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first-to-file opportunities represent over $79 billion in U.S. brand sales for the twelve months ended June 30, 2024, according to IQVIA.

IQVIA reported brand sales are one of the many indicators of future potential value of a launch, but equally important are the mix and timing of competition, as well as cost effectiveness. The potential advantages of being the first filer with respect to some of these products may be subject to forfeiture, shared exclusivity or competition from so-called “authorized generics,” which may ultimately affect the value derived.

 

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In the third quarter of 2024, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications. A “tentative approval” indicates that the FDA has substantially completed its review of an application and final approval is expected once the relevant patent expires, a court decision is reached, a 30-month regulatory stay lapses, or a 180-day exclusivity period awarded to another manufacturer either expires or is forfeited.

 

Generic Name

   Brand Name     Total Annual U.S.
Branded Sales at Time
of Launch

(U.S. $ in millions
(IQVIA))*
 

Palbociclib Capsules

     Ibrance ®    $ 504  

Binimetinib Tablets, 15 mg

     Mektovi ®    $ 176  

 

* 

The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch.

For information regarding our innovative and biosimilar products pipeline, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

United States Gross Profit

Gross profit from our United States segment in the third quarter of 2024 was $1,265 million, an increase of 19%, compared to $1,060 million in the third quarter of 2023.

Gross profit margin for our United States segment in the third quarter of 2024 increased to 56.9%, compared to 55.9% in the third quarter of 2023. This increase was mainly due to a favorable mix of products primarily driven by higher revenues from lenalidomide capsules (the generic version of Revlimid®) and AUSTEDO.

United States R&D Expenses

R&D expenses relating to our United States segment in the third quarter of 2024 were $151 million, a decrease of 3%, compared to $156 million in the third quarter of 2023.

For a description of our R&D expenses in the third quarter of 2024, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

United States S&M Expenses

S&M expenses relating to our United States segment in the third quarter of 2024 were $259 million, an increase of 6%, compared to $243 million in the third quarter of 2023. This increase was mainly due to promotional activities related to AUSTEDO, primarily the direct-to-consumer advertising campaign and our patient support programs.

United States G&A Expenses

G&A expenses relating to our United States segment in the third quarter of 2024 were $107 million, an increase of 16% compared to $93 million in the third quarter of 2023.

United States Profit

Profit from our United States segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our United States segment in the third quarter of 2024 was $748 million, an increase of 31% compared to $571 million in the third quarter of 2023. This increase was mainly due to higher gross profit, partially offset by higher S&M and G&A expenses, as discussed above.

 

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Europe Segment

The following table presents revenues, expenses and profit for our Europe segment for the three months ended September 30, 2024 and 2023:

 

     Three months ended September 30,  
     2024     2023  
     (U.S. $ in millions / % of Segment Revenues)  

Revenues

   $ 1,265        100   $ 1,146        100

Gross profit

     698        55.2     648        56.6

R&D expenses

     55        4.3     62        5.4

S&M expenses

     203        16.0     184        16.0

G&A expenses

     67        5.3     66        5.7

Other loss (income)

     1        §       §        §  
  

 

 

    

 

 

   

 

 

    

 

 

 

Segment profit*

   $ 373        29.5   $ 338        29.5
  

 

 

    

 

 

   

 

 

    

 

 

 

 

*

Segment profit does not include amortization and certain other items.

§

Represents an amount less than $0.5 million or 0.5%, as applicable.

Europe Revenues

Our Europe segment includes the European Union, the United Kingdom and certain other European countries.

Revenues from our Europe segment in the third quarter of 2024 were $1,265 million, an increase of 10%, or $119 million, compared to the third quarter of 2023. In local currency terms, revenues increased by 11% compared to the third quarter of 2023, mainly due to higher revenues from generic and OTC products as well as AJOVY. Our higher revenues in the third quarter of 2024 were also partly driven by the sale of certain product rights.

In the third quarter of 2024, revenues were negatively impacted by exchange rate fluctuations of $6 million, net of hedging effects, compared to the third quarter of 2023. Revenues in the third quarter of 2024, included $10 million from a negative hedging impact, which is included in “Other” in the table below. Revenues in the third quarter of 2023 included $15 million from a positive hedging impact, which is included in “Other” in the table below. See note 8d to our consolidated financial statements.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended September 30, 2024 and 2023:

 

     Three months ended
September 30,
     Percentage
Change
 
     2024      2023      2024-2023  
     (U.S. $ in millions)         

Generic products

   $ 973      $ 886        10

AJOVY

     56        41        37

COPAXONE

     53        55        (5 %) 

Respiratory products

     60        61        (1 %) 

Other*

     124        104        19
  

 

 

    

 

 

    

Total

   $ 1,265      $ 1,146        10
  

 

 

    

 

 

    

 

*

Other revenues in the third quarter of 2024 include the sale of certain product rights.

 

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Generic products revenues (including OTC and biosimilar products) in our Europe segment in the third quarter of 2024, were $973 million, an increase of 10% compared to the third quarter of 2023. In local currency terms, revenues increased by 8%, mainly due to price increases as a result of market conditions such as inflationary pressures in certain markets, as well as higher revenues from recently launched products.

AJOVY revenues in our Europe segment in the third quarter of 2024 increased by 37% to $56 million, compared to $41 million in the third quarter of 2023. In local currency terms revenues increased by 36% due to growth in volume.

For information about AJOVY patent protection, see “—United States Revenues—Revenues by Major Products and Activities” above.

COPAXONE revenues in our Europe segment in the third quarter of 2024 were $53 million, a decrease of 5% in both U.S. dollars and local currency terms, compared to the third quarter of 2023, due to price reductions and a decline in volume resulting from availability of alternative therapies and competing glatiramer acetate products.

In certain countries, Teva remains in litigation against generic companies regarding COPAXONE.

Respiratory products revenues in our Europe segment in the third quarter of 2024 were $60 million, a decrease of 1% compared to the third quarter of 2023. In local currency terms, revenues decreased by 3% compared to the third quarter of 2023, mainly due to net price reductions and lower volumes.

Product Launches and Pipeline

As of September 30, 2024, our generic products pipeline in Europe included 412 generic approvals relating to 53 compounds in 108 formulations, with no European Medicines Agency (“EMA”) approvals received. In addition, approximately 1,508 marketing authorization applications are pending approval in 37 European countries, relating to 94 compounds in 215 formulations. Two applications are pending with the EMA relating to seven strengths in 30 markets.

For information regarding our innovative medicines and biosimilar products pipeline, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

Europe Gross Profit

Gross profit from our Europe segment in the third quarter of 2024 was $698 million, an increase of 8% compared to $648 million in the third quarter of 2023.

Gross profit margin for our Europe segment in the third quarter of 2024 decreased to 55.2%, compared to 56.6% in the third quarter of 2023. This decrease was mainly due to a negative exchange rate impact from hedging activities.

Europe R&D Expenses

R&D expenses relating to our Europe segment in the third quarter of 2024 were $55 million, a decrease of 11% compared to $62 million in the third quarter of 2023.

For a description of our R&D expenses in the third quarter of 2024, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

Europe S&M Expenses

S&M expenses relating to our Europe segment in the third quarter of 2024 were $203 million, an increase of 10% compared to $184 million in the third quarter of 2023. This increase was mainly to support revenue growth in generic products and AJOVY.

Europe G&A Expenses

G&A expenses relating to our Europe segment in the third quarter of 2024 were $67 million, an increase of 2% compared to $66 million in the third quarter of 2023.

Europe Profit

Profit from our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our Europe segment in the third quarter of 2024 was $373 million, an increase of 10%, compared to $338 million in the third quarter of 2023. This increase was mainly due to higher gross profit resulting mainly from proceeds from the sale of certain product rights, partially offset by S&M expenses.

 

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International Markets Segment

The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2024 and 2023:

 

     Three months ended
September 30,
 
     2024     2023  
     (U.S. $ in millions / % of Segment Revenues)  

Revenues

   $ 613        100   $ 591        100

Gross profit

     306        49.9     293        49.6

R&D expenses

     27        4.4     30        5.1

S&M expenses

     134        21.9     116        19.6

G&A expenses

     36        5.8     33        5.5

Other loss (income)

     §        §       (2      §  
  

 

 

    

 

 

   

 

 

    

 

 

 

Segment profit*

   $ 109        17.8   $ 117        19.7
  

 

 

    

 

 

   

 

 

    

 

 

 

 

*

Segment profit does not include amortization and certain other items.

§

Represents an amount less than $0.5 million or 0.5%, as applicable.

International Markets Revenues

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical industry. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada is reported under our International Markets segment and is no longer included as part of our United States segment. Prior period amounts were recast to reflect this change. See note 15 to our consolidated financial statements.

The countries in our International Markets segment include highly regulated, mainly generic markets, such as Canada and Israel, branded generics-oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan.

In February 2022, Russia launched an invasion of Ukraine. As of the date of this Quarterly Report on Form 10-Q, sustained conflict and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results and we have no manufacturing or R&D facilities in these markets. During the three months ended September 30, 2024, the impact of this conflict on our International Markets segment’s results of operations and financial condition was immaterial. Consistent with our foreign exchange risk management hedging programs, in the nine months ended September 30, 2024 we partially hedged our exposure to currency exchange rate fluctuations with respect to our balance sheet assets, revenues and expenses. However, as of the end of the third quarter of 2024, we hedge a small part of our projected net revenues in Russian ruble for 2024. Prior to and since the escalation of the conflict, we have been taking measures to reduce our operational cash balances in Russia and Ukraine. We have been monitoring the solvency of our customers in Russia and Ukraine and have taken measures, where practicable, to mitigate our exposure to risks related to the conflict in the region. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the conflict cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets.

Revenues from our International Markets segment in the third quarter of 2024 were $613 million, an increase of 4% compared to the third quarter of 2023. In local currency terms, revenues increased by 18% compared to the third quarter of 2023, mainly due to higher revenues from generic products in most markets, partially offset by regulatory price reductions and generic competition to off-patented products in Japan. Our higher revenues in the third quarter of 2024 were also partly driven by the sale of certain product rights.

In the third quarter of 2024, revenues were negatively impacted by exchange rate fluctuations of $84 million, including hedging effects, compared to the third quarter of 2023. Revenues in the third quarter of 2024 included $1 million from a positive hedging impact, compared to a positive hedging impact of $7 million in the third quarter of 2023, which are included in “Other” in the table below. See note 8d to our consolidated financial statements.

 

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Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the three months ended September 30, 2024 and 2023:

 

     Three months ended
September 30,
     Percentage
Change
 
     2024      2023      2024-2023  
     (U.S. $ in millions)         

Generic products

   $ 477      $ 470        1

AJOVY

     24        18        35

COPAXONE

     13        16        (18 %) 

Other*

     99        87        14
  

 

 

    

 

 

    

Total

   $ 613      $ 591        4
  

 

 

    

 

 

    

 

*

Other revenues in the third quarter of 2024 include the sale of certain product rights.

Generic products revenues (including OTC and biosimilar products) in our International Markets segment were $477 million in the third quarter of 2024, an increase of 1% compared to the third quarter of 2023. In local currency terms, revenues increased by 13% compared to the third quarter of 2023, mainly due to higher revenues in most markets, largely driven by price increases as a result of higher costs due to inflationary pressure in certain markets and higher volumes, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.

AJOVY was launched in certain markets in our International Markets segment, including in Canada, Japan, Australia, Israel, South Korea, Brazil and others. AJOVY revenues in our International Markets segment in the third quarter of 2024 were $24 million, compared to $18 million in the third quarter of 2023, due to growth in existing markets in which AJOVY was launched.

COPAXONE revenues in our International Markets segment in the third quarter of 2024 were $13 million compared to $16 million in the third quarter of 2023.

AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022, for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia. In February 2024, we announced a strategic partnership for the marketing and distribution of AUSTEDO in China. We continue with additional submissions in various other markets.

International Markets Gross Profit

Gross profit from our International Markets segment in the third quarter of 2024 was $306 million, an increase of 4% compared to $293 million in the third quarter of 2023.

Gross profit margin for our International Markets segment in the third quarter of 2024 increased to 49.9%, compared to 49.6% in the third quarter of 2023. This increase was mainly due to price increases largely as a result of inflationary pressures in certain markets, the sale of certain product rights and a favorable mix of products, partially offset by regulatory price reductions and generic competition to off-patented products in Japan, as well as higher costs due to inflationary and other macroeconomic pressures.

International Markets R&D Expenses

R&D expenses relating to our International Markets segment in the third quarter of 2024 were $27 million, a decrease of 11% compared to the third quarter of 2023.

For a description of our R&D expenses in the third quarter of 2024, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

 

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International Markets S&M Expenses

S&M expenses relating to our International Markets segment in the third quarter of 2024 were $134 million, an increase of 16% compared to the third quarter of 2023, mainly to support revenue growth including through our strategic partnership in China for AUSTEDO.

International Markets G&A Expenses

G&A expenses relating to our International Markets segment in the third quarter of 2024 were $36 million, an increase of 10% compared to the third quarter of 2023.

International Markets Other Income

Other income in the third quarter of 2024 was minimal, compared to $2 million in the third quarter 2023. Other income in the third quarter of 2023 included a capital gain from the sale of assets.

International Markets Profit

Profit from our International Markets segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.

Profit from our International Markets segment in the third quarter of 2024 was $109 million, a decrease of 7%, compared to $117 million in the third quarter of 2023. This decrease was mainly due to higher S&M expenses in the third quarter of 2024.

Other Activities

We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.

On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale, which divestment is expected to be completed in the first half of 2025. The intention to divest is in alignment with our Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.

Our revenues from other activities in the third quarter of 2024 were $229 million, an increase of 6% in U.S. dollars, or 5% in local currency terms, compared to the third quarter of 2023.

API sales to third parties in the third quarter of 2024 were $130 million, reflecting an increase of 4% in both U.S. dollars and local currency terms, compared to the third quarter of 2023, following a reallocation of an immaterial business within our other activities, in line with our intention to divest our API business.

Teva Consolidated Results

The data presented with respect to other asset impairments, restructuring and other items, operating income (loss), income taxes, net income (loss) attributable to Teva and earnings (loss) per share for the prior period have been revised to reflect a revision in relation to a contingent consideration and related expenses in our consolidated financial statements. For additional information, see note 1c to our consolidated financial statements.

Revenues

Revenues in the third quarter of 2024 were $4,332 million, an increase of 13% in U.S. dollars, or 15% in local currency terms, compared to the third quarter of 2023. This increase was mainly due to higher revenues from generic products in all our segments, from AUSTEDO in our United States segment, as well as from the sale of product rights in our Europe and International Markets segments. See “—United States Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.

Exchange rate movements during the third quarter of 2024, including hedging effects, negatively impacted revenues by $88 million, compared to the third quarter of 2023. See note 8d to our consolidated financial statements.

 

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Gross Profit

Gross profit in the third quarter of 2024 was $2,148 million, an increase of 16% compared to $1,851 million in the third quarter of 2023.

Gross profit margin was 49.6% in the third quarter of 2024, compared to 48.1% in the third quarter of 2023. This increase was mainly due to a favorable mix of products, primarily AUSTEDO, partially offset by a negative impact from foreign exchange rate movements including hedging effects.

Research and Development (R&D) Expenses, net

Our R&D activities for innovative medicines and biosimilar products in each of our segments include costs of discovery research, preclinical work, drug formulation, early- and late-stage clinical development and product registration costs. These expenditures are reported net of contributions received from collaboration partners. Our spending takes place throughout the development process, including (i) early-stage projects in both discovery and preclinical phases; (ii) middle-stage projects in clinical programs up to Phase 3; (iii) late-stage projects in Phase 3 programs, including where a new drug application is currently pending approval; (iv) post-approval studies for marketed products; and (v) indirect expenses, such as costs of internal administration, infrastructure and personnel.

Our R&D activities for generic products in each of our segments include both (i) direct expenses relating to product formulation, analytical method development, stability testing, management of bioequivalence and other clinical studies and regulatory filings; and (ii) indirect expenses, such as costs of internal administration, infrastructure and personnel.

In the third quarter of 2024, our R&D expenses related primarily to innovative product candidates and marketed products in immunology and immuno-oncology, neuroscience (such as neuropsychiatry, including post-approval commitments) and selected other areas, as well as generic products and biosimilars.

R&D expenses, net in the third quarter of 2024 were $240 million, a decrease of 5% compared to $253 million in the third quarter of 2023.

Our lower R&D expenses, net in the third quarter of 2024 were largely driven by reimbursements from our strategic partnerships (see note 2 to our consolidated financial statements), reflecting a decrease related to our late-stage innovative pipeline, partially offset by an increase in R&D expenses relating to immunology projects. As we continue to execute on our Pivot to Growth strategy, we see higher R&D spend in some of our late-stage innovative pipeline assets.

R&D expenses as a percentage of revenues were 5.5% in the third quarter of 2024, compared to 6.6% in the third quarter of 2023.

Innovative Medicines Pipeline

Below is a description of key products in our innovative medicines pipeline as of November 1, 2024:

 

   

Phase 2

 

Phase 3

Neuroscience

   

Olanzapine LAI

(TEV-‘749)

Schizophrenia

(September 2022)

Immunology

 

Duvakitug (anti-TL1A) (1)

(TEV-’574)

Inflammatory Bowel Disease

 

ICS/SABA(3)

(TEV-’248)

Respiratory

(February 2023)

 

Emrusolmin(2)

(TEV-‘286)

Multiple System Atropy

 

 

(1)

In collaboration with Sanofi.

(2)

In collaboration with Modag.

(3)

In collaboration with Launch Therapeutics.

 

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Biosimilar Products Pipeline

We have additional biosimilar products in development internally and with our partners that are in various stages of clinical trials and regulatory review worldwide, including Phase 3 clinical trials for biosimilars to Xgeva® (denosumab) and Xolair® (omalizumab), biosimilars to Eylea® (afilbercept), Simponi®, Simponi Aria® (golimumab) and Entyvio® (vedolizymab), which are in collaboration with Alvotech for the U.S. market, as well as our proposed biosimilar to Prolia® (denosumab), which was submitted for regulatory review in the U.S. and Europe.

Selling and Marketing (S&M) Expenses

S&M expenses in the third quarter of 2024 were $626 million, an increase of 9% compared to the third quarter of 2023. This increase was mainly a result of the factors discussed above under “—United States segment—S&M Expenses,” “—Europe segment— S&M Expenses” and “—International Markets Segment—S&M Expenses.”

S&M expenses as a percentage of revenues were 14.5% in the third quarter of 2024, compared to 15.0% in the third quarter of 2023.

General and Administrative (G&A) Expenses

G&A expenses in the third quarter of 2024 were $298 million, an increase of 11% compared to the third quarter of 2023.

G&A expenses as a percentage of revenues were 6.9% in the third quarter of 2024 compared to 7.0% in the third quarter of 2023.

Intangible Asset Impairments

We recorded expenses of $28 million for identifiable intangible asset impairments in the third quarter of 2024, compared to expenses of $47 million in the third quarter of 2023. See note 5 to our consolidated financial statements.

Goodwill Impairment

We recorded a goodwill impairment charge of $600 million related to Teva’s API reporting unit in the third quarter of 2024. No goodwill impairment charge was recorded in the third quarter of 2023. See note 6 to our consolidated financial statements.

Other Asset Impairments, Restructuring and Other Items

We recorded income of $23 million for other asset impairments, restructuring and other items in the third quarter of 2024, compared to expenses of $57 million in the third quarter of 2023. See note 12 to our consolidated financial statements.

Legal Settlements and Loss Contingencies

We recorded expenses of $450 million in legal settlements and loss contingencies in the third quarter of 2024, compared to expenses of $314 million in the third quarter of 2023. See note 9 to our consolidated financial statements.

Other Income (Loss)

Other income in the third quarter of 2024 was $21 million, compared to $9 million in the third quarter of 2023. Other income in the third quarter of 2024 included a capital gain from the sale of a business in our International Markets segment.

Operating Income (Loss)

Operating loss was $51 million in the third quarter of 2024, compared to an operating income of $344 million in the third quarter of 2023. This decrease was mainly due to a goodwill impairment charge and higher legal settlements and loss contingencies, partially offset by higher gross profit in the third quarter of 2024.

Operating loss as a percentage of revenues was 1.2% in the third quarter of 2024, compared to an operating income as a percentage of revenues of 8.9% in the third quarter of 2023.

 

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Financial Expenses, Net

In the third quarter of 2024, financial expenses, net were $272 million, mainly comprised of net-interest expenses of $225 million and a negative exchange rate impact driven mainly from currencies which we were unable to hedge. In the third quarter of 2023, financial expenses, net were $280 million, mainly comprised of net-interest expenses of $247 million and a negative exchange rate impact driven mainly from currencies which we were unable to hedge.

Reconciliation Table to Consolidated Income (Loss) Before Income Taxes

The following table presents a reconciliation of our segment profits to our consolidated operating income (loss) and to consolidated income (loss) before income taxes for the three months ended September 30, 2024 and 2023:

 

     Three months ended
September 30,
 
     2024      2023  
     (U.S. $ in millions)  

United States profit

   $ 748      $ 571  

Europe profit

     373        338  

International Markets profit

     109        117  
  

 

 

    

 

 

 

Total reportable segments profit

     1,230        1,025  

Profit (loss) of other activities

     (16      (5
  

 

 

    

 

 

 

Total segments profit

     1,214        1,020  

Amounts not allocated to segments:

     

Amortization

     146        145  

Other assets impairments, restructuring and other items*

     (23      57  

Goodwill impairment

     600        —   

Intangible assets impairments

     28        47  

Legal settlements and loss contingencies

     450        314  

Other unallocated amounts

     64        112  
  

 

 

    

 

 

 

Consolidated operating income (loss) *

     (51      344  
  

 

 

    

 

 

 

Financial expenses, net

     272        280  
  

 

 

    

 

 

 

Consolidated income (loss) before income taxes *

   $ (324    $ 64  
  

 

 

    

 

 

 

 

*

The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1c to our consolidated financial statements.

Income Taxes

In the third quarter of 2024, we recognized a tax expense of $69 million, on a pre-tax loss of $324 million. In the third quarter of 2023, we recognized a tax benefit of $12 million, on a pre-tax income of $64 million. See note 11 to our consolidated financial statements.

Net Income (Loss) Attributable to Teva

Net loss was $437 million in the third quarter of 2024, compared to a net income of $69 million in the third quarter of 2023. This decrease was mainly due to changes in operating (income) loss discussed above.

 

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Diluted Shares Outstanding and Earnings (Loss) per Share

The weighted average diluted shares outstanding used for the fully diluted share calculations for the three months ended September 30, 2024 and 2023 was 1,133 million shares and 1,135 million shares, respectively.

Diluted loss per share was $0.39 in the third quarter of 2024, compared to diluted earnings per share of $0.06 in the third quarter of 2023. See note 13 to our consolidated financial statements.

Share Count for Market Capitalization

We calculate share amounts using the outstanding number of shares (i.e., excluding treasury shares) plus shares that would be outstanding upon the exercise of options and vesting of RSUs and PSUs, and the conversion of our convertible senior debentures, in each case, at period end.

As of September 30, 2024 and 2023, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,167 million shares and 1,157 million shares, respectively.

Impact of Currency Fluctuations on Results of Operations

In the third quarter of 2024, approximately 45% of our revenues were denominated in currencies other than the U.S. dollar. Because our results are reported in U.S. dollars, we are subject to significant foreign currency risks. Accordingly, changes in the rate of exchange between the U.S. dollar and local currencies in the markets in which we operate (primarily the euro, British pound, Russian ruble, Canadian dollar, Swiss franc, Japanese yen and the new Israeli shekel) impact our results.

During the third quarter of 2024, the following main currencies relevant to our operations decreased in value against the U.S. dollar (each compared on a quarterly average basis): Argentinian peso by 67%, Turkish lira by 20%, Brazilian real by 12%, Ukraine hryvna by 10% and Mexican peso by 10%. The following main currencies relevant to our operations increased in value against the U.S. dollar: Polish zloty by 6%, Russian ruble by 6%, Swedish krona by 4% and the euro by 1%.

As a result, exchange rate movements during the third quarter of 2024, including hedging effects, negatively impacted overall revenues by $88 million and operating income by $57 million, compared to the third quarter of 2023.

In the third quarter of 2024, a negative hedging impact of $9 million was recognized under revenues, and a positive hedging impact of $1 million was recognized under cost of sales. In the third quarter of 2023, a positive hedging impact of $22 million was recognized under revenues and a negative hedging impact of $7 million was recognized under cost of sales.

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. See note 8d to our consolidated financial statements.

Commencing in the third quarter of 2018, the cumulative inflation in Argentina exceeded 100% or more over a three-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.

Commencing in the second quarter of 2022, the cumulative inflation in Turkey exceeded 100% or more over a three-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.

Comparison of Nine Months Ended September 30, 2024 to Nine Months Ended September 30, 2023

Unless specified otherwise, the factors used to explain quarterly changes on a year-over-year basis are also relevant for the comparison of the results for the nine months ended September 30, 2024 and 2023. Where there are different factors affecting the nine months comparison, we have described them below.

 

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Segment Information

United States Segment

The following table presents revenues, expenses and profit for our United States segment for the nine months ended September 30, 2024 and 2023:

 

            Nine months ended September 30,  
     2024     2023  
     (U.S. $ in millions / % of Segment Revenues)  

Revenues

   $ 6,060        100   $ 5,465        100

Gross profit

     3,291        54.3     2,866        52.4

R&D expenses

     475        7.8     460        8.4

S&M expenses

     789        13.0     700        12.8

G&A expenses

     300        5.0     289        5.3

Other loss (income)

     (1      §       (3      §  
  

 

 

    

 

 

   

 

 

    

 

 

 

Segment profit*

   $ 1,727        28.5   $ 1,421        26.0
  

 

 

    

 

 

   

 

 

    

 

 

 

 

*

Segment profit does not include amortization and certain other items.

§

Represents an amount less than 0.5%.

United States Revenues

As part of a recent shift in executive management responsibilities and in line with our Pivot to Growth strategy, commencing January 1, 2024, Canada is reported as part of our International Markets segment. Prior period amounts were recast to reflect this change. See note 15 to our consolidated financial statements.

Revenues from our United States segment in the first nine months of 2024 were $6,060 million, an increase of 11% compared to $5,465 million in the first nine months of 2023.

Revenues by Major Products and Activities

The following table presents revenues for our United States segment by major products and activities for the nine months ended September 30, 2024 and 2023:

 

     Nine months ended September 30,      Percentage
Change
2024-2023
 
     2024      2023  
     (U.S. $ in millions)         

Generic products

   $ 2,924      $ 2,471        18

AJOVY

     144        154        (6 %) 

AUSTEDO

     1,124        817        38

BENDEKA and TREANDA

     127        185        (31 %) 

COPAXONE

     179        224        (20 %) 

UZEDY

     75        14        N/A  

Anda

     1,134        1,183        (4 %) 

Other

     352        417        (16 %) 
  

 

 

    

 

 

    

Total

   $ 6,060      $ 5,465        11
  

 

 

    

 

 

    

 

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AJOVY revenues in our United States segment in the first nine months of 2024 were $144 million, a decrease of 6% compared to $154 million in the first nine months of 2023, mainly due to an increase in sales allowance due to a non-recurring item, partially offset by growth in volume.

Anda revenues from third-party products in our United States segment in the first nine months of 2024 decreased by 4% to $1,134 million, compared to $1,183 million in the first nine months of 2023, mainly due to lower volume.

United States Gross Profit

Gross profit from our United States segment in the first nine months of 2024 was $3,291 million, an increase of 15%, compared to $2,866 million in the first nine months of 2023.

Gross profit margin for our United States segment in the first nine months of 2024 increased to 54.3% compared to 52.4% in the first nine months of 2023.

United States R&D Expenses

R&D expenses relating to our United States segment in the first nine months of 2024 were $475 million, an increase of 3%, compared to $460 million in the first nine months of 2023.

For a description of our R&D expenses in the first nine months of 2024, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

United States S&M Expenses

S&M expenses relating to our United States segment in the first nine months of 2024 were $789 million, an increase of 13%, compared to $700 million in the first nine months of 2023.

United States G&A Expenses

G&A expenses relating to our United States segment in the first nine months of 2024 were $300 million, an increase of 4%, compared to $289 million in the first nine months of 2023.

United States Profit

Profit from our United States segment in the first nine months of 2024 was $1,727 million, an increase of 22%, compared to $1,421 million in the first nine months of 2023.

Europe Segment

The following table presents revenues, expenses and profit for our Europe segment for the nine months ended September 30, 2024 and 2023:

 

     Nine months ended September 30,  
     2024     2023  
     (U.S. $ in millions % of Segment Revenues)  

Revenues

   $ 3,749        100.0   $ 3,493        100.0

Gross profit

     2,113        56.3     1,943        55.6

R&D expenses

     173        4.6     168        4.8

S&M expenses

     605        16.1     565        16.2

G&A expenses

     197        5.2     196        5.6

Other loss (income)

     1        §       (2      §  
  

 

 

    

 

 

   

 

 

    

 

 

 

Segment profit*

   $ 1,137        30.3   $ 1,017        29.1
  

 

 

    

 

 

   

 

 

    

 

 

 

 

*

Segment profit does not include amortization and certain other items.

§

Represents an amount less than 0.5%.

 

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Europe Revenues

Our Europe segment includes the European Union, the United Kingdom, and certain other European countries.

Revenues from our Europe segment in the first nine months of 2024 were $3,749 million, an increase of 7% or $257 million, compared to the first nine months of 2023. In local currency terms, revenues increased by 6% compared to the first nine months of 2023.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the nine months ended September 30, 2024 and 2023:

 

     Nine months ended September 30,     

Percentage

Change

2024-2023

 
     2024      2023  
            (U.S. $ in millions)         

Generic products

   $ 2,947      $ 2,727        8

AJOVY

     158        115        37

COPAXONE

     163        174        (6 %) 

Respiratory products

     183        195        (6 %) 

Other*

     299        282        6
  

 

 

    

 

 

    

Total

   $ 3,749      $ 3,493        7
  

 

 

    

 

 

    

 

*

Other revenues in the first nine months of 2024 include the sale of certain product rights.

Europe Gross Profit

Gross profit from our Europe segment in the first nine months of 2024 was $2,113 million, an increase of 9% compared to $1,943 million in the first nine months of 2023.

Gross profit margin for our Europe segment in the first nine months of 2024 increased to 56.3% compared to 55.6% in the first nine months of 2023. This increase was mainly due to price increases of generic products as a result of market conditions such as inflationary pressures in certain markets.

Europe R&D Expenses

R&D expenses relating to our Europe segment in the first nine months of 2024 were $173 million, an increase of 3% compared to $168 million in the first nine months of 2023.

Europe S&M Expenses

S&M expenses relating to our Europe segment in the first nine months of 2024 were $605 million, an increase of 7% compared to $565 million in the first nine months of 2023.

Europe G&A Expenses

G&A expenses relating to our Europe segment in the first nine months of 2024 were $197 million, an increase of 1% compared to the first nine months of 2023.

Europe Profit

Profit from our Europe segment in the first nine months of 2024 was $1,137 million, an increase of 12% compared to $1,017 million in the first nine months of 2023.

 

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International Markets Segment

The following table presents revenues, expenses and profit for our International Markets segment for the nine months ended September 30, 2024 and 2023:

 

     Nine months ended September 30,  
     2024     2023  
     (U.S. $ in millions / % of Segment Revenues)  

Revenues

   $ 1,802        100   $ 1,750        100

Gross profit

     889        49.3     861        49.2

R&D expenses

     85        4.7     81        4.6

S&M expenses

     397        22.0     353        20.2

G&A expenses

     109        6.0     105        6.0

Other loss (income)

     (1      §       (34      (2.0 %) 
  

 

 

    

 

 

   

 

 

    

 

 

 

Segment profit*

   $ 299        16.6   $ 356        20.4
  

 

 

    

 

 

   

 

 

    

 

 

 

 

*

Segment profit does not include amortization and certain other items.

§

Represents an amount less than 0.5%.

International Markets Revenues

Our International Markets segment includes all countries in which we operate other than the United States and the countries included in our Europe segment. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada is reported under our International Markets segment and is no longer included as part of our United States segment. Prior period amounts were recast to reflect this change. See note 15 to our consolidated financial statements.

Revenues from our International Markets segment in the first nine months of 2024 were $1,802 million, an increase of $53 million, or 3%, compared to the first nine months of 2023. In local currency terms, revenues increased by 19%, compared to the first nine months of 2023.

In the first nine months of 2024, revenues were negatively impacted by exchange rate fluctuations of $281 million including hedging effects, compared to the first nine months of 2023. Revenues in the first nine months of 2024 included a negligible hedging impact compared to a positive hedging impact of $12 million in the first nine months of 2023, which are included in “Other” in the table below. See note 8d to our consolidated financial statements.

Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the nine months ended September 30, 2024 and 2023:

 

     Nine months ended September 30,      Percentage
Change
2024-2023
 
     2024      2023  
     (U.S. $ in millions)         

Generic products

   $ 1,440      $ 1,425        1

AJOVY

     63        45        39

COPAXONE

     38        50        (23 %) 

Other*

     261        229        14
  

 

 

    

 

 

    

Total

   $ 1,802      $ 1,750        3
  

 

 

    

 

 

    

 

*

Other revenues in the first nine months of 2024 include the sale of certain product rights.

 

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International Markets Gross Profit

Gross profit from our International Markets segment in the first nine months of 2024 was $889 million, compared to $861 million in the first nine months of 2023.

Gross profit margin for our International Markets segment in the first nine months of 2024 was 49.3%, compared to 49.2% in the first nine months of 2023.

International Markets R&D Expenses

R&D expenses relating to our International Markets segment in the first nine months of 2024 were $85 million, an increase of 5% compared to $81 million in the first nine months of 2023.

International Markets S&M Expenses

S&M expenses relating to our International Markets segment in the first nine months of 2024 were $397 million, an increase of 12% compared to $353 million in the first nine months of 2023.

International Markets G&A Expenses

G&A expenses relating to our International Markets segment in the first nine months of 2024 were $109 million an increase of 3% compared to $105 million in the first nine months of 2023.

International Markets Other Income

Other income in the first nine months of 2024 was $1 million, compared to $34 million in the first nine months of 2023. Other income in the first nine months of 2023 included a capital gain from the sale of assets.

International Markets Profit

Profit from our International Markets segment in the first nine months of 2024 was $299 million, a decrease of 16%, compared to $356 million in the first nine months of 2023.

Other Activities

We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our United States, Europe or International Markets segments described above.

On January 31, 2024, we announced that we intend to divest our API business (including its R&D, manufacturing and commercial activities) through a sale, which divestment is expected to be completed in the first half of 2025. The intention to divest is in alignment with our Pivot to Growth strategy. However, there can be no assurance regarding the ultimate timing or structure of a potential divestiture or that a divestiture will be agreed or completed at all.

Our revenues from other activities in the first nine months of 2024 were $703 million, an increase of 3% in both U.S. dollars and in local currency terms, compared to the first nine months of 2023.

API sales to third parties in the first nine months of 2024 were $409 million, an increase of 4% in both U.S. dollars and local currency terms, compared to the first nine months of 2023, following a reallocation of an immaterial business within our other activities, in line with our intention to divest our API business.

Teva Consolidated Results

The data presented with respect to other asset impairments, restructuring and other items, operating income (loss), income taxes, net income (loss) attributable to Teva and earnings (loss) per share for the prior period have been revised to reflect a revision in relation to a contingent consideration and related expenses in the consolidated financial statements. For additional information, see note 1c to our consolidated financial statements.

Revenues

Revenues in the first nine months of 2024 were $12,315 million, an increase of 8% compared to the first nine months of 2023. In local currency terms, revenues increased by 10%, compared to the first nine months of 2023.

 

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Exchange rate movements during the first nine months of 2024, including hedging effects, negatively impacted revenues by $249 million, compared to the first nine months of 2023. See note 8d to our consolidated financial statements.

Gross Profit

Gross profit in the first nine months of 2024 was $5,943 million, an increase of 14% compared to the first nine months of 2023.

Gross profit margin was 48.3% in the first nine months of 2024, compared to 45.9% in the first nine months of 2023.

Research and Development (R&D) Expenses

R&D expenses in the first nine months of 2024 were $751 million, an increase of 3% compared to the first nine months of 2023, as we continue to execute on our Pivot to Growth strategy, mainly related to investments in our innovative pipeline.

R&D expenses as a percentage of revenues were 6.1% in the first nine months of 2024, compared to 6.4% in the first nine months of 2023.

Selling and Marketing (S&M) Expenses

S&M expenses in the first nine months of 2024 were $1,891 million, an increase of 10% compared to the first nine months of 2023.

S&M expenses as a percentage of revenues were 15.4% in the first nine months of 2024, compared to 15.2% in the first nine months of 2023.

General and Administrative (G&A) Expenses

G&A expenses in the first nine months of 2024 were $859 million, a decrease of 1% compared to the first nine months of 2023.

G&A expenses as a percentage of revenues were 7.0% in the first nine months of 2024, compared to 7.6% in the first nine months of 2023.

Intangible Asset Impairments

We recorded expenses of $169 million for identifiable intangible asset impairments, in the first nine months of 2024, compared to expenses of $289 million in the first nine months of 2023. See note 5 to our consolidated financial statements.

Goodwill Impairment

We recorded goodwill impairment charges of $1,000 million related to Teva’s API reporting unit in the first nine months of 2024, compared to a goodwill impairment charge of $700 million related to our International Markets reporting unit in the first nine months of 2023. See note 6 to our consolidated financial statements.

Other Asset Impairments, Restructuring and Other Items

We recorded expenses of $931 million for other asset impairments, restructuring and other items in the first nine months of 2024, compared to expenses of $276 million in the first nine months of 2023. See note 12 to our consolidated financial statements.

Legal Settlements and Loss Contingencies

We recorded expenses of $638 million in legal settlements and loss contingencies in the first nine months of 2024, compared to expenses of $1,009 million in the first nine months of 2023. See note 9 to our consolidated financial statements.

Other Income (Loss)

Other income in the first nine months of 2024 was $22 million, compared to $43 million in the first nine months of 2023. Other income in the first nine months of 2023 included a capital gain from the sale of assets in our International Markets segment.

 

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Operating Income (Loss)

Operating loss was $274 million in the first nine months of 2024, compared to an operating loss of $323 million in the first nine months of 2023. The lower operating loss in the first nine months of 2024 was mainly due to higher gross profit and lower legal settlements and loss contingencies, partially offset by higher other asset impairments, restructuring and other items as well as higher goodwill impairment charges in the first nine months of 2024.

Operating loss as a percentage of revenues was 2.2% in the first nine months of 2024, compared to an operating loss as a percentage of revenues of 2.8% in the first nine months of 2023.

Financial Expenses, Net

In the first nine months of 2024, financial expenses, net were $763 million, mainly comprised of net-interest expenses of $691 million and a negative exchange rate impact driven mainly from currencies which we were unable to hedge. In the first nine months of 2023, financial expenses, net were $808 million, mainly comprised of net-interest expenses of $723 million and a negative exchange rate impact driven mainly from currencies which we were unable to hedge.

Reconciliation Table to Consolidated Income (Loss) Before Income Taxes

The following table presents a reconciliation of our segment profits to our consolidated operating income (loss) and to consolidated income (loss) before income taxes for the nine months ended September 30, 2024 and 2023:

 

     Nine months ended
September 30,
 
     2024      2023  
     (U.S. $ in millions)  

United States profit

   $ 1,727      $ 1,421  

Europe profit

     1,137        1,017  

International Markets profit

     299        356  

Total reportable segments profit

     3,163        2,794  

Profit of other activities

     (1      22  

Total segments profit

     3,162        2,816  

Amounts not allocated to segments:

     

Amortization

     444        471  

Other assets impairments, restructuring and other items (1)

     931        276  

Goodwill impairment

     1,000        700  

Intangible assets impairments

     169        289  

Legal settlements and loss contingencies

     638        1,009  

Other unallocated amounts

     254        394  
     —         —   
  

 

 

    

 

 

 

Consolidated operating income (loss) (1)

     (274      (323
  

 

 

    

 

 

 

Financial expenses, net

     763        808  
  

 

 

    

 

 

 

Consolidated income (loss) before income taxes (1)

   $ (1,037    $ (1,131
  

 

 

    

 

 

 

 

(1)

The data presented for 2023 have been revised to reflect a revision in relation to a contingent consideration and related expenses in the consolidated financial statements. See note 1C to our consolidated financial statements for additional information.

Income Taxes

In the first nine months 2024, we recognized a tax expense of $648 million, on pre-tax loss of $1,037 million. In the first nine months of 2023, we recognized a tax benefit of $48 million, on pre-tax loss of $1,131 million. See note 11 to our consolidated financial statements.

 

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Net Income (Loss) Attributable to non-controlling interests

Net loss attributable to non-controlling interests was $262 million in the first nine months of 2024, compared to a net loss attributable to non-controlling interests of $60 million in the first nine months of 2023. The higher net loss in the first nine months of 2024 was mainly due to higher impairments of tangible assets largely related to the classification of our business venture in Japan as held for sale. See note 12 to our consolidated financial statements.

Net Income (Loss) Attributable to Teva

Net loss was $1,422 million in the first nine months of 2024, compared to a net loss of $1,022 million in the first nine months of 2023.

Diluted Shares Outstanding and Earnings (Loss) per Share

The weighted average diluted shares outstanding used for the fully diluted share calculations for the nine months ended September 30, 2024 and 2023 was 1,130 million shares and 1,119 million shares, respectively.

Diluted loss per share was $1.26 for the nine months ended September 30, 2024, compared to diluted loss per share of $0.91 for the nine months ended September 30, 2023. See note 13 to our consolidated financial statements.

Impact of Currency Fluctuations on Results of Operations

In the first nine months of 2024, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar. Because our results are reported in U.S. dollars, we are subject to significant foreign currency risks and, accordingly, changes in the exchange rate between the U.S. dollar and local currencies in markets in which we operate (primarily the euro, British pound, Canadian dollar, Swiss franc, Russian ruble, Japanese yen and new Israeli shekel) impact our results.

During the first nine months of 2024, the following main currencies relevant to our operations decreased in value against the U.S. dollar: Argentinian peso by 72%, Turkish lira by 31%, Chilean peso by 12%, Japanese yen by 9% and Russian ruble by 8% (all compared on a nine-month average basis). The following main currencies relevant to our operations increased in value against the U.S. dollar: Polish zloty by 7%, British pound by 3%, Swiss franc by 2% and Swedish krona by 1%.

As a result, exchange rate movements during the first nine months of 2024, including hedging effects, negatively impacted overall revenues by $249 million and our operating income by $124 million, in comparison to the first nine months of 2023.

In the first nine months of 2024, a positive hedging impact of $1 million was recognized under revenues, and a negative hedging impact of $5 million was recognized under cost of sales. In the first nine months of 2023, a positive hedging impact of $20 million was recognized under revenues and a negative hedging impact of $8 was recognized under cost of sales.

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. See note 8d to our consolidated financial statements.

2024 Aggregated Contractual Obligations

There have not been any material changes in our assessment of material contractual obligations and commitments as set forth in Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2023.

Liquidity and Capital Resources

Total balance sheet assets were $41,758 million as of September 30, 2024, compared to $43,479 million as of December 31, 2023.

Our working capital balance, which includes accounts receivables net of SR&A, inventories, prepaid expenses and other current assets, accounts payables, employee-related obligations, accrued expenses and other current liabilities, was negative $2,009 million as of September 30, 2024, compared to negative $1,374 million as of December 31, 2023. This decrease was mainly due to a classification of the working capital balance related to our business venture in Japan as held for sale (see note 2 to our consolidated financial statements), an increase in provisions for legal settlements and loss contingencies, and a negative impact from several tax items, primarily the agreement with the Israeli Tax Authorities entered into in June 2024 (see note 11 to our consolidated financial statements), partially offset by a decrease in accounts payables.

 

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Employee-related obligations, as of September 30, 2024 were $619 million, compared to $611 million as of December 31, 2023. The increase in the first nine months of 2024 was mainly due to an accrual for performance incentive payments to employees for 2024, partially offset by performance incentive payments to employees for 2023.

Cash investment in property, plant and equipment and intangible assets in the third quarter of 2024 was $148 million compared to $149 million in the third quarter of 2023. Depreciation in the third quarter of 2024 was $113 million, compared to $138 million in the third quarter of 2023.

Cash and cash equivalents as of September 30, 2024 were $3,319 million compared to $3,226 million as of December 31, 2023.

Our cash on hand that is not used for ongoing operations is generally invested in bank deposits as well as liquid securities that bear fixed and floating rates.

Teva’s principal sources of short-term liquidity are its cash on hand, existing cash investments, liquid securities and available credit facilities, primarily our $1.8 billion unsecured syndicated sustainability-linked revolving credit facility, entered into in April 2022, as amended in February 2023 and on May 3, 2024 (“RCF”). See note 7 to our consolidated financial statements.

Debt Balance and Movements

As of September 30, 2024, our debt was $18,980 million, compared to $19,833 million as of December 31, 2023. This decrease was mainly due to repayment at maturity of $956 million of our 6% senior notes, partially offset by $88 million of exchange rate fluctuations.

In April 2024, we repaid $956 million of our 6% senior notes at maturity.

In October 2024, we repaid at maturity $685 million of our 1.13% senior notes due in 2024.

As of September 30, 2024, our debt was effectively denominated in the following currencies: 58% in U.S. dollars, 40% in euros and 2% in Swiss francs.

The portion of total debt classified as short-term as of September 30, 2024 was 14% compared to 8% as of December 31, 2023.

Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 75% as of September 30, 2024, compared to 71% as of December 31, 2023. Our average debt maturity was approximately 5.5 years as of September 30, 2024, compared to 6.0 years as of December 31, 2023.

Total Equity

Total equity was $6,383 million as of September 30, 2024, compared to $8,126 million as of December 31, 2023. This decrease was mainly due to a net loss of $1,684 million, and a negative impact from exchange rate fluctuations of $94 million.

Exchange rate fluctuations affected our balance sheet, as approximately 94% of our net assets as of September 30, 2024 (including both monetary and non-monetary assets) were in currencies other than the U.S. dollar. When compared to December 31, 2023, changes in currency rates as of September 30, 2024 had a negative impact of $94 million on our equity. The following main currencies increased in value against the U.S. dollar: British pound by 5%, Polish zloty by 3% and the euro by 1%. The following main currencies decreased in value against the U.S. dollar: Mexican peso by 16%, Russian ruble by 6%, Chilean peso by 2%, Canadian dollar by 2% and Japanese yen by 1%. All comparisons are on a year-to-date basis.

Cash Flow

We continually seek to improve the efficiency of our working capital management. Periodically, as part of our cash and commercial relationship management activities, we make decisions in our commercial and supply chain activities which may drive an acceleration of receivable payments from customers, or deceleration of payments to third parties. This has the effect of increasing or decreasing cash from operations during any given period. In connection with strategic continual improvement, we obtained more favorable payment terms from many of our vendors which are expected to continue in future periods. In addition, in periods in which receivable payments from customers are delayed, we have and expect we may in the future extend the time to pay certain vendors, so as to balance our liquidity position. Such decisions may have a material impact on our annual operating cash flow measurement, as well as on our quarterly results.

 

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Cash flow generated from operating activities during the third quarter of 2024 was $693 million, compared to $5 million of cash flow generated from operating activities in the third quarter of 2023. The higher cash flow generated from operating activities in the third quarter of 2024 resulted mainly from higher profit in our United States segment, as well as from changes in working capital items, including a positive impact from accounts receivables, net of SR&A, and from accounts payables and inventory levels, partially offset by higher legal payments during the third quarter of 2024.

During the third quarter of 2024, we generated free cash flow of $922 million, which we define as comprising $693 million in cash flow generated from operating activities, $339 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $38 million in divestitures of businesses and other assets, partially offset by $148 million in cash used for capital investment. During the third quarter of 2023, we generated free cash flow of $229 million, which we define as comprising $5 million in cash flow generated from operating activities, $362 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $10 million in proceeds from divestitures of businesses and other assets, partially offset by $149 million in cash used for capital investment. The increase in the third quarter of 2024, resulted mainly from higher cash flow generated from operating activities.

Dividends

We have not paid dividends on our ordinary shares or ADSs since December 2017.

Commitments

In addition to financing obligations under short-term debt and long-term senior notes and loans, debentures and convertible debentures, our major contractual obligations and commercial commitments include leases, royalty payments, contingent payments pursuant to acquisition agreements, collaboration agreements, development funding agreements and participation in joint ventures associated with R&D activities. For further information on our agreements with mAbxience, Launch Therapeutics and Abingworth, Biolojic Design, Royalty Pharma, Sanofi, Modag, Alvotech, Takeda and MedinCell, see note 2 to our consolidated financial statements.

We are committed to paying royalties to owners of know-how, partners in alliances and certain other arrangements, and to parties that financed R&D at a wide range of rates as a percentage of sales of certain products, as defined in the agreements. In some cases, the royalty period is not defined; in other cases, royalties will be paid over various periods not exceeding 20 years.

In connection with certain development, supply and marketing, and research and collaboration or services agreements, we are required to indemnify, in unspecified amounts, the parties to such agreements against third-party claims relating to (i) infringement or violation of intellectual property or other rights of such third party; or (ii) damages to users of the related products. Except as described in our financial statements, we are not aware of any material pending action that may result in the counterparties to these agreements claiming such indemnification.

Non-GAAP Net Income and Non-GAAP EPS Data

We present non-GAAP net income and non-GAAP earnings per share (“EPS”) as management believes that such data provide useful information to investors because they are used by management and our Board of Directors, in conjunction with other performance metrics, to evaluate our operational performance, to prepare and evaluate our work plans and annual budgets and ultimately to evaluate the performance of management, including annual compensation. While other qualitative factors and judgment also affect annual compensation, the principal quantitative element in the determination of such compensation are performance targets tied to the work plan, which are based on these non-GAAP measures.

Non-GAAP financial measures have no standardized meaning and accordingly have limitations in their usefulness to investors. Investors are cautioned that, unlike financial measures prepared in accordance with U.S. GAAP, non-GAAP measures may not be comparable with the calculation of similar measures for other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using non-GAAP financial measures as performance measures are that they provide a view of our results of operations without including all events during a period and may not provide a comparable view of our performance to other companies in the pharmaceutical industry. Investors should consider non-GAAP net income and non-GAAP EPS in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP.

 

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In preparing our non-GAAP net income and non-GAAP EPS data, we exclude items that either have a non-recurring impact on our financial performance or which, in the judgment of our management, are items that, either as a result of their nature or size, could, were they not excluded, potentially cause investors to extrapolate future performance from an improper base that is not reflective of our underlying business performance. Certain of these items are also excluded because of the difficulty in predicting their timing and scope. The items excluded from our non-GAAP net income and non-GAAP EPS include:

 

   

amortization of purchased intangible assets;

 

   

legal settlements and material litigation fees and/or loss contingencies, due to the difficulty in predicting their timing and scope;

 

   

impairments of long-lived assets, including intangibles, property, plant and equipment and goodwill;

 

   

restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to the rationalization of our plants or to certain other strategic activities, such as the realignment of R&D focus or other similar activities;

 

   

acquisition- or divestment- related items, including changes in contingent consideration, integration costs, banker and other professional fees and inventory step-up;

 

   

expenses related to our equity compensation;

 

   

significant one-time financing costs, amortization of issuance costs and terminated derivative instruments, and marketable securities investment valuation gains/losses;

 

   

unusual tax items;

 

   

other awards or settlement amounts, either paid or received;

 

   

other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as impacts due to significant costs for remediation of plants, or other unusual events; and

 

   

corresponding tax effects of the foregoing items.

The following tables present our non-GAAP net income and non-GAAP EPS for the three and nine months ended September 30, 2024 and 2023, as well as reconciliations of each measure to their nearest GAAP equivalents:

 

    Three months ended
September 30,
    Nine months ended
September 30,
 
($ in millions except per share amounts)   2024      2023      2024      2023   

Net income (Loss) attributable to Teva(1)

  ($ )       (437     69     ($ )       (1,422     (1,022

Increase (decrease) for excluded items:

           

Amortization of purchased intangible assets

      146       145         444       471  

Legal settlements and loss contingencies(2)

      450       314         638       1,009  

Goodwill impairment(3)

      600       —          1,000       700  

Impairment of long-lived assets(4)

      (51     48         758       310  

Restructuring costs

      21       27         52       93  

Equity compensation

      29       31         89         93  

Contingent consideration(1)(5)

      34         27         305       140  

Loss (Gain) on sale of business

      (20     (5       (21     (3

Accelerated depreciation

      1       25         8       74  

Financial expenses

      11       14         35       53  

Items attributable to non-controlling interests(4)

      41       (1       (276     (91

 

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Other non-GAAP items(6)

      56       64         162       252  

Corresponding tax effects and unusual tax items(7)

      (83     (80       270       (315

Non-GAAP net income attributable to Teva

  ($ )       798       677     ($ )       2,043       1,762  

Non-GAAP tax rate(8)

      16.0     9.0       15.5     13.0

GAAP diluted earnings (loss) per share attributable to Teva

  ($ )       (0.39     0.06     ($ )       (1.26     (0.91

EPS difference(9)

      1.08       0.54         3.04       2.47  

Non-GAAP diluted EPS attributable to Teva(9)

  ($ )       0.69       0.60     ($ )       1.78       1.56  

Non-GAAP average number of shares (in millions)(9)

      1,155       1,135         1,148       1,131  

 

(1)

The data presented for the prior period have been revised to reflect a revision in the presentation of these items in the consolidated financial statements. For additional information see note 1c to our consolidated financial statements.

(2)

Adjustments for legal settlements and loss contingencies in the third quarter of 2024 were mainly related to a provision of $350 million recorded in connection with a decision by the European Commission in its antitrust investigation into COPAXONE®, and to an update to the estimated settlement provision of $121 million for the opioid cases (mainly related to the settlement agreement with the city of Baltimore and the effect of the passage of time on the net present value of the discounted payments). Adjustments for legal settlements and loss contingencies in the third quarter of 2023 were mainly related to a provision of $270 million in connection with the U.S. DOJ patient assistance program litigation.

Adjustments for legal settlements and loss contingencies in the nine months ended September 30, 2024 were mainly related to a provision of $350 million recorded in connection with a decision by the European Commission in its antitrust investigation into COPAXONE®, and to an update to the estimated settlement provision of $239 million for the opioid cases (mainly the effect of the passage of time on the net present value of the discounted payments and the settlement agreement with the city of Baltimore). Adjustments for legal settlements and loss contingencies in the nine months ended September 30, 2023 were mainly related to an update to the estimated provision of $370 million related to the DOJ patient assistance program litigation, an update to the estimated settlement provision of $248 million related to the remaining opioid cases, the provision of $204 million relating to the U.S. DOJ criminal antitrust charges on the marketing and pricing of certain Teva USA generic products, and the provision of $100 million related to the settlement of the reverse-payment antitrust litigation over certain HIV medicines. See note 10 to our consolidated financial statements.

(3)

Goodwill impairment charges of $600 million and $1,000 million related to Teva’s API reporting unit were recorded in the three and nine months ended September 30, 2024, respectively. A goodwill impairment charge of $700 million related to our International Markets reporting unit was recorded in the nine months ended September 30, 2023.

(4)

Adjustments for impairment of long-lived assets and items attributable to non-controlling interests, for the first nine months of 2024 primarily consisted of $561 million and $275 million, respectively, related to the classification of the business venture in Japan as held for sale. Adjustments for impairment of long-lived assets, for the first nine months of 2023 primarily consisted of $206 million related to impairments of identifiable product rights and $83 million related to impairments of IPR&D assets.

(5)

Adjustments for contingent consideration primarily related to a change in the estimated future royalty payments to Allergan in connection with

lenalidomide capsules (the generic version of Revlimid®), of $28 million and $266 million, respectively for the three and nine months ended September 30, 2024, and of $23 million and $111 million, respectively for the three and nine months ended September 30, 2023.

(6)

Other non-GAAP items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, primarily related to the rationalization of our plants, certain inventory write-offs, material litigation fees and other unusual events.

(7)

Adjustments for corresponding tax effects and unusual tax items for the nine months ended September 30, 2024, include a tax item in an amount of $495 million related to the settlement agreement with the ITA to settle certain litigation with respect to taxes payable for the Company’s taxable years 2008 through 2020.

(8)

Non-GAAP tax rate is tax expenses (benefit) excluding the impact of non-GAAP tax adjustments presented above as a percentage of income (loss) before income taxes excluding the impact of non-GAAP adjustments presented above. GAAP tax rate for the three and nine months ended September 30, 2024 was 21% and 62% respectively and for the three and nine months ended September 30, 2023 was 19% and 4% respectively.

 

(9)

EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares.

 

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Off-Balance Sheet Arrangements

Except for securitization transactions, which are disclosed in note 10f to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2023, we do not have any material off-balance sheet arrangements.

Critical Accounting Policies

For a summary of our significant accounting policies, see note 1 to our consolidated financial statements and “Critical Accounting Policies” included in our Annual Report on Form 10-K for the year ended December 31, 2023. Additionally, see note 6 to our consolidated financial statements on this Form 10-Q for disclosure regarding reporting units at risk identified during our annual goodwill impairment test.

Recently Issued Accounting Pronouncements

See note 1 to our consolidated financial statements.

 

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has not been any material change in our assessment of market risk as set forth in Item 7A to our Annual Report on Form 10-K for the year ended December 31, 2023.

 

ITEM 4.

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Teva maintains “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) that are designed to provide reasonable assurance that information required to be disclosed in Teva’s reports filed or submitted under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Teva’s management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating these disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.

After evaluating the effectiveness of our disclosure controls and procedures as of September 30, 2024, our Chief Executive Officer and Chief Financial Officer concluded that, due to a material weakness in internal control over financial reporting described below, as of such date, the Company’s disclosure controls and procedures were not effective.

Previously Identified Material Weakness in Internal Control over Financial Reporting

A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of the company’s annual or interim financial statements will not be prevented or detected on a timely basis.

As previously disclosed, in our Annual Report on Form 10-K for the year ended December 31, 2023, during the preparation of our consolidated financial statements for the year ended December 31, 2023, management identified a material weakness in our internal control over financial reporting, which continues to exist as of September 30, 2024.

We did not design and maintain effective control over the contingent consideration liability and related expenses in connection with estimated future royalty payments. This material weakness resulted in the misstatement of our “Other asset impairments, restructuring and other items,” “Net income” and “Other taxes and long-term liabilities” and related financial disclosures, and led to the revision of the Company’s consolidated financial statements for the year ended December 31, 2022, and the interim financial information for the quarterly and year-to-date periods ended June 30, 2022, September 30, 2022, December 31, 2022, March 31, 2023, June 30, 2023 and September 30, 2023. Additionally, this material weakness could result in a misstatement of the aforementioned account balances or disclosures that would result in a material misstatement to the annual or interim consolidated financial statements that would not be prevented or detected.

 

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Remediation Plan

Management has designed and implemented the following specific controls to address the material weakness and enhance our disclosure controls and procedures over the contingent consideration liability: (i) defined responsibilities over the end-to-end process; (ii) enhanced the formality and rigor of reconciliation procedures; and (iii) implemented additional monitoring controls through management reviews. In addition, management has conducted trainings for the related control owners.

Although the new controls have been designed and implemented, they have not been operated for a sufficient period of time for management to conclude, through testing, that these controls are operating effectively. Accordingly, the material weakness described above is not remediated as of September 30, 2024.

Changes in Internal Control over Financial Reporting

During the three months ended September 30, 2024, there were no changes in internal control over financial reporting that materially affected or are reasonably likely to materially affect Teva’s internal control over financial reporting.

 

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PART II — OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

We are subject to various litigation and other legal proceedings. For a discussion of these matters, see “Commitments and Contingencies” included in note 10 to our consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q.

 

ITEM 1A.

RISK FACTORS

There are no material changes to the risk factors previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2023.

 

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Unregistered Sales of Equity Securities

There were no sales of unregistered equity securities during the three months ended September 30, 2024.

Repurchase of Shares

We did not repurchase any of our shares during the three months ended September 30, 2024 and currently cannot conduct share repurchases or pay dividends due to our accumulated deficit.

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

Not applicable.

 

ITEM 4.

MINE SAFETY DISCLOSURES

Not applicable.

 

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ITEM 5.
OTHER INFORMATION
Director and Officer Rule
10b5-1
Trading Arrangements
During the three months ended September 30, 2024, the following officer adopted a Rule
10b5-1
trading arrangement (as such term is defined in Item 408 of Regulation
S-K).
The trading plan is intended to satisfy the affirmative defense of Rule
10b5-1(c)
under the Exchange Act.
 
Name and Title
  
Date
    
Action
    
Expiration Date
    
Maximum Shares
Subject to Plan
 (1)
 
Christine Fox, EVP, U.S. Commercial
     August 13, 2024        Adopted        March 6, 2025        83,953  
 
(1)
 
The plan includes shares to be sold solely to cover tax withholding obligations.
 
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ITEM 6.

EXHIBITS

 

31.1    Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2    Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
32    Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
101.INS    Inline XBRL Taxonomy Instance Document
101.SCH    Inline XBRL Taxonomy Extension Schema Document
101.CAL    Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF    Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB    Inline XBRL Taxonomy Extension Labels Linkbase Document
101.PRE    Inline XBRL Taxonomy Extension Presentation Linkbase Document
104    Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

 

*

Filed herewith.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

    TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Date: November 6, 2024     By:  

/s/ Eli Kalif

    Name:   Eli Kalif
    Title:  

Executive Vice President,

Chief Financial Officer

(Duly Authorized Officer)

 

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