根据1934年证券交易法第13或15(d)条款的季度报告 |
根据1934年证券交易法第13或15(d)条款的过渡报告 |
(依據所在地或其他管轄區) 的註冊地或組織地點) |
(IRS雇主 識別號碼) | |
(總部辦公地址) |
（郵遞區號） | |
每種類別的名稱 |
交易 標的 |
每個交易所的名稱 註冊在哪裡的 | ||
| ☒ | 加速檔案提交者 | ☐ | ||||
非加速公司 文件處理器 |
☐ | 較小報告公司 | ||||
| 新興成長型企業 | ||||||
第一部分。 |
||||||
项目1。 |
基本報表 (未經審計) | |||||
| 合併資產負債表 | 5 | |||||
| 綜合損益表 | 6 | |||||
| 綜合損益表 | 7 | |||||
| 綜合損益表變動表 | 8 | |||||
| 綜合現金流量表 | 10 | |||||
| 基本報表註 | 11 | |||||
项目2。 |
管理層對財務狀況和業績的討論與分析 | 57 | ||||
项目3。 |
有關市場風險的定量和定性披露 | 85 | ||||
項目 4。 |
控制項和程序 | 85 | ||||
第二部分。 |
||||||
项目1。 |
法律訴訟 | 87 | ||||
项目1A。 |
風險因素 | 87 | ||||
项目2。 |
股票權益的未註冊銷售和資金用途 | 87 | ||||
项目3。 |
優先證券違約 | 87 | ||||
項目 4。 |
礦業安全披露 | 87 | ||||
项目5。 |
其他信息 | 88 | ||||
第6項。 |
附件 | 89 | ||||
| 簽名 | 90 | |||||
| • | 我們在市場上成功競爭的能力，包括：我們在很大程度上依賴我們的仿製產品；我們的客戶群體和商業聯盟對我們的依賴程度很高；新仿製產品推出的延遲；我們開發和商業化生物製藥產品的能力；我們創新藥品的競爭；我們從產品管線投資中實現預期結果的能力；我們開發和商業化其他藥品的能力；我們成功執行「轉型增長」戰略的能力，包括擴展我們的創新和仿製生物藥品管線並盈利地商業化創新藥品和仿製生物藥品組合，無論是通過有機擴張還是通過業務發展，並維持和集中我們的仿製藥品組合；以及我們專利和其他措施保護我們的知識產權的有效性，包括在美國對我們的《橙皮書》專利清單可能存在的挑戰； |
| • | 我們的巨額負債，可能限制我們增加額外負債、進行額外交易或進行新投資的能力，可能會導致我們的信貸評級未來下調；以及我們無法以有利於我們的金額或條件籌集債務或借款資金； |
| • | 我們的業務和運營總體情況，包括：全球經濟形勢和其他宏觀經濟發展以及政府和社會對此的回應的影響；疾病的廣泛爆發或其他傳染病，或其他公共衛生危機；我們優化努力的有效性；吸引、招聘、整合和留住高技能人員的能力；我們供應鏈中斷或內部或第三方製造問題；信息技術系統中斷；我們數據安全挑戰的違約，包括在全球範圍內開展業務時面臨的政治或經濟不穩定、重大沖突或恐怖主義活動，比如俄羅斯和烏克蘭之間的持續衝突以及以色列宣佈的戰爭狀態；因我們所受制藥監管的廣泛性導致的成本和延誤；我們成功買盤適當的收購目標或許可機會，或完成和整合收購；以及我們如果賣出資產或業務部門，並關閉或出售工廠和設施，在此如果我們能夠成功，以及高效率地完成此類出售和出售，包括我們計劃出售API業務的出售； |
| • | 合規、監管和訴訟事項，包括：未能遵守複雜的法律和監管環境的影響；政府和民事訴訟以及我們是或將來成爲當事人的影響；衛生法規改革及藥品定價、報銷和覆蓋範圍的影響；與公衆對濫用阿片藥物的關注相關的增加的法律和監管行動；我們及時根據全國阿片類藥物和按照協議的條款所需的支付且提供Narcan的仿製版本 ® （納洛酮鹽酸鹽鼻噴劑）按協議的要求時間和數量達到的能力；受到全球競爭和定價機構的審查，包括我們遵守和執行與美國司法部（DOJ）達成的推諉起訴協議（「DPA」）的能力；知識產權侵權的潛在責任；產品責任索賠；未能遵守複雜的醫療保險、醫療補助和其他政府計劃的報告和付款義務；遵守反腐敗、制裁和貿易控制法律；環境風險；以及可持續性問題的影響； |
| • | 以色列宣佈戰爭狀態及該地域的軍事活動對我們的業務和設施產生影響，例如位於以色列的製造和研發設施，以及我們的員工因爲是軍事預備役士兵而被召入軍隊的影響，還有戰爭對以色列的經濟、社會和政治穩定造成的影響； |
| • | 其他金融和經濟風險，包括：我們對貨幣波動和限制的敞口以及信用風險；我們長期資產的潛在減值；地緣政治衝突的影響，包括以色列宣佈的戰爭狀態和俄烏衝突；潛在重大增加的稅務責任；政府計劃或稅收優惠終止或到期，或業務發生變化對我們整體有效稅率的影響；以及我們糾正現有財務報告內部控制方面重大缺陷的能力； |
項目1。 |
基本報表 |
2022年9月30日 |
12月31日， |
|||||||
2024 |
2023 |
|||||||
| 資產 |
||||||||
| 流動資產： |
||||||||
| 現金及現金等價物 |
$ | $ | ||||||
| 應收賬款，扣除信用損失準備 |
||||||||
| 存貨 |
||||||||
| 預付費用 |
||||||||
| 其他資產 |
||||||||
| 待售資產 |
||||||||
| |
|
|
|
|||||
| 總流動資產 |
||||||||
| 延遲所得稅 |
||||||||
| 其他 非流動性 資產 |
||||||||
| 物業、廠房和設備，淨值 |
||||||||
| 保險業 租賃權 |
||||||||
| 可識別無形資產淨值 |
||||||||
| 商譽 |
||||||||
| |
|
|
|
|||||
| 資產總額 |
$ | $ | ||||||
| |
|
|
|
|||||
| 負債和股東權益 |
||||||||
| 流動負債: |
||||||||
| 短期債務 |
$ | $ | ||||||
| 銷售準備金和折扣 |
||||||||
| 應付賬款 |
||||||||
| 與僱員相關的義務 |
||||||||
| 應計費用 |
||||||||
| 其他流動負債 |
||||||||
| 待售負債 |
||||||||
| |
|
|
|
|||||
| 流動負債合計 |
||||||||
| 長期負債： |
||||||||
| 延遲所得稅 |
||||||||
| 其他稅收和長期負債 |
||||||||
| 優先票據和貸款 |
||||||||
| 經營租賃負債 |
||||||||
| |
|
|
|
|||||
| 長期負債總額 |
||||||||
| |
|
|
|
|||||
| 承諾和 contingencies |
||||||||
| 負債合計 |
||||||||
| |
|
|
|
|||||
| 股東權益： |
||||||||
| 梯瓦股東權益: |
||||||||
| 以新以色列謝克爾的普通股爲名義金額- |
||||||||
| 共計 實收資本 資本金 |
||||||||
| 累積赤字 |
( |
) | ( |
) | ||||
| 累計其他綜合損失 |
( |
) | ( |
) | ||||
| 2024年9月30日和2023年12月31日的庫藏股： |
( |
) | ( |
) | ||||
| |
|
|
|
|||||
| |
|
|
|
|||||
| 非控制權益 其他權益 |
||||||||
| |
|
|
|
|||||
| 股東權益總計 |
||||||||
| |
|
|
|
|||||
| 負債和所有者權益總額 |
$ | $ | ||||||
| |
|
|
|
|||||
截止 2022年9月30日 |
九個月結束 2022年9月30日 |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
| 淨利潤 |
$ | $ | $ | $ | ||||||||||||
| 銷售成本 |
||||||||||||||||
| 毛利潤 |
||||||||||||||||
| 研發費用 |
||||||||||||||||
| 銷售和市場費用 |
||||||||||||||||
| 一般及管理費用 |
||||||||||||||||
| 無形資產減值 |
||||||||||||||||
| 商譽減值 |
||||||||||||||||
| 其他資產減值、重組及其他項目 |
( |
) | ||||||||||||||
| 法律和損失準備金 |
||||||||||||||||
| 其他 損失 （收益） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 業務利潤（虧損） |
( |
) | ( |
) | ( |
) | ||||||||||
| 財務費用，淨額 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 稅前收益（虧損） |
( |
) | ( |
) | ( |
) | ||||||||||
| 所得稅（利益） |
( |
) | ( |
) | ||||||||||||
| 分享關聯公司的淨利潤損失 |
( |
) | § | ( |
) | ( |
) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| |
( |
) | ( |
) | ( |
) | ||||||||||
| 歸屬於淨利潤（損失） 非控制股權 其他權益 |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 歸屬梯瓦的淨利潤（虧損） |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 每股盈利（虧損）歸屬於普通股股東： |
||||||||||||||||
| 基礎 |
$ | ( |
) | $ | $ | ( |
) | $ | ( |
) | ||||||
| |
|
|
|
|
|
|
|
|||||||||
| 攤薄後 |
$ | ( |
) | $ | $ | ( |
) | $ | ( |
) | ||||||
| |
|
|
|
|
|
|
|
|||||||||
| 每股加權平均股數（以百萬計）： |
||||||||||||||||
| 基礎 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 攤薄後 |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| § | 代表少於$的金額 |
截止 2022年9月30日 |
九個月結束 2022年9月30日 |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
| |
$ | ( |
) | $ | $ | ( |
) | $ | ( |
) | ||||||
| 其他綜合收益(損失), 淨額(稅後): |
||||||||||||||||
| 貨幣翻譯調整 |
( |
) | ( |
) | ( |
) | ||||||||||
| 金融工具衍生物未實現收益（損失），淨額 |
||||||||||||||||
| 企業年金計劃未實現損失 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 其他綜合收益（損失）總額 |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 總綜合收益（損失） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
| 歸屬於的綜合收益（損失） 非控制股權 其他權益 |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| 歸屬梯瓦的綜合收益（損失） |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| |
|
|
|
|
|
|
|
|||||||||
梯瓦製藥股東權益 |
||||||||||||||||||||||||||||||||||||
普通股 |
||||||||||||||||||||||||||||||||||||
股數 股份（在 （以百萬計） |
說明 價值 |
額外的 實收資本 資本金 |
留存收益 盈餘 （累積的 deficit) |
累積的 其他 綜合 （虧損） |
國庫 股 |
梯瓦總額 股東的 股東權益 |
非控制權益 其他權益 |
總計 股東權益 |
||||||||||||||||||||||||||||
（以百萬美元計） |
||||||||||||||||||||||||||||||||||||
| 2024年6月30日餘額 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
| 淨利潤 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
| 其他綜合收益（損失） |
||||||||||||||||||||||||||||||||||||
| 股份發行 |
* | * | * | * | ||||||||||||||||||||||||||||||||
| 股票補償費用 |
||||||||||||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| 2024年9月30日餘額 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | $ | $ | |
|||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| * | 表示小於某一金額 |
梯瓦製藥股東權益 |
||||||||||||||||||||||||||||||||||||
普通股 |
||||||||||||||||||||||||||||||||||||
股數 shares (in millions) |
說明 價值 |
額外的 實收資本 資本金 |
留存收益 盈餘 （累積 赤字） |
累積的 其他 綜合 （損失） |
國庫 股 |
梯瓦製藥 股東的 股東權益 |
非控制權益 其他權益 |
總計 股東權益 |
||||||||||||||||||||||||||||
（以百萬美元計） |
||||||||||||||||||||||||||||||||||||
| 2023年12月31日的餘額 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
| 淨利潤 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
| 其他綜合收益（損失） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
| 股份發行 |
* | |||||||||||||||||||||||||||||||||||
| 股票補償費用 |
— | |||||||||||||||||||||||||||||||||||
| 期權行使所得 |
||||||||||||||||||||||||||||||||||||
| 應分配的股息 非控制股權 interests** |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||
| Purchase of shares from 非控制股權 interests*** |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| 2024年9月30日餘額 |
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | $ | $ | ||||||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
| * | 代表少於$的金額 |
| ** | 關於分紅派息給 非控制股權 日本梯瓦製藥合資企業中的股份。 |
| *** | 從 購買公司股份 非控制股權 瑞士的梯瓦製藥子公司中的股份。 |
梯瓦股東權益 |
||||||||||||||||||||||||||||||||||||
普通股 |
||||||||||||||||||||||||||||||||||||
股數 股份數（以 百萬計） |
說明 價值 |
額外的 實收資本 資本金 |
留存收益 盈餘 （累積 虧損） |
累積的 其他 綜合的 （虧損） |
國庫 股 |
梯瓦總額 股東的 股東權益 |
非控制權益 其他權益 |
總計 股東權益 |
||||||||||||||||||||||||||||
（以百萬美元計） |
||||||||||||||||||||||||||||||||||||
| 2023年6月30日餘額 ** |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
| 淨利潤（虧損）** |
||||||||||||||||||||||||||||||||||||
| 其他綜合收益（損失） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
| 股份發行 |
* | * | * | |||||||||||||||||||||||||||||||||
| 股票補償費用 |
||||||||||||||||||||||||||||||||||||
| 應分配的股息 非控制股權 interest *** |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||
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| Balance at September 30, 2023 ** |
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | |
$ | $ | |
||||||||||||||||||||
| |
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| * | 代表少於$的金額 |
| ** | 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. |
| *** | 關於分紅派息聲明 非控制股權 對梯瓦製藥在日本的合資企業的利益。 |
梯瓦製藥股東權益 |
||||||||||||||||||||||||||||||||||||
普通股 |
||||||||||||||||||||||||||||||||||||
股數 股份（以百萬美元計） |
說明 價值 |
額外的 實收資本 資本金 |
留存收益 盈餘 (accumulated 虧損) |
累積的 其他 全面 (損失) |
國庫 股 |
梯瓦總額 股東的 股東權益 |
非控制權益 其他權益 |
總計 股東權益 |
||||||||||||||||||||||||||||
（以百萬美元計） |
||||||||||||||||||||||||||||||||||||
| 2022年12月31日的餘額 ** |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
| 淨利潤 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
| 其他綜合收益（損失） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||
| 股份發行 |
* | * | * | * | ||||||||||||||||||||||||||||||||
| 股票補償費用 |
— | |||||||||||||||||||||||||||||||||||
| 應分配的股息 非控制股權 利息 *** |
( |
) | ( |
) | ||||||||||||||||||||||||||||||||
| |
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|
|||||||||||||||||||
| 2023年9月30日結餘 ** |
$ | $ | $ | ( |
) | $ | ( |
) | $ | ( |
) | $ | $ | $ | ||||||||||||||||||||||
| |
|
|
|
|
|
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|||||||||||||||||||
| * | 代表少於$的金額 |
| ** | 過往時期呈現的數據已經修訂，以反映綜合財務報表中與相關費用相關的應收待攤負債的修訂。有關更多信息，請參閱附註1c。 |
| *** | 關於對股息的宣佈 非控制股權 在日本梯瓦製藥的合資公司的權益。 |
截止 2022年9月30日 |
九個月結束 9月30日， |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
經營活動： |
||||||||||||||||
| $ | ( |
) | $ | ( |
) | ( |
) | |||||||||
調整以重新計算淨利潤（虧損）爲經營活動提供的淨現金： |
||||||||||||||||
折舊和攤銷 |
||||||||||||||||
商譽減值 |
||||||||||||||||
長期資產和待售資產減值 |
( |
) | ||||||||||||||
經營性資產和負債淨變動額 |
( |
) | ( |
) | ( |
) | ||||||||||
遞延所得稅-淨額和不確定稅務立場 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
股票補償 |
||||||||||||||||
其他項目 * |
( |
) | ||||||||||||||
出售業務和長期資產的淨虧損（盈利） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
經營活動產生的淨現金流量 |
||||||||||||||||
投資活動： |
||||||||||||||||
收集的有益權益，以換取證券化的應收賬款 |
||||||||||||||||
購買固定資產、廠房和設備以及無形資產 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
出售業務和長期資產的收益 |
||||||||||||||||
收購企業，扣除現金淨額 |
( |
) | ||||||||||||||
購買投資和其他資產 |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||
出售投資所得款 |
||||||||||||||||
其他投資活動 |
( |
) | ( |
) | ||||||||||||
投資活動產生的淨現金流量 |
||||||||||||||||
籌資活動： |
||||||||||||||||
償還優先票據、貸款和其他長期負債 |
( |
) | ( |
) | ( |
) | ||||||||||
從 購買公司股份 非控制股權 其他權益 |
( |
) | ||||||||||||||
Others 非控制股權 其他權益 |
( |
) | ||||||||||||||
優先票據淨額，扣除發行成本 |
||||||||||||||||
短期債務收入 |
||||||||||||||||
短期債務償還 |
( |
) | ( |
) | ||||||||||||
其他融資活動 |
( |
) | ( |
) | ( |
) | ||||||||||
籌集資金的淨現金流量 |
( |
) | ( |
) | ( |
) | ||||||||||
現金及現金等價物的翻譯調整 |
( |
) | ( |
) | ( |
) | ||||||||||
經營性現金流淨額 |
( |
) | — |
( |
) | |||||||||||
期初現金、現金等價物和受限現金餘額 |
||||||||||||||||
期末現金、現金等價物和受限現金餘額 |
$ | |||||||||||||||
現金及現金等價物 |
||||||||||||||||
其他流動資產中包含的受限制現金 |
||||||||||||||||
現金、現金等價物及限制性現金的總額（見現金流量表） |
||||||||||||||||
非現金 融資和投資活動: |
||||||||||||||||
交換帳戶應收賬款獲得的有利權益 |
$ | $ | ||||||||||||||
向股東分紅的 非控制股權 其他權益 |
$ | $ | ||||||||||||||
| * | 2024年9月30日結束的九個月期間的調整主要涉及與以色列稅務當局達成協議，解決了某些訴訟，涉及金額爲$ |
a. |
報表基礎 |
b. |
重大會計政策 |
c. |
修訂之前報告的綜合基本報表 |
| 截至三個月 | 截至九個月 | |||||||||||||||||||||||
| 2023年9月30日 | 2023年9月30日 | |||||||||||||||||||||||
| 以百萬美元計（每股金額除外） | ||||||||||||||||||||||||
| (未經審計) | ||||||||||||||||||||||||
| 調整後 之前 報告 |
調整 | 修訂後 | 此前 報告了 |
調整 | 經修訂 | |||||||||||||||||||
| 其他資產減值、重組及其他事項 |
$ | $ | ||||||||||||||||||||||
| 營業收入（虧損） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| 稅前收入（虧損） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| 所得稅（收益） |
( |
) | § | ( |
) | ( |
) | § | ( |
) | ||||||||||||||
| 凈利潤（虧損） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| 歸屬於梯瓦製藥的凈利潤（虧損） |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
| 歸屬於普通股股東的每股收益（虧損）： |
||||||||||||||||||||||||
| 基本和稀釋後的每股虧損 |
$ | ( |
) | $ | ( |
) | ( |
) | ( |
) | ||||||||||||||
| § | 代表少於 $ 的金額 |
| 2023年9月30日 | ||||||||||||
| 調整後 之前 報告過 |
調整 | 如修訂 | ||||||||||
| (未經審計) | ||||||||||||
遞延所得稅 |
$ | |||||||||||
總資產 |
||||||||||||
其他稅收和長期負債 |
||||||||||||
長期負債總額 |
||||||||||||
總負債 |
||||||||||||
梯瓦製藥股東權益： |
||||||||||||
累計虧損 |
( |
) | ( |
) | ( |
) | ||||||
總權益 |
( |
) | ||||||||||
總負債及權益 |
$ | |||||||||||
9月30日， |
12月31日， |
|||||||
2024 |
2023 |
|||||||
(以百萬美元計算) |
||||||||
| 存貨 |
||||||||
| 應收賬款 |
||||||||
| 商譽 |
||||||||
| 可識別的無形資產淨值 |
||||||||
| 物業、廠房及設備，淨值 |
||||||||
| 其他流動和 非流動 資產 |
||||||||
| 預計銷售損失* |
( |
) | ||||||
| |
|
|
|
|||||
| 合併資產負債表中分類爲待售的處置組的總資產 |
$ | $ | ||||||
| |
|
|
|
|||||
| 應付賬款 |
( |
) | ||||||
| 其他負債 |
( |
) | ( |
) | ||||
| 預計銷售損失* |
( |
) | ||||||
| |
|
|
|
|||||
| 合併資產負債表中分類爲待售的處置組的總負債 |
$ | ( |
) | $ | ( |
) | ||
| |
|
|
|
|||||
| * | 包括由於銷售而將貨幣折算調整重新分類至合併損益表的預計損失。 |
截至2024年9月30日的三個月 |
||||||||||||||||||||
美國 |
歐洲 |
國際 市場 |
其他活動 |
總計 |
||||||||||||||||
(百萬美元) |
||||||||||||||||||||
| 商品銷售 |
||||||||||||||||||||
| 許可安排 |
||||||||||||||||||||
| 分配 |
§ | |||||||||||||||||||
| 其他 |
§ | |||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| $ | $ | $ | |
$ | $ | |
||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| § | 代表小於50萬美元的金額。 |
截至2023年9月30日的三個月 |
||||||||||||||||||||
美國 |
歐洲 |
國際 市場 |
其他活動 |
總計 |
||||||||||||||||
(百萬美元) |
||||||||||||||||||||
| 商品銷售 |
||||||||||||||||||||
| 許可安排 |
||||||||||||||||||||
| 分配 |
§ | |||||||||||||||||||
| 其他 |
§ | |||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| $ | $ | $ | |
$ | $ | |
||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| § | 代表低於50萬美元的金額。 |
截至2024年9月30日的九個月 |
||||||||||||||||||||
美國 |
歐洲 |
國際 市場 |
其他活動 |
總計 |
||||||||||||||||
(以百萬美元計) |
||||||||||||||||||||
| 商品銷售 |
||||||||||||||||||||
| 許可協議 |
||||||||||||||||||||
| 分配 |
§ | |||||||||||||||||||
| 其他 |
§ | |||||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| |
|
|
|
|
|
|
|
|
|
|||||||||||
| § | 表示金額少於50萬美元。 |
截至2023年9月30日的九個月 |
||||||||||||||||||||
美國 |
歐洲 |
國際 市場 |
其他活動 |
總計 |
||||||||||||||||
(以百萬美元計) |
||||||||||||||||||||
商品銷售 |
||||||||||||||||||||
許可安排 |
||||||||||||||||||||
分配 |
§ | |||||||||||||||||||
其他 |
§ | |||||||||||||||||||
| $ | $ | $ | $ | $ | ||||||||||||||||
| § | 表示金額低於50萬美元。 |
銷售準備金和減免 |
||||||||||||||||||||||||||||||||
儲備 包含在內 賬戶 應收賬款淨額 |
折扣 |
醫療補助和 其他 政府的 津貼 |
退款 |
收益 |
其他 |
總儲備 包含於 銷售儲備 和減免 |
總計 |
|||||||||||||||||||||||||
(以百萬美元計算) |
||||||||||||||||||||||||||||||||
2024年1月1日的餘額 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
與本年度銷售相關的準備金 |
||||||||||||||||||||||||||||||||
與以前年度銷售相關的準備金 |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||
信用和支付 |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
翻譯差異 |
( |
) | ||||||||||||||||||||||||||||||
截至2024年9月30日的餘額 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
銷售準備金和補助 |
||||||||||||||||||||||||||||||||
儲備 包含在 賬戶 應收款，淨額 |
折扣 |
醫療補助和 其他 政府的 津貼 |
扣款 |
收益 |
其他 |
總儲備 包括在 銷售準備金 和讓步 |
總計 |
|||||||||||||||||||||||||
（以百萬美元計） |
||||||||||||||||||||||||||||||||
截至2023年1月1日的餘額 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
與當前年度內銷售有關的準備金 |
||||||||||||||||||||||||||||||||
與以前期間銷售有關的準備金 |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||
信用和付款 |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||
翻譯差異 |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||
截至2023年9月30日的餘額 |
$ | $ | $ | $ | $ | $ | $ | $ | ||||||||||||||||||||||||
9月30日， |
12月31日， |
|||||||
2024 |
2023 |
|||||||
(以百萬美元計) |
||||||||
成品 |
$ | $ | ||||||
原材料和封裝材料 |
||||||||
在製品 |
||||||||
在途材料和賬戶支付 |
||||||||
| $ | $ | |||||||
毛額淨額 減值 |
累計攤銷 |
淨賬面價值 |
||||||||||||||||||||||
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 |
|||||||||||||||||||
(以百萬美元計) |
||||||||||||||||||||||||
產品權益 |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
商標名稱 |
||||||||||||||||||||||||
在研開發 |
||||||||||||||||||||||||
總計 |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
| (a) | 知識產權與研發資產爲$ |
| (b) | 可識別的產品權利爲$ |
| (a) | 可識別的產品權利爲$ |
| (b) | 知識產權與研發資產爲$ |
| (a) | 可識別的產品權利爲$ |
| (b) | 知識產權與研發資產爲$ |
北部 美國 |
聯合 州 |
歐洲 |
國際 市場 |
其他 |
總計 |
|||||||||||||||||||||||
梯瓦的 API |
美迪斯 |
|||||||||||||||||||||||||||
(以百萬美元計算) |
||||||||||||||||||||||||||||
截至2023年12月31日的餘額（1） |
$ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
與加拿大轉向國際市場相關的商譽分配 |
( |
) | ||||||||||||||||||||||||||
截至2024年1月1日的餘額 |
$ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
期間的其他變動： |
||||||||||||||||||||||||||||
商譽減值 |
( |
) |
( |
) | ||||||||||||||||||||||||
重分類爲待售資產的商譽 |
( |
) | ( |
) | ||||||||||||||||||||||||
翻譯差異及其他 |
( |
) | ( |
) | ||||||||||||||||||||||||
截至2024年9月30日的餘額（1） |
$ | $ | $ | $ | $ | $ | $ | |||||||||||||||||||||
| (1) | 截至2024年9月30日和2023年12月31日累計的商譽減值約爲$ |
a. |
短期債務： |
截至的利率 2024年9月30日 |
到期 |
9月30日， |
12月31日， |
|||||||||||||
2024 |
2023 |
|||||||||||||||
(以百萬美元計算) |
||||||||||||||||
可轉換高級債券 |
% | |||||||||||||||
長期負債的當前到期部分 |
||||||||||||||||
所有短期債務 |
$ | $ | ||||||||||||||
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 |
% | |||||||||||||||
| Senior notes EUR |
% | |||||||||||||||
| Senior notes EUR |
% | |||||||||||||||
| Senior notes USD |
% | |||||||||||||||
| Senior notes EUR |
% | |||||||||||||||
| Senior notes CHF |
% | |||||||||||||||
| Senior notes USD |
% | |||||||||||||||
| Senior notes EUR |
% | |||||||||||||||
| Sustainability-linked senior notes USD |
% | |||||||||||||||
| Sustainability-linked senior notes EUR |
% | |||||||||||||||
| Senior notes USD |
% | |||||||||||||||
| Senior notes EUR |
% | |||||||||||||||
| Sustainability-linked senior notes USD |
% | |||||||||||||||
| Sustainability-linked senior notes USD |
% | |||||||||||||||
| Sustainability-linked senior notes EUR |
% | |||||||||||||||
| Sustainability-linked senior notes EUR |
% | |||||||||||||||
| Sustainability-linked senior notes USD |
% | |||||||||||||||
| Sustainability-linked senior notes EUR |
% | |||||||||||||||
| Senior notes USD |
% | |||||||||||||||
| Senior notes USD |
% | |||||||||||||||
| |
|
|
|
|||||||||||||
| Total senior notes |
||||||||||||||||
| Other long-term debt |
||||||||||||||||
| Less current maturities |
( |
) | ( |
) | ||||||||||||
| Less debt issuance costs |
( |
) | ( |
) | ||||||||||||
| |
|
|
|
|||||||||||||
| Total senior notes and loans |
$ | $ | ||||||||||||||
| |
|
|
|
|||||||||||||
| (1) | If Teva fails to achieve certain sustainability performance targets, a one-time premium payment of |
| (2) | If Teva fails to achieve certain sustainability performance targets, the interest rate shall increase by May 9, 2026 . |
| (3) | If Teva fails to achieve certain sustainability performance targets, the interest rate shall increase by |
| (4) | In April 2024, Teva repaid $ |
| (5) | In October 2024, Teva repaid $ |
| * | 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. |
a. |
Foreign exchange risk management: |
b. |
Interest risk management: |
c. |
Bifurcated embedded derivatives: |
September 30, |
December 31, |
|||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
Cross-currency swap - cash flow hedge (1) |
$ | $ | ||||||
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 |
$ | $ | $ | $ | ||||||||||||
Other non-current assets: |
||||||||||||||||
Cross-currency swap-cash flow hedge (1) |
||||||||||||||||
Liability derivatives: |
||||||||||||||||
Other current liabilities: |
||||||||||||||||
Option and forward contracts |
( |
) | ( |
) | ||||||||||||
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 |
$ | $ | $ | $ | ( |
) | ||||||||||
Cross-currency swaps - cash flow hedge (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 |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||
Cross-currency swaps - cash flow hedge (1) |
( |
) | ( |
) | ( |
) | ||||||||||
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 |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||
Option and forward contracts (2) |
||||||||||||||||
Option and forward contracts economic hedge (3) |
( |
) | ||||||||||||||
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 |
$ | $ | $ | ( |
) | $ | ( |
) | ||||||||
Option and forward contracts (2) |
( |
) | ( |
) | ||||||||||||
Option and forward contracts economic hedge (3) |
( |
) | ( |
) | ||||||||||||
| (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 $ |
| (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 $ revenues was $ |
e. |
Amortizations due to terminated derivative instruments: |
f. |
Securitization: |
g. |
Supplier Finance Program Obligation |
Three months ended |
Nine months ended |
|||||||||||||||
September 30, |
September 30, |
|||||||||||||||
2024 |
2023 |
2024 |
2023 |
|||||||||||||
(U.S. $ in millions) |
(U.S. $ in millions) |
|||||||||||||||
| of long-lived tangible assets (1) |
$ | ( |
) | $ | $ | $ | ||||||||||
| Contingent consideration (2) |
||||||||||||||||
| Restructuring |
||||||||||||||||
| Other |
( |
) | ||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
$ | ( |
) | $ | $ | $ | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| (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. |
Three months ended September 30, |
||||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
| Restructuring |
||||||||
| Employee termination |
$ | $ | ||||||
| Other |
||||||||
| |
|
|
|
|||||
| Total |
$ | $ | ||||||
| |
|
|
|
|||||
Nine months ended September 30, |
||||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
| Restructuring |
||||||||
| Employee termination |
$ | $ | ||||||
| Other |
||||||||
| |
|
|
|
|||||
| Total |
$ | $ | ||||||
| |
|
|
|
|||||
Employee termination costs |
Other |
Total |
||||||||||
(U.S. $ in millions) |
||||||||||||
| Balance as of January 1, 2024 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
| Provision |
( |
) | ( |
) | ( |
) | ||||||
| Utilization and other* |
||||||||||||
| |
|
|
|
|
|
|||||||
| Balance as of September 30, 2024 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
| |
|
|
|
|
|
|||||||
Employee termination costs |
Other |
Total |
||||||||||
(U.S. $ in millions) |
||||||||||||
| Balance as of January 1, 2023 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
| Provision |
( |
) | ( |
) | ( |
) | ||||||
| Utilization and other* |
||||||||||||
| |
|
|
|
|
|
|||||||
| Balance as of September 30, 2023 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
| |
|
|
|
|
|
|||||||
| * | Includes adjustments for foreign currency translation. |
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 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| |
|
|
|
|
|
|
|
|||||||||
| Other comprehensive income (loss) before reclassifications |
( |
) | — | ( |
) | |||||||||||
| Amounts reclassified to the statements of income |
— | ( |
) | |||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net other comprehensive income (loss) before tax |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Corresponding income tax |
( |
) | — | — | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net other comprehensive income (loss) after tax* |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Balance as of September 30, 2024, net of taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| |
|
|
|
|
|
|
|
|||||||||
| * | Amounts do not include a $ 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 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| |
|
|
|
|
|
|
|
|||||||||
| Other comprehensive income (loss) before reclassifications |
( |
) | ( |
) | — | ( |
) | |||||||||
| Amounts reclassified to the statements of income |
— | ( |
) | |||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net other comprehensive income (loss) before tax |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Corresponding income tax |
( |
) | — | — | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Net other comprehensive income (loss) after tax* |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Balance as of September 30, 2023, net of taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
| |
|
|
|
|
|
|
|
|||||||||
| * | Amounts do not include a $ non-controlling interests. |
a. |
Segment information: |
Three months ended September 30, |
||||||||||||
2024 |
||||||||||||
United States |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | $ | $ | |||||||||
Gross profit |
||||||||||||
R&D expenses |
||||||||||||
S&M expenses |
||||||||||||
G&A expenses |
||||||||||||
Other loss ( income) |
§ | § | ||||||||||
Segment profit |
$ | $ | $ | |||||||||
| § | Represents an amount less than $0.5 million. |
Three months ended September 30, |
||||||||||||
2023 |
||||||||||||
United States |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | $ | $ | |||||||||
Gross profit |
||||||||||||
R&D expenses |
||||||||||||
S&M expenses |
||||||||||||
G&A expenses |
||||||||||||
Other loss ( income) |
( |
) | § | ( |
) | |||||||
Segment profit |
$ | $ | $ | |||||||||
| § | Represents an amount less than $0.5 million. |
Nine months ended September 30, |
||||||||||||
2024 |
||||||||||||
United States |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | $ | $ | |||||||||
Gross profit |
||||||||||||
R&D expenses |
||||||||||||
S&M expenses |
||||||||||||
G&A expenses |
||||||||||||
Other loss ( income) |
( |
) | ( |
) | ||||||||
Segment profit |
$ | $ | $ | |||||||||
Nine months ended September 30, |
||||||||||||
2023 |
||||||||||||
United States |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | $ | $ | |||||||||
Gross profit |
||||||||||||
R&D expenses |
||||||||||||
S&M expenses |
||||||||||||
G&A expenses |
||||||||||||
Other loss ( income) |
( |
) | ( |
) | ( |
) | ||||||
Segment profit |
$ | $ | $ | |||||||||
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 |
$ | $ | $ | $ | ||||||||||||
| Europe profit |
||||||||||||||||
| International Markets profit |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total reportable segments profit |
||||||||||||||||
| Profit (loss) of other activities |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total segments profit |
||||||||||||||||
| Amounts not allocated to segments: |
||||||||||||||||
| Amortization |
||||||||||||||||
| Other assets impairments, restructuring and other items* |
( |
) | ||||||||||||||
| Goodwill impairment |
||||||||||||||||
| Intangible assets impairments |
||||||||||||||||
| Legal settlements and loss contingencies |
||||||||||||||||
| Other unallocated amounts |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Consolidated operating income (loss) * |
( |
) | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Financial expenses, net |
||||||||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Consolidated income (loss) before income taxes * |
$ | ( |
) | $ | $ | ( |
) | $ | ( |
) | ||||||
| |
|
|
|
|
|
|
|
|||||||||
| * | 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. |
| United States | Three months ended September 30, |
|||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
| Generic products |
$ | $ | ||||||
| AJOVY ® |
||||||||
| AUSTEDO |
||||||||
| BENDEKA ® and TREANDA® |
||||||||
| COPAXONE |
||||||||
| UZEDY |
||||||||
| Anda |
||||||||
| Other |
||||||||
| |
|
|
|
|||||
| Total |
$ | $ | ||||||
| |
|
|
|
|||||
United States |
Nine months ended September 30, |
|||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
| Generic products |
$ |
$ |
||||||
| AJOVY |
||||||||
| AUSTEDO |
||||||||
| BENDEKA and TREANDA |
||||||||
| COPAXONE |
||||||||
| UZEDY |
||||||||
| Anda |
||||||||
| Other |
||||||||
| |
|
|
|
|||||
| Total |
$ |
$ |
||||||
| |
|
|
|
|||||
Europe |
Three months ended September 30, |
|||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
| Generic products |
$ |
$ |
||||||
| AJOVY |
||||||||
| COPAXONE |
||||||||
| Respiratory products |
||||||||
| Other* |
||||||||
| |
|
|
|
|||||
| Total |
$ |
$ |
||||||
| |
|
|
|
|||||
| * | 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 |
$ |
$ |
||||||
| AJOVY |
||||||||
| COPAXONE |
||||||||
| Respiratory products |
||||||||
| Other* |
||||||||
| |
|
|
|
|||||
| Total |
$ |
$ |
||||||
| |
|
|
|
|||||
| * | Other revenues in the first nine months of 2024 include the sale of certain product rights. |
International markets |
Three months ended September 30, |
|||||||
2024 |
2023 |
|||||||
(U.S. $ in millions) |
||||||||
| Generic products |
$ |
$ |
||||||
| AJOVY |
||||||||
| COPAXONE |
||||||||
| Other* |
||||||||
| |
|
|
|
|||||
| Total |
$ |
$ |
||||||
| |
|
|
|
|||||
| * | 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 |
$ |
$ |
||||||
| AJOVY |
||||||||
| COPAXONE |
||||||||
| Other* |
||||||||
| |
|
|
|
|||||
| Total |
$ |
$ |
||||||
| |
|
|
|
|||||
| * | Other revenues in the first nine months of 2024 include the sale of certain product rights. |
September 30, 2024 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
| Cash and cash equivalents: |
||||||||||||||||
| Money markets |
$ | $ | — | $ | — | $ | ||||||||||
| Cash, deposits and other |
— | — | ||||||||||||||
| Investment in securities: |
||||||||||||||||
| Equity securities |
— | — | ||||||||||||||
| Other |
— | — | ||||||||||||||
| Derivatives: |
||||||||||||||||
| : |
||||||||||||||||
| Options and forward contracts |
— | — | ||||||||||||||
| : |
||||||||||||||||
| Options and forward contracts |
— | ( |
) | — | ( |
) | ||||||||||
| Bifurcated embedded derivatives |
— | — | § | — | ||||||||||||
| Contingent consideration* |
— | — | ( |
) | ( |
) | ||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||
| |
|
|
|
|
|
|
|
|||||||||
December 31, 2023 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
| Cash and cash equivalents: |
||||||||||||||||
| Money markets |
$ | $ | — | $ | — | $ | ||||||||||
| Cash, deposits and other |
— | — | ||||||||||||||
| Investment in securities: |
||||||||||||||||
| Investment in convertible bond security |
||||||||||||||||
| Equity securities |
— | — | ||||||||||||||
| Other |
— | — | ||||||||||||||
| Restricted cash |
— | — | ||||||||||||||
| Derivatives: |
||||||||||||||||
| : |
||||||||||||||||
| Options and forward contracts |
— | — | ||||||||||||||
| Cross-currency interest rate swap |
||||||||||||||||
| : |
||||||||||||||||
| Options and forward contracts |
— | ( |
) | — | ( |
) | ||||||||||
| Bifurcated embedded derivatives |
— | — | § | — | ||||||||||||
| Contingent consideration* |
$ | — | — | ( |
) | ( |
) | |||||||||
| |
|
|
|
|
|
|
|
|||||||||
| Total |
$ | $ | ( |
) | $ | |||||||||||
| |
|
|
|
|
|
|
|
|||||||||
| § | Represents an amount less than $ 0.5 million. |
| * | Contingent consideration represents liabilities recorded at fair value in connection with acquisitions. |
Nine months ended September 30, 2024 |
Nine months ended September 30, 2023 |
|||||||
(U.S. $ in millions) |
||||||||
Fair value at the beginning of the period |
$ | ( |
) | ( |
) | |||
Investment in convertible bond** |
— | |||||||
Conversion option** |
— | |||||||
Redemption of convertible bond security** |
( |
) | — | |||||
Bifurcated embedded derivatives |
§ | § | ||||||
Adjustments to provisions for contingent consideration: |
||||||||
Allergan transaction* |
( |
) | ( |
) | ||||
Eagle transaction |
( |
) | ( |
) | ||||
Novetide transaction |
( |
) | ||||||
Settlement of contingent consideration: |
||||||||
Allergan transaction |
||||||||
Eagle transaction |
||||||||
Novetide transaction |
||||||||
Fair value at the end of the period |
$ | ( |
) | $ | ( |
) | ||
| § | 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 $ |
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 |
$ | $ | ||||||
Senior notes and convertible senior debentures included under short-term debt |
||||||||
Total |
$ | $ | ||||||
| * | The fair value was estimated based on quoted market prices . |
| 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.
57
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. |
58
| • | 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
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.
60
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.
61
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.
62
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.
63
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. |
64
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.
66
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.
67
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 | %) | ||||||||
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| 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 | ) | § | |||||||||||
|
|
|
|
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|
|
|
|||||||||
| Segment profit* |
$ | 1,137 | 30.3 | % | $ | 1,017 | 29.1 | % | ||||||||
|
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| * | 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 | % | ||||||||
|
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|
|
|||||||||
| Total |
$ | 3,749 | $ | 3,493 | 7 | % | ||||||
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|
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| * | 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 | %) | |||||||||
|
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|
|
|
|
|
|||||||||
| Segment profit* |
$ | 299 | 16.6 | % | $ | 356 | 20.4 | % | ||||||||
|
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| * | 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 | % | ||||||||
|
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|
|
|
|||||||||
| Total |
$ | 1,802 | $ | 1,750 | 3 | % | ||||||
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|||||||||
| * | 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 | ||||||
| — | — | |||||||
|
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|
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| Consolidated operating income (loss) (1) |
(274 | ) | (323 | ) | ||||
|
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|
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| Financial expenses, net |
763 | 808 | ||||||
|
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|
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| Consolidated income (loss) before income taxes (1) |
$ | (1,037 | ) | $ | (1,131 | ) | ||
|
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| (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 |
Name and Title |
Date |
Action |
Expiration Date |
Maximum Shares Subject to Plan (1) |
||||||||||||
(1) |
The plan includes shares to be sold solely to cover tax withholding obligations. |
| 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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