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What changed in TEVA PHARMACEUTICAL INDUSTRIES LTD's 10-K — 2023 vs 2024

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Paragraph-level year-over-year comparison of TEVA PHARMACEUTICAL INDUSTRIES LTD's 2023 and 2024 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2024 report.

+638 added−590 removedSource: 10-K (2025-02-05) vs 10-K (2024-02-12)

Top changes in TEVA PHARMACEUTICAL INDUSTRIES LTD's 2024 10-K

638 paragraphs added · 590 removed · 486 edited across 7 sections

Item 1. Business

Business — how the company describes what it does

160 edited+65 added−40 removed96 unchanged
Biggest changeThe following table presents our workforce headcount by employment type: December 31, 2023 2022 2021 Full-time 35,001 34,004 34,713 Part-time 1,471 1,121 1,266 Contractor 1,379 1,701 1,558 Total 37,851 36,826 37,537 Total full time equivalent 37,226 36,520 37,037 The following table presents our workforce headcount by geographic area (excluding contractors): December 31, 2023 2022 2021 North America 6,330 6,099 6,302 Europe 18,602 17,834 18,122 International Markets (excluding Israel) 8,155 7,952 7,955 Israel 3,385 3,240 3,600 Total (excluding contractors) 36,472 35,125 35,979 17 Table of Contents We monitor our employee turnover on an ongoing basis, as it is an important indicator in connection with our human capital management that informs our understanding of our retention, recruitment and talent engagement.
Biggest changeThe following table presents our workforce headcount by employment type: December 31, 2024 2023 2022 Full-time 33,892 35,001 34,004 Part-time 1,794 1,471 1,121 Contractor 1,144 1,379 1,701 Total 36,830 37,851 36,826 Total full time equivalent 36,167 37,226 36,520 The following table presents our workforce headcount by geographic area (excluding contractors) 1 : December 31, 2024 2023 2022 United States (1) 5,104 5,438 5,249 Europe 18,555 18,602 17,834 International Markets (excluding Israel) 8,707 9,047 8,802 Israel 3,320 3,385 3,240 Total (excluding contractors) 35,686 36,472 35,125 We monitor our employee turnover on an ongoing basis, as it is an important indicator in connection with our human capital management that informs our understanding of our retention, recruitment and talent engagement. 1 Workforce headcount of employees was adjusted to reflect the change in our segments, with the move of Canada from our North America segment (now referred to as United States segment), to our International Markets segment. 17 Table of Contents Inclusion and Diversity Teva’s Board of Directors and executive management view inclusion and diversity as important to our ability to innovate and grow our business, leveraging our diverse workforce to deliver on business excellence and innovation.
We are one of the leading generic pharmaceutical companies in the United States. We market approximately 500 generic prescription products in more than 1,400 dosage strengths, packaging sizes and forms, including oral solid dosage forms, injectable products, inhaled products, transdermal patches, liquids, ointments and creams.
We are one of the leading generic pharmaceutical companies in the United States. We market approximately 500 generic prescription products in more than 1,400 dosage strengths, packaging sizes and forms, including oral solid dosage forms, injectable products, inhaled products, liquids, transdermal patches, ointments and creams.
BENDEKA and TREANDA • BENDEKA (bendamustine hydrochloride) injection and TREANDA (bendamustine hydrochloride) for injection are approved in the United States for the treatment of patients with Chronic Lymphocytic Leukemia (“CLL”) and patients with indolent B-cell Non-Hodgkin’s Lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
BENDEKA and TREANDA • BENDEKA ® (bendamustine hydrochloride) injection and TREANDA ® (bendamustine hydrochloride) injection are approved in the United States for the treatment of patients with Chronic Lymphocytic Leukemia (“CLL”) and patients with indolent B-cell Non-Hodgkin’s Lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen.
Certain countries, such as Russia, China, Korea, Turkey, Argentina, Brazil and India (for exported products), already have laws mandating serialization and aggregation and we are working to comply with these requirements. Other countries, including India (domestic market), Indonesia, Kazakhstan, Malaysia, Taiwan, Ukraine and other Latin American countries are currently considering mandating similar requirements.
Certain countries, such as Russia, China, Korea, Turkey, Argentina, Brazil and India (for exported products), already have laws mandating serialization and aggregation and we are working to comply with these requirements. Other countries, including India (for domestic market), Indonesia, Kazakhstan, Malaysia, Taiwan, Ukraine and other Latin American countries are currently considering mandating similar requirements.
We are among the top three generic pharmaceutical companies in a number of European markets, including some of the largest markets in the European Union. We are not substantially dependent on any single country in Europe for our total generic European revenues which could be affected by pricing reforms or changes in regulations and public policy.
We are among the top three generic pharmaceutical companies in a number of European markets, including some of the largest markets in Europe. We are not substantially dependent on any single country in Europe for our total generic European revenues, which could be affected by pricing reforms or changes in regulations and public policy.
We are one of only a few companies with a pan-European footprint, while most of our European competitors focus on a limited number of selected markets or business lines. Our leadership position in Europe allows us to be a reliable partner to fulfill the needs of patients, physicians, pharmacies, customers and payers.
We are one of a few companies with a pan-European footprint, while most of our European competitors focus on a limited number of selected markets or business lines. Our leadership position in Europe allows us to be a reliable partner to fulfill the needs of patients, physicians, pharmacies, customers and payers.
As a result of the state of war declared in Israel in October 2023 and the military activity in the region, the health, safety and wellbeing of our Israel-based employees have been a top priority. We provided support through mental health professionals, training for managers, designated support groups, and initiatives to support our employees’ families.
As a result of the state of war declared in Israel in October 2023 and the ongoing military activity in the region, the health, safety and wellbeing of our Israel-based employees have been a top priority. We provided support through mental health professionals, training for managers, designated support groups, and initiatives to support our employees’ families.
Specifically, in Japan, ongoing regulatory pricing reductions and generic competition to off-patented products have negatively affected our sales in Japan. These conditions result in intense competition in generics, with generic companies competing for advantage based on pricing, time to market, reputation and customer service.
In Japan, ongoing regulatory pricing reductions and generic competition to off-patented products have negatively affected our sales. These conditions result in intense competition in generics, with generic companies competing for advantage based on pricing, time to market, reputation and customer service.
The Federal Food, Drug, and Cosmetic Act, the Controlled Substances Act (“CSA”) and other federal and state statutes and regulations govern or influence the development, manufacture, testing, safety, efficacy, labeling, approval, storage, distribution, recordkeeping, advertising, promotion, sale, import and export of our products.
The Federal Food, Drug, and Cosmetic Act (“FCDA”), the Controlled Substances Act (“CSA”) and other federal and state statutes and regulations govern or influence the development, manufacture, testing, safety, efficacy, labeling, approval, storage, distribution, recordkeeping, advertising, promotion, sale, import and export of our products.
The Federal Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”) mandates the adoption of specific standards for electronic transactions and code sets that are used to transmit certain types of health information.
The Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (collectively, “HIPAA”) mandates the adoption of specific standards for electronic transactions and code sets that are used to transmit certain types of health information.
Our I&D global team monitors and assesses our I&D programs and efforts, using regular surveys and feedback to strengthen and adapt our programs, as needed. We seek to support our inclusive and diverse culture through employee resource groups (“ERGs”), mentoring programs and training, among other things.
Our I&D global team monitors and assesses our I&D programs and efforts, using regular surveys to strengthen and adapt our programs, as needed. We seek to support our inclusive and diverse culture through employee resource groups (“ERGs”), mentoring programs and training, among other things.
AJOVY • AJOVY (fremanezumab-vfrm) injection is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (“CGRP”) and it is indicated for the preventive treatment of migraine in adults.
AJOVY • AJOVY ® (fremanezumab-vfrm) injection is a fully humanized monoclonal antibody that binds to calcitonin gene-related peptide (“CGRP”) and is indicated for the preventive treatment of migraine in adults.
By the end of 2023, we launched AJOVY in most European countries and in certain countries within our International Markets segment, such as Japan, Australia, Israel, South Korea, Brazil and others.
By the end of 2023, we launched AJOVY in most European countries and in certain countries within our International Markets segment, such as Canada, Japan, Australia, Israel, South Korea, Brazil and others.
The vast majority of the countries in which we market our products have enacted and/or amended privacy regulation. We and our partners are implementing measures as needed to comply with such privacy requirements.
The majority of the countries in which we market our products have enacted and/or amended privacy regulation. We and our partners are implementing measures as needed to comply with such privacy requirements.
These capabilities provide us with the means to respond on a global scale to a wide range of therapeutic and commercial requirements of patients, customers and healthcare providers. Pharmaceutical Production We operate 36 finished dosage and packaging pharmaceutical plants in 27 countries. These plants manufacture solid dosage forms, sterile injectables, liquids, semi-solids, inhalers, transdermal patches and other medicinal products.
These capabilities provide us with the means to respond on a global scale to a wide range of therapeutic and commercial requirements of patients, customers and healthcare providers. Pharmaceutical Production We operate 34 finished dosage and packaging pharmaceutical plants in 27 countries. These plants manufacture solid dosage forms, sterile injectables, liquids, semi-solids, inhalers, transdermal patches and other medicinal products.
In the U.S., the Teva Employee Resource Group Network represents ten distinct ERGs, which have a key role in creating a culture of inclusion and bringing together employees with shared characteristics and life experiences to foster opportunities for networking, mentoring, collaboration, community outreach, career development, leadership training and cultural exchanges.
In the U.S., the Teva Employee Resource Group Network represents several distinct ERGs, which have a key role in creating a culture of inclusion and bringing together employees with shared characteristics and life experiences to foster opportunities for networking, mentoring, collaboration, community outreach, career development, leadership training and cultural exchanges.
Transitional provisions (which were extended in early 2023) apply to the marketing of devices certified under the MDD under certain conditions and depending on the device’s risk classification. In the U.K., the EU MDD, as adopted into U.K. law, remains applicable to all medical devices, although new UK legislation relating to medical devices is expected in 2024.
Transitional provisions (which were extended in early 2023) apply to the marketing of devices certified under the MDD under certain conditions and depending on the device’s risk classification. In the U.K., the EU MDD, as adopted into U.K. law, remains applicable to all medical devices, although new UK legislation relating to medical devices is expected in 2025.
On Environment, Health and Safety (“EHS”), among other things, in 2023: • we continued the implementation of our global EHS management system in all countries where we operate, which promotes proactive compliance with applicable EHS requirements, establishes EHS standards throughout our global operations and helps drive continuous improvement in our EHS performance; • proactively evaluated EHS compliance through self-evaluation and an internal audit program in addition to some external audits, addressing non-conformities through appropriate corrective and preventative action; • developed EHS leading indicators to drive consistent work patterns of high performing organizations; and • continued to promote climate change mitigation and adaptation strategy according to international standards.
On Environment, Health and Safety (“EHS”), among other things, in 2024: • we continued the implementation of our global EHS management system in all countries where we operate, which promotes proactive compliance with applicable EHS requirements, establishes EHS standards throughout our global operations and helps drive continuous improvement in our EHS performance; • proactively evaluated EHS compliance through self-evaluation and an internal audit program in addition to some external audits, addressing non-conformities through appropriate corrective and preventative actions; • developed EHS leading indicators to drive consistent work patterns of high performing organizations; and • continued to promote climate change mitigation and adaptation strategy according to international standards.
Department of Health and Human Services (“HHS”) is directed to negotiate a subset of medicines with the highest annual expenditures to Medicare Parts B and D that have been on the market for 9 years (or 13 years for biologics) without an available generic (or biosimilar) on the market.
Department of Health and Human Services (“HHS”) is directed to select a subset of medicines with the highest annual expenditures to Medicare Parts B and D that have been on the market for 9 years (or 13 years for biologics) without an available generic (or biosimilar) on the market.
COPAXONE is indicated for the treatment of patients with relapsing forms of MS (“RMS”), including the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (“RRMS”), including in patients who have experienced a first clinical episode and have MRI features consistent with MS. • COPAXONE is believed to have a unique mechanism of action that works with the immune system, unlike many therapies that are believed to rely on general immune suppression or cell sequestration to exert their effect.
COPAXONE is indicated for the treatment of patients with relapsing forms of MS (“RMS”), including the reduction of the frequency of relapses in relapsing-remitting multiple sclerosis (“RRMS”), including in patients who have experienced a first clinical episode and have MRI features consistent with MS. 9 Table of Contents • COPAXONE is believed to have a unique mechanism of action that works with the immune system, unlike many therapies that are believed to rely on general immune suppression or cell sequestration to exert their effect.
In addition to patent protection, exclusivity provisions in the European Union may prevent companies from applying for marketing approval for a generic product for eight years (or ten years for orphan medicinal products) from the date of the first marketing authorization of the original product in the European Union.
In addition to patent protection, exclusivity provisions in the European Union may prevent companies from applying for marketing approval for a generic product for eight years (or 10 years for orphan medicinal products) from the date of the first marketing authorization of the original product in the European Union.
Regulation United States Food and Drug Administration and the Drug Enforcement Administration All pharmaceutical manufacturers selling products in the United States are subject to extensive regulation by the United States federal government, principally by the FDA and the Drug Enforcement Administration (“DEA”), and, to a lesser extent, by state and local governments.
Regulation United States Food and Drug Administration and the Drug Enforcement Administration All pharmaceutical manufacturers selling products in the United States are subject to extensive regulation by the United States federal government, principally by the Food and Drug Administration (“FDA”) and the Drug Enforcement Administration (“DEA”), and, to a lesser extent, by state and local governments.
You may review these filings on the website of the MAGNA system operated by the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the Tel Aviv Stock Exchange (the “TASE”) at www.tase.co.il. Our 2023 ESG Progress report, which will provide enhanced ESG disclosures, is expected to be published in May 2024.
You may review these filings on the website of the MAGNA system operated by the Israeli Securities Authority at www.magna.isa.gov.il or on the website of the Tel Aviv Stock Exchange (the “TASE”) at www.tase.co.il. Our 2024 ESG Progress report, which will provide enhanced ESG disclosures, is expected to be published in April 2025.
We offer a broad range of basic chemical entities, as well as specialized product families, such as sterile products, hormones, high-potency drugs and cytotoxic substances, in both parenteral and solid dosage forms. We also offer generic products with medical devices and combination products. Our generics business has a wide-reaching commercial presence.
We offer a broad range of 5 Table of Contents basic chemical entities, as well as specialized product families, such as sterile products, hormones, high-potency drugs and cytotoxic substances, in both parenteral and solid dosage forms. We also offer generic products with medical devices and combination products. Our generics business has a wide-reaching commercial presence.
Operations We operate our business globally and believe that our global infrastructure provides us with the following capabilities and advantages: • global R&D facilities that enable us to have a broad global generic pipeline and product line, as well as a focused pipeline of innovative medicines; • API manufacturing capabilities that offer a stable, high-quality supply of key APIs, vertically integrated with our pharmaceutical operations; • pharmaceutical manufacturing facilities approved by the FDA, EMA and other regulatory authorities located around the world, which offer a broad range of production technologies and the ability to concentrate production in order to achieve high quality and economies of scale; and • high-volume, technologically advanced distribution facilities for solid dosage forms, injectable and blow-fill-seal, which are available mainly in North America, Europe, Latin America, India and Israel, and which allow us to deliver new products to our customers quickly and efficiently, providing a cost-effective, safe and reliable supply.
Operations We operate our business globally and believe that our global infrastructure provides us with the following capabilities and advantages: • global R&D facilities that enable us to have a broad global generic pipeline and product line, as well as a focused pipeline of innovative medicines; • API manufacturing capabilities that offer a stable, high-quality supply of key APIs, vertically integrated with our pharmaceutical operations, which we intend to divest as mentioned above; • pharmaceutical manufacturing facilities approved by the FDA, EMA and other regulatory authorities located around the world, which offer a broad range of production technologies and the ability to concentrate production in order to achieve high quality and economies of scale; and • high-volume, technologically advanced distribution facilities for solid dosage forms, injectable and blow-fill-seal, which are available mainly in North America, Europe, Latin America, India and Israel, 13 Table of Contents and which allow us to deliver new products to our customers quickly and efficiently, providing a cost-effective, safe and reliable supply.
Orphan designated products, which receive, under certain conditions, a blanket period of ten years of market exclusivity, may receive an additional two years of exclusivity instead of an extension of the SPC if the requirements of the pediatric regulation are met.
Orphan designated products, which receive, under certain conditions, a blanket period of 10 years of market exclusivity, may receive an additional two years of exclusivity instead of an extension of the SPC if the requirements of the pediatric regulation are met.
In return for this additional funding, the FDA has entered into agreements with each of the affected industries (known as the “user fee agreements”) that commit the agency to interacting with manufacturers and reviewing applications such as NDAs, ANDAs and BLAs in certain ways, and taking action on those applications 21 Table of Contents at certain times.
In return for this additional funding, the FDA has entered into agreements with each of the affected industries (known as the “user fee agreements”) that commit the agency to interacting with manufacturers and reviewing applications such as NDAs, ANDAs and BLAs in certain ways, and taking action on those applications at certain times.
We also operate several clinics where most of our bioequivalence studies are performed as well as most of our Phase 1 studies for innovative medicines and biosimilar products. We have more than 1,100 generic products in our pre-approved global pipeline, which includes products in all stages of the approval process: pre-submission, post-submission and after tentative approval.
We also operate several clinics where most of our bioequivalence studies are performed as well as most of our Phase 1 studies for innovative medicines. We have more than 1,000 generic products in our pre-approved global pipeline, which includes products in all stages of the approval process: pre-submission, post-submission and after tentative approval.
Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States. Europe Our Europe segment includes the European Union, the United Kingdom and certain other European countries. We are one of the leading generic pharmaceutical companies in Europe.
Anda is able to compete in the distribution market by maintaining a broad portfolio of products, competitive pricing and delivery throughout the United States. 3 Table of Contents Europe Our Europe segment includes the European Union, the United Kingdom and certain other European countries. We are one of the leading generic pharmaceutical companies in Europe.
We are also subject to country specific data protection laws and regulations applicable to the 24 Table of Contents collection and processing of personal data around the world. In addition, we are subject to various national, regional and local environmental protection laws and regulations, including those governing ESG related matters, such as mandatory reporting and due diligence obligations.
We are also subject to country specific data protection laws and regulations applicable to the collection and processing of personal data around the world. In addition, we are subject to various national, regional and local environmental protection laws and regulations, including those governing ESG related matters, such as mandatory reporting and due diligence obligations.
Under the Hatch-Waxman Act, any company submitting an ANDA or an NDA under Section 505(b)(2) of the Food, Drug, and Cosmetic Act (i.e., an NDA that, similar to an ANDA, relies, in whole or in part, on FDA’s prior approval of another company’s drug product; also known as a “505(b)(2) application”) must make certain certifications with respect to the patent status of the drug for which it is seeking approval.
Under the Hatch-Waxman Act, any company submitting an ANDA or an NDA under Section 505(b)(2) of the FDCA (i.e., an NDA that, similar to an ANDA, relies, in whole or in part, on FDA’s prior approval of another company’s drug product; also known as a “505(b)(2) application”) must make certain certifications with respect to the patent status of the drug for which it is seeking approval.
Our Product Portfolio and Business Offering Our product and service portfolio includes generic medicines, biopharmaceuticals, innovative medicines, OTC products, a distribution business, API and contract manufacturing. Each region manages the entire range of products and services offered in its region and our generics, biosimilars and innovative franchise units optimize our pipeline and product lifecycle across therapeutic areas.
Our Product Portfolio and Business Offering Our product and service portfolio includes generic medicines, biosimilar medicines, innovative medicines, OTC products, a distribution business, API and contract manufacturing. Each region manages the entire range of products and services offered in its area, and our generics, biosimilars, OTC and innovative franchise units optimize our pipeline and product lifecycle across therapeutic areas.
Information in our ESG Progress Report shall not be deemed incorporated by reference into this Annual Report or any other filing with the SEC. 26 Table of Contents
Information in our ESG Progress Report shall not be deemed incorporated by reference into this Annual Report or any other filing with the SEC. 28 Table of Contents
We anticipate that the downward pressure on uptake may ease in the future as physicians and payers become increasingly aware of the benefits of biosimilars and more comfortable prescribing them. 16 Table of Contents Our innovative medicines business faces intense competition from both innovative and generic pharmaceutical companies.
We anticipate that the downward pressure on uptake may ease in the future as physicians and payers become increasingly aware of the benefits of biosimilars and more comfortable prescribing them. Our innovative medicines business faces intense competition from both innovative and generic pharmaceutical companies.
We have neuroscience projects in areas such as neuropsychiatry, migraine and movement disorders/neurodegeneration. Our immunology projects include both novel compounds and delivery systems designed to address unmet patient needs. We develop generic products for our North America, Europe and International Markets segments. Our focus is on high-value generics and complex formulations with complex technologies, which have higher barriers to entry.
We have neuroscience projects in areas such as neuropsychiatry, migraine and movement disorders/neurodegeneration. Our immunology projects include both novel compounds and delivery systems designed to address unmet patient needs. We develop generic products for our United States, Europe and International Markets segments. Our focus is on high-value generics and complex formulations with complex technologies, which have higher barriers to entry.
Generally, for generic drugs marketed under ANDAs, manufacturers (including Teva) are required to rebate 13% of the average manufacturer price, and for products marketed under NDAs or BLAs, manufacturers are required to rebate the greater of 23.1% of the average manufacturer price or the difference between such price and the commercial best price during a specified period.
Generally, for generic drugs marketed under ANDAs, 22 Table of Contents manufacturers (including Teva) are required to rebate 13% of the average manufacturer price, and for products marketed under NDAs or BLAs, manufacturers are required to rebate the greater of 23.1% of the average manufacturer price or the difference between such price and the commercial best price during a specified period.
Other competitors to BENDEKA include combination therapies such as R-CHOP (a combination of cyclophosphamide, vincristine, doxorubicin and 9 Table of Contents prednisone in combination with rituximab) and CVP-R (a combination of cyclophosphamide, vincristine and prednisolone in combination with rituximab) for the treatment of NHL, as well as a combination of fludarabine, doxorubicin and rituximab for the treatment of CLL and newer targeted oral therapies, such as ibrutinib, idelilisib and venetoclax.
Other competitors to BENDEKA include combination therapies such as R-CHOP (a combination of cyclophosphamide, vincristine, doxorubicin and prednisone in combination with rituximab) and CVP-R (a combination of cyclophosphamide, vincristine and prednisolone in combination with rituximab) for the treatment of NHL, as well as a combination of fludarabine, doxorubicin and rituximab for the treatment of CLL and newer targeted oral therapies, such as ibrutinib, idelilisib and venetoclax.
The IRA restructures Medicare’s benefit design and requires manufacturers of certain drugs to engage in price negotiations with Medicare, imposes rebates and discount requirements under Medicare Part B and Medicare Part D, and replaces the Part D coverage gap discount program with a new discounting program. In particular, the U.S.
The IRA restructures Medicare’s benefit design and requires manufacturers of certain drugs to engage in price setting discussions with Medicare, imposes rebates and discount requirements under Medicare Part B and Medicare Part D, and replaces the Part D coverage gap discount program with a new discounting program. In particular, the U.S.
In our International Markets, our global scale and broad portfolio give us a competitive advantage over local competitors, allowing us to optimize our offerings through a combination of high-quality medicines and unique go-to-market approaches. Furthermore, in significant markets such as Japan and Russia, governments have issued or are in process of issuing regulations designed to increase generic penetration.
In our International Markets, our global scale and broad portfolio give us a competitive advantage over local competitors, allowing us to optimize our offerings through a combination of high-quality medicines and unique go-to-market approaches. Furthermore, in several markets such as Japan, governments have issued or are in the process of issuing regulations designed to increase generic penetration.
Generics are required to meet similar governmental requirements as their brand-name equivalents, such as those relating to current Good Manufacturing Practices (“cGMP”), manufacturing processes and health authorities’ inspections, and must receive regulatory approval prior to their sale in any given country.
Generic medicines are required to meet similar governmental requirements as their brand-name equivalents, such as those relating to current Good Manufacturing Practices (“cGMP”), manufacturing processes and health authorities’ inspections, and must receive regulatory approval prior to their sale in any given country.
The FDA also has the authority to deny or revoke approvals of marketing applications and the power to halt the operations of non-complying manufacturers. Any failure to comply with applicable FDA policies and regulations could have a material adverse effect on our operations.
Department of Justice (“DOJ”). The FDA also has the authority to deny or revoke approvals of marketing applications and the power to halt the operations of non-complying manufacturers. Any failure to comply with applicable FDA policies and regulations could have a material adverse effect on our operations.
However, our ability to do so may be limited by regulatory and other requirements. In recent years, we closed or divested a significant number of manufacturing plants in the United States, Europe, Israel and Japan in connection with a restructuring plan. We are continuing our ongoing efforts to consolidate our manufacturing and supply network.
However, our ability to do so may be limited by regulatory and other requirements. In recent years, we have closed or divested a significant number of manufacturing plants in the United States, Europe, Israel, Japan and India in connection with a restructuring plan and our ongoing efforts to consolidate our manufacturing and supply network.
We also have innovative medicines in oncology and selected other areas. 6 Table of Contents We deploy medical and sales and marketing professionals within specific therapeutic areas who seek to address the needs of patients and healthcare professionals. We tailor our patient support, payer relations and medical affairs activities to the distinct characteristics of each therapeutic area and medicine.
We also have innovative medicines in respiratory, oncology and selected other areas. We deploy medical and sales and marketing professionals within specific therapeutic areas who seek to address the needs of patients and healthcare professionals. We tailor our patient support, payer relations and medical affairs activities to the distinct characteristics of each therapeutic area and medicine.
In September 2022, the FDA User Fee Reauthorization Act of 2022 (“FUFRA”) was enacted in the United States. The FUFRA authorizes the FDA to collect user fees from parties that submit drug, biosimilar or medical device product applications for review or that are named in approved applications as the sponsor of certain products.
In September 2022, the FDA User Fee Reauthorization Act of 2022 (“FUFRA”) was enacted in the United States. The FUFRA authorizes the FDA to collect user fees from parties that submit drug, biosimilar or medical device product applications for review or that are named in approved applications as the sponsor of certain products through FDA fiscal year 2027.
In general, these exclusivity provisions prevent the approval and/or submission of generic drug applications to the health authorities for a fixed period of time following the first approval of the brand-name product in that country.
In general, these exclusivity provisions prevent 26 Table of Contents the approval and/or submission of generic drug applications to the health authorities for a fixed period of time following the first approval of the brand-name product in that country.
We have established administrative, physical and technical safeguards to protect the confidentiality, integrity and availability of PHI maintained or transmitted by such entities. Numerous states have or are in the process of enacting state level data privacy laws and regulations governing the collection, use and processing of personal data.
We have established administrative, physical and technical safeguards to protect the confidentiality, integrity and availability of PHI to the extent we are subject to HIPAA maintained or transmitted by such entities. Numerous states have or are in the process of enacting state level consumer privacy laws and regulations governing the collection, use and processing of personal data.
The criteria and protection period for orphan designated products are currently under review by the European Commission, as part of the review of the general pharmaceutical legislation referred to above. 23 Table of Contents The legislation also allows for R&D work during the patent term for the purpose of developing and submitting registration dossiers.
The criteria and protection period for orphan designated products are currently under review by the European Commission, as part of the review of the general pharmaceutical legislation referred to above. The legislation also allows for R&D work during the patent and SPC term for the purpose of developing and submitting registration dossiers.
Our Environment, Health, Safety and Sustainability Policy and global Environment Health and Safety Management System guide our employee health and safety practices. We have implemented this system, which often exceeds regulatory requirements, to provide a global standard of care.
Our Environment, Health, Safety and Sustainability Policy and global Environment Health and Safety Management 18 Table of Contents System guide our employee health and safety practices. We have implemented this system, which often exceeds regulatory requirements, to provide a global standard of care.
Additionally, the California Consumer Privacy Act (“CCPA”) established a privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors, and creating a new and potentially severe statutory 25 Table of Contents damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.
Additionally, the California Consumer Privacy Act of 2018 (“CCPA”) as amended established a privacy framework for covered businesses by creating an expanded definition of personal information, establishing new data privacy rights for consumers in the State of California, imposing special rules on the collection of consumer data from minors, and creating a new and potentially severe statutory damages framework for violations of the CCPA and for businesses that fail to implement reasonable security procedures and practices to prevent data breaches.
In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses. • There are 17 patents listed in the U.S. Orange Book for BENDEKA with expiration dates in 2026 and 2031. In April 2020, the U.S.
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.
Our facilities in various locations worldwide include two large development centers focusing on synthetic products, four centers with specific expertise specializing in fermentation and semi-synthetic products, a center for oligonucleotides and peptides and centers for high-potency APIs.
Our facilities in various locations worldwide include one large development center focusing on synthetic products, three centers with specific expertise specializing in fermentation, semi-synthetic products and high-potency APIs, and a center for oligonucleotides and peptides.
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. 2 Table of Contents Our Business Segments We operate our business through three segments: North America, Europe and International Markets.
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. 2 Table of Contents Our Business Segments We operate our business through three segments: United States (previously referred to as the North America segment), Europe and International Markets.
Innovative Medicines Our innovative medicines business is focused on delivering innovative solutions to patients and providers via medicines, devices and services in key regions and markets around the world, and includes our core therapeutic areas of CNS (with a strong emphasis on neurodegenerative disorders, neuropsychiatry, movement disorders, migraine and MS) and respiratory medicines (with a focus on asthma and COPD).
Innovative Medicines Our innovative medicines business is focused on delivering innovative solutions to patients and providers via medicines, devices and services in key regions and markets around the world, and includes our core therapeutic area of CNS, with a strong emphasis on neurodegenerative disorders, neuropsychiatry, movement disorders, migraine and MS.
In 2023, we produced approximately 77 billion tablets and capsules and approximately 573 million sterile units. The manufacturing sites located in North America, Europe, Latin America, India and Israel make up the majority of our production capacity. We use several external contract manufacturers to achieve operational and cost benefits.
In 2024, we produced approximately 72 billion tablets and capsules, and approximately 547 million sterile units. The manufacturing sites located in North America, Europe, Latin America, India and Israel make up the majority of our production capacity. We use several external contract manufacturers to achieve operational and cost benefits.
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, 3 Table of Contents pharmacy retail chains, hospitals and physician offices in the United States.
Anda, our distribution business in the United States, distributes generic, biosimilar 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.
Our position in the generics market is supported by our global R&D function, as well as our API R&D and manufacturing activities, which provide significant vertical integration for our products.
Our position in the generics market has been supported by our global R&D function, as well as our API R&D and manufacturing activities, which provide vertical integration for our products.
We are one of a few generic pharmaceutical companies with a pan-European footprint, while most of our competitors focus on a select few markets or business lines.
We are one of a few generic pharmaceutical companies with a pan-European footprint, while most of our competitors focus on a limited number of selected markets or business lines.
This waiver applies from July 2, 2022 to all SPCs that came into effect after July 1, 2019 or, if the SPC was applied for after July 1, 2019, from the date the SPC comes into effect. This legislation is due to be reviewed prior to July 2024.
This waiver applies from July 2, 2022 to all SPCs that came into effect after July 1, 2019 or, if the SPC was applied for after July 1, 2019, from the date the SPC comes into effect. This legislation was due to be reviewed prior to July 2024, but the review has been delayed.
In July 2019, the SPC Manufacturing Waiver Regulation came into force in the European Union (subject to certain conditions) allowing products manufactured prior to SPC expiration to be exempt from SPC infringement if such products are manufactured for export to non-European Union markets or for launch in the European Union upon expiration of the SPC.
In July 2019, the SPC Manufacturing Waiver Regulation came into force in the European Union (subject to certain conditions) allowing products manufactured prior to SPC expiration to be exempt from SPC infringement if such products are manufactured for export to non-European Union markets or (no earlier than six months before SPC expiry) for launch in the European Union upon expiration of the SPC.
Management regularly updates our Board of Directors on internal metrics in these areas. Employees As of December 31, 2023, Teva’s global workforce consisted of 37,851 employees. As a global company, we have employees in 58 countries around the world, representing a wide range of nationalities. In certain countries, we are party to collective bargaining agreements with certain groups of employees.
Management regularly updates our Board of Directors on internal metrics in these areas. Employees As of December 31, 2024, Teva’s global workforce consisted of 36,830 employees. As a global company, we have employees in 57 countries around the world, representing a wide range of nationalities. In certain countries, we are party to collective bargaining agreements with certain groups of employees.
Our talent development programs benefit employees individually by providing them with the resources they need to enhance their professional and management abilities, develop leadership skills and achieve their career aspirations, which in turn helps us to remain competitive in our industry.
Employee Career Growth, Training and Development We invest in employee career growth and development at Teva. Our talent development programs benefit employees individually by providing them with the resources they need to enhance their professional and management abilities, develop leadership skills and achieve their career aspirations, which in turn helps us to remain competitive in our industry.
In the case of ANDAs, the Hatch-Waxman Act provides for a potential 180-day period of generic exclusivity for the first company to submit an ANDA with a Paragraph IV certification.
In the case of ANDAs, the Hatch-Waxman Act provides for a potential 180-day period of generic exclusivity for the first company to file a “substantially complete” ANDA with a Paragraph IV certification.
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 ® .
Oral branded and generic treatments for MS, such as Tecfidera ® (generic: Dimethyl) and Gilenya ® (generic: Fingolimod) 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 ® , Kesimpta ® and Tysabri ® .
Europe General In Europe, marketing authorizations for pharmaceutical products may be obtained either through a centralized procedure for a license valid in all member countries of the European Union, which is granted by the EMA, or licenses granted by the national competent authorities via a mutual recognition procedure which requires submission of applications in other chosen member states following approval by a so-called reference member state, a decentralized procedure that entails simultaneous submission of applications to chosen member states or occasionally through a local national procedure. 22 Table of Contents During 2022, we continued to register products in the European Union, primarily using the decentralized procedure (simultaneous submission of applications to chosen member states).
Europe General In Europe, marketing authorizations for pharmaceutical products may be obtained either through a centralized procedure for a license valid in all member countries of the European Union, which is granted by the EMA, or through national procedures granted by the national competent authorities via a mutual recognition procedure which requires submission of applications in other chosen member states following approval by a so-called reference member state, a decentralized procedure that entails simultaneous submission of applications to chosen member states or occasionally through a local national procedure.
Our other activities are not included in our North America, Europe and International Markets segments described above. Research and Development Our R&D activities span the breadth of our business, including innovative medicines, generic medicines (finished goods and API), biosimilars and OTC medicines.
Our other activities are not included in our United States, Europe and International Markets segments described above. 11 Table of Contents Research and Development Our R&D activities span the breadth of our business, including innovative medicines, generic medicines (finished goods and API), biosimilars and OTC medicines.
It is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults, which is a debilitating, often irreversible movement disorder caused by certain medications used to treat mental health or gastrointestinal conditions. • AUSTEDO was launched in China and Israel in 2021 and in Brazil in 2022.
It is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults, which is a debilitating, often irreversible movement disorder caused by certain medications used to treat mental health or gastrointestinal conditions.
Patient Support Programs are currently operated in many countries around the world in multiple therapeutic areas. We believe that it is important to provide a range of services and solutions tailored to meet the needs of patients according to their specific condition and local market requirements. We believe this capability provides an important competitive advantage in the innovative medicines business.
Patient Support Programs are currently operated in many countries around the world in multiple therapeutic areas. We believe that it is important to provide a range of services and solutions tailored to meet the needs of patients according to their specific condition and local market requirements.
We believe that our primary competitive advantages include our commercial marketing teams, global R&D capabilities, the body of scientific evidence substantiating the safety and efficacy of our various medicines, our patient-centric solutions, physician and patient experience with our medicines and our medical capabilities, which are tailored to our product offerings, regional and local markets and the needs of our stakeholders.
We believe that our primary competitive advantages include our commercial marketing teams, global R&D capabilities, the body of scientific evidence substantiating the safety and efficacy of our various medicines, our patient-centric solutions, physician and patient experience with our medicines and our medical capabilities, which are tailored to our product offerings, regional and local markets and the needs of our stakeholders. 16 Table of Contents Human Capital Management Our People Our employees are the heart of our Company.
The following table presents percentage of our global employee population identifying as female and male, as of December 31, 2023: Female Male Total employees 47 % 53 % Managers 49 % 51 % Senior management 29 % 71 % 18 Table of Contents Health and Safety The health and safety of our employees is critical to our ability to supply medicines to our patients.
The following table presents percentage of our global employee population identifying as female and male, as of December 31, 2024: Female Male Total employees 47 % 53 % Managers 49 % 51 % Senior management 34 % 66 % Health and Safety The health and safety of our employees is critical to our ability to supply medicines to our patients.
Although the FDA announced in August 2023 a one-year of enforcement discretion for these enhanced requirements, Teva’s packing sites, distribution centers and CMOs for the U.S. market comply with the requirements. Additionally, in February 2019, the EU enacted the Falsified Medicines Directive (“FMD”), traceability requirements for drug products, which Teva complies with as well.
Although the FDA announced additional extensions and periods of enforcement discretion in August 2023 and October 2024, Teva’s packing sites, distribution centers and CMOs for the U.S. market comply with the requirements. Additionally, in February 2019, the EU enacted the Falsified Medicines Directive (“FMD”), traceability requirements for drug products, which Teva complies with as well.
District Court for the District of Delaware. • 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.
District Court for the District of Delaware, following its filing of a 505(b)(2) NDA for a bendamustine product, and that litigation is still pending. • 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 10 Table of Contents 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.
AJOVY was launched in the U.S. in 2018 and was approved in Canada in April 2020. • During 2019, AJOVY was granted a marketing authorization in the European Union by the European Medicines Agency (“EMA”) in a centralized process and began receiving marketing authorizations in various countries in our International Markets segment.
AJOVY was launched in the U.S. in 2018. 8 Table of Contents • During 2019, AJOVY was granted a marketing authorization in the European Union by the European Medicines Agency (“EMA”) in a centralized process and began receiving marketing authorizations in various countries in our International Markets segment.
Nothing on our website, including our 2022 ESG Progress Report or sections thereof, shall be deemed incorporated by reference into this Annual Report or any other filing with the Securities and Exchange Commission.
Nothing on our website, including our 2023 ‘Healthy Future’ Sustainability Report or sections thereof, shall be deemed incorporated by reference into this Annual Report or any other filing with the Securities and Exchange Commission.
In addition, a number of states, including New York, have enacted legislation that requires entities to pay assessments or taxes on the sale or distribution of opioid medications in order to address the misuse of prescription opioid medications. Finally, a number of states have implemented IRA-like price controls on pharmaceutical manufacturers.
In addition, a number of states, including New York, have enacted legislation that requires entities to pay assessments or taxes on the sale or distribution of opioid medications in order to address the misuse of prescription opioid medications.
For information about our product launches and pipeline of generic medicines in North America and Europe, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Segment Information—North America Segment” and “Item 7—Management’s Discussions and Analysis of Financial Condition and Results of Operations—Segment Information—Europe Segment.” Biologic medicines are large and complex medicines produced by or made from living cells or organisms, often produced using cutting-edge biotechnological methods.
For information about our product launches and pipeline of generic medicines in the United States and Europe, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Segment Information—United States Segment” and “Item 7—Management’s Discussions and Analysis of Financial Condition and Results of Operations—Segment Information—Europe Segment.” Biologic medicines are large and complex medicines produced by or made from living cells or organisms.
The FDA also requires validation of manufacturing processes so that a company may market new products. The FDA conducts pre-approval and post-approval reviews and plant inspections to implement these requirements. The federal CSA and its implementing regulations establish a closed system of controlled substance distribution for legitimate handlers.
The FDA also requires validation of manufacturing processes so that a company may market new products. The FDA conducts pre-approval and post-approval reviews and plant inspections to ensure compliance with regulatory standards and to verify the quality and safety of products. The federal CSA and its implementing regulations establish a closed system of controlled substance distribution for legitimate handlers.
Proposed changes have been published in 2023, although the implementation date and transitional provisions remain unclear. The term of certain pharmaceutical patents may be extended in the European Union by up to five years upon grant of Supplementary Patent Certificates (“SPC”).
Proposed changes have been published in 2023 and amendments are being discussed. The implementation date and transitional provisions remain unclear. 24 Table of Contents The term of certain pharmaceutical patents may be extended in the European Union by up to five years upon grant of Supplementary Protection Certificates (“SPC”).
It was launched in Europe in August 2016. • CINQAIR/CINQAERO (reslizumab) injection is a humanized interleukin-5 antagonist monoclonal antibody for add-on maintenance treatment of adult patients with severe asthma and with an eosinophilic phenotype.
It was launched in Europe in August 2016. • CINQAIR/CINQAERO (reslizumab) injection is a humanized interleukin-5 antagonist monoclonal antibody for add-on maintenance treatment of adult patients with severe asthma and with an eosinophilic phenotype. This biologic treatment was launched in the U.S. and in certain European countries in 2016 and in Canada in 2017.
Below is an overview of our three business segments: North America Our North America segment includes the United States and Canada. As part of a recent shift in executive management responsibilities, commencing January 1, 2024, Canada will be reported as part of our International Markets segment. See note 19 to our consolidated financial statements.
Below is an overview of our three business segments: United States 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. See note 19 to our consolidated financial statements.
There are no further patent litigations pending regarding AUSTEDO. • AUSTEDO XR (deutetrabenazine) extended-release tablets was approved by the FDA on February 17, 2023, and became commercially available in the U.S. in May 2023.
There are no further patent litigations pending regarding AUSTEDO at this time. • 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.

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Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

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Biggest changeAn adverse resolution of these proceedings may result in large monetary fines, damages, additional litigation, such as securities and derivative actions, and other non-monetary sanctions and remedies, such as mandated compliance agreements, all of which can be expensive and disruptive to our operations and business, and can impact decisions related to our product offerings and portfolio. 40 Table of Contents Due to increasing numbers of securities claims over the last several years and related payouts under insurance policies, in addition to increased settlement values in “event-driven” litigation and a growing number of plaintiff shareholder law firms eager to bring claims, premiums and deductibles for insurance, including D&O insurance, have been increasing and some insurers are reducing the number of companies they insure, causing the supply of insurance to lag behind demand.
Biggest changeDue to increasing numbers of securities claims over the last several years and related payouts under insurance policies, in addition to increased settlement values in “event-driven” litigation and a growing number of plaintiff shareholder law firms eager to bring claims, premiums and deductibles for insurance, including D&O insurance, have been increasing and some insurers are reducing the number of companies they insure, causing the supply of insurance to lag behind demand.
For example, the following may have a significant effect on our financial results and cash flow: • our future success depends on our ability to maximize the growth and commercial success of AUSTEDO and AUSTEDO XR.
For example, the following may have a significant effect on our financial results and cash flow: • AUSTEDO: our future success depends on our ability to maximize the growth and commercial success of AUSTEDO and AUSTEDO XR.
Our business operations are subject to extensive regulation by the FDA and various other U.S. federal and state authorities, the EMA and other foreign regulatory authorities that establish requirements relating to, among other things, manufacturing practices, product labeling, and advertising and post marketing reporting, including adverse event reports and field alerts due to manufacturing quality concerns.
Our business operations are subject to extensive regulation by the FDA and various other U.S. federal and state regulatory authorities, the EMA and other foreign regulatory authorities that establish requirements relating to, among other things, manufacturing practices, product labeling, and advertising and post marketing reporting, including adverse event reports and field alerts due to manufacturing quality concerns.
The payments required to be made under this settlement agreement and others may have an adverse impact on our operations and cash flows and there is no assurance that we will have the liquidity or other resources necessary to make such payments and provide supplies of our generic version of Narcan ® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of our nationwide settlements.
The payments required to be made under this settlement agreement and others may have an adverse impact on our operations and cash flows and there is no assurance that we will have the liquidity or other resources necessary to make such payments and provide supplies of naloxone hydrochloride nasal spray (our generic version of Narcan ® ) in the amounts and at the times required under the terms of our nationwide and other settlements.
Congress and certain state legislatures in the United States have also passed, or proposed passing, legislation that could adversely impact our ability to settle patent litigations.
Congress and certain state legislatures in the United States have also passed, or have proposed passing, legislation that could adversely impact our ability to settle patent litigations.
The state of war declared in Israel in October 2023, and the military activity in the region, may result in disruption to our operations and facilities, such as our manufacturing and R&D facilities located in Israel, and impact our employees, some of which are military reservists being called to active military duty, and impact the economic, social and political stability of Israel.
The state of war declared in Israel in October 2023, and the ongoing military activity in the region, may result in disruption to our operations and facilities, such as our manufacturing and R&D facilities located in Israel, and impact our employees, some of which are military reservists being called to active military duty, and impact the economic, social and political stability of Israel.
Certain of the regions in which we operate may be more susceptible to political and economic instability, such as the state of war declared in Israel in October 2023 and the military activity in the region, and the ongoing conflict between Russia and Ukraine, that could result in a loss of sales in such regions.
Certain of the regions in which we operate may be more susceptible to political and economic instability, such as the state of war declared in Israel in October 2023 and the ongoing military activity in the region, as well as the conflict between Russia and Ukraine, that could result in a loss of sales in such regions.
Additionally, could lead to the disclosure of information which may have a negative impact on our operations and reputation, and which may lead to additional exposure. Failure to accurately comply with any ESG reporting obligations may result in enforcement actions, sanctions, reputational harm or private litigation.
Additionally, could lead to the disclosure of information which may have a negative impact on our operations and reputation, and which may lead to additional exposure. Failure to accurately comply with any ESG obligations may result in enforcement actions, sanctions, reputational harm or private litigation.
Risks related to our ability to successfully compete in the marketplace Sales of our generic medicines comprise a significant portion of our business, and we are subject to the significant risks associated with the generic pharmaceutical business. Sales of our generics medicines have historically represented and are expected to continue to represent a significant portion of our business.
Risks related to our ability to successfully compete in the marketplace Sales of our generic medicines comprise a significant portion of our business, and we are subject to the significant risks associated with the generic pharmaceutical business. Sales of our generic medicines have historically represented and are expected to continue to represent a significant portion of our business.
We could fail, or be perceived to fail, either in identifying our ESG focus areas, or in our achievement of our initiatives or goals, whether described in our announcements, our ESG progress report or otherwise, or we could fail to accurately report our progress on such initiatives and goals.
We could fail, or be perceived to fail, either in identifying our ESG focus areas, or in our achievement of our initiatives or goals, whether described in our announcements, our Sustainability progress report or otherwise, or we could fail to accurately report our progress on such initiatives and goals.
In addition, we, or the partners with which we may enter into licensing or other collaboration agreements, may not be able to perform effectively under such agreements, impairing our ability to monetize opportunities related to them. 38 Table of Contents We may decide to sell, close or otherwise divest business units, assets or facilities, and any failure to successfully and cost-effectively consummate such divestitures could adversely affect our prospects and opportunities for growth.
In addition, we, or the partners with which we may enter into licensing or other collaboration agreements, may not be able to perform effectively under such agreements, impairing our ability to monetize opportunities related to them. 40 Table of Contents We may decide to sell, close or otherwise divest business units, assets or facilities, and any failure to successfully and cost-effectively consummate such divestitures could adversely affect our prospects and opportunities for growth.
Following calls in recent years from policy makers and other stakeholders in many countries for governmental intervention to address the high prices of certain pharmaceutical products, we are currently, and may in the future be, subject to governmental investigations, claims or other legal or regulatory actions regarding our pricing and/or other alleged exclusionary practices. These include U.S.
Following calls in recent years from policy makers and other stakeholders in many countries for governmental intervention to address the high prices of certain pharmaceutical products, we are currently, and may in the future be, subject to governmental investigations, claims or other legal or regulatory actions regarding our pricing and/or other alleged exclusionary practices. These include, among others, U.S.
Any of the following could have a material effect on our overall effective tax rate: some government programs may be discontinued, or the applicable tax rates may increase; we may be unable to meet the requirements for continuing to qualify for some programs and the restructuring plan may lead to the loss of certain tax benefits we currently receive; these programs and tax benefits may be unavailable at their current levels; upon expiration of a particular benefit, we may not be eligible to participate in a new program or qualify for a new tax benefit that would offset the loss of the expiring tax benefit; or we may be required to refund previously recognized tax benefits if we are found to be in violation of the stipulated conditions.
Any of the following could have a material effect on our overall effective tax rate: some government programs may be discontinued, or the applicable tax rates may increase; we may be unable to meet the requirements for continuing to qualify for some programs and certain restructuring activities have led and may lead to the loss of certain tax benefits we currently receive; these programs and tax benefits may be unavailable at their current levels; upon expiration of a particular benefit, we may not be eligible to participate in a new program or qualify for a new tax benefit that would offset the loss of the expiring tax benefit; or we may be required to refund previously recognized tax benefits if we are found to be in violation of the stipulated conditions.
The FDA has stated that it has established new steps to enhance competition, promote access and lower drug prices and is approving increasing numbers of generic applications. While these FDA improvements are expected to benefit our generic product pipeline, they will also benefit competitors that seek to launch products in established generic markets where we currently offer products.
The FDA has stated that it has established new steps to enhance competition, promote access and lower drug prices and is approving increasing numbers of generic applications. While these FDA initiatives are expected to benefit our generic product pipeline, they will also benefit competitors that seek to launch products in established generic markets where we currently offer products.
We are currently defendants in antitrust actions brought by U.S. states, the European Commission and private plaintiffs involving numerous settlement agreements and, since 2015, we are subject to a consent decree with the FTC, which imposes on us certain injunctive reliefs with respect to our ability to enter into patent settlements in the United States. The U.S.
We are currently defendants in antitrust actions brought by U.S. states, the European Commission and private plaintiffs involving numerous settlement agreements and, since 2015, we have been subject to a consent decree with the FTC, which imposes on us certain injunctive reliefs with respect to our ability to enter into patent settlements in the United States. The U.S.
We have procedures, tools, processes and services in place to detect and respond to cyber-attacks, data breaches, security incidents, and compromises of personal information.
We have procedures, tools, processes and services in place to detect and respond to cyber-attacks, data breaches, security incidents, and compromises of personal and other information.
Accordingly, our operations and information technology systems could be materially and adversely affected by acts of terrorism, including through cybersecurity threats, or if major hostilities were to occur in the Middle East or trade between Israel and its present trading partners were materially impaired, including as a result of acts of terrorism in the United States or elsewhere.
Accordingly, our operations and information technology systems could be materially and adversely affected by acts of terrorism, including through cybersecurity threats, or if major hostilities were to escalate in the Middle East or trade between Israel and its present trading partners were materially impaired, including as a result of acts of terrorism in the United States or elsewhere.
For a description of our net sales from our major customers, see note 19 to our consolidated financial statements. 27 Table of Contents Our revenues and profits from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy. Our generic drugs face intense competition.
For a description of our net sales from our major customers, see note 19 to our consolidated financial statements. 29 Table of Contents Our revenues and profits from generic products may decline as a result of competition from other pharmaceutical companies and changes in regulatory policy. Our generic drugs face intense competition.
Fluctuations in exchange rates between the currencies in which we operate in, and the U.S. dollar, may have a material adverse effect on our results of operations, the value of balance sheet items denominated in foreign currencies and our financial condition. In 2023, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar.
Fluctuations in exchange rates between the currencies in which we operate in, and the U.S. dollar, may have a material adverse effect on our results of operations, the value of balance sheet items denominated in foreign currencies and our financial condition. In 2024, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar.
Although we intend to invest in the development of more complex, high-value generics products such as drug device combinations and long-acting injectables, there is no assurance as to when we will be successful in achieving our expected results, if at all.
Although we intend to invest in the development of more complex, high-value generic products such as drug device combinations and long-acting injectables, there is no assurance as to when we will be successful in achieving our expected results, if at all.
Our ability to attract and retain such employees may be diminished by the financial, legal and regulatory challenges we have faced in recent years, the increased importance of delivering on corporate ESG goals and their reputational impact as well as increased competition for talent.
Our ability to attract and retain such employees may be diminished by the financial, legal and regulatory challenges we have faced in recent years, the increased importance of delivering on corporate sustainability goals and their reputational impact as well as increased competition for talent.
We cannot predict which additional measures may be adopted or the impact of current and additional measures on the marketing, pricing and demand for our products, which could have a material adverse effect on our business, financial condition and results of operations. The U.S.
We cannot predict which additional measures may be adopted or the impact of current and additional measures on the marketing, pricing and demand for our products, which could have a material adverse effect on our business, financial condition and results of operations.
Any data breach may subject us to civil fines and penalties, or regulatory fines or sanctions such as under the GDPR, or equivalent under relevant national laws, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended, and other relevant state and federal privacy laws in the United States including the California Consumer Privacy Act (“CCPA”) and other laws and regulations including across our International Markets.
Any data breach may subject us to civil fines and penalties, or regulatory orders, fines or sanctions such as under the EU GDPR or EU NIS2, or equivalent under relevant national laws, the federal Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) as amended, and other relevant state and federal privacy laws in the United States, including the California Consumer Privacy Act (“CCPA”) and other laws and regulations including across our International Markets.
Our inability to timely manufacture any of our key products may result in claims and penalties from customers and could have a material adverse effect on our business, financial condition and results of operations as well as result in reputational harm. 35 Table of Contents In recent years, medicine shortages have become an increasingly widespread problem around the world.
Our inability to timely manufacture any of our key products may result in claims and penalties from customers and could have a material adverse effect on our business, financial condition and results of operations as well as result in reputational harm. In recent years, medicine shortages have become an increasingly widespread problem around the world.
We may, therefore, be denied access to our customers or suppliers or denied the ability to ship products from any of our sites as a result of a closing of the borders of the countries in which we sell our products, or in which our operations are located, due to economic, legislative, political and military conditions, including hostilities and acts of terror, in such 37 Table of Contents countries.
We may, therefore, be denied access to our customers or suppliers or denied the ability to ship products from any of our sites as a result of a closing of the borders of the countries in which we sell our products, or in which our operations are located, due to economic, legislative, political and military conditions, including hostilities and acts of terror, in such countries.
Collecting, measuring, and reporting ESG information and metrics can be costly, difficult and time consuming, is subject to evolving reporting standards, and can present numerous operational, reputational, financial, legal and 46 Table of Contents other risks, any of which could have a material impact, including on our business, financial condition, reputation and stock price.
Collecting, measuring, and reporting ESG information and metrics can be costly, difficult and time consuming, is subject to evolving reporting standards, and can present numerous operational, reputational, financial, legal and other risks, any of which could have a material impact, including on our business, financial condition, reputation and stock price.
Israeli corporate law regulates acquisitions of shares through tender offers and mergers, requires special approvals for transactions involving directors, officers or significant shareholders, and regulates other matters 49 Table of Contents that may be relevant to these types of transactions. Furthermore, Israeli tax considerations may make potential acquisition transactions unappealing to us or to some of our shareholders.
Israeli corporate law regulates acquisitions of shares through tender offers and mergers, requires special approvals for transactions involving directors, officers or significant shareholders, and regulates other matters that may be relevant to these types of transactions. Furthermore, Israeli tax considerations may make potential acquisition transactions unappealing to us or to some of our shareholders.
FDA and EMA requirement on material use, and delays or failures to obtain required regulatory 30 Table of Contents approvals for the product candidate or the facilities in which it is manufactured. In addition, our innovative medicines require much greater use of a direct sales force than does our generics business.
FDA and EMA requirement on material use, and delays or failures to obtain required regulatory approvals for the product candidate or the facilities in which it is manufactured. In addition, our innovative medicines require much greater use of a direct sales force than does our generics business.
We have benefited, and currently benefit, from a variety of Israeli and other government programs and tax benefits that generally carry conditions that we must meet in order to be eligible to obtain such benefits.
We have benefited, and currently benefit, from a variety of government programs and tax benefits that generally carry conditions that we must meet in order to be eligible to obtain such benefits.
We are currently subject to several governmental and civil proceedings and litigations relating to our pricing and marketing practices, intellectual property, product liability, competition matters, opioids, securities disclosure, financial reporting and accounting practices, corporate governance and environmental matters. These investigations and litigations are costly and involve a significant diversion of management attention.
We are currently subject to several governmental and civil proceedings and litigations relating to our pricing marketing, and manufacturing practices, intellectual property, product liability, competition matters, opioids, securities disclosures, financial reporting and accounting practices, corporate governance and environmental matters. These investigations and litigations are costly and involve a significant diversion of management attention.
For example, the time from discovery to commercial launch of an innovative medicine can be 15 years or more and involves multiple stages, including intensive preclinical and clinical testing and highly complex, lengthy and expensive regulatory approval processes, which vary from country to country.
For example, the time from discovery to commercial launch of an innovative medicine can be 15 years or more and involves multiple 32 Table of Contents stages, including intensive preclinical and clinical testing and highly complex, lengthy and expensive regulatory approval processes, which vary from country to country.
As a result of delays we have experienced in the timing of launches, we may not be able to realize the economic benefits anticipated in connection with our planned launch timing.
As a result of delays in the timing of launches, we may not be able to realize the economic benefits anticipated in connection with our planned launch timing.
The process of obtaining regulatory approvals to market a drug or medical device can be costly and time-consuming, and approvals might not be granted for future products, or additional indications or uses of existing products, on a timely basis, if at all.
The process of obtaining regulatory approvals to market a drug or medical device can be costly and time-consuming, and approvals might not be granted for future products, or additional indications or uses of existing products, on a timely basis, if at 41 Table of Contents all.
Certain U.S. states have implemented or are considering, pharmaceutical price controls or patient access constraints under the Medicaid program, and some jurisdictions have implemented or are considering price-control regimes that would apply to broader segments of their populations that are not Medicaid-eligible.
Certain U.S. states have implemented or are considering, pharmaceutical price controls or patient access constraints under the Medicaid program, and some jurisdictions have implemented or are considering price-control regimes that would 43 Table of Contents apply to broader segments of their populations that are not Medicaid-eligible.
In the normal course of our business, we are also exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or property damage or personal injuries, and which could require remediation of contaminated soil and groundwater.
In the normal course of our business, we are also exposed to risks relating to possible releases of hazardous substances into the environment, which could cause environmental or property damage or personal injuries, and which could require remediation, including of contaminated soil and/or groundwater, or replacement of equipment.
We have been issued numerous patents 31 Table of Contents covering our innovative medicines, and have filed, and expect to continue to file, patent applications seeking to protect newly developed technologies and products in various countries, including the United States. Currently pending patent applications may not result in issued patents or be approved on a timely basis or at all.
We have been issued numerous patents covering our innovative medicines, and have filed, and expect to continue to file, patent applications seeking to protect newly developed technologies and products in various countries, including the United States. Currently pending patent applications may not result in issued patents or be approved on a timely basis or at all.
For example, several major hospital systems in the United States formed a nonprofit company in 2018 to manufacture their own generics medicines. We expect the trend of increased pricing pressures from our customers and price erosion to continue.
For example, several major hospital systems in the United States formed a nonprofit company in 2018 to manufacture their own generic medicines. We expect the trend of pricing pressures from our customers and price erosion to continue.
The new laws and proposals from the federal and state governments could serve to change, directly and indirectly, the Hatch-Waxman Act and BPCIA, including the incentives to develop generic and biosimilar products, as well as the ability of generic manufacturers to accelerate the launch of their new generic and biosimilar products.
The new laws and proposals from the federal and state governments could serve to change, directly 30 Table of Contents and indirectly, the Hatch-Waxman Act and BPCIA, including the incentives to develop generic and biosimilar products, as well as the ability of generic manufacturers to accelerate the launch of their new generic and biosimilar products.
We have entered into, and expect to pursue, in-licensing, acquisition, collaboration, funding and partnership opportunities to supplement and expand our existing innovative medicines and biosimilar pipeline, such as our collaborations with Alvotech, Modag, Sanofi, Royalty Pharma and Biolojic.
We have entered into, and expect to pursue, in-licensing, acquisition, collaboration, funding and partnership opportunities to supplement and expand our existing innovative medicines and biosimilar pipeline, such as our collaborations with Alvotech, Modag, Sanofi, Royalty Pharma, Biolojic, Launch Therapeutics and mAbxience.
The implementation of an Environmental, Health and Safety Management System across our facilities has resulted in the development of processes to prepare and respond to a range of natural emergencies that may occur, including extreme weather events.
The implementation of an Environmental, Health and Safety Management System across our facilities has resulted in the development of processes to prepare and respond to a range of natural 48 Table of Contents emergencies that may occur, including extreme weather events.
We may not be able to pursue opportunities due to financial capacity constraints, we may not be able to obtain necessary regulatory approvals, and we may fail to consummate an announced acquisition.
We may not be able to pursue opportunities due to financial capacity constraints, we may not be able to obtain necessary regulatory approvals, and we may fail to consummate an announced transaction.
As we have substantial international operations, fluctuations in exchange rates between the currencies in which we operate and the U.S. dollar could increase our operating costs and adversely affect our results of operations, profits and cash flows.
As we have substantial international operations, fluctuations in exchange rates between the currencies in which we operate and the U.S. dollar could increase our operating costs and 35 Table of Contents adversely affect our results of operations, profits and cash flows.
Consequently, our ability to sustain our sales and profitability on any given product over time is affected by the number of companies selling such product, including new market entrants, and the timing of their approvals.
Consequently, our ability to sustain our sales and profitability on any given product over time is affected by the number of companies selling competitive products, including new market entrants, and the timing of their approvals.
Because of the discount pricing typically involved with generic pharmaceutical products, patented brand products generally realize a significantly higher profit margin than generic pharmaceutical products. As a result, the damages assessed may be significantly higher than our profits.
Because of the discount pricing typically 46 Table of Contents involved with generic pharmaceutical products, patented brand products generally realize a significantly higher profit margin than generic pharmaceutical products. As a result, the damages assessed may be significantly higher than our profits.
Violations of these laws and regulations could result in fines, criminal sanctions against us, our officers or our employees, implementation of compliance programs and prohibitions on the conduct of our business.
Violations of these laws and 39 Table of Contents regulations could result in fines, criminal sanctions against us, our officers or our employees, implementation of compliance programs and prohibitions on the conduct of our business.
We have been involved in numerous litigations involving challenges to the validity or enforceability of listed patents (including our own), and therefore settling patent litigations has been and will likely continue to be an important part of our business. There is continued scrutiny of our patent settlements, including from the U.S. Federal Trade Commission (“FTC”) and the European Commission.
We have been involved in numerous litigations involving challenges to the validity or enforceability of listed patents (including our own), and therefore settling patent litigations has been and will likely continue to be an important part of our business. There is continued scrutiny of our patent settlements, including from the U.S.
Furthermore, our systems and networks have been, and are expected to continue to be, the target of increasingly advanced and evolving cyber-attacks which may pose a risk to the security of our systems and the confidentiality, availability and integrity of our data, as well as disrupt our operations or damage our facilities or those of third parties.
Furthermore, our systems and networks, and those managed by our third-party service providers, have been, and are expected to continue to be, the target of increasingly advanced and evolving cyber-attacks which may pose a risk to the security of our systems and the confidentiality, availability and integrity of our data, as well as disrupt our operations or damage our facilities or those of third parties.
If we experience further difficulty in this market, this may continue to adversely affect our revenues and profits from our North America business segment or cause us to recognize one or more goodwill impairments relating to this reporting unit.
If we experience further difficulty in this market, this may continue to adversely affect our revenues and profits from our United States business segment or cause us to recognize one or more goodwill impairments relating to this reporting unit.
For example, as previously announced, we intend to divest our API business in the first half of 2025, which divestiture is subject to various conditions, including reaching an agreement with a prospective purchaser on terms satisfactory to Teva, satisfying any conditions to closing the divestiture and obtaining any necessary approvals.
For example, as previously announced, we intend to divest our API business, which divestiture is subject to various conditions, including reaching an agreement with a prospective purchaser on terms satisfactory to Teva, satisfying any conditions to closing the divestiture and obtaining any necessary approvals.
Climate change, and evolving laws, regulations and policies regarding climate change, could also pose additional legal or regulatory requirements related to greenhouse gas (“GHG”) emissions and climate risk reporting, carbon pricing, and mandatory reduction targets.
Climate change, and evolving laws, regulations and policies regarding climate change, could also pose additional legal or regulatory requirements related to greenhouse gas (“GHG”) emissions and climate risk reporting, carbon pricing, cap-and-trade programs, carbon taxes and mandatory reduction targets.
In addition, although the majority of our operating costs are recorded in, or linked to, the U.S. dollar, in 2023, we incurred a substantial amount of operating costs in currencies other than the U.S. dollar, which only partially offset the currency risk derived from our sales in non-U.S. dollars.
In addition, although the majority of our operating costs are recorded in, or linked to, the U.S. dollar, in 2024, we incurred a 50 Table of Contents substantial amount of operating costs in currencies other than the U.S. dollar, which only partially offset the currency risk derived from our sales in non-U.S. dollars.
If we fail to meet the conditions upon which certain favorable tax treatment is based, we would not be able to claim future 48 Table of Contents tax benefits and could be required to refund tax benefits already received.
If we fail to meet the conditions upon which certain favorable tax treatment is based, we would not be able to claim future tax benefits and could be required to refund tax benefits already received.
It may also be difficult to effect service of process on these persons in the United States, Europe or elsewhere. ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
It may also be difficult to effect service of process on these persons in the United States, Europe or elsewhere. 53 Table of Contents 0000818686 ITEM 1B. UNRESOLVED STAFF COMMENTS Not applicable.
We may be unable to take advantage of the increasing number of high-value biosimilars opportunities. We aim to be a global leader in biopharmaceuticals. As part of our Pivot to Growth strategy, we intend to capitalize on our late-stage pipeline of biosimilar products.
We may be unable to take advantage of the increasing number of high-value biosimilars opportunities. We aim to be a global leader in biopharmaceuticals. As part of our Pivot to Growth strategy, we have been capitalizing on our late-stage pipeline of biosimilar products.
We have and will continue to implement changes to optimize our business operations and reallocate resources towards growth opportunities. As part of such optimization efforts, we may face wrongful termination, discrimination or other legal claims from employees affected by ongoing changes in our workforce.
Implementation of ongoing optimization efforts may adversely affect our business, financial condition and results of operations. We have and will continue to implement changes to optimize our business operations and reallocate resources towards growth opportunities. As part of such optimization efforts, we may face wrongful termination, discrimination or other legal claims from employees affected by ongoing changes in our workforce.
Any workforce reduction and site consolidation may result in the loss of numerous long-term employees, the loss of institutional knowledge and expertise, the reallocation of certain job responsibilities and the disruption of business continuity, all of which could negatively affect operational efficiencies and our ability to achieve growth and profitability through the development and sale of new pharmaceutical products.
Any workforce reduction and site consolidation may result in the loss of numerous long-term employees, the loss of institutional knowledge and expertise, the reallocation of certain job responsibilities, the disruption of business continuity and legal claims from affected employees, all of which could negatively affect operational efficiencies and our ability to achieve growth and profitability through the development and sale of new 36 Table of Contents pharmaceutical products.
However, generic pharmaceuticals are, as a general matter, less profitable than innovative medicines, and have faced price erosion in each of our business segments, placing even greater importance on our ability to continually introduce new products.
However, generic pharmaceuticals are generally less profitable than innovative medicines, and have faced price erosion in each of our business segments, placing even greater importance on our ability to continually introduce new products.
For instance, we must comply with requirements of the FDA, EMA and other healthcare regulators with respect to the manufacture, labeling, sale, distribution, marketing, advertising, promotion and development of pharmaceutical products, as further described below.
For instance, we must comply with requirements of the FDA, EMA, U.S. state licensure bodies, and other healthcare regulators with respect to the manufacture, labeling, sale, distribution, marketing, advertising, promotion and development of pharmaceutical products, as further described below.
Any such investigation may have a material adverse effect on our reputation, business, financial condition and results of operations. For further information, see “Competition Matters” and “Government Investigations and Litigation Relating to Pricing and Marketing” in note 12b to our consolidated financial statements.
Congress expressed similar concerns of the FTC. Any such investigation may have a material adverse effect on our reputation, business, financial condition and results of operations. For further information, see “Competition Matters” and “Government Investigations and Litigation Relating to Pricing and Marketing” in note 12b to our consolidated financial statements.
If our efforts to protect the security of data are unsuccessful, a cyber-attack, data breach, security incident, or compromise of personal information may result in costly legal claims and liability, financial penalties, government enforcement actions, for example under the GDPR, private litigation, negative publicity or a reduction in supply of essential medicines to the public, each of which could further result in reputation or brand damage with customers, and our business, financial condition, results of operations or prospects could suffer.
If our efforts to protect the security of data are unsuccessful, a cyber-attack, data breach, security incident, or compromise of personal information may result in costly legal claims and liability, financial penalties, government enforcement actions, for example under the EU GDPR or EU NIS2, private litigation, negative publicity or a reduction in supply of essential medicines to the public, or regulator orders requiring us to change the way our business is conducted, each of which could further result in reputation or brand damage with customers, and our business, financial condition, results of operations or prospects could suffer.
Risks related to our substantial indebtedness We have substantial debt outstanding, which requires significant interest and principal payments, requires compliance with certain covenants and restricts our ability to incur additional indebtedness or engage in other transactions. As of December 31, 2023, we have consolidated debt of $19,833 million outstanding, compared to $21,212 million outstanding as of December 31, 2022.
Risks related to our significant indebtedness We have significant debt outstanding, which requires significant interest and principal payments, requires compliance with certain covenants and restricts our ability to incur additional indebtedness or engage in other transactions. As of December 31, 2024, we have consolidated debt of $17,783 million outstanding, compared to $19,833 million outstanding as of December 31, 2023.
Additionally, the enactment of the Inflation Reduction Act of 2022 (the “IRA”) represents the most significant pharmaceutical pricing reform in the United States to date and includes legislative changes that could lead to greater pricing pressures on our products such as amendments to (i) eliminate the “donut hole” under the Medicare Part D program beginning in 2025; (ii) modify the “noninterference” provisions of the Medicare Part D enabling statute to require the U.S.
Additionally, the enactment of the IRA represents the most significant pharmaceutical pricing reform in the United States to date and includes legislative changes that could lead to greater pricing pressures on our products, which could be material, such as amendments to (i) eliminate the “donut hole” under the Medicare Part D program beginning in 2025; (ii) modify the “noninterference” provisions of the Medicare Part D enabling statute to require the U.S.
As a result, we may not be able to obtain the type and amount of insurance we desire, or any insurance on reasonable terms, in the markets in which we operate. For further information regarding our current material product liability cases, see note 12b to our consolidated financial statements.
As a result, we may not be able to obtain the type and amount of insurance we desire, or any insurance on reasonable terms, in the markets in which we operate. For further information see “Product Liability Litigation” in note 12b to our consolidated financial statements.
Some of the applicable laws may impose liability even in the absence of specific intent to defraud. The subjective decisions and complex methodologies used in making calculations 44 Table of Contents under these programs are subject to review and challenge, and it is possible that such reviews could result in material changes.
Some of the applicable laws may impose liability (and possible exclusion from Medicare, Medicaid and other programs), even in the absence of specific intent to defraud. The subjective decisions and complex methodologies used in making calculations under these programs are subject to review and challenge, and it is possible that such reviews could result in material changes.
We have also closed or divested a significant number of manufacturing plants and R&D facilities over the prior few years and may close or divest additional plants and facilities as part of our ongoing efforts regarding optimizing our business.
We have also closed or divested a significant number of manufacturing plants and R&D facilities in the past and may close or divest additional plants and facilities as part of our ongoing efforts regarding optimizing our business.
We may fail to integrate acquisitions successfully into our existing business, and could incur or assume significant debt and unknown or contingent liabilities, including, among others, patent infringement or product liability claims.
We may fail to integrate acquired assets successfully into our existing business, and could incur or assume significant debt and unknown or contingent liabilities, including, among others, patent infringement, product liability or breach of diligence claims.
If our revenues derived from AUSTEDO and AUSTEDO XR do not increase as expected or if we lose market share to competing therapies, it may have an adverse effect on our results of operations; • AJOVY faces strong competition from two products that were introduced into the market around the same time and are competing for market share in the same space, as well as from other emerging competing therapies, including oral CGRP products; • UZEDY is a later entrant which faces competition from four well-established products.
If our revenues derived from AUSTEDO and AUSTEDO XR do not increase as expected if we lose market share to competing therapies, it may have an adverse effect on our results of operations; • AJOVY faces strong competition from two products that were introduced into the market around the same time and are competing for market share in the same space, as well as from other emerging competing therapies, including oral CGRP products; • UZEDY is a late entrant in the atypical antipsychotic long-acting injectables (LAIs) space and faces significant competition from multiple well-established products.
These more stringent requirements could increase our costs of sourcing, production, and transportation, as well as 45 Table of Contents have negative reputational impacts if we fail to meet such requirements.
These more stringent requirements could, among other things, increase our costs of sourcing, production, and transportation, as well as have negative reputational impacts if we fail to meet such requirements.
In addition, a shareholder who is aware that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company.
In addition, a shareholder shall refrain from depriving other shareholders, and a shareholder who is aware that it possesses the power to determine the outcome of a shareholder vote or to appoint or prevent the appointment of a director or executive officer in the company has a duty of fairness toward the company.
While we maintain insurance coverage that is designed to address certain aspects of cyber risks, such insurance coverage may be insufficient to cover all losses or all types of claims that may arise in the event we experience a cybersecurity incident, data security breach or disruption, unauthorized access or failure of systems. 36 Table of Contents A data security breach could adversely affect our business and reputation.
While we maintain insurance coverage that is designed to address certain aspects of cyber risks, such insurance coverage may be insufficient to cover all losses or all types of claims that may arise in the event we experience a cybersecurity incident, data security breach or disruption, unauthorized access, or failure of systems.
Our tax expenses and the resulting effective tax rate reflected in our consolidated financial statements may increase over time as a result of changes in corporate income tax rates, other changes in the tax laws of the various countries in which we operate or changes in our product mix or the mix of countries where we generate profit.
Our tax expenses and the resulting effective tax rate reflected in our consolidated financial statements may increase over time as a result of changes in corporate income tax rates, other changes in the tax laws of the various countries in which we operate, such as the recent enactments by both the European Union and non-European Union countries of a global minimum tax, or changes in our product mix or the mix of countries where we generate profit.
Constitution, but such legislation still creates a risk of significant potential exposure for settling patent litigations and, in turn, makes it more difficult to settle in the first place, which could have a material adverse effect on our business.
The enforcement of this law has been preliminarily enjoined on constitutional grounds, but such legislation still creates a risk of significant potential exposure for settling patent litigations and, in turn, makes it more difficult to settle in the first place, which could have a material adverse effect on our business.
We regularly review our long-lived assets, including identifiable intangible assets, goodwill and property, plant and equipment, for impairment. Goodwill and acquired indefinite life intangible assets are subject to impairment review on an annual basis and whenever potential impairment indicators are present. Other long-lived assets are reviewed when there is an indication that impairment may have occurred.
Goodwill and acquired indefinite life intangible assets are subject to impairment review on an annual basis and whenever potential impairment indicators are present. Other long-lived assets are reviewed when there is an indication that impairment may have occurred.
We also expect to continue to experience significant adverse challenges in the U.S. generics market deriving from limitations on our ability to influence generic medicine pricing in the long term and a decrease in value from future launches and growth. These and other challenges have required us to recognize significant goodwill impairments in past years.
We also expect to continue to experience significant adverse challenges in the U.S. generics market deriving from limitations on our ability to influence generic medicine pricing in the long term and a decrease in value from future launches and growth.
Delays in the receipt of, or 39 Table of Contents failure to obtain approvals for, future products, or new indications and uses, could result in delayed realization of product revenues, reduction in revenues and substantial additional costs.
Delays in the receipt of, or failure to obtain approvals for, future products, or new indications and uses, could result in delayed realization of product revenues, reduction in revenues and substantial additional costs. We may continue to experience similar delays.
Given the size, complexity and global reach of our business and our multiple areas of focus, we are especially reliant upon our ability to recruit and retain highly qualified management and other key employees.
Our continued success depends on our ability to attract, hire, integrate and retain highly skilled key personnel. Given the size, complexity and global reach of our business and our multiple areas of focus, we are especially reliant upon our ability to recruit and retain highly qualified management and other key employees.
In addition, the success of our R&D activity depends on our ability to attract and retain sufficient numbers of skilled scientific personnel, which may be limited due to our R&D spending and programs.
In addition, the success of our R&D activity depends on our ability to attract and retain sufficient numbers of skilled scientific personnel.
From time to time, we announce certain initiatives, including goals, regarding our focus areas, which include environmental matters, responsible procurement, promoting access to medicines, social investments, compliance and ethics and I&D.
From time to time, we announce certain initiatives, including goals, regarding our focus areas, which include environmental matters, sustainable procurement, access to medicines and healthcare, compliance and integrity and I&D.
In addition, even if we do not suffer damages, we may incur significant legal and related expenses in the course of successfully defending against infringement claims. We may be susceptible to significant product liability claims that are not covered by insurance. Our business inherently exposes us to claims for injuries allegedly resulting from the use of our products.
In addition, even if we do not suffer damages, we may incur significant legal and related expenses in the course of successfully defending against infringement claims. We may be susceptible to significant product liability claims that are not covered by insurance.
While we seek to pass along such increased costs to our customers, there is no assurance that we will be able to successfully and promptly increase our pricing to offset such increased costs in the future.
We have experienced increases in labor and other operational costs, partly due to macroeconomic pressures. While we seek to pass along such increased costs to our customers, there is no assurance that we will be able to successfully and promptly increase our pricing to offset such increased costs in the future.

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Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

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Biggest changeThese systems include programs and processes relating to internal and external communications, ordering and managing materials from suppliers, collecting, processing and storing data produced by our clinical trials and other research and development initiatives, converting materials to finished products, shipping products to customers, processing transactions, processing payments to employees and vendors, calculating sales receivables, generating our financial results for each reporting period, summarizing and reporting results of operations, and complying with information technology security compliance and other regulatory, legal or tax requirements. 51 Table of Contents We have not been materially impacted by risks from cybersecurity threats and as of the date of this Annual Report on Form 10-K, we are not aware of any cybersecurity risks that are reasonably likely to materially affect our business.
Biggest changeThese systems include programs and processes relating to internal and external communications, ordering and managing materials from suppliers, collecting, processing and storing data produced by our clinical trials and other research and development initiatives, converting materials to finished products, shipping products to customers, processing transactions, processing payments to employees and vendors, calculating sales receivables, generating our financial results for each reporting period, summarizing and reporting results of operations, and complying with information technology security compliance and other regulatory, legal or tax requirements.
Such procedures and policies include: actively monitoring our information technology systems to ensure compliance with applicable legal and regulatory requirements; engaging third-party consultants and other service providers to monitor and, as appropriate, respond to cybersecurity risks; requiring our service providers and our business partners who connect directly to our information technology systems, to comply with our cybersecurity standards, due diligence processes and be subject to our non-disclosure and other confidentiality agreements that include cybersecurity-related terms; providing and analyzing specialized industry sector intelligence on cybersecurity threats; regularly testing our cybersecurity systems and disaster preparedness, including our back-up information technology systems; developing and updating incident response plans to address potential cybersecurity threats; and maintaining and training our personnel on cybersecurity incident reporting procedures.
Such procedures and policies include: actively monitoring our information technology systems to ensure compliance with applicable legal and regulatory requirements; engaging third-party consultants and other service providers to monitor and, as appropriate, respond to cybersecurity risks; requiring our service providers and our business partners who connect directly to our information technology systems to comply with our cybersecurity standards and due diligence processes and be subject to our non-disclosure and other confidentiality agreements that include cybersecurity-related terms; providing and analyzing specialized industry sector intelligence on cybersecurity threats; regularly testing our cybersecurity systems and disaster preparedness, including our back-up information technology systems; developing and updating incident response plans to address potential cybersecurity threats; and maintaining and training our personnel on cybersecurity incident reporting procedures.
Depending on its nature and scale, a cybersecurity threat may be managed within our information security office, escalated to our CISO and CIO, or escalated to our management, and Board of Directors and Audit Committee, as appropriate. In certain instances, our GSR may be initiated and will collectively manage Teva’s response to a crisis on a corporate level.
Depending on its nature and scale, a cybersecurity threat may be managed within our information security office, escalated to our CISO and CIO, or escalated to our management, and Audit Committee and Board of Directors, as appropriate. In certain instances, our GSR may be initiated and will collectively manage Teva’s response to a crisis on a corporate level.
ITEM 1C. CYBERSECURITY Cybersecurity Risk Management Program Overview As cybersecurity threats rapidly evolve in sophistication and become more prevalent, especially with the increasing use of artificial intelligence technology, we have implemented a cybersecurity risk management program as part of our oversight, evaluation and mitigation of enterprise-level risks.
ITEM 1C. CYBERSECURITY Cybersecurity Risk Management Program Overview As cybersecurity threats rapidly evolve in sophistication and become more prevalent, especially with the increasing use of artificial intelligence (“AI”) technology, we have implemented a cybersecurity risk management program as part of our oversight, evaluation and mitigation of enterprise-level risks.
However, our systems and networks have been, and are expected to continue to be, the target of increasingly advanced and evolving cyber-attacks and cybersecurity incidents in the future may adversely impact our business, financial condition and results of operations, and we are continuing to actively monitor such threats.
Our systems and networks have been, and are expected to continue to be, the target of increasingly advanced and evolving cyber-attacks and cybersecurity incidents in the future may adversely impact our business, financial condition and results of operations, and we are continuing to actively monitor such threats.
The GSR is comprised of members from our various business units and regions, including senior leadership from a variety of functions, such as information security, legal, finance, human resources, communications and compliance. We carry insurance that provides protection against the potential losses arising from a cybersecurity incident.
The GSR is comprised of members from our various business units and regions, including senior leadership from a variety of functions, such as information security, legal, finance, human resources, communications and compliance. 55 Table of Contents We carry insurance that provides protection against the potential losses arising from a cybersecurity incident.
Additionally, our CISO, CIO and other members of our information security office may, from time to time, consult and coordinate with other Teva departments and members of management to manage cybersecurity risks and implement cybersecurity incident responses.
Additionally, our CISO, CIO and other members of our information security office may, from time to time, consult and coordinate with other Teva departments and members of management to manage cybersecurity risks, promote cybersecurity awareness and implement cybersecurity incident responses.
As part of our cybersecurity risk management program, we maintain industry standard procedures and policies, which are reviewed and revised frequently, and certified to comply with ISO 27001 standards, to both proactively assess, identify and manage potential cybersecurity risks and respond to any actual cybersecurity threats and incidents.
As part of our cybersecurity risk management program, we maintain industry standard procedures and policies, which are reviewed and revised periodically, and certified to comply with ISO 27001 standards, to both 54 Table of Contents proactively assess, identify and manage potential cybersecurity risks and respond to any actual cybersecurity threats and incidents.
Our CIO updates our executive management on a regular basis 50 Table of Contents to share cybersecurity related matters and discuss strategies to proactively manage cybersecurity threats. Our CISO and CIO brief our Audit Committee on our cybersecurity and risk management programs.
Our CIO updates our executive management on a regular basis to share cybersecurity related matters and discuss strategies to proactively manage cybersecurity threats. Our CISO and CIO brief our Audit Committee on our cybersecurity and risk management programs.
Management, including our CISO and CIO, provide updates on our cybersecurity risk management program and cybersecurity matters to the Audit Committee, and also reports to the Board of Directors as necessary. During 2023, the Board received dedicated cybersecurity training and performed an exercise tabletop relating to potential cybersecurity risks.
Management, including our CISO and CIO, provide updates on our cybersecurity risk management program and cybersecurity matters to the Audit Committee, and also reports to the Board of Directors as necessary.
In early 2024, our management team performed an exercise tabletop relating to potential cybersecurity risks. As part of its overall risk oversight function, our Audit Committee, which is comprised entirely of independent directors, considers cybersecurity risks in connection with overseeing our overall enterprise risk management system.
As part of its cybersecurity program, Teva conducts periodic tabletop exercises to assess its cybersecurity incident response process. As part of its overall risk oversight function, our Audit Committee, which is comprised entirely of independent directors, oversees cybersecurity risks in connection with overseeing our overall enterprise risk management system.
Added
These updates and reports include updates on Teva’s cybersecurity risks and threats, the status of projects intended to strengthen its information security systems, assessments of the information security program (including remediation, mitigation, and management of identified vulnerabilities), and the emerging threat landscape.
Added
Teva engages with key vendors, industry participants, and intelligence and law enforcement communities as part of its continuing efforts to obtain current threat intelligence, collaborate on security enhancements, and evaluate and improve the effectiveness of its information security program.
Added
In addition, as cybersecurity attacks may become increasingly complex as they are enhanced or facilitated by the emergence of new technologies such as AI used to identify and target new vulnerabilities in our information technology systems or those of our customers, third-party vendors and other business partners, we are taking measures to manage these risks by utilizing new tools and capabilities, including AI.
Added
We have not been materially impacted by risks from cybersecurity threats and as of the date of this Annual Report on Form 10-K, we are not aware of any cybersecurity risks that are reasonably likely to materially affect our business. However, there can be no assurance that Teva will not be materially affected by such risks in the future.

Item 2. Properties

Properties — owned and leased real estate

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Biggest changeAs of December 31, 2023, our manufacturing and R&D facilities are used by our business segments as follows: Business Segment Number of Facilities Square Feet (in thousands) North America 18 3,350 Europe 25 9,000 International Markets 16 4,850 Worldwide Total Manufacturing and R&D Facilities 59 17,200 In addition to the manufacturing and R&D facilities discussed above, we maintain numerous office, distribution and warehouse facilities around the world.
Biggest changeAs of December 31, 2024, our manufacturing and R&D facilities are located in our business segments as follows: Business Segment 1 Number of Facilities Square Feet (in thousands) United States 13 3,340 Europe 25 9,000 International Markets 19 4,850 Worldwide Total Manufacturing and R&D Facilities 57 17,150 1 Number of facilities was adjusted to reflect the change in our segments, with the move of Canada from our North America segment (now referred to as United States segment), to our International Markets segment.
ITEM 2. PROPERTIES We own or lease 59 manufacturing and R&D facilities, occupying approximately 17 million square feet.
ITEM 2. PROPERTIES We own or lease 57 manufacturing and R&D facilities, occupying approximately 17 million square feet.
We have an operating lease for our office space in Tel Aviv-Jaffa for an initial term of twelve and a half years, with an option for three extensions. In North America, our principal executive offices are our U.S. headquarters in Parsippany, New Jersey. In Europe, our principal executive offices are in Amsterdam, the Netherlands.
In Israel, our principal executive offices and corporate headquarters are located in Tel Aviv-Jaffa. We have an operating lease for our office space in Tel Aviv-Jaffa for an initial term of twelve and a half years, with an option for three extensions. In the United States, our principal executive offices are our U.S. headquarters in Parsippany, New Jersey.
Our principal executive offices in North America and in Europe are leased by us. 52 Table of Contents We are continuing the ongoing review and optimization of our manufacturing and supply network, which may include closures and/or divestment of manufacturing plants around the world.
In Europe, our principal executive offices are in Haarlem, the Netherlands. Our principal executive offices in the United States and in Europe are leased by us. We are continuing the ongoing review and optimization of our manufacturing and supply network, which may include closures and/or divestment of manufacturing plants around the world.
We generally seek to own our manufacturing facilities. Office, R&D, distribution and warehouse facilities are often leased. We are committed to maintaining all of our properties in good operating condition and repair, and the facilities are well utilized. In Israel, our principal executive offices and corporate headquarters are located in Tel Aviv-Jaffa.
In addition to the manufacturing and R&D facilities discussed above, we maintain numerous office, distribution and warehouse facilities around the world. We generally seek to own our manufacturing facilities. Office, R&D, distribution and warehouse facilities are often leased. We are committed to maintaining all of our properties in good operating condition and repair, and the facilities are well utilized.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

3 edited+0 added−0 removed4 unchanged
Biggest changeUnregistered Sales of Equity Securities and Use of Proceeds None. 54 Table of Contents Performance Graph Set forth below is a performance graph comparing the cumulative total return (assuming reinvestment of dividends), in U.S. dollars, for the calendar years ended December 31, 2019, 2020, 2021, 2022 and 2023, of $100 invested on December 31, 2018 in the Company’s ADSs, the Standard & Poor’s 500 Index and the Dow Jones U.S.
Biggest changeUnregistered Sales of Equity Securities and Use of Proceeds None. 57 Table of Contents Performance Graph Set forth below is a performance graph comparing the cumulative total return (assuming reinvestment of dividends), in U.S. dollars, for the calendar years ended December 31, 2020, 2021, 2022, 2023 and 2024, of $100 invested on December 31, 2019 in the Company’s ADSs, the Standard & Poor’s 500 Index and the Dow Jones U.S.
Various other stock exchanges quote derivatives and options on our ADSs under the symbol “TEVA.” Ordinary Shares Our ordinary shares have been listed on the Tel Aviv Stock Exchange (“TASE”) since 1951. Holders The number of record holders of ADSs at December 31, 2023 was 1,934. The number of record holders of ordinary shares at December 31, 2023 was 151.
Various other stock exchanges quote derivatives and options on our ADSs under the symbol “TEVA.” Ordinary Shares Our ordinary shares have been listed on the Tel Aviv Stock Exchange (“TASE”) since 1951. Holders The number of record holders of ADSs at December 31, 2024 was 1,747. The number of record holders of ordinary shares at December 31, 2024 was 142.
Pharmaceuticals Index. * $100 invested on December 31, 2018 in stock or index – including reinvestment of dividends. Indexes calculated on month-end basis. ITEM 6. [RESERVED] 55 Table of Contents
Pharmaceuticals Index. * $100 invested on December 31, 2019 in stock or index – including reinvestment of dividends. Indexes calculated on month-end basis. ITEM 6. [RESERVED] 58 Table of Contents

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

156 edited+45 added−32 removed53 unchanged
Biggest changeThe 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 changes in accounting, significant costs for remediation of plants, or other unusual events; and • corresponding tax effects of the foregoing items. 77 Table of Contents The following table presents our non-GAAP net income and non-GAAP EPS for the years ended December 31, 2023 and 2022, as well as reconciliations of each measure to their nearest GAAP equivalents: Year ended December 31, ($ in millions except per share amounts) 2023 2022 Net income (loss) attributable to Teva (5) ($) (559 ) (2,446 ) Increase (decrease) for excluded items: Amortization of purchased intangible assets 616 732 Legal settlements and loss contingencies 1,043 2,082 Goodwill impairment 700 2,045 Impairment of long-lived assets 378 402 Restructuring costs 111 146 Costs related to regulatory actions taken in facilities 4 7 Equity compensation 121 124 Contingent consideration (5) 548 261 Gain on sale of business (3 ) (47 ) Accelerated depreciation 80 117 Financial expenses 66 61 Share in profits (losses) of associated companies – net — (22 ) Items attributable to non-controlling interests (92 ) (96 ) Other non-GAAP items (1) 330 465 Corresponding tax effects and unusual tax items (5) (446 ) (1,021 ) (4) Non-GAAP net income attributable to Teva ($) 2,898 2,812 Non-GAAP tax rate (2) 13.0 % 11.7 % GAAP diluted earnings (loss) per share attributable to Teva ($) (0.50 ) (2.20 ) EPS difference (3) 3.06 4.73 Non-GAAP diluted EPS attributable to Teva (3) ($) 2.56 2.52 Non-GAAP average number of shares (in millions) (3) 1,131 1,115 (1) 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.
Biggest changeThe 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 changes in accounting, significant costs for remediation of plants, or other unusual events; and • corresponding tax effects of the foregoing items. 80 Table of Contents The following table presents our non-GAAP net income and non-GAAP EPS for the years ended December 31, 2024 and 2023, as well as reconciliations of each measure to their nearest GAAP equivalents: Year ended December 31, ($ in millions except per share amounts) 2024 2023 Net income (Loss) attributable to Teva ($) (1,639 ) (559 ) Increase (decrease) for excluded items: Amortization of purchased intangible assets 588 616 Legal settlements and loss contingencies (1) 761 1,043 Goodwill impairment (2) 1,280 700 Impairment of long-lived assets (3) 1,275 378 Restructuring costs 74 111 Equity compensation 123 121 Contingent consideration (4) 303 548 Loss (Gain) on sale of business (15 ) (3 ) Accelerated depreciation 13 80 Financial expenses 49 66 Items attributable to non-controlling interests (3) (339 ) (92 ) Other non-GAAP items (5) 229 335 Corresponding tax effects and unusual tax items (6) 157 (446 ) Non-GAAP net income attributable to Teva ($) ($) 2,860 2,898 Non-GAAP tax rate (7) 15.3 % 13.0 % GAAP diluted earnings (loss) per share attributable to Teva ($) ($) (1.45) (0.50 ) EPS difference (8) 3.94 3.06 Non-GAAP diluted EPS attributable to Teva (8) ($) ($) 2.49 2.56 Non-GAAP average number of shares (in millions) (8) 1,150 1,131 (1) Adjustments for legal settlements and loss contingencies in 2024 were mainly related to legal expenses of $357 million recorded in connection with a decision by the European Commission in its antitrust investigation into COPAXONE, and an update to the estimated settlement provision of $278 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).
However, although inflationary and other macroeconomic pressures may ease, the higher costs we have experienced during the recent periods have already impacted our operations and will likely continue to have an effect on our financial results.
However, although inflationary and other macroeconomic pressures have and may continue to ease, 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.
We have implemented certain measures in response to such macroeconomic pressures and geopolitical 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.
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.
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-clinical development and product registration costs. These expenditures are reported net of contributions received from collaboration partners.
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.
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 vendors.
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 drive an acceleration of receivable payments from customers, or deceleration of payments to vendors.
The more significant estimates and assumptions inherent in the estimate of the fair value of identifiable intangible assets include (i) assumptions associated with forecasting product profitability, including sales and cost to sell projections, (ii) tax rates which seek to incorporate the geographic diversity of the projected cash flows, (iii) expected impact of competitive, legal and/or regulatory forces on the projections and the impact of 82 Table of Contents technological risk, R&D expenditure for ongoing support of product rights or continued development of IPR&D, and (iv) estimated useful lives and IPR&D expected launch dates.
The more significant estimates and assumptions inherent in the estimate of the fair value of identifiable intangible assets include (i) assumptions associated with forecasting product profitability, including sales and cost to sell projections, (ii) tax rates which seek to incorporate the geographic diversity of the projected cash flows, (iii) expected impact of competitive, legal and/or regulatory forces on the projections and the impact of technological risk, R&D expenditure for ongoing support of product rights or continued development of IPR&D, and (iv) estimated useful lives and IPR&D expected launch dates.
Investors are cautioned that, unlike financial measures prepared in accordance with U.S. 76 Table of Contents 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.
Investors are cautioned that, unlike financial measures prepared in accordance with U.S. 79 Table of Contents 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.
In local currency terms, revenues increased by 16%, mainly due to higher revenues in most markets, as well as price increases largely as a result of higher costs due to inflationary pressure, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.
In local currency terms, revenues increased by 15%, mainly due to higher revenues in most markets, as well as price increases, largely as a result of higher costs due to inflationary pressure, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.
This decrease was mainly due to higher S&M and R&D expenses and lower other income. 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.
This decrease was mainly due to higher S&M expenses, lower other income and higher R&D expenses. 71 Table of Contents 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.
Since 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, Canadian dollar, Russian ruble, Japanese yen, Swiss franc, Israeli shekel and Polish zloty) impact our results.
Since 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, Canadian dollar, Swiss franc, Russian ruble, Japanese yen and the new Israeli shekel) impact our results.
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 56 Table of Contents the continuation, escalation or expansion of this war.
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.
Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations. 72 Table of Contents Commencing the second quarter of 2022, the cumulative inflation in Turkey exceeded 100% or more over a three-year period.
Commencing 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.
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. 61 Table of Contents In 2023, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications.
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. In 2024, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications.
Collectively, these first to file opportunities represent over $72 billion in U.S. brand sales for the twelve months ended September 30, 2023, 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.
Collectively, these first to file opportunities represent over $80 billion in U.S. brand sales for the twelve months ended September 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.
For a comparison of our results of operations and financial condition for fiscal years 2022 and 2021, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2022 Annual Report on Form 10-K, filed with the SEC on February 10, 2023.
For a comparison of our results of operations and financial condition for fiscal years 2023 and 2022, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2023 Annual Report on Form 10-K, filed with the SEC on February 12, 2024.
The critical accounting estimates relate to the following: • Revenue Recognition and SR&A in the United States • Income Taxes • Contingencies • Goodwill • Identifiable Intangible Assets Revenue Recognition and SR&A in the United States Our gross product revenues are subject to a variety of deductions which are generally estimated and recorded in the same period that the revenues are recognized, and primarily represent chargebacks, rebates and 79 Table of Contents sales allowances to wholesalers, retailers and government agencies with respect to our pharmaceutical products.
The critical accounting estimates relate to the following: • Revenue Recognition and SR&A in the United States • Income Taxes • Contingencies • Goodwill • Identifiable Intangible Assets • Contingent consideration Revenue Recognition and SR&A in the United States Our gross product revenues are subject to a variety of deductions which are generally estimated and recorded in the same period that the revenues are recognized, and primarily represent chargebacks, rebates and sales allowances to wholesalers, retailers and government agencies with respect to our pharmaceutical products.
(2) 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.
(7) 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.
As of December 31, 2023 and 2022, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,157 million and 1,143 million, respectively. Impact of Currency Fluctuations on Results of Operations In 2023, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar.
As of December 31, 2024 and 2023, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,174 million and 1,157 million, respectively. Impact of Currency Fluctuations on Results of Operations In 2024, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar.
As of December 31, 2023, if all development milestones and targets, for compounds in phase 2 and more advanced stages of development, are achieved, the total contingent payments could reach an aggregate amount of up to $20 million. Additional contingent payments are owed upon achievement of product approval or launch milestones.
As of December 31, 2024, if all development milestones and targets, for compounds in Phase 2 and more advanced stages of development, are achieved, the total contingent payments could reach an aggregate amount of up to $91 million. Additional contingent payments are owed upon achievement of product approval or launch milestones.
During 2023, we generated free cash flow of $2,387 million, which we define as comprising $1,368 million in cash flow generated from operating activities, $1,477 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $68 million proceeds from sale of businesses and long-lived assets, partially offset by $526 million in cash used for capital investments.
During 2023, we generated free cash flow of $2,387 million, which we define as comprising $1,368 million in cash flow generated from operating activities, $1,477 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $68 million proceeds from divestitures of businesses and other assets, partially offset by $526 million in cash used for capital investments.
Goodwill is not amortized, and is assigned to reporting units and tested for impairment at least annually, in the second quarter of the fiscal year. We perform an impairment test annually and whenever events or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable.
Goodwill is not amortized, and is assigned to reporting units and tested for impairment at least annually, in the second quarter of the fiscal year, and whenever events or changes in circumstances indicate the carrying value of a reporting unit may not be recoverable.
Approximately 78% of pending applications include a paragraph IV patent challenge and we believe we are first to file with respect to 62 of these products, or 88 products including final approvals where launch is pending a settlement agreement or court decision.
Approximately 78% of pending applications include a paragraph IV patent challenge and we believe we are first to file with respect to 54 of these products, or 82 products including final approvals where launch is pending a settlement agreement or court decision.
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 (“RCF”).
Teva’s principal sources of short-term liquidity are its cash on hand, existing cash investments, liquid securities and available credit facilities, primarily its $1.8 billion unsecured syndicated sustainability-linked revolving credit facility entered into in April 2022, as amended on February 6, 2023 and on May 3, 2024 (“RCF”).
In addition, in large part as a result of the nature of its business, Teva 80 Table of Contents is frequently subject to litigation, governmental investigations and other legal proceedings.
In addition, in large part as a result of the nature of its business, Teva is frequently subject to litigation, governmental investigations and other legal proceedings.
Accordingly, management’s assessments involve complex judgments concerning future events and often rely heavily on estimates and assumptions. Goodwill Goodwill reflects the excess of the consideration transferred, including the fair value of any contingent consideration and any non-controlling interest in the acquiree, over the assigned fair values of the identifiable net assets acquired.
Accordingly, management’s assessments involve complex judgments concerning future events and often rely heavily on estimates and assumptions. Goodwill Goodwill reflects the excess of the consideration transferred, including the fair value of any contingent consideration and any non-controlling interest in the acquiree, over the assigned fair values of the identifiable net assets acquired, as part of a business combination.
Key estimates include the revenue growth rates taking into consideration industry and market conditions, terminal growth rate and the discount rate. The discount rate used is based on the WACC, adjusted for the relevant risk associated with country-specific and business-specific characteristics.
Key estimates include the revenue growth rates taking into consideration 84 Table of Contents industry and market conditions, terminal growth rate and the discount rate. The discount rate used is based on the WACC, adjusted for the relevant risk associated with country-specific and business-specific characteristics.
As of December 31, 2023, our generic products pipeline in the United States includes 137 product applications awaiting FDA approval, including 63 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.
As of December 31, 2024, our generic products pipeline in the United States includes 127 product applications awaiting FDA approval, including 65 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.
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 $1,374 million as of December 31, 2023, compared to negative $119 million as of December 31, 2022.
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 $2,837 million as of December 31, 2024, compared to a negative $1,374 million as of December 31, 2023.
Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended September 30, 2023 of approximately $107 billion, according to IQVIA.
Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended September 30, 2024 of approximately $122 billion, according to IQVIA.
The total gross amount of unrecognized tax benefits for uncertain tax positions was $651 million at December 31, 2023. Payment of these obligations would result from settlements with tax authorities. Due to the difficulty in determining the timing and magnitude of settlements, these obligations are not included in the table above.
The total gross amount of unrecognized tax benefits for uncertain tax positions was $449 million on December 31, 2024. Payment of these obligations would result from settlements with tax authorities. Due to the difficulty in determining the timing and magnitude of settlements, these obligations are not included in the table above.
Exchange rate fluctuations affected our balance sheet, as approximately 81% of our net assets (including both non-monetary and monetary assets) were in currencies other than the U.S. dollar. When compared to December 31, 2022, changes in currency rates had a positive impact of $80 million on our equity as of December 31, 2023.
Exchange rate fluctuations affected our balance sheet, as approximately 93% of our net assets (including both non-monetary and monetary assets) were in currencies other than the U.S. dollar. When compared to December 31, 2023, changes in currency rates had a negative impact of $530 million on our equity as of December 31, 2024.
In local currency terms, revenues increased by 5%, mainly due to higher revenues from generic and OTC products as well as higher revenues from AJOVY, partially offset by lower revenues from COPAXONE and certain other respiratory products. Higher revenues from our Europe segment in 2023 were also driven by the sale of certain product rights.
In local currency terms, revenues increased by 4%, mainly due to higher revenues from generic and OTC products as well as higher revenues from AJOVY, partially offset by lower revenues from COPAXONE, respiratory products and other products. Our revenues in 2024 and 2023 were also impacted by the sale of certain product rights.
Europe R&D Expenses R&D expenses relating to our Europe segment in 2023 were $220 million, an increase of 3% compared to $213 million in 2022. For a description of our R&D expenses in 2023, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe R&D Expenses R&D expenses relating to our Europe segment in 2024 were $229 million, an increase of 4% compared to $220 million in 2023. For a description of our R&D expenses in 2024, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
This decrease was mainly due to regulatory price reductions and generic competition to off-patented products in Japan, partially offset by price increases largely as a result of higher costs due to inflationary pressure, a favorable mix of products sold and a positive hedging impact.
This increase was mainly due to the sale of certain product rights, price increases largely as a result of higher costs due to inflationary pressure, a favorable mix of products sold, and a positive hedging impact, partially offset by regulatory price reductions and generic competition to off-patented products in Japan.
Other Asset Impairments, Restructuring and Other Items We recorded expenses of $718 million for other asset impairments, restructuring and other items in 2023, compared to expenses of $512 million in 2022. See note 15 to our consolidated financial statements.
Other Asset Impairments, Restructuring and Other Items We recorded expenses of $1,338 million for other asset impairments, restructuring and other items in 2024, compared to expenses of $718 million in 2023. See note 15 to our consolidated financial statements.
Such decisions may have a material impact on our annual operating cash flow measurement, as well as on our quarterly results. Cash flow generated from operating activities in 2023 was $1,368 million, compared to $1,590 million in 2022.
Such decisions have and may in the future have a material impact on our annual operating cash flow measurement, as well as on our quarterly results. Cash flow generated from operating activities in 2024 was $1,247 million, compared to $1,368 million in 2023.
Our R&D expenses, net in 2023 were $953 million, an increase of 14% compared to $838 million in 2022, as we continue to execute on our Pivot to Growth strategy.
Our R&D expenses, net in 2024 were $998 million, an increase of 5% compared to $953 million in 2023, as we continue to execute on our Pivot to Growth strategy.
Gross profit margin was 48.2% in 2023, compared to 46.7% in 2022.
Gross profit margin was 48.7% in 2024, compared to 48.2% in 2023.
Our higher R&D expenses, net in 2023 compared to 2022, were mainly due to an increase related to our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), in immunology and in immuno-oncology, partially offset by a decline in various generics projects, as well as lower R&D expenses related to our biosimilar products pipeline.
Our higher R&D expenses, net in 2024, compared to 2023, were mainly due to an increase in immunology and in immuno-oncology, our late-stage innovative pipeline in neuroscience (mainly neuropsychiatry), and our biosimilars pipeline, partially offset by a decline in various generics projects.
For further information on our agreements with Biolojic Design, Sanofi, Modag, Alvotech, Takeda and MedinCell, see note 2 to our consolidated financial statements.
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.
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: North America, Europe and International Markets.
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 the North America segment, see below “—United States Segment”), Europe and International Markets.
This method starts with a forecast of all expected future net cash flows associated with the asset and then adjusts the forecast to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams.
The fair value of acquired identifiable intangible assets is determined using an income approach. This method starts with a forecast of all expected future net cash flows associated with the asset and then adjusts the forecast to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams.
Trend Information The following factors are expected to have a significant effect on our 2024 results: • continued success of our innovative medicines AUSTEDO, AJOVY and UZEDY; • continued execution on the key pillars of our Pivot to Growth strategy; • expanding our existing innovative medicines and biosimilar pipeline, including by pursuing business development and other partnership opportunities; 78 Table of Contents • ability to successfully execute key generic launches in a timely manner; • ability to successfully develop and launch new biosimilar products; • continued decline in sales of COPAXONE and other innovative medicines due to loss of exclusivity, generic competition and/or availability of alternative therapies; • continued competition for our generic products where multiple similar generic products have been launched, resulting in pricing pressure in the generics markets.
Trend Information The following factors are expected to have a significant effect on our 2025 results: • continued growth of our innovative medicines AUSTEDO, AJOVY and UZEDY; • continued execution on the key pillars of our Pivot to Growth strategy; • expanding and accelerating our innovative medicines and biosimilar pipeline, including by pursuing business development and other partnership opportunities; • ability to successfully execute key generic launches in a timely manner including complex generic products, and to successfully develop and launch new biosimilar products; • continued competition for our generic products where multiple similar generic products have been launched, resulting in pricing pressure in the generics markets.
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.
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.
In addition, approximately 1,318 marketing authorization applications pending approval in 37 European countries, relating to 99 compounds in 214 formulations. Two applications are pending with the EMA. For a description of our innovative medicines pipeline, see “Item 1—Business—Research and Development” above.
In addition, approximately 1,483 marketing authorization applications are pending approval in 37 European countries, which approvals relate to 92 compounds in 212 formulations. No applications are pending with the EMA. For a description of our innovative medicines pipeline, see “Item 1—Business—Research and Development” above.
Revenues increased by 9% compared to 2022. Profit increased by 20% compared to 2022. • Our Europe segment generated revenues of $4,837 million and profit of $1,478 million in 2023. Revenues increased by 7% in U.S. dollars or 5% in local currency terms, compared to 2022.
Revenues increased by 4% and profit increased by 4% compared to 2023. • Our Europe segment generated revenues of $5,103 million and profit of $1,575 million in 2024. Revenues increased by 5% in U.S. dollars or 4% in local currency terms, compared to 2023.
Cash investment in property, plant and equipment and intangible assets in 2023 was $526 million, compared to $548 million in 2022. Depreciation was $537 million in 2023, compared to $576 million in 2022. Cash and cash equivalents as of December 31, 2023 were $3,226 million compared to $2,801 million as of December 31, 2022.
Cash investment in property, plant and equipment and intangible assets in 2024 was $498 million, compared to $526 million in 2023. Depreciation was $471 million in 2024, compared to $537 million in 2023. Cash and cash equivalents as of December 31, 2024 were $3,300 million compared to $3,226 million as of December 31, 2023.
Highlights Significant highlights of 2023 included: • Our revenues in 2023 were $15,846 million, an increase of 6% in U.S. dollars, or 7% in local currency terms, compared to 2022.
Highlights Significant highlights of 2024 included: • Our revenues in 2024 were $16,544 million, an increase of 4% in U.S. dollars, or 6% in local currency terms, compared to 2023.
International Markets R&D Expenses R&D expenses relating to our International Markets segment in 2023 were $83 million, an increase of 16% compared to $72 million in 2022. 67 Table of Contents For a description of our R&D expenses in 2023, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
International Markets R&D Expenses R&D expenses relating to our International Markets segment in 2024 were $112 million, an increase of 7% compared to $104 million in 2023. For a description of our R&D expenses in 2024, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe Segment The following table presents revenues, expenses and profit for our Europe segment for the past two years: Year ended December 31, 2023 2022 (U.S. $ in millions / % of Segment Revenues) Revenues $ 4,837 100% $ 4,525 100% Gross profit 2,726 56.4% 2,700 59.7% R&D expenses 220 4.6% 213 4.7% S&M expenses 767 15.9% 748 16.5% G&A expenses 263 5.4% 246 5.4% Other (income) expense (2 ) § (3 ) § Segment profit* $ 1,478 30.6% $ 1,496 33.1% * Segment profit does not include amortization and certain other items. § Represents an amount less than 0.5%.
Europe Segment The following table presents revenues, expenses and profit for our Europe segment for the past two years: Year ended December 31, 2024 2023 (U.S. $ in millions / % of Segment Revenues) Revenues $ 5,103 100.0% $ 4,837 100.0% Cost of sales 2,197 43.1% 2,111 43.6% Gross profit 2,905 56.9% 2,726 56.4% R&D expenses 229 4.5% 220 4.5% S&M expenses 826 16.2% 767 15.9% G&A expenses 272 5.3% 263 5.4% Other loss (income) 3 § (2 ) § Segment profit* $ 1,575 30.9% $ 1,478 30.6% * Segment profit does not include amortization and certain other items. § Represents an amount less than 0.5%.
For example, a successful challenge of our patent rights by a competitor would likely result in generic competition earlier than expected. And conversely, a lost challenge of patent rights in connection with our generic file would likely result in delayed entry. • A significant adverse change in the extent or manner in which an asset is used.
And conversely, a lost challenge of patent rights in connection with our generic file would likely result in delayed entry. 85 Table of Contents • A significant adverse change in the extent or manner in which an asset is used.
In local currency terms, revenues decreased by 5%, mainly due to net price reductions and lower volumes. Product Launches and Pipeline As of December 31, 2023, our generic products pipeline in Europe included 442 generic approvals relating to 67 compounds in 124 formulations, no EMA approvals received during 2023.
In local currency terms, revenues decreased by 9%, mainly due to net price reductions and lower volumes. 67 Table of Contents Product Launches and Pipeline As of December 31, 2024, our generic products pipeline in Europe included 686 generic approvals relating to 71 compounds in 149 formulations and one EMA approval received during 2024.
For more information on AJOVY, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—AJOVY.” AUSTEDO revenues in our North America segment in 2023 increased by 27% to $1,225 million, compared to 2022, mainly due to growth in volume including the launch of AUSTEDO XR in May 2023.
For more information on AJOVY, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—AJOVY.” AUSTEDO revenues in our United States segment in 2024 increased by 34% to $1,642 million, compared to 2023, mainly due to growth in volume including the launch of AUSTEDO XR in May 2023, as well as expanded access for patients.
Legal Settlements and Loss Contingencies In 2023, we recorded expenses of $1,043 million in legal settlements and loss contingencies, compared to expenses of $2,082 million in 2022. See note 11 to our consolidated financial statements. Other Income Other income in 2023 was $49 million, compared to $107 million in 2022. See note 16 to our consolidated financial statements.
Legal Settlements and Loss Contingencies In 2024, we recorded expenses of $761 million in legal settlements and loss contingencies, compared to expenses of $1,043 million in 2023. See note 11 to our consolidated financial statements. 73 Table of Contents Other Income Other income in 2024 was $14 million, compared to $49 million in 2023.
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 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. 72 Table of Contents 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.
For a description of our innovative medicines pipeline, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines” above. North America Gross Profit Gross profit from our North America segment in 2023 was $4,421 million, an increase of 13% compared to $3,926 million in 2022.
For a description of our innovative medicines pipeline, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines” above. United States Gross Profit Gross profit from our United States segment in 2024 was $4,388 million, an increase of 2% compared to $4,310 million in 2023.
See “—North America Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above. Exchange rate movements during 2023, including hedging effects, negatively impacted revenues by $172 million, compared to 2022. See note 10d to our consolidated financial statements. Gross Profit Gross profit in 2023 was $7,645 million, an increase of 10% compared to 2022.
See “—United States Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above. Exchange rate movements during 2024, net of hedging effects, negatively impacted revenues by $257 million, compared to 2023. See note 10d to our consolidated financial statements. Gross Profit Gross profit in 2024 was $8,064 million, an increase of 5% compared to 2023.
During 2023, the following main currencies relevant to our operations decreased in value against the U.S. dollar (each on an annual average compared to annual average basis): the Argentinian peso by 52%, the Turkish lira by 29%, the Russian ruble by 20%, the Ukraine hryvna by 13%, the Israeli shekel by 9% and the Japanese yen by 7%.
During 2024, the following main currencies relevant to our operations decreased in value against the U.S. dollar (each on an annual average compared to annual average basis): the Argentinian peso by 68%, the Turkish lira by 28%, the Chilean peso by 11%, the Ukraine hryvna by 8%, the Russian ruble by 8%, the Brazilian real by 7% and the Japanese yen by 7%.
In local currency terms, revenues decreased by 16%, mainly due to price reductions and lower volumes resulting from competing glatiramer acetate products and availability of alternative therapies. For more information on COPAXONE, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—COPAXONE.” Respiratory products revenues in our Europe segment in 2023 decreased by 3% to $265 million, compared to 2022.
This decrease was mainly due to price reductions and a decline in volume resulting from the availability of alternative therapies and competing glatiramer acetate products. For more information on COPAXONE, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—COPAXONE.” Respiratory products revenues in our Europe segment in 2024 decreased by 8% to $244 million, compared to 2023.
See note 7 and note 19 to our consolidated financial statements for further details on the goodwill impairments recognized in 2023 and 2022, and Teva’s operating and reporting segments.
See note 7 and note 19 to our consolidated financial statements for further details on the goodwill impairments recognized in 2024 and 2023, and on Teva’s operating and reporting segments. Identifiable Intangible Assets Identifiable intangible assets are comprised of definite and indefinite life intangible assets.
See note 9 to our consolidated financial statements. 2023 Debt Balance and Movements As of December 31, 2023, our debt was $19,833 million, compared to $21,212 million as of December 31, 2022. This decrease was mainly due to $1,646 million senior notes repaid at maturity, partially offset by $302 million of exchange rate fluctuations.
See note 9 to our consolidated financial statements. 2024 Debt Balance and Movements As of December 31, 2024, our debt was $17,783 million, compared to $19,833 million as of December 31, 2023. This decrease was mainly due to the repayment at maturity of $1,641 million of our senior notes and $429 million of exchange rate fluctuations.
Europe Revenues Our Europe segment includes the European Union, the United Kingdom and certain other European countries. Revenues from our Europe segment in 2023 were $4,837 million, an increase of $312 million, or 7%, compared to 2022.
Europe Revenues Our Europe segment includes the European Union, the United Kingdom and certain other European countries. 66 Table of Contents Revenues from our Europe segment in 2024 were $5,103 million, an increase of $266 million, or 5%, compared to 2023.
As such, immediately after acquisition or impairment, even small declines in the outlook for these assets can negatively impact our ability to recover the carrying value and can result in an impairment charge. Recently Issued Accounting Pronouncements See note 1 to our consolidated financial statements. 83 Table of Contents
As such, immediately after acquisition or impairment, even small declines in the outlook for these assets can negatively impact our ability to recover the carrying value and can result in an impairment charge.
In local currency terms, revenues increased by 27% due to higher volumes. For more information on AJOVY, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—AJOVY.” COPAXONE revenues in our Europe segment in 2023 decreased by 14% to $231 million, compared to 2022.
For more information on AJOVY, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—AJOVY.” COPAXONE revenues in our Europe segment in 2024 decreased by 8% to $213 million, compared to 2023, in both U.S. dollars and local currency terms, compared to 2023.
Our S&M expenses were primarily the result of the factors discussed above under “—North America 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 14.7% in 2023, compared to 15.2% in 2022.
Our S&M expenses were primarily the 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 15.4% in 2024, compared to 14.7% in 2023. General and Administrative (G&A) Expenses G&A expenses in 2024 were $1,161 million, flat compared to 2023.
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.
However, there can be no assurance regarding the ultimate timing or structure of the potential divestiture or that a divestiture will be agreed or completed at all. For further information, see note 2 to our consolidated financial statements.
In 2022, a positive impact of $11 million was recognized under revenues and a negative impact of $7 million was recognized under cost of sales.
In 2024, a positive hedging impact of $34 million was recognized under revenues and a negative hedging impact of $5 million was recognized under cost of sales.
In 2023, revenues were positively impacted by exchange rate fluctuations of $88 million, net of hedging effects, compared to 2022. Revenues in 2023 were affected by a $12 million negative hedging impact, compared to a $17 million positive hedging impact in 2022, which are included in “Other” in the table below.
In 2024, revenues were positively impacted by exchange rate fluctuations of $64 million, including hedging effects, compared to 2023. Revenues in 2024 were affected by a $21 million positive hedging impact, compared to a $12 million negative hedging impact in 2023, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.
North America R&D Expenses R&D expenses relating to our North America segment in 2023 were $625 million, an increase of 18% compared to $532 million in 2022. For a description of our R&D expenses in 2023, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
For a description of our R&D expenses in 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 2024 were $1,049 million, an increase of 12% compared to $938 million in 2023.
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. 75 Table of Contents Aggregated Contractual Obligations The following table summarizes our material contractual obligations and commitments as of December 31, 2023: Payments Due by Period Total Less than 1 year 1-3 years 3-5 years More than 5 years (U.S. $ in millions) Long-term debt obligations, including estimated interest* $ 25,847 $ 2,534 $ 6,814 $ 6,180 $ 10,319 Purchase obligations (including purchase orders) 1,523 1,189 207 108 19 Total $ 27,370 $ 3,723 $ 7,021 $ 6,288 $ 10,338 * Long-term debt obligations mainly include senior notes, sustainability-linked senior notes and convertible senior debentures, as disclosed in note 9 to our consolidated financial statements.
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. 78 Table of Contents Aggregated Contractual Obligations The following table summarizes our material contractual obligations and commitments as of December 31, 2024: Payments Due by Period Total Less than 1 year 1-3 years 3-5 years More than 5 years (U.S. $ in millions) Long-term debt obligations, including estimated interest* $ 22,818 $ 2,549 $ 7,618 $ 5,373 $ 7,278 Purchase obligations (including purchase orders) 1,806 1,493 227 39 47 Total $ 24,624 $ 4,042 $ 7,845 $ 5,412 $ 7,325 * Long-term debt obligations mainly include senior notes, sustainability-linked senior notes and convertible senior debentures, as disclosed in note 9 to our consolidated financial statements.
In local currency terms, revenues increased by 35%. For more information on AJOVY, see “Item 1—Business—Our Product Portfolio and Business Offering— Innovative Medicines—AJOVY.” COPAXONE revenues in our International Markets segment in 2023 increased by 9% to $39 million, compared to 2022. In local currency terms, revenues increased by 25%.
For more information on AJOVY, see “Item 1—Business—Our Product Portfolio and Business Offering— Innovative Medicines—AJOVY.” COPAXONE revenues in our International Markets segment in 2024 decreased by 24% to $48 million, compared to 2023. In local currency terms, revenues decreased by 11%, mainly due to market share erosion and competition.
This increase was mainly due to an upfront payment received in connection with the collaboration on our anti-TL1A asset, as discussed above, as well as a favorable mix of products primarily driven by an increase in revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid ® ), partially offset by higher costs due to inflationary and other macroeconomic pressures.
This increase in gross profit margin was mainly due to a favorable mix of products, primarily driven by higher revenues from AUSTEDO and lenalidomide capsules (the generic version of Revlimid ® ), and the sale of certain product rights, partially offset by an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset.
We recorded goodwill impairment charges of $2,045 million in the year ended December 31, 2022, of which $979 million is related to our International Markets reporting unit and $1,066 million is related to Teva’s API reporting unit. See note 7 to our consolidated financial statements.
Goodwill Impairment We recorded goodwill impairment charges of $1,280 million in the year ended December 31, 2024, related to our Teva API reporting unit. We recorded a goodwill impairment charge of $700 million in the year ended December 31, 2023 related to our International Markets reporting unit. See note 7 to our consolidated financial statements.
This increase was mainly due to an upfront payment received in connection with the collaboration on our anti-TL1A asset, higher revenues from generic products in our International Markets and Europe segments, from our innovative products AUSTEDO and AJOVY, the sale of certain product rights in our Europe segment, as well as higher revenues from Anda, partially offset by lower revenues from COPAXONE, API sales to third parties, BENDEKA and TREANDA, and generic products in our North America segment.
This increase was mainly due to higher revenues from generic products in all our segments, including from lenalidomide capsules (the generic version of Revlimid ® ) in our U.S. segment, from our innovative products AUSTEDO, UZEDY and AJOVY, as well as the sale of certain product rights, partially offset by an upfront payment received in 2023 related to the collaboration on our duvakitug (anti-TL1A) asset, and lower revenues from certain innovative products, primarily COPAXONE and BENDEKA and TREANDA.
Europe Profit Profit of 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 2023 was $1,478 million, a decrease of 1% compared to $1,496 million in 2022.
Europe Profit Profit of our Europe segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and any other loss (income) related to this segment. Segment profit does not include amortization and certain other items.
International Markets Profit Profit of 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 2023 was $464 million a decrease of 3% compared to $479 million in 2022.
Other income in 2023 was mainly the result of a capital gain from the sale of assets. International Markets Profit Profit of our International Markets segment consists of revenues less cost of sales, R&D expenses, S&M expenses, G&A expenses and any other loss (income) related to this segment. Segment profit does not include amortization and certain other items.
Profit decreased by 1% compared to 2022. • Our International Markets segment generated revenues of $1,958 million and profit of $464 million in 2023. Revenues increased by 3% in U.S. dollars or 16% in local currency terms, compared to 2022.
Profit increased by 7% compared to 2023. • Our International Markets segment generated revenues of $2,463 million and profit of $440 million in 2024. Revenues increased by 5% in U.S. dollars or 18% in local currency terms, compared to 2023.
During 2022, we generated free cash flow of $2,243 million, which we define as comprising $1,590 million in cash flow generated from operating activities, $1,140 million in beneficial interest collected in exchange for securitized accounts receivables and $68 million proceeds from sale of businesses and long-lived assets, partially offset by $548 million in cash used for capital investments and $7 million in cash used for acquisition of businesses, net of cash acquired.
During 2024, we generated free cash flow of $2,068 million, which we define as comprising $1,247 million in cash flow generated from operating activities, $1,291 million in beneficial interest collected in exchange for securitized accounts receivables (under our EU securitization program) and $43 million proceeds from divestitures of businesses and other assets, partially offset by $498 million in cash used for capital investments and $15 million in cash used for acquisition of businesses, net of cash acquired.
Europe S&M Expenses S&M expenses relating to our Europe segment in 2023 were $767 million, an increase of 3% compared to $748 million in 2022. This increase was mainly to support revenue growth as well as due to exchange rate fluctuations.
Europe S&M Expenses S&M expenses relating to our Europe segment in 2024 were $826 million, an increase of 8% compared to $767 million in 2023. This increase was mainly to support revenue growth. Europe G&A Expenses G&A expenses relating to our Europe segment in 2024 were $272 million, an increase of 3% compared to $263 million in 2023.
In addition to rising inflation, heightened interest rates and fluctuating foreign exchange rates, the global economy has also been impacted by geopolitical tensions which have resulted in disruptions to global supply chains, including to our internal supply chain. In October 2023, Israel was attacked by a terrorist organization and entered a state of war.
The 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 Annual Report on Form 10-K is ongoing.

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Item 7A. Quantitative and Qualitative Disclosures About Market Risk

Market Risk — interest-rate, FX, commodity exposure

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Biggest changeCurrency (sold) Cross Currency (bought) Net Notional Value Fair Value 2023 Weighted Average Cross Currency Prices or Strike Prices 2023 2022 2023 2022 (U.S. $ in millions) Forward: EUR CHF 409 354 10 (3 ) 0.95 EUR USD 367 252 (5 ) (8 ) 0.92 EUR GBP 293 246 1 (17 ) 0.87 JPY USD 239 179 (6 ) (4 ) 145.00 EUR PLN 187 151 2 (1 ) 4.40 USD INR 162 122 1 (8 ) 83.80 USD ILS 144 79 5 2 3.73 GBP USD 105 58 4 (18 ) 1.23 USD PLN 97 58 (1 ) 1 4.03 CAD USD 61 52 (1 ) (5 ) 1.38 CHF USD 56 50 (2 ) (2 ) 1 MXN USD 56 * (2 ) — 18 Options: EUR USD * 132 — (3 ) — GBP USD * 86 — (2 ) 1.23 USD ILS * 68 1 (2 ) 3.66 CAD USD * * — — 1.38 CHF USD * * — (1 ) 1 * Represents net notional value of less than $50 million. 85 Table of Contents Foreign Subsidiaries Net Assets Under certain market conditions, we may hedge against possible fluctuations in foreign subsidiaries’ net assets (“net investment hedge”).
Biggest changeCurrency (sold) Cross Currency (bought) Net Notional Value Fair Value 2024 Weighted Average Cross Currency Prices or Strike Prices 2024 2023 2024 2023 (U.S. $ in millions) Forward: USD ILS 857 79 7 2 3.69 EUR GBP 646 246 5 (17 ) 0.85 JPY USD 306 179 11 (4 ) 150.05 EUR CHF 300 354 (3 ) (3 ) 0.95 EUR PLN 279 151 3 (1 ) 4.32 EUR USD 236 252 (2 ) (8 ) 1.09 USD INR 179 122 (2 ) (8 ) 83.75 GBP USD 126 58 5 (18 ) 1.28 CHF USD 118 50 5 (2 ) 0.87 USD PLN 117 58 3 1 4.00 CAD USD 116 52 3 (5 ) 1.36 USD SEK 87 * 2 — 10.55 MXN USD 69 * 1 — 18.26 EUR CAD 61 * — — 1.49 Options: EUR USD * 132 — (3 ) — GBP USD * 86 — (2 ) — USD ILS * 68 — (2 ) — CAD USD * * — — — CHF USD * * — (1 ) — * Represents net notional value of less than $50 million. 88 Table of Contents Foreign Subsidiaries Net Assets Under certain market conditions, we may hedge against possible fluctuations in foreign subsidiaries’ net assets (“net investment hedge”).
The table below presents the net notional and fair values of the financial derivatives entered into as of December 31, 2023 in order to reduce currency exposure arising from our cash flow and balance sheet exposures. The table below presents only currency paired with hedged net notional values exceeding $50 million.
The table below presents the net notional and fair values of the financial derivatives entered into as of December 31, 2024 in order to reduce currency exposure arising from our cash flow and balance sheet exposures. The table below presents only currency paired with hedged net notional values exceeding $50 million.
As of December 31, 2023, we hedged part of our expected operating results for 2024 in currencies other than the U.S. dollar, primarily the euro, British pound, Canadian dollar, Swiss franc, Swedish krona, Polish zloty, Japanese yen, Chilean peso, Indian rupee and Israeli shekel.
As of December 31, 2024, we hedged part of our expected operating results for 2025 in currencies other than the U.S. dollar, primarily the British pound, Canadian dollar, Swiss franc, Swedish krona, Polish zloty, Japanese yen, Chilean peso, Indian rupee and Israeli shekel.
As of December 31, 2023, all outstanding senior notes, sustainability-linked senior notes and convertible debentures bear a fixed interest rate.
As of December 31, 2024, all outstanding senior notes, sustainability-linked senior notes and convertible debentures bear a fixed interest rate.
Cash Flow Exposure Our total revenues were $15,846 million in 2023. Of these revenues, approximately 47% were denominated in currencies other than the U.S. dollar, of which 21% in euros and the rest in other currencies, none of which accounted for more than 3% of total revenues in 2023. In most currencies, we record corresponding expenses.
Cash Flow Exposure Our total revenues were $16,544 million in 2024. Of these revenues, approximately 47% were denominated in currencies other than the U.S. dollar, of which 22% in euros and the rest in other currencies, none of which accounted for more than 3% of total revenues in 2024. In most currencies, we recorded corresponding expenses.
As of December 31, 2022, we had outstanding derivatives, primarily forwards and currency option contracts, with a corresponding notional amount of approximately $1.9 billion and $0.3 billion, respectively.
As of December 31, 2023, we had outstanding derivatives, primarily forwards and currency option contracts, with a corresponding notional amount of approximately $2.5 billion and $0.2 billion, respectively.
To the extent possible, the hedging activity is carried out on a consolidated level. 84 Table of Contents The table below presents exposures exceeding $50 million in absolute values: Net exposure as of December 31, 2023 Liability/Asset (U.S. $ in millions) CHF/EUR 406 GBP/EUR 324 USD/EUR 279 BGN/EUR 247 USD/JPY 220 PLN/EUR 199 GBP/USD 167 EUR/RUB 140 INR/USD 101 USD/PLN 65 USD/MXN 58 Outstanding Foreign Exchange Hedging Transactions As of December 31, 2023, we had outstanding derivatives, primarily forwards and currency option contracts, with a corresponding notional amount of approximately $2.5 billion and $0.2 billion, respectively.
To the extent possible, the hedging activity is carried out on a consolidated level. 87 Table of Contents The table below presents exposures exceeding $50 million in absolute values: Net exposure as of December 31, 2024 Liability/Asset (U.S. $ in millions) IL/USD 833 GBP/EUR 647 PLN/EUR 313 USD/JPY 287 CHF/EUR 269 BGN/EUR 202 EUR/RUB 167 INR/USD 149 EUR/USD 101 USD/PLN 82 EUR/CAD 81 USD/MXN 81 USD/CAD 54 Outstanding Foreign Exchange Hedging Transactions As of December 31, 2024, we had outstanding derivatives, primarily forwards and currency option contracts, with a corresponding notional amount of approximately $3.9 billion and $21 million, respectively.
The table below presents the aggregate outstanding debt by currencies and maturities as of December 31, 2023: Currency Total Amount Interest Rate Ranges 2024 2025 2026 2027 2028 2029 & thereafter (U.S. dollars in millions) Fixed Rate: USD 11,880 3.15 % 8.13 % 957 427 3,375 1,000 1,250 4,891 Euro 7,592 1.13 % 7.88 % 691 1,001 — 1,986 824 3,090 CHF 416 1.00 % 1.00 % — 416 — — — — USD convertible debentures* 23 0.25 % 0.25 % — — — — — — Variable Rate: Others 1 1.00 % 2.00 % — — — — — — Total: 19,912 $ 1,648 $ 1,843 $ 3,375 $ 2,986 $ 2,074 $ 7,961 Less debt issuance costs (80 ) Total: $ 19,833 * Classified under short-term debt. 86 Table of Contents 2034-12-312033-12-312026-12-312025-12-312024-12-31http://fasb.org/us-gaap/2023#IncomeLossFromContinuingOperationsBeforeIncomeTaxesMinorityInterestAndIncomeLossFromEquityMethodInvestmentshttp://fasb.org/us-gaap/2023#PropertyPlantAndEquipmentNethttp://fasb.org/us-gaap/2023#PropertyPlantAndEquipmentNethttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesNoncurrentTeva determines if an arrangement is a lease at inception.
The table below presents the aggregate outstanding debt by currencies and maturities as of December 31, 2024: Currency Total Amount Interest Rate Ranges 2025 2026 2027 2028 2029 2030 & thereafter (U.S. dollars in millions) Fixed Rate: USD 10,920 3.15 % 8.13 % 427 3,374 1,000 1,250 1,600 3,269 Euro 6,514 1.63 % 7.88 % 945 — 1,873 778 835 2,083 CHF 387 1.00 % 1.00 % 387 — — — — — USD convertible debentures* 23 0.25 % 0.25 % — — — — — — Variable Rate: Total: 17,844 $ 1,759 $ 3,374 $ 2,873 $ 2,028 $ 2,435 $ 5,352 Less debt issuance costs (61 ) Total: $ 17,783 * Classified under short-term debt. 89 Table of Contents http://fasb.org/us-gaap/2024#IncomeLossFromContinuingOperationsBeforeIncomeTaxesMinorityInterestAndIncomeLossFromEquityMethodInvestments2026-04-30http://www.tevapharm.com/20241231#IntangibleAssetsImpairmentshttp://fasb.org/us-gaap/2024#OperatingIncomeLosshttp://fasb.org/us-gaap/2024#OperatingIncomeLosshttp://fasb.org/us-gaap/2024#OperatingIncomeLoss2025-12-312026-12-312027-12-312034-12-312035-12-31http://fasb.org/us-gaap/2024#RevenueFromContractWithCustomerExcludingAssessedTaxhttp://fasb.org/us-gaap/2024#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesNoncurrenthttp://fasb.org/us-gaap/2024#PropertyPlantAndEquipmentNethttp://fasb.org/us-gaap/2024#PropertyPlantAndEquipmentNethttp://fasb.org/us-gaap/2024#LiabilitiesCurrenthttp://fasb.org/us-gaap/2024#LiabilitiesCurrenthttp://fasb.org/us-gaap/2024#Liabilitieshttp://www.tevapharm.com/20241231#ImpairmentsRestructuringAndOthershttp://www.tevapharm.com/20241231#ImpairmentsRestructuringAndOthershttp://www.tevapharm.com/20241231#ImpairmentsRestructuringAndOthershttp://fasb.org/us-gaap/2024#OtherAssetsCurrenthttp://fasb.org/us-gaap/2024#OtherAssetsCurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesCurrenthttp://fasb.org/us-gaap/2024#OtherLiabilitiesCurrent
Removed
Lease classification is governed by five criteria in ASC 842-10-25-2. If any of these five criteria is met, Teva classifies the lease as a finance lease. Otherwise, Teva classifies the lease as an operating lease.
Removed
When determining lease classification, Teva’s approach in assessing two of the mentioned criteria is: (i) generally, 75% or more of the remaining economic life of the underlying asset is a major part of the remaining economic life of that underlying asset; and (ii) generally, 90% or more of the fair value of the underlying asset comprises substantially all of the fair value of the underlying asset.http://fasb.org/us-gaap/2023#RevenueFromContractWithCustomerExcludingAssessedTax2026-04-30http://fasb.org/us-gaap/2023#LiabilitiesCurrenthttp://fasb.org/us-gaap/2023#LiabilitiesCurrenthttp://fasb.org/us-gaap/2023#Liabilitieshttp://www.tevapharm.com/20231231#ImpairmentsRestructuringAndOthershttp://fasb.org/us-gaap/2023#OtherAssetsCurrenthttp://fasb.org/us-gaap/2023#OtherLiabilitiesCurrent

Other TEVA 10-K year-over-year comparisons