☒ | ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Israel |
Not A ble | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered | ||
American Depositary Shares, each representing one Ordinary Share |
TEVA |
New York Stock Exchange |
Large accelerated filer |
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Accelerated filer |
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Non-accelerated filer |
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Smaller reporting company |
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Emerging growth company |
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TABLE OF CONTENTS
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PART I | ||||||
Item 1. |
2 | |||||
Item 1A. |
27 | |||||
Item 1B. |
52 | |||||
Item 2. |
52 | |||||
Item 3. |
53 | |||||
Item 4. |
53 | |||||
PART II | ||||||
Item 5. |
Market for the Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 53 | ||||
Item 6. |
54 | |||||
Item 7. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
55 | ||||
Item 7A. |
83 | |||||
Item 8. |
86 | |||||
Item 9. |
Changes in and Disagreements with Accountants on Accounting and Financial Disclosure |
170 | ||||
Item 9A. |
170 | |||||
Item 9B. |
171 | |||||
Item 9C. |
Disclosure Regarding Foreign Jurisdictions that Prevent Inspections (Not Applicable) |
171 | ||||
PART III | ||||||
Item 10. |
171 | |||||
Item 11. |
171 | |||||
Item 12. |
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 171 | ||||
Item 13. |
Certain Relationships and Related Transactions, and Director Independence |
172 | ||||
Item 14. |
172 | |||||
PART IV | ||||||
Item 15. |
173 | |||||
Item 16. |
178 |
INTRODUCTION AND USE OF CERTAIN TERMS
Unless otherwise indicated, all references to the “Company,” “we,” “our” and “Teva” refer to Teva Pharmaceutical Industries Limited and its subsidiaries, and references to “revenues” refer to net revenues. References to “U.S. dollars,” “dollars,” “U.S. $” and “$” are to the lawful currency of the United States of America, and references to “NIS” are to new Israeli shekels. References to “ADS(s)” are to Teva’s American Depositary Share(s). References to “MS” are to multiple sclerosis. Market data, including both sales and share data, is based on information provided by IQVIA, a provider of market research to the pharmaceutical industry (“IQVIA”), unless otherwise stated. References to “R&D” are to Research and Development, references to “IPR&D” are to in-process R&D, references to “S&M” are to Selling and Marketing and references to “G&A” are to General and Administrative. Some amounts in this report may not add up due to rounding. All percentages have been calculated using unrounded amounts. This report on Form 10-K contains many of the trademarks and trade names used by Teva in the United States and internationally to distinguish its products and services. Any third-party trademarks mentioned in this report are the property of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND RISK FACTOR SUMMARY
In addition to historical information, this Annual Report on Form 10-K, and the reports and documents incorporated by reference in this Annual Report on Form 10-K, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to:
• | our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; concentration of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our innovative medicines, including AUSTEDO®, AJOVY® and COPAXONE®; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights; |
• | our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us; |
• | our business and operations in general, including: the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto; the widespread outbreak of an illness or any other communicable disease, or any other public health crisis; effectiveness of our optimization efforts; our ability to attract, hire, integrate and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or |
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to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets; |
• | compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and any delay in our ability to obtain sufficient participation of plaintiffs for the nationwide settlement of our opioid-related litigation in the United States; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice (“DOJ”) criminal charges of Sherman Act violations; potential liability for intellectual property right infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption, sanctions and trade control laws; environmental risks; and the impact of Environmental, Social and Governance (“ESG”) issues; |
• | other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our long-lived assets; the impact of geopolitical conflicts including the ongoing conflict between Russia and Ukraine; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business; |
and other factors discussed in this Annual Report on Form 10-K, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.
PART I
ITEM 1. BUSINESS
Business Overview
We are a global pharmaceutical company, committed to helping patients around the world to access affordable medicines and benefit from innovations to improve their health. Our mission is to be a global leader in generics, innovative medicines and biopharmaceuticals, improving the lives of patients.
We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Our key strengths include our world-leading generic medicines expertise and portfolio, focused innovative medicines portfolio and global infrastructure and scale.
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. Each business segment manages our entire product portfolio in its region, including generics, which includes biosimilars and over-the-counter (“OTC”) products, as well as innovative medicines. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.
In addition to these three segments, we have other activities, primarily the sale of active pharmaceutical ingredients (“API”) to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis.
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For information regarding our major customers, see note 19 to our consolidated financial statements.
Below is an overview of our three business segments.
North America
Our North America segment includes the United States and Canada.
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. Most of our generic sales in the United States are made to retail drug chains, mail order distributors and wholesalers.
Our wholesale and retail selling efforts are supported by participation in key pharmaceutical conferences as well as focused advertising in professional journals and on leading pharmacy websites. We continue to strengthen consumer awareness of the benefits of generic medicines through partnerships and digital marketing programs.
Our innovative medicines portfolio in North America focuses on three main areas: central nervous system (“CNS”), respiratory and oncology.
Our CNS portfolio includes AJOVY® for the preventive treatment of migraine in adults, AUSTEDO® for the treatment of neurodegenerative and movement disorders – chorea associated with Huntington’s disease and tardive dyskinesia and COPAXONE®, for the treatment of multiple sclerosis (“MS”). In April 2022, the FDA issued a Complete Response Letter (“CRL”) regarding the new drug application (“NDA”) for risperidone LAI, and in October 2022, we resubmitted the NDA. The FDA accepted our NDA and we await the FDA’s response.
We are committed to maintaining a significant presence in the respiratory business by delivering a range of medicines for the treatment of asthma and chronic obstructive pulmonary disease (“COPD”), including QVAR®, ProAir® Digihaler® and CINQAIR®.
We maintain a meaningful presence in oncology medicines, including both innovative and generic medicines (including biosimilars). In 2019, we launched Truxima®, our first oncology biosimilar product in the United States. BENDEKA® is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride that we licensed from Eagle Pharmaceuticals, Inc. (“Eagle”).
Anda, our distribution business in the United States, distributes generic, innovative and OTC pharmaceutical products from various third-party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda is able to compete in the secondary distribution market by maintaining high inventory levels for a broad offering of products, competitive pricing and offering next day 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. 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.
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Despite their diversity and highly fragmented nature, the European markets share many characteristics that allow us to leverage our pan-European presence and broad portfolio. Global customers are important partners in our generic business and are expanding across Europe, although customer consolidation is lower than in the United States. 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.
Our OTC portfolio in Europe includes global brands such as SUDOCREM® as well as local and regional brands such as NasenDuo®, DICLOX FORTE®, OLFEN® Max and FLEGAMINA®.
Our innovative medicines portfolio in Europe focuses on three main areas: CNS (including migraine), respiratory and oncology. Our leading product, COPAXONE, continues to be among the leading products for the treatment of MS, though new treatments are being introduced to various markets in Europe. AJOVY was granted EU marketing authorization in 2019 and, as of December 31, 2022, we have launched AJOVY in most European countries and we are planning to launch AJOVY in other European countries.
International Markets
Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical industry.
The countries in our International Markets segment include highly regulated, pure generic markets, such as Israel, branded generics-oriented markets, such as Russia and certain Latin America markets, and hybrid markets, such as Japan. Each market’s strategy is built upon differentiation and filling the unmet needs of that market. Our integrated sales force enables us to extract synergies across our branded generic, OTC and innovative medicines product offerings and across various channels (e.g., retail, institutional).
In Japan, one of our key markets within our International Markets segment, we operate a majority of our business through a business venture with Takeda Pharmaceutical Companies Limited (“Takeda”), in which we own a 51% stake and Takeda owns the remaining 49%. On February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.
Our innovative medicines portfolio in our International Markets segment focuses on three main areas: CNS, respiratory and oncology. By the end of 2022, we launched AJOVY in certain countries within our International Markets segment, such as Australia, Israel, South Korea, Brazil and others. AUSTEDO was launched in China in 2021 and in Brazil in 2022.
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 global marketing and portfolio function optimizes our pipeline and product lifecycle across therapeutic areas. In most markets in which we operate, we use an integrated and comprehensive marketing model, offering a broad portfolio of products, including innovative medicines, generic products, biosimilars and OTC products.
Generic Medicines
Generic medicines are the chemical and therapeutic equivalents of originator medicines and are typically more affordable in comparison to the originator’s products. 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
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prior to their sale in any given country. Generic medicines may be manufactured and marketed if relevant patents on their brand-name equivalents (and any additional government-mandated market exclusivity periods) have expired or have been challenged or otherwise circumvented.
We develop, manufacture and sell generic medicines in a variety of dosage forms, including tablets, capsules, injectables, inhalants, liquids, transdermal patches, ointments and creams. 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 have a top three leadership position in many countries, including the United States and some key European markets. We have a robust product portfolio, comprehensive R&D capabilities and product pipeline and a global operational network, which enables us to execute key generic launches to further expand our product pipeline and diversify our revenue stream. We use these capabilities to help overcome price erosion in our generics business.
When considering whether to develop a generic medicine, we take into account a number of factors, including our overall strategy, regional and local patient and customer needs, R&D and manufacturing capabilities, regulatory considerations, commercial factors and the intellectual property landscape. We will challenge patents when appropriate if we believe they are either invalid or would not be infringed by our generic version. We may seek alliances to acquire rights to products we do not have in our portfolio, to share development costs or litigation risks, or to resolve patent and regulatory barriers to entry.
We have been optimizing our global generics portfolio, particularly in the United States, through product discontinuation and price adjustments, with a focus on increasing profitability. This resulted in the restructuring and optimization of our generics business, including our manufacturing and supply network, and the closure or divestment of a significant number of manufacturing plants around the world. We are continuing our ongoing efforts regarding network consolidation activities and optimization of our global generics portfolio.
In markets such as the United States, the United Kingdom, Canada, the Netherlands and Israel, generic medicines may be substituted by the pharmacist for their brand name equivalent or prescribed by International Nonproprietary Name (“INN”). In these so-called “pure generic” markets, physicians and patients have little control over the choice of generic manufacturer, and consequently generic medicines are not actively marketed or promoted to physicians or consumers. Instead, the relationship between the manufacturer and pharmacy chains and distributors, health funds and other health insurers is critical. Many of these markets have automatic substitution models when generics are available as alternatives to brands. In Russia, Turkey, Ukraine, Kazakhstan and certain Latin American and European countries, generic medicines are generally sold under brand names alongside the originator brand. These markets are referred to as “branded generic” markets and in certain cases are “out of pocket” markets in which consumers can pay for a particular branded generic medicine (as opposed to government or privately funded medical health insurance), often at the recommendation of their physician. Branded generic products are actively promoted and a sales force is necessary to create and maintain brand awareness. Other markets, such as Germany, Japan, France, Italy and Spain, are hybrid markets with elements of both approaches.
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.
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.”
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Biologic medicines are large and complex medicines produced by or made from living cells or organisms, often produced using cutting-edge biotechnological methods. Biosimilars are highly similar to the reference biologic, in both structure and function (e.g., pharmacodynamics, pharmacokinetics, safety, efficacy and immunogenicity) and, for any approved uses, have no clinically meaningful differences from the reference product in terms of safety, purity, and potency.
In November 2019 and February 2020, we launched Truxima® (rituximab-abbs), a biosimilar to Rituxan® (rituximab), in the United States and in Canada, respectively. It is our first oncology biosimilar product in the United States and is the first rituximab biosimilar to be approved in the United States.
In January 2020 and March 2020, we launched Herzuma® (trastuzumab-pkrb), a biosimilar to Herceptin® (trastuzumab), in Canada and the United States, respectively.
During the third quarter of 2022, the European Commission granted a marketing authorization for Ranivisio® (ranibizumab), a biosimilar to Lucentis®, which was also launched in the United Kingdom during the third quarter of 2022, as ONGAVIA®. We are moving forward with plans to launch in other countries in the European Union.
For information on our biosimilar products pipeline, see “—Research and Development” below.
Innovative Medicines
Our innovative medicines business, previously referred to as our specialty 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). We also have innovative medicines in 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.
The U.S. market is the most significant market in our innovative medicines business. In Europe and International Markets, we leverage existing synergies between our innovative medicines business and our generics and OTC businesses. Our innovative medicines presence in International Markets is mainly built on our CNS, respiratory and oncology medicines.
We have built specialized “Patient Support Programs” to help patients adhere to their treatments, improve patient outcomes and, in certain markets, to ensure timely delivery of medicines and assist in securing reimbursement. These programs reflect the importance we place on supporting patients and ensuring better medical outcomes for them. 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.
Below is a description of our key innovative medicines:
CNS (including Movement Disorders and Migraine)
Our CNS portfolio includes AJOVY for the preventive treatment of migraine, AUSTEDO for the treatment of tardive dyskinesia and chorea associated with Huntington’s disease and COPAXONE for the treatment of relapsing forms of MS.
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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 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 Japan in August 2021. By the end of 2022, we launched AJOVY in most European countries and in certain International Markets countries, such as Australia, Israel, South Korea, Brazil and others. We are moving forward with plans to launch in other countries around the world. |
• | Our auto-injector device for AJOVY became commercially available in the U.S. in April 2020 and in Canada in April 2021. We have also received approval from the EMA for AJOVY’s auto-injector submission in the European Union in October 2019, and we commenced launch in March 2020. |
• | AJOVY is the only anti-CGRP subcutaneous product indicated for quarterly treatment. |
• | AJOVY is protected by patents expiring in 2026 in Europe and in 2027 in the United States. Applications for patent term extensions have been submitted in various markets around the world, and certain extensions in Europe and other countries have already been granted until 2031. Additional patents relating to the use of AJOVY in the treatment of migraine have also been issued in the United States and will expire between 2035 and 2039. Such patents are also pending in other countries. AJOVY will also be protected by regulatory exclusivity for 12 years from marketing approval in the United States and 10 years from marketing approval in Europe. |
• | We filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.’s (“Lilly”) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents, including three method of treatment patents and six composition of matter patents. Lilly then submitted inter partes review (“IPR”) petitions to the Patent Trial and Appeal Board (“PTAB”), challenging the validity of the nine Teva patents. The PTAB issued decisions upholding the three method of treatment patents but finding the six composition of matter patents invalid, which decisions were affirmed by the Court of Appeals for the Federal Circuit on August 16, 2021. A jury trial regarding the three method of treatment patents began on October 18, 2022, and on November 9, 2022, the jury issued a verdict in Teva’s favor, finding the three method of treatment patents valid and infringed by Lilly and awarding Teva $176.5 million in damages. On January 28, 2023, Lilly filed a motion requesting that the District Court overturn the jury’s verdict. Once the motion is decided, the losing party may appeal the decision to the Court of Appeals for the Federal Circuit. On June 8, 2021, we filed another lawsuit against Lilly in the U.S. District Court for the District of Massachusetts alleging that Lilly’s marketing and sale of galcanezumab product infringes three patents related to the treatment of refractory migraine. Lilly’s IPR petitions challenging the patentability of these three patents were instituted by the PTAB. The litigation in the District of Massachusetts was stayed during the pendency of these IPR proceedings. In addition, in 2018 we entered into separate agreements with Alder Biopharmaceuticals, Inc. and Lilly resolving the European Patent Office oppositions that they filed against our AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom. |
AUSTEDO
• | AUSTEDO (deutetrabenazine) is a deuterated form of a small molecule inhibitor of vesicular monoamine 2 transporter, or VMAT2, that is designed to regulate the levels of a specific neurotransmitter, dopamine, in the brain. The FDA granted deutetrabenazine New Chemical Entity exclusivity until April 2022 and Orphan Drug exclusivity for the treatment of chorea associated with Huntington’s disease until April 2024. |
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• | AUSTEDO was launched in the U.S. in 2017. 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 in early 2021, and was also launched in Israel during 2021. In August 2022, AUSTEDO was launched in Brazil. We continue with additional submissions in various other countries around the world. |
• | AUSTEDO is protected in the United States by nine Orange Book patents expiring between 2031 and 2038 and in Europe by two patents expiring in 2029. We received notice letters from two ANDA filers regarding the filing of their ANDAs with paragraph (IV) certifications for certain of the patents listed in the Orange Book for AUSTEDO. On July 1, 2021, we sued two generic ANDA filers, Aurobindo and Lupin, in the U.S. District Court for the District of New Jersey. In addition, Apotex filed a petition for IPR by the PTAB of the patent covering the deutetrabenazine compound that expires in 2031. On March 9, 2022, the U.S. Patent and Trademark Office denied Apotex’s petition and declined to institute a review of the deutetrabenazine patent. On April 29, 2022 and June 8, 2022, we reached agreements with Lupin and Aurobindo, respectively, to sell their generic products beginning April 2033, or earlier under certain circumstances. There are no further patent litigations pending regarding AUSTEDO. |
COPAXONE
• | COPAXONE (glatiramer acetate injection) continues to play an important role in the treatment of MS in the United States (according to IQVIA data as of late 2022). 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 provides a proven mix of efficacy, safety and tolerability. |
• | One European patent protecting COPAXONE 40 mg/mL was found invalid by the Board of Appeal of the European Patent Office in September 2020 and two additional patents expiring in 2030 were found invalid in December 2021. In certain countries, Teva remains in litigation against generic companies on an additional COPAXONE 40 mg/mL patent that expires in 2030. |
• | In December 2018, Teva sued Pharmascience regarding its application to sell a generic version of COPAXONE in Canada. In December 2020, the Canadian Federal Court issued a decision finding the 2028 method of use patent invalid and the 2030 dosing regimen patent valid and infringed. In January 2022, the Canadian Federal Court of Appeals affirmed Teva’s victory against Pharmascience on the 2030 dosing regimen patent. Pharmascience’s appeal to the Supreme Court of Canada was dismissed on September 29, 2022. Then on October 28, 2022, the Re-examination Board, in a decision resolving the re-examination proceeding initiated by Pharmascience at the Canadian Patent office, upheld the validity of the 2030 dosing regimen patent and allowed a number of additional claims. We previously settled our Canadian litigation with Sandoz regarding their application for a generic version of COPAXONE in Canada. Additionally, a case against Mylan with respect to its Canadian application for a generic version of COPAXONE was stayed pending the outcome of the Pharmascience appeal and the action has been discontinued. |
• | The market for MS treatments continues to develop, particularly with generic versions of COPAXONE. Oral treatments for MS, such as Tecfidera®, Gilenya® and Aubagio®, continue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies, such as Ocrevus® and Kesimpta®. |
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Oncology
Our innovative oncology medicines portfolio includes BENDEKA and TREANDA®, GRANIX® and TRISENOX® in the United States and LONQUEX®, TEVAGRASTIM®/RATIOGRASTIM® and TRISENOX outside the United States.
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. We launched BENDEKA in the United States in January 2016. It is a liquid, low-volume (50 mL) and short-time 10-minute infusion formulation of bendamustine hydrochloride that we licensed from Eagle. |
• | BENDEKA faces direct competition from Belrapzo® (a ready-to-dilute bendamustine hydrochloride product from Eagle). 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. |
• | In April 2019, we signed an amendment to the license agreement with Eagle extending the royalty term applicable to the United States to the full period for which we sell BENDEKA and increased the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses. |
• | There are 16 patents listed in the U.S. Orange Book for BENDEKA with expiry dates in 2026 and 2031. In September 2019, a patent infringement action against four of six ANDA filers for generic versions of BENDEKA was tried in the U.S. District Court for the District of Delaware. On April 27, 2020, the district court upheld the validity of all of the asserted patents and found that all four ANDA filers infringe at least one of the patents. Three of the four ANDA filers appealed the district court decision. Teva settled with one of the three ANDA filers, and on August 13, 2021, the Federal Circuit issued a Rule 36 affirmance of the district court decision. On December 14, 2021, Apotex filed a Petition for a Writ of Certiorari with the U.S. Supreme Court, which was denied. Litigation against the fifth ANDA filer was dismissed after the withdrawal of its patent challenge, and the case against a sixth ANDA filer was also settled. |
• | Additionally, in July 2018, Teva and Eagle filed suit against Hospira, Inc. (“Hospira”) related to its 505(b)(2) NDA referencing BENDEKA in the U.S. District Court for the District of Delaware. On December 16, 2019, the district court dismissed the case against Hospira on all but one of the asserted patents, which expires in 2031. On April 18, 2022, Teva and Eagle settled this matter, allowing Hospira to launch its product on January 17, 2028 or earlier under certain circumstances. Teva had also filed suit against two other 505(b)(2) NDA filers, Doctor Reddy’s Laboratories (“DRL”) and Accord Healthcare (“Accord”). On December 10, 2022, Teva and Eagle settled with Accord, allowing Accord to launch its product on January 17, 2028 or earlier under certain circumstances. A trial against the remaining 505(b)(2) NDA filer, DRL, is set to begin in May 2023. |
• | 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. The orphan drug exclusivity that had attached to bendamustine products expired in December 2022. To-date we are aware of one generic TREANDA product on the market. |
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Respiratory
Our respiratory portfolio includes our legacy products, as well as our new digital inhalers with built-in sensors: ProAir Digihaler, AirDuo® Digihaler and ArmonAir® Digihaler. Our portfolio also includes ProAir RespiClick®, QVAR, BRALTUS®, CINQAIR/CINQAERO®, DuoResp® Spiromax® and AirDuo® RespiClick®/ ArmonAir® RespiClick.
We are committed to maintaining a leading presence in the respiratory market by delivering a range of medicines for the treatment of asthma and COPD. Our portfolio is centered on optimizing respiratory treatment for patients and healthcare providers through the development and commercialization of innovative delivery systems and therapies that help address unmet needs.
The key areas of focus for our respiratory R&D are the development of differentiated respiratory therapies for patients using innovative delivery systems to deliver chemical and biological therapies. Our device strategy is intended to result in “device consistency,” allowing physicians to choose the device that best matches a patient’s needs both in terms of ease of use and effectiveness of delivery of the prescribed molecule, and includes three main types of devices: (i) Digihaler, which captures and shares objective inhaler use data; (ii) a breath-actuated inhaler (“BAI”) used in QVAR RediHaler®; and (iii) RespiClick (U.S.) or Spiromax (EU), a novel inhalation-driven multi-dose dry powder inhaler (“MDPI”).
Our legacy products include ProAir RespiClick and QVAR:
• | ProAir RespiClick (albuterol sulfate) inhalation powder is a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist inhaler for the treatment or prevention of bronchospasm with reversible obstructive airway disease and for the prevention of exercise-induced bronchospasm in patients four years of age and older. |
• | QVAR (beclomethasone dipropionate HFA) is indicated as a maintenance treatment for asthma as a prophylactic therapy in patients five years of age or older. QVAR is also indicated for asthma patients who require systemic corticosteroid administration, where adding QVAR may reduce or eliminate the need for systemic corticosteroids. Three generic manufacturers have filed ANDAs for the metered-dose inhaler (“MDI”) presentation of QVAR. Teva filed suit against two of those ANDA filers in the U.S. District Court for the District of New Jersey. A settlement was reached with one of those two filers on December 5, 2022, and a trial was held against the other during November 2022. A decision is expected in the first half of 2023. |
• | QVAR RediHaler (beclomethasone dipropionate HFA) inhalation aerosol, a BAI, is indicated for the maintenance treatment of asthma as a prophylactic therapy in patients four years of age and older. |
Our Digihaler portfolio is the first and only family of smart inhalers with built-in sensors that automatically capture objective inhaler use data that may help health care professionals and patients make more informed treatment decisions that may improve health outcomes. Our Digihaler portfolio consists of:
• | ProAir Digihaler (albuterol sulfate 117 mcg) inhalation powder was launched in the U.S. in July 2020. Our rescue inhaler connects to a companion mobile application and provides inhaler use information for people with asthma and COPD. |
• | ArmonAir Digihaler (fluticasone propionate 113 mcg) inhalation powder was launched in the U.S. in September 2020. Our inhaled corticosteroid (“ICS”) maintenance inhaler connects to a companion mobile application and provides inhaler use information for people with asthma. |
• | AirDuo Digihaler (fluticasone propionate 113 mcg and salmeterol 14 mcg) inhalation powder was launched in the U.S. in September 2020. Our dual-ICS and long-acting beta agonist maintenance inhaler connects to a companion mobile application and provides inhaler use information for people with asthma. |
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Additional products in our respiratory portfolio include:
• | BRALTUS (tiotropium bromide) is a long-acting muscarinic antagonist, indicated for adult patients with COPD, delivered via the Zonda® inhaler. 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. |
• | AirDuo RespiClick (fluticasone propionate and salmeterol inhalation powder) (and its authorized generic) is a combination of an inhaled corticosteroid and a long acting beta-agonist bronchodilator, approved in the United States for the treatment of asthma in patients aged 12 years and older who are uncontrolled on an ICS or whose disease severity clearly warrants the use of an ICS/long-acting beta2-adrenergic agonist combination. |
For information on our innovative medicines pipeline, see “—Research and Development” below.
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.
We produce approximately 350 APIs for our own use and for sale to third parties in many therapeutic areas. APIs used in pharmaceutical products are subject to regulatory oversight by health authorities. We utilize a variety of production technologies, including chemical synthesis, semi-synthetic fermentation, enzymatic synthesis, high potency manufacturing, plant extract technology, peptide synthesis, vitamin D derivatives synthesis and prostaglandins synthesis. Our advanced technology and expertise in the field of solid state particle technology enable us to meet specifications for particle size distribution, bulk density, specific surface area and polymorphism, as well as other characteristics.
We provide contract manufacturing services related to products divested in connection with the sale of certain business lines, as well as other miscellaneous items. 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 generic medicines (finished goods and API), biosimilars, innovative medicines and OTC medicines.
All of our R&D activities are concentrated under one global group with overall responsibility for generics, biosimilars and innovative medicines, enabling better focus and efficiency.
A strong focus for Teva is the development of new generic medicines. We develop generic products for our North America, Europe and International Markets segments. Our focus is on developing complex formulations with complex technologies, which have higher barriers to entry. Generic R&D activities, which are carried out in development centers located around the world, include product formulation, analytical method development, stability testing, management of bioequivalence, bio-analytical studies, other clinical studies and registration of generic drugs in all of the markets where we operate. We also operate several clinics where most of our bioequivalent studies are performed as well as most of our phase 1 studies for innovative and biosimilar products. We have more than 1,200 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.
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In addition, our generic R&D supports our OTC business in developing OTC products, as well as in overseeing the work performed by contract developers.
Our current R&D capabilities include solid oral dosage forms (such as tablets and capsules), inhalation, semi-solid and liquid formulations (such as ointments and creams), sterile formulations and other dosage forms, and delivery systems, such as matrix systems, special coating systems for sustained release products, orally disintegrating systems, sterile systems, such as vials, syringes, blow-fill-seal systems, long-acting release injectable, transdermal patches, oral thin film, drug device combinations and nasal delivery systems. In addition, we are in the process of developing multiple AB-rated respiratory programs and devices for our long active injectable pipeline.
We pursue biosimilar pipeline projects in other therapeutic and disease areas that leverage our global R&D and commercial areas of expertise. Biosimilar development activities, such as analytical method development, testing for analytical biosimilarity, pre-clinical work, clinical studies and regulatory strategy, are conducted in Teva’s various global development sites.
Our innovative R&D product pipeline is focused on biologic and selected small molecule products. Innovative medicines development activities include preclinical assessment (including toxicology, pharmacokinetics, pharmacodynamics and pharmacology studies), clinical development (including pharmacology and the design, execution and analysis of global safety and efficacy trials), as well as regulatory strategy to deliver registration of our pipeline products. We develop novel innovative medicines in our core therapeutic and disease focus areas. We have neuroscience projects in areas such as migraine, movement disorders/neurodegeneration and neuropsychiatry. Our immunology projects are focused on respiratory medicines and include both novel compounds and delivery systems designed to address unmet patient needs.
Our API R&D division focuses on the development of processes and physical compound characterization for the manufacturing of APIs, including intermediates, synthetic and fermentation products, for both our generic and proprietary drugs. Our facilities in various locations worldwide include two large development centers focusing on synthetic products, three centers with specific expertise specializing in fermentation and semi-synthetic products, a center for oligonucleotides and peptides and centers for high-potency APIs. Our substantial investment in API R&D generates a steady flow of API products, supporting the timely introduction of generic products to market in compliance with increasing regulatory requirements. The API R&D division also seeks methods to continuously reduce API production costs, enabling us to improve our cost structure.
While our focus is on internal growth that leverages our R&D capabilities, we have entered into, and expect to pursue, in-licensing, acquisition and partnership opportunities to supplement and expand our existing innovative medicines and biosimilar pipeline (e.g., the transactions with Alvotech and Modag). In parallel, we evaluate and expand the development scope of our existing R&D pipeline products as well as our existing products for submission in additional markets.
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Innovative Medicines Pipeline
Below is a description of key products in our innovative medicines pipeline as of February 1, 2023:
Phase 2 |
Phase 3 |
Pre-Submission | Under Regulatory Review | |||||
Neuroscience | Deutetrabenazine Dyskinesia in Cerebral Palsy (September 2019) | Risperidone LAI Schizophrenia (1) | ||||||
Olanzapine LAI Schizophrenia (September 2022) | ||||||||
Immunology | TEV-48574 Inflammatory Bowel Disease |
|||||||
Other | Digihaler® (budesonide and formoterol fumarate dihydrate) (EU) | |||||||
Digihaler® (beclomethasone dipropionate HFA)(U.S.) |
(1) | Developed under a license agreement with MedinCell. In August 2021, the FDA accepted the NDA for risperidone LAI, based on phase 3 data from two pivotal studies. In April 2022, the FDA issued a CRL regarding the NDA for risperidone LAI and in October 2022, we resubmitted the NDA. The FDA accepted our NDA and we await the FDA’s response. |
During 2022, development of the following projects was discontinued:
• | TEV-53275 for respiratory; and |
• | fasinumab for the treatment of osteoarthritic pain. |
Biosimilar Products Pipeline
We have additional biosimilar products in development internally and with our partners that are in various stages of clinical trials and regulatory review worldwide, including phase 3 clinical trials for biosimilars to Prolia® (denosumab), Xolair® (omalizumab) and Eylea® (afilbercept), a biosimilar to Lucentis® (ranibizumab) that was submitted in Canada, and biosimilars to Stelara® (ustekinumab) and to Humira® (adalimumab), each of which are currently under U.S. regulatory review.
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; |
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• | 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 that allow us to deliver new products to our customers quickly and efficiently, providing a cost-effective, safe and reliable supply. |
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 39 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 2022, we produced approximately 75 billion tablets and capsules and approximately 600 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. We continue to strengthen our third-party operations unit to strategically work with our supplier base in order to meet cost, supply security and quality targets on a sustainable basis in alignment with our global procurement organization.
Our policy is to maintain multiple supply sources for APIs to appropriately mitigate risk in our supply chain to the extent possible. However, our ability to do so may be limited by regulatory and other requirements.
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.
Raw Materials for Pharmaceutical Production
In general, we purchase our raw materials and supplies required for the production of our products in the open market. For some products, we purchase such raw materials and supplies from one source (the only source available to us) or a single source (the only approved source among many available to us), thereby requiring us to obtain such raw materials and supplies from that particular source. We mitigate, where possible, our raw material supply risks through inventory management and alternative sourcing strategies. See also “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Macroeconomic Environment.”
We source a large portion of our APIs from our own manufacturing facilities. Additional APIs are purchased from suppliers located in Europe, Asia and the Americas. We have implemented a supplier audit program to ensure that our suppliers meet our high standards and are able to fulfill the requirements of our global operations.
We currently have 14 API production facilities, producing approximately 350 APIs in various therapeutic areas. Our API intellectual property portfolio includes hundreds of granted patents and pending applications.
We have expertise in a variety of production technologies, including chemical synthesis, semi-synthetic fermentation, enzymatic synthesis, high-potency manufacturing, plant extract technology, peptides synthesis,
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vitamin D derivatives synthesis and prostaglandins synthesis. Our advanced technology and expertise in the field of solid state particle technology enable us to meet specifications for particle size distribution, bulk density, specific surface area and polymorphism, as well as other characteristics.
Our API facilities are required to comply with applicable cGMP requirements under U.S., European, Japanese and other applicable quality standards. Our API plants are regularly inspected by the FDA, European agencies and other authorities, as applicable.
Patents and Other Intellectual Property Rights
We rely on a combination of patents, trademarks, copyrights, trade secrets and other proprietary know-how and regulatory exclusivities, as well as contractual protections, to establish and protect our intellectual property rights. We own or license numerous patents covering our products in the United States and other countries. We have also developed many brand names and own many trademarks covering our products. We consider the overall protection of our intellectual property rights to be of material value and act to protect these rights from infringement. We license or assign certain intellectual property rights to third parties in connection with certain business transactions.
Environment, Health and Safety
We are committed to business practices that promote socially and environmentally responsible economic growth. During 2022, we continued to make significant progress on our ESG strategy.
On Environment, Health and Safety (“EHS”), among other things, in 2022:
• | 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; and |
• | continued to promote climate change mitigation and adaptation strategy according to international standards. |
Please see the section entitled “Environmental” from Teva’s 2021 ESG Progress Report (which is located on our website) for more detailed information regarding our environmental goals and activities. Nothing on our website, including Teva’s 2021 ESG Progress Report or sections thereof, shall be deemed incorporated by reference into this Annual Report or any other filing with the U.S. Securities and Exchange Commission.
Quality
We are committed not only to complying with quality requirements but to developing and leveraging quality as a competitive advantage. In 2022, we completed numerous inspections by various regulatory agencies of our finished dosage pharmaceutical and API plants and we actively engaged in discussions with authorities to mitigate drug shortages and participated in several industry-wide task forces. We continue to focus on maintaining a solid and sustainable quality compliance foundation, as well as making quality a priority to foster continuous compliance. We seek to ensure that quality is an embedded part of our corporate culture and is reflected in all of our daily operations, delivering reliable and high quality products.
For information regarding significant regulatory events, see note 15 to our consolidated financial statements.
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Competition
Sales of generic medicines have benefitted from increasing awareness and acceptance on the part of healthcare insurers and institutions, consumers, physicians and pharmacists around the world. Factors contributing to this increased awareness are the passage of legislation permitting or encouraging generic substitution and the publication by regulatory authorities of lists of equivalent pharmaceuticals, which provide physicians and pharmacists with generic alternatives. In addition, various government agencies and many private managed care or insurance programs encourage the substitution of brand-name pharmaceuticals with generic products as a cost-savings measure in the purchase of, or reimbursement for, prescription pharmaceuticals.
In the United States, we are subject to competition in the generic drug market from domestic and international generic drug manufacturers and brand-name pharmaceutical companies through introduction of next-generation medicines, authorized generics, existing brand equivalents and manufacturers of therapeutically similar drugs. An increase in FDA approvals for existing generic products is increasing the competition on our base generic products. Price competition from additional generic versions of the same product typically results in margin pressures, which is causing some generics companies to increase focus on portfolio efficiency.
The European market continues to be even more competitive, especially in terms of pricing, higher quality standards, customer service and portfolio relevance. 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.
In our International Markets, our global scale and broad portfolio give us a significant 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. 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.
The biosimilars business is also highly competitive and continues to evolve as intellectual property protections for biological products continue to expire in the United States. While we believe that our biologics knowledge and experience provide us with competitive advantages, we anticipate significant competition in the biosimilar space. Risks related to commercialization of our prospective biosimilars include the number of competitors, potential for steeper than anticipated price erosion, and intellectual property challenges that may impact timely commercialization. There is also a risk of lower or slower uptake due to various factors that may differ among biosimilars such as competitive practices, physician hesitancy to prescribe biosimilars for certain therapeutic areas, and level of financial incentives (payer or government). 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. Our innovative medicines business may continue to be affected by price reforms and changes in the political landscape, following recent public debate in the United States. 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.
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Human Capital Management
Our People
Our employees are the heart of our Company. In the highly competitive pharmaceutical industry, it is imperative that we attract, develop and retain top talent on an ongoing basis. To do this, we seek to make Teva an inclusive, diverse and safe workplace, with meaningful compensation, benefits and wellbeing programs, and we offer training and leadership development programs that foster career growth.
Oversight
Our Human Resources and Compensation Committee, Compliance Committee and Board play key roles in overseeing culture and talent at Teva and devote time throughout the year to human capital strategy and execution in such areas as: inclusion and diversity, Company culture, employee engagement, training and development, recruiting and turnover, leadership development and succession planning. Management regularly updates the Board on internal metrics in these areas.
Employees
As of December 31, 2022, Teva’s global workforce consisted of 36,826 employees. In 2022, the size of our global workforce continued to contract modestly as we continued our focus on network consolidation activities.
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.
The following table presents our workforce headcount by employment type:
December 31, | ||||||||||||
2022 | 2021 | 2020 | ||||||||||
Full-time |
34,004 | 34,713 | 37,100 | |||||||||
Part-time |
1,121 | 1,266 | 1,272 | |||||||||
Contractor |
1,701 | 1,558 | 1,844 | |||||||||
Total |
36,826 | 37,537 | 40,216 | |||||||||
Total full time equivalent |
36,520 | 37,037 | 39,717 |
The following table presents our workforce headcount by geographic area (excluding contractors):
December 31, | ||||||||||||
2022 | 2021 | 2020 | ||||||||||
North America |
6,099 | 6,302 | 6,918 | |||||||||
Europe |
17,834 | 18,122 | 18,569 | |||||||||
International Markets (excluding Israel) |
7,952 | 7,955 | 9,210 | |||||||||
Israel |
3,240 | 3,600 | 3,675 | |||||||||
Total (excluding contractors) |
35,125 | 35,979 | 38,372 |
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. Recently, we have been monitoring our turnover rates even more closely due to the current labor market dynamics and the increased external competition for talent observed globally.
Inclusion and Diversity
Inclusion and diversity are essential to our ability to innovate and to grow our business. We strive to create and sustain an inclusive and diverse work environment.
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Teva’s Position on Inclusion and Diversity outlines our commitment to establishing a comfortable, open environment across all business units, for all employees. Our Inclusion and Diversity (“I&D”) framework, governed by our I&D task force, provides a foundation for embedding I&D across our business. Our dedicated global I&D lead is responsible for the execution of the global I&D framework, including strategy and initiatives, partnerships and alignment of activities across regions and business units.
We are committed to pay equity at all levels and we conduct equitable pay research and report our findings annually in our Progress ESG Report. For example, in 2021, the most recent year for which findings are available, we conducted comprehensive equitable pay research among 100% of our employees, and found that among those in the same level, function/profession and location, we pay our women employees an average of 1% more than our male employees in terms of annual base salaries.
In addition, we support recruitment, development and retention of individuals with diverse backgrounds. Our I&D task force 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, sponsorship, and training, among other things. For instance, we developed a global mentoring program for women, aimed at advancing women to senior leadership positions. In addition, in January 2022, we launched the Catalyst program, a group of senior leaders tasked with establishing a plan to support the progression of women to senior leadership roles.
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. These ERGs foster opportunities for networking, mentoring, collaboration, community outreach, career development, leadership training and cultural exchanges. Currently, our ERGs include groups for women, men, Black Heritage, Latinx, Asian Pacific Americans, Abilities (individuals with disabilities), Veterans, LGBTQ+, Working Families, and MERGE (multigenerational).
In Israel, we partnered with Co-Impact, a non-governmental organization focused on supporting employment among the Arab community. We developed a website in Arabic to support recruiting and videos to increase awareness about Teva and our efforts to promote I&D among potential candidates.
In addition, we provided mandatory training for all employees globally on fostering inclusive behavior, and we include an inclusive leadership module in all Teva global leadership development programs.
The following table presents percentage of our global employee population identifying as female and male, as of December 31, 2022:
Female | Male | |||||||
Total employees |
46 | % | 54 | % | ||||
Managers |
48 | % | 52 | % | ||||
Senior management |
27 | % | 73 | % |
Health and Safety
The health and safety of our employees is critical to our ability to supply medicines to our patients. 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.
As our employees and communities continued to face the impact of the COVID-19 pandemic, protecting our employees remained our priority. We maintained and adapted global and country-level governance processes established at the start of the pandemic and implemented safety and wellbeing measures in line with public health
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best practices. In addition to keeping our employees safe, this allowed for the development, production and distribution of medicines across our supply chains to remain largely uninterrupted.
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.
We maintain a range of learning resources to support employees of all levels in developing skills and contributing to Teva’s strategy, ultimately driving business performance. Much of our employee training is in-role, amplified by global online training and locally-tailored training modules to meet different challenges, help gain new leadership and essential skills and ensure compliance with our policies.
Our Teva Grow program for employees provides development in essential soft skills, success in a global setting and company knowledge. We also provide an extensive catalog of lessons from an online learning platform. For Teva managers, we refreshed our development programs to develop the skills, capabilities and mindset required of managers, taking into account the challenges of a disruptive environment and the importance of maintaining the wellbeing of our employees.
We focus on succession planning through global and local talent review processes that identify and accelerate successors’ readiness to fill senior positions across Teva. In order to measure our success at promoting talent from inside our organization, we track the proportion of positions filled with internal candidates and other related statistics.
Compensation, Benefits and Wellbeing
We provide competitive compensation, health and retirement programs for our employees. We offer variable pay in the form of bonuses and stock-based compensation for eligible employees and have one global annual bonus plan.
In 2022, we began implementing our wellbeing strategy globally. In addition to having our first global wellbeing month dedicated to raising awareness of the importance of wellbeing, we leveraged practical tools and local programs to address the physical, financial, social and mental health needs of our employees and their families. We offer programs and initiatives that promote healthy diet, physical activity and mental wellbeing. For example, our organizations in many countries introduced or expanded employee assistance programs to cover psychological support and counseling for employees and their families and we included wellbeing as part of our managerial training programs.
During 2022, as the COVID-19 pandemic evolved and it became appropriate and safe again to work in the office in various countries, we continued the rollout of our updated remote work policy, allowing relevant employees to work remotely in accordance with certain parameters.
Employee Engagement and Satisfaction
To understand whether our human capital strategies are effective and are resonating with our employees, and where we can improve, we conduct an annual employee survey. In 2022, we achieved an 83% response rate. Results of the survey show that employee engagement levels have remained high and steady. Employees feel connected with Teva’s mission and values, are confident in Teva’s positive impact on society, and believe they are treated with respect. In addition, they feel they are able to be themselves at work, they are treated fairly regardless of personal background or characteristics, and that Teva promotes a culture of diversity and inclusiveness.
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Management reviews the survey results closely to determine areas for improvement and creates action plans to address any gaps. Survey results are communicated to employees though global communications and town halls and shared with our Board of Directors.
Please see the section entitled “Social” from our Teva 2021 ESG Progress Report (which is located on our website) for more detailed information regarding our Human Capital programs and initiatives. Nothing on our website, including our 2021 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.
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. 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. Our facilities are periodically inspected by the FDA, which has extensive enforcement powers over the activities of pharmaceutical manufacturers. Noncompliance with applicable requirements may result in fines, criminal penalties, civil injunction against shipment of products, recall and seizure of products, total or partial suspension of production, sale or import of products, refusal of the government to enter into supply contracts or to approve NDAs, ANDAs or BLAs and criminal prosecution by the U.S. 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.
FDA approval is required before any “new drug” (including generic versions of previously approved drugs) may be marketed, including new strengths, dosage forms and formulations of previously approved drugs. Applications for FDA approval must contain information relating to bioequivalence (for generics), safety, toxicity and efficacy (for new drugs), product formulation, raw material suppliers, stability, manufacturing processes, packaging, labeling and quality control. FDA procedures generally require that commercial manufacturing equipment be used to produce test batches for FDA approval. 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 CSA imposes registration, security, recordkeeping and reporting, storage, manufacturing, distribution, importation and other requirements upon legitimate handlers under the oversight of the DEA. The DEA categorizes controlled substances into one of five schedules—Schedule I, II, III, IV, or V—with varying qualifications for listing in each schedule. Facilities that manufacture, distribute, conduct chemical analysis, import or export any controlled substance must register annually with the DEA. The DEA performs an inspection of all entities requesting a DEA registration prior to issuing a controlled substance registration for review of the facility and material security, material handling procedures, record keeping, and reporting procedures. The DEA also performs cyclical inspections of all DEA registrants to review accountability, record keeping, and security. Failure to maintain compliance with applicable requirements, particularly as manifested in the loss or diversion of controlled substances, can result in enforcement action, such as civil penalties, refusal to renew necessary registrations or the initiation of proceedings to revoke those registrations. In certain circumstances, violations could lead to criminal prosecution.
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The Drug Price Competition and Patent Term Restoration Act (the “Hatch-Waxman Act”) established the procedures for obtaining FDA approval for generic forms of brand-name drugs. This act also provides market exclusivity provisions that can delay the approval of certain NDAs and ANDAs. One such provision allows a five-year period of data exclusivity for NDAs containing new chemical entities and a three-year period of market exclusivity for NDAs (including different dosage forms) containing new clinical trial(s) essential to the approval of the application. The Orphan Drug Act grants seven years of exclusive marketing rights to a specific drug for a specific orphan use. The term “orphan drug” refers, generally, to a drug that treats a rare disease affecting fewer than 200,000 Americans. Market exclusivity provisions are distinct from patent protections and apply equally to patented and non-patented drug products. Another provision of the Hatch-Waxman Act extends certain patents for up to five years as compensation for the reduction of effective life of the patent which resulted from time spent in clinical trials and time spent by the FDA reviewing a drug application.
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. In the event that such applicant plans to challenge the validity or enforceability of an existing listed patent or asserts that the proposed product does not infringe an existing listed patent, it files 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 submit an ANDA with a Paragraph IV certification. This filing triggers a regulatory process in which the FDA is required to delay the final approval of subsequently filed ANDAs containing Paragraph IV certifications until 180 days after the first commercial marketing. For both ANDAs and 505(b)(2) applications, when litigation is brought by the patent holder, in response to this Paragraph IV certification, the FDA generally may not approve the ANDA or 505(b)(2) application until the earlier of 30 months or a court decision finding the patent invalid, not infringed or unenforceable. Submission of an ANDA or a 505(b)(2) application with a Paragraph IV certification can result in protracted and expensive patent litigation.
Products manufactured outside the United States and marketed in the United States are subject to all of the above regulations, as well as to FDA, DEA and U.S. customs regulations at the port of entry. Products marketed outside the United States that are manufactured in the United States are additionally subject to various export statutes and regulations, as well as regulation by the country in which the products are to be sold.
Our products also include biopharmaceutical products that are comparable to brand-name biologics, as well as products that are approved as biosimilar versions of brand-name biological products. While regulations are still being developed by the FDA relating to the Biologics Price Competition and Innovation Act of 2009, which created a statutory pathway for the approval of biosimilar versions of brand-name biological products and a process to resolve patent disputes, the FDA has issued guidance to provide a roadmap for development of biosimilar products.
In September 2022, the FDA user fee reauthorization legislation, known as the FDA User Fee Reauthorization Act of 2022 (“FUFRA”) was enacted in the United States. The agreements for pharmaceuticals, biosimilars and medical devices were negotiated with industry representatives over the course of 2021 to establish the amounts regulated companies would pay the FDA to support the product review process at the agency. Various fees must be paid by these manufacturers at different times, such as annually and with the submission of different types of applications. 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. The agency is obligated to set specific timelines to communicate with companies, meet with company product sponsors during the review process and take action on their applications.
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The Inflation Reduction Act and Certain Government Programs
The Inflation Reduction Act (“IRA”) of 2022 is the most significant pharmaceutical pricing reform to become law in the United States in the last two decades. Since 2019, pharmaceutical companies have been responsible for providing a 70% discount on branded prescription pharmaceuticals to Medicare Part D patients who had entered the coverage gap discount program, also known as the “donut hole.”
The IRA restructures Medicare’s benefit design and eliminates the Part D donut hole in 2025. Pharmaceutical manufacturers will be required to provide a 10% discount of all biosimilar and brand name prescription drugs covered under the Medicare Part D plan benefit during the initial coverage period before the beneficiary reaches the $2,000 out-of-pocket spending cap. Once the patient reaches the out-of-pocket spending cap, they enter catastrophic coverage and drug manufacture liability for biosimilar and brand name drugs increases to 20%.
In addition to the benefit redesign, the IRA modifies the “noninterference” clause of the Medicare Modernization Act of 2003 by requiring the U.S. Department of Health and Human Services (“HHS”) to negotiate the prices of certain drugs and biologics. In particular, 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.
Drugs with an available generic or biosimilar, certain drugs that represent a limited portion of Medicare program spending, drugs with an orphan designation as their only FDA approved indication, and all plasma-derived products are exempt from direct negotiation. The number of negotiated products will be phased in between 2026 and 2029, and the law sets a maximum fair price the manufacturer can charge based on the number of years the product has been on the market. The law allows HHS to levy an excise and civil monetary penalties against non-compliant manufacturers or those who refuse to negotiate.
The IRA also imposes rebate requirements on manufacturers of single-source generics and other drugs covered under Medicare Part B and Part D where the price of the drug increases faster than inflation. Multisource generics and all products with an average manufacturer’s price less than $100 per year, per individual, are exempt from rebate requirements. Beginning on October 1, 2022 for Part D products and on January 1, 2023 for Part B products, CMS will monitor for products with price increases higher than the rate of inflation on a quarterly basis. Rebates will be calculated as the total number of units sold by the amount the product exceeds the inflation-adjusted price, with 2021 as the base year to measure cumulative changes relative to inflation. Noncompliant manufacturers will be subject to a civil monetary penalty of at least 125% of the calculated rebate amount.
Previously, the Patient Protection and Affordable Care Act (“ACA”) of 2010 represented the most significant health care reform in the United States in over thirty years. It was passed to require individuals to have health insurance and to control the rate of growth in healthcare spending through, among other things, stronger prevention and wellness measures, increased access to primary care, changes in healthcare delivery systems and the creation of health insurance exchanges.
The ACA requires the pharmaceutical industry to share in the costs of reform by increasing Medicaid rebates, expanding Medicaid rebates to Medicaid managed care programs and funding of pharmaceutical costs for Medicare. Additionally, an excise tax was levied against certain branded pharmaceutical products. The tax is specified by statute to be approximately $2.8 billion in 2019 and each year thereafter. The tax is apportioned to qualifying pharmaceutical companies based on an allocation of their governmental programs as a portion of total pharmaceutical government programs.
The Centers for Medicare & Medicaid Services (“CMS”) administer the Medicaid drug rebate program, in which pharmaceutical manufacturers pay quarterly rebates to each state Medicaid agency. 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
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greater of 23.1% of the average manufacturer price or the difference between such price and the commercial best price during a specified period. An additional rebate for products marketed under ANDAs, NDAs or BLAs is payable if the average manufacturer price increases at a rate higher than inflation and other methodologies apply to new formulations of existing drugs.
Various state Medicaid programs have implemented voluntary supplemental drug rebate programs that may provide states with additional manufacturer rebates in exchange for preferred status on a state’s formulary or for patient populations that are not included in the traditional Medicaid drug benefit coverage. 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.
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.
During 2022, we continued to register products in the European Union, primarily using the decentralized procedure (simultaneous submission of applications to chosen member states). We continue to use, on occasion, the mutual recognition and centralized procedures.
The European pharmaceutical industry is highly regulated and much of the legislative and regulatory framework is driven by the European Commission, together with the European Parliament and the Council of Europe. This has many benefits, including the potential to harmonize standards across the complex European market, but it also has the potential to create complexities affecting the entire European market.
European Union
The medicines regulatory framework of the European Union requires that medicinal products, including generic versions of previously approved products and new strengths, dosage forms and formulations of previously approved products, receive a marketing authorization before they can be placed on the market in the European Union. Authorizations are granted after a favorable assessment of quality, safety and efficacy by the respective health authorities. To comply with formal requirements, the application must contain the quality related information of the product (chemical, physical, biological and microbiological data, information about manufacturing process, raw materials, packaging and labelling data, quality control procedures), data confirming product safety (toxicological and pharmacological information), and product efficacy information (clinical studies or clinical trials).
In order to control expenditures on pharmaceuticals, most member states of the European Union regulate the pricing of such products and in some cases limit the range of different forms of a drug available for prescription by national health services. These controls can result in considerable price differences among member states.
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. Further, the generic product will be barred from market entry (marketing exclusivity) for a further two years, with the possibility of extending the market exclusivity by one additional year under certain circumstances. As part of the European Commission’s review of the general pharmaceutical legislation, the provisions relating to
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regulatory exclusivity are currently under review. Proposed changes are expected to be published in 2023, although the implementation date and transitional provisions are 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”). The purpose of this extension is to increase effective patent life (i.e., the period between grant of a marketing authorization and patent expiry) to 15 years.
Subject to the respective pediatric regulation, the holder of an SPC may obtain a further patent term extension of up to six months under certain conditions. This six-month period cannot be claimed if the license holder claims a one-year extension of the period of marketing exclusivity based on the grounds that a new pediatric indication brings a significant clinical benefit in comparison with other existing therapies.
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 expiry 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 expiry of the SPC. 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.
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. The criteria and protection period for orphan designated products are currently under review by the European Commission, with proposed changes expected to be published in 2023.
The legislation also allows for R&D work during the patent term for the purpose of developing and submitting registration dossiers.
In November 2020 the European Commission published a “Pharmaceutical strategy for Europe,” which sets out a suite of policies that will shape the future European regulatory environment. These wide-ranging policies represent a multi-year program aimed, through review and revision of existing legislation, to provide a flexible regulatory system that, amongst other things, will lead to accelerated availability of medicines and promote sustainability of that system.
On December 31, 2020, the United Kingdom formally left the European Union (also known as “Brexit”). Legislative changes are expected as the UK government begins to enact national legislation in place of certain provisions which derive from EU legislation. Although certain regulatory and technical challenges remain, we continue to have processes and contingencies in place to minimize their impact, and to maintain our ability to supply medicines to patients in the United Kingdom, and to supply medicines made in the United Kingdom to other markets.
Medical Devices
Although not subject to FDA regulation as standalone medical devices, certain of our products are regulated as medical devices in the European Union. In 2017, the European Union adopted the European Union Medical Device Regulation (“EU MDR”), replacing the prior European Union Medical Device Directive (“EU MDD”) framework. The EU MDR specifies new risk classification rules, as well as changes to clinical studies, post-marketing surveillance, device traceability and oversight by notified bodies. The EU MDR became applicable on May 26, 2021. Devices certified under the prior EU MDD regime may continue to be first placed on the market whilst their certificates remain valid provided there are no significant changes in the design or intended purpose; however, any devices placed on the market for the first time after May 27, 2024 must comply in full with EU MDR. From May 27, 2025 all medical devices sold in the European Union must be fully MDR compliant. In the
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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.
International Markets
In addition to regulations in the United States and Europe, we, and our partners, are subject to a variety of regulations in other jurisdictions governing, among other things, clinical trials and any commercial sales, marketing and distribution of our products. Such regulations may be similar or, in some cases, more stringent than those applicable in the United States and Europe.
Whether or not we, or our partners, obtain FDA approval for a product, we must obtain the requisite approvals from regulatory authorities in foreign countries prior to the commencement of clinical trials or marketing of such product in those countries. The requirements and processes governing the conduct of clinical trials, product licensing, pricing and reimbursement vary from country to country. In addition, we, and our partners, may be subject to foreign laws and regulations and other compliance requirements, including, without limitation, anti-kickback laws, false claims laws and other fraud and abuse laws, as well as laws and regulations requiring transparency of pricing and marketing information and governing the privacy and security of personal information. The majority of the countries in which we market our products have enacted privacy regulation. In 2022, the existing privacy legislation in Russia and Japan were amended. We and our partners are implementing measures as needed to comply with such privacy requirements.
If we, or our partners, fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.
Miscellaneous Regulatory Matters
We are subject to various national, regional and local laws of general applicability, such as laws regulating working conditions. 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 the emission of material into the environment. We are also subject to various national, regional and local laws regulating how we interact with healthcare professionals and representatives of government that impact our promotional and other commercial activities. Additionally, we may be subject in the future to various new national, regional and local laws and regulations, such as the NIS2 Directive, the EU Digital Services Act, the European Health Data Space and the EU Artificial Intelligence Regulation, which could impact our business activities.
Data exclusivity provisions exist in many countries around the world and may be introduced in additional countries in the future, although their application is not uniform. 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. As these exclusivity provisions operate independently of patent exclusivity, they may prevent the submission of generic drug applications for some products even after the patent protection has expired.
In July 2020, the European Court of Justice in a case known as “Schrems II”, invalidated the adequacy of the EU-US Privacy Shield Certification Programme under the EU General Data Protection Regulation (“GDPR”). In the same year, the European Commission updated its Standard Contractual Clauses, one mechanism under Chapter V of the GDPR to lawfully allow transfers of personal data outside the EU. As a result, companies are required to conduct and document comprehensive data transfer assessments, and if supplementary measures cannot address an adequate level of protection, then such transfers shall be restricted. In March 2022, the European Commission and the U.S. Administration announced that they had reached an agreement in principle on a new EU-U.S. Data Privacy Framework, which will address the concerns raised in the Schrems II decision; additionally, in October 2022, the U.S. announced an Executive Order implementing this
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principle into U.S. law, both of which were important steps in order to facilitate trans-Atlantic data flows from the EU to the U.S. We continue to monitor these developments and to address requirements regarding data transfers.
In the United States, the legislative and regulatory landscape for data privacy and protection continues to evolve with an increasing focus on privacy and data protection issues. 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. HIPAA also sets forth federal rules protecting the privacy and security of protected health information (“PHI”). The law provides both criminal and civil fines and penalties for covered entities that fail to comply with HIPAA. In 2009, the law was amended to impose certain of the HIPAA privacy and security requirements directly upon business associates of covered entities and significantly increased the monetary penalties for violations of HIPAA. During 2022, certain of Teva’s U.S. entities have become subject to HIPAA as business associates. We have established administrative, physical and technical safeguards to protect the confidentiality, integrity and availability of PHI maintained or transmitted by such entities.
Additionally, the California Consumer Privacy Act (“CCPA”) established a new 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. Further, the California Privacy Rights Act (“CPRA”), effective January 1, 2023 (with certain provisions having retroactive effect to January 1, 2022), creates additional obligations with respect to processing and storing personal information. While clinical trial data and information governed by HIPAA are currently exempt from the current versions of the CCPA and CPRA, other personal information may be applicable and possible changes to the CCPA and CPRA may broaden its scope.
In October 2015, the European Commission adopted regulations providing detailed rules for the safety features appearing on the packaging of medicinal products for human use. This legislation, part of the Falsified Medicines Directive (“FMD”), is intended to prevent counterfeit medicines entering into the supply chain and will allow wholesale distributors and others who supply medicines to the public to verify the authenticity of the medicine at the level of the individual pack. The safety features comprise a unique identifier and a tamper-evident seal on the outer packaging, which are to be applied to certain categories of medicines. FMD is effective as of February 2019. Teva’s packaging sites, distribution centers and contract manufacturing operators (“CMOs”) for the European market comply with this new requirement.
In November 2013, the federal Drug Supply Chain Security Act (the “DSCSA”) became effective in the United States, mandating an industry-wide, national serialization system for pharmaceutical packaging with a ten-year phase-in process. By November 2018, all manufacturers and re-packagers were required to mark each prescription drug package with a unique serialized code. Teva’s packing sites, distribution centers and CMOs for the U.S. market comply with the new requirements. In addition, under the DSCSA, Teva is required by November 2023, to provide to downstream trading partners, serial number specific transaction details. This will require additional modification to the packing sites, distribution centers and CMOs for the U.S. market. Subsequently, in February 2019, the EU enacted the Falsified Medicines Directive (“FMD”), traceability requirements for drug products, which Teva complies with as well. Other countries are following suit with variations of two main requirements: (i) to be able to associate the unit data with the uniquely-identified shipping package, or (ii) to report the data for tracking and tracing of products, reimbursements and other purposes. 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.
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Available Information
Our main corporate website address is http://www.tevapharm.com. Copies of our Quarterly Reports on Form 10-Q, Annual Report on Form 10-K and Current Reports on Form 8-K filed or furnished to the U.S. Securities and Exchange Commission (the “SEC”), and any amendments to the foregoing, will be provided without charge to any shareholder submitting a written request to our company secretary at our principal executive offices or by sending an email to TevaIR@tevapharm.com. All of our SEC filings are also available on our website at http://www.tevapharm.com, as soon as reasonably practicable after having been electronically filed or furnished to the SEC. The SEC maintains an Internet site that contains reports, proxy and information statements and other information regarding issuers that file electronically with the SEC at www.sec.gov. The information on our website is not, and will not be deemed, a part of this Report or incorporated into any other filings we make with the SEC. We also file our annual reports and other information with the Israeli Securities Authority through its fair disclosure electronic system called MAGNA. 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 2022 ESG Progress report, which will provide enhanced ESG disclosures, is expected to be published in May 2023. Information in our ESG Progress Report shall not be deemed incorporated by reference into this Annual Report or any other filing with the SEC.
ITEM 1A. RISK FACTORS
Our business faces significant risks. You should carefully consider all of the information set forth in this Annual Report and in our other filings with the SEC, including the following risk factors which we face and which are faced by our industry. Our business, financial condition and results of operations could be materially adversely affected by any of these risks. This report also contains forward-looking statements that involve risks and uncertainties. Our results could materially differ from those anticipated in these forward-looking statements as a result of certain factors including the risks described below and elsewhere in this report and our other SEC filings. For a summary of the risk factors included in this Item 1A and for further details on our forward-looking statements, see “Forward-Looking Statements and Summary of Risk Factors” on page 1.
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.
In 2022, total revenues from sales of our generic medicines in all our business segments were $8,601 million, or 58% of our total revenues. 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. We have become more dependent on sales of our generics medicines and are increasingly subject to market and regulatory factors and other risks affecting generic pharmaceuticals worldwide.
In recent years, our business has experienced increased volatility in volumes due in large part to global supply chain issues and the COVID-19 pandemic. In 2022, the global economy was continuing to recover from the impacts of the COVID-19 pandemic and also began experiencing additional macroeconomic pressures such as rising inflation and disruptions to the global supply chain, in part resulting from the ongoing conflict between Russia and Ukraine. Due to the complexity of our supply chain, we have experienced supply discontinuities due to macroeconomic issues, regulatory actions, including sanctions and trade restrictions, labor disturbances and approval delays, which impacted our ability to timely meet demand in certain instances. These adverse market forces have a direct impact on our overall performance. Any such disruptions could have a material adverse impact on our business and our results of operation and financial condition.
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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. 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.
Sales of our generic products may be adversely affected by the concentration of our customer base and commercial alliances among our customers.
A significant portion of our sales are made to relatively few U.S. retail drug chains, wholesalers, managed care purchasing organizations, mail order distributors and hospitals. These customers have undergone significant consolidation and formed various commercial alliances, which may continue to increase the pricing pressures that we face in the United States. The presence of large buying groups, and the prevalence and influence of managed care organizations and similar institutions, have increased pressure on price, as well as terms and conditions required to do business. There are three large Group Purchasing Organizations (“GPOs”) that account for more than 80% of generics purchases in the United States in 2022, which provides each of them with significant bargaining power. We expect the trend of increased pricing pressures from our customers and price erosion in the U.S. generics market to continue.
Furthermore, the traditional model for distribution of pharmaceutical products is also undergoing disruption as a result of the entry or potential entry of new competitors and significant mergers among key industry participants, including Mylan and Pfizer’s Upjohn merger in November 2020, forming Viatris Inc. In addition, several major hospital systems in the United States announced a plan to form a nonprofit company that will provide U.S. hospitals with a number of generic drugs. These and similar changes to the traditional supply chain could lead to our customers having increased negotiation leverage and to additional pricing pressure and price erosion.
Our net sales may also be affected by fluctuations in the buying patterns of our significant customers, whether resulting from seasonality, pricing, wholesaler buying decisions or other factors. In addition, since a significant portion of our U.S. revenues is derived from relatively few key customers, any financial difficulties experienced by a single key customer, or any delay in receiving payments from such a customer, could have a material adverse effect on our business, financial condition and results of operations.
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. Prices of generic drugs may, and often do, decline, sometimes dramatically, especially as additional generic pharmaceutical companies receive approvals and enter the market for a given product and competition intensifies. 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. The goals established under the Generic Drug User Fee Act, and increased funding of the FDA’s Office of Generic Drugs, have led to more and faster generic approvals, and consequently increased competition for some of our products. The FDA has stated that it has established new steps to enhance competition, promote access and lower drug prices and is approving record-breaking 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.
Furthermore, brand pharmaceutical companies continue to manage products in a challenging environment through marketing agreements with payers, pharmacy benefits managers and generic manufacturers. For example, brand companies often sell or license their own generic versions of their products, either directly or through other generic pharmaceutical companies (so-called “authorized generics”). No significant regulatory
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approvals are required for authorized generics, and brand companies do not face any other significant barriers to entry into such market. Brand companies may seek to delay introductions of generic equivalents through a variety of commercial and regulatory tactics. Many pharmaceutical companies increasingly have used state and federal legislative and regulatory means to delay generic (including biosimilar) competition. These efforts have included pursuing new patents for existing products to extend patent protection; selling the brand product as their own generic equivalent (an authorized generic); using the Citizen Petition process to request amendments to FDA standards or otherwise delay generic (or biosimilar) drug approvals; seeking changes to U.S. Pharmacopeia, an organization which publishes industry recognized compendia of drug standards; using the legislative and regulatory process to have drugs reclassified or rescheduled; attaching patent extension amendments to unrelated federal legislation; and entering into agreements with pharmacy benefit management companies to block the dispensing of generic (including biosimilar) products. These actions may increase the costs and risks of our efforts to introduce generic products and may delay or prevent such introduction altogether.
In addition, the U.S. Congress and various state legislatures in the United States have passed, or have proposed passing, legislation that could have an adverse impact on pharmaceutical manufacturers’ ability to (i) settle litigation initiated pursuant to the Hatch-Waxman Act and Biologics Price Competition and Innovation Act (“BPCIA”); (ii) secure the full benefit of first-to-file regulatory approval status secured under the Hatch-Waxman Act; and (iii) recover their investments into the development of an innovative, generic or biosimilar product. Hatch-Waxman and BPCIA create various pathways for generic drug manufacturers to secure accelerated approvals of their abbreviated new drug applications and abbreviated biologics license applications. 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. They also could impact the ability of brand manufacturers to protect their investments in the intellectual property associated with their branded specialty and innovative biologic products. 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. Department of Health and Human Services (“HHS”) to negotiate the prices of a subset of drugs and biologics with the highest annual expenditures under Medicare Parts B and D; and (iii) impose rebate requirements on manufacturers of certain single-source drugs and biologics covered under Medicare Part B and any Part D covered, FDA-approved drug or biologic or biosimilar, as well as generic drugs. A number of state legislatures have also begun considering legislation that would implement IRA-like frameworks for state regulated insurance markets. We continue to monitor these legislative developments, evaluate whether any changes to our business practices and operations are necessary in order to comply with such legislative reforms and advocate for policies that support both innovation and access to high quality medicines for patients. However, we cannot accurately predict the ultimate impact of such legislative developments on our business or whether additional changes in regulatory policies will occur in the future.
We have experienced, and may continue to experience, delays in launches of our new generic products.
Although we believe we have one of the most extensive pipelines of generic products in the industry, in recent years we were unable to successfully execute a number of generic launches and these challenges may continue in the foreseeable future. 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. If we cannot execute timely launches of new products, we may not be able to offset the increasing price erosion on existing products in the United States resulting from pricing pressures and accelerated generics approvals for competing products. Such unsuccessful launches can be caused by many factors, including, delays in regulatory approvals, lack of operational or clinical readiness or patent litigation. Failure or delays to execute launches of new generic products could have a material adverse effect on our business, financial condition and results of operations.
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The increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products may adversely affect our revenues and profits.
Our ability to achieve continued growth and profitability through sales of generic pharmaceuticals is dependent on our continued success in challenging patents, developing non-infringing products or developing products with increased complexity to provide opportunities with U.S. market exclusivity or limited competition.
To the extent that we succeed in being the first to market a generic version of a product, and particularly if we are the only company authorized to sell the generic product during the 180-day period of exclusivity in the U.S. market as provided under the Hatch-Waxman Act, our sales, profits and profitability can be substantially increased in the period following the introduction of such product and prior to a competitor’s introduction of a generic product. Even after the exclusivity period ends, there is often continuing benefit from having the first generic product in the market.
However, the number of generic manufacturers targeting significant new generic opportunities with exclusivity under the Hatch-Waxman Act, or which are complex to develop, has increased in recent years. Additionally, many of the smaller generic manufacturers have increased their capabilities, level of sophistication and development resources in recent years. The FDA has also been limiting the availability of exclusivity periods for new products, which reduces the economic benefit from being first-to-file for generic approvals. The failure to maintain our industry-leading performance in the United States on first-to-file opportunities and to develop and commercialize high complexity generic products could adversely affect our sales and profitability.
The 180-day market exclusivity period is triggered by commercial marketing of the generic product. However, the exclusivity period can be forfeited by failure to obtain approval or to launch a product within a specified time or if certain conditions are met, some of which may be outside our control. Accordingly, we may face the risk that our exclusivity period is forfeited before we are able to commercialize a product.
We may be unable to take advantage of the increasing number of high-value biopharmaceutical opportunities.
We aim to be a global leader in biopharmaceuticals. We are developing a product pipeline and manufacturing capabilities for biosimilar products, which are expected to make up an increasing proportion of the high-value generic opportunities in the coming years. The development, manufacture and commercialization of biopharmaceutical products require specialized expertise and are very costly and subject to complex regulation, which is still evolving. Due to the complex process and significant financial and other resources required to develop biosimilars, obstacles and delays, including budget constraints may arise, which increase the cost of development or force us to abandon a potential product in which we may have invested substantial amounts of time and resources. We were behind many of our competitors in developing biopharmaceuticals and are making and still require significant investments and collaborations with third parties to benefit from these opportunities. Failure to develop and commercialize biopharmaceuticals, either by us or through collaborations with third parties, could have a material adverse effect on our business, financial condition, results of operations and prospects.
Our innovative medicines face intense competition from companies that have greater resources and capabilities.
We face intense competition to our innovative medicines. Many of our competitors are larger and/or have substantially more experience in the development, acquisition and marketing of branded, innovative and consumer-oriented products. They may be able to respond more quickly to new or emerging market preferences or to devote greater resources to the development and marketing of new products and/or technologies than we can. As a result, any products and/or innovations that we develop may become obsolete or noncompetitive before we can recover the expenses incurred in connection with their development. In addition, we must demonstrate the benefits of our products relative to competing products that are often more familiar or otherwise better
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established to physicians, patients and third-party payers. If competitors introduce new products or new variations on their existing products, our marketed products, even those protected by patents, may be replaced in the marketplace or we may be required to lower our prices. 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. If our revenues derived from AUSTEDO 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 calcitonin gene-related peptide (“CGRP”) products. |
• | COPAXONE faces increasing competition from generic versions in the U.S. and competing glatiramer acetate products in Europe, as well as from orally-administered therapies. Following the approval of generic competition, COPAXONE’s revenues and profitability have decreased. We expect the trend of decreasing revenues and profitability for COPAXONE to continue in the future. |
In addition, our innovative medicines require much greater use of a direct sales force than does our core generics business. Our ability to realize significant revenues from direct marketing and sales activities depends on our ability to attract and retain qualified sales personnel. Competition for qualified sales personnel is intense. We may also need to enter into co-promotion, contract sales force or other such arrangements with third parties, for example, where our own direct sales force is not large enough or sufficiently well-aligned to achieve maximum market penetration. Any failure to attract or retain qualified sales personnel or to enter into third-party arrangements on favorable terms could prevent us from successfully maintaining current sales levels or commercializing new innovative medicines.
If generic or biosimilar products that compete with any of our innovative medicines are approved and sold, sales of our innovative medicines will be adversely affected.
Certain of our leading innovative medicines face patent challenges and impending patent expirations. For example, following our own launch of a ProAir authorized generic in the U.S. in January 2019, the launch of an additional generic version of Ventolin® HFA and other generic versions of ProAir in 2020, we discontinued marketing ProAir HFA in October 2022, while focusing our marketing efforts on albuterol sulfate inhalation aerosol (our ProAir authorized generic) and ProAir Digihaler (albuterol sulfate 117 mcg). Some of our other innovative medicines have recently become susceptible to generic competition, such as TREANDA in 2022, and we reached agreements with Lupin and Aurobindo to resolve the disputes in connection with their ANDAs filed for generic deutetrabenazine (AUSTEDO).
Generic equivalents and biosimilars for branded pharmaceutical products are typically sold at lower costs than the branded products. After the introduction of a competing generic product, a significant percentage of the prescriptions previously written for the branded product are often written for the generic version. Legislation enacted in most U.S. states allows or, in some instances, mandates that a pharmacist dispense an available generic equivalent (or interchangeable biosimilar) when filling a prescription for a branded product in the absence of specific instructions from the prescribing physician. Branded products typically experience a significant loss in revenues following the introduction of a competing generic (or biosimilar) product, even if the branded product is still subject to an existing patent since generic manufacturers may offer generic (or biosimilar) products while patent litigation is pending. Our innovative medicines are or may become subject to competition from generic equivalents because our patent protection expired or may expire soon. In addition, we may not be successful in our efforts to obtain additional patent protection for our innovative medicines through the development and commercialization of proprietary product improvements and new and enhanced dosage forms.
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Investments in our pipeline of innovative medicines and other products may not achieve expected results.
We must invest significant resources to develop innovative medicines and biosimilars, both through our own efforts and through collaborations with, and in-licensing or acquisition of products from, third parties. We have entered into, and expect to pursue, in-licensing, acquisition and partnership opportunities to supplement and expand our existing innovative medicines and biosimilar pipeline (e.g., the transactions with Alvotech and Modag).
The development of innovative medicines involves processes and expertise different from those used in the development of generic medicines, which increase the risk of failure. 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 approval processes, which vary from country to country. The longer it takes to develop a new product, the less time that remains to recover development costs and generate profits.
During each stage, we may encounter obstacles that delay the development process and increase expenses, potentially forcing us to abandon a potential product in which we may have invested substantial amounts of time and resources. These obstacles may include preclinical failures, difficulty enrolling patients in clinical trials, delays in completing formulation and other work needed to support an application for approval, adverse reactions or other safety concerns arising during clinical testing, insufficient clinical trial data to support the safety or efficacy of the product candidate, widespread supply chain breakdowns, delays as a result of new requirements implemented by health authorities such as the U.S. FDA and EMA requirement on material use, and delays or failure to obtain the required regulatory approvals for the product candidate or the facilities in which it is manufactured.
When we enter into partnerships, joint ventures or strategic alliances with third parties, such as our collaborations with Alvotech and Modag, we face the risk that some of these third parties may fail to perform their obligations, which in certain circumstances include obtaining regulatory approvals, or fail to reach the levels of success that we are relying on to meet our revenue and profit goals.
There is a trend in the innovative medicines industry of seeking to “outsource” drug development by acquiring companies with promising drug candidates and we face substantial competition from historically innovative companies, as well as companies with greater financial resources than us, for such acquisition targets.
Our success depends on our ability to develop and commercialize additional pharmaceutical products.
Our financial results depend upon our ability to develop and commercialize additional generic, innovative and biosimilar products in a timely manner, particularly in light of the generic competition to our existing innovative medicines. Commercialization requires that we successfully develop, test and manufacture pharmaceutical products. All of our products must receive regulatory approval and meet (and continue to comply with) regulatory and safety standards; if health or safety concerns arise with respect to a product, we may be forced to withdraw it from the market. Developing and commercializing additional pharmaceutical products is also subject to difficulties relating to the availability, on commercially reasonable terms, of raw materials, including API and other key ingredients; preclusion from commercialization by the proprietary rights of others; the costs of manufacture and commercialization; costly legal actions brought by our competitors that may delay or prevent development or commercialization of a new product; and delays and costs associated with the approval process of the FDA and other U.S. and international regulatory agencies.
The development and commercialization process, particularly with respect to innovative medicines and biosimilar medicines, as well as the complex generic medicines that we increasingly focus on, is both time-consuming and costly, and involves a high degree of business risk. Our products currently under development, if and when fully developed and tested, may not perform as we expect. Necessary regulatory approvals may not be
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obtained in a timely manner, if at all, and we may not be able to produce and market such products successfully and profitably. Delays in any part of the process or our inability to obtain regulatory approval of our products could adversely affect our operating results by restricting or delaying our introduction of new products.
We depend on the effectiveness of our patents, confidentiality agreements and other measures to protect our intellectual property rights.
The success of our innovative medicines business depends substantially on our ability to obtain patents and to defend our intellectual property rights. If we fail to protect our intellectual property adequately, competitors may manufacture and market products identical or similar to ours. 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. Any existing or future patents issued to or licensed by us may not provide us with any competitive advantages for our products or may be challenged or circumvented by competitors or governments.
Efforts to defend the validity of our patents are expensive and time-consuming, and there can be no assurance that such efforts will be successful. Our ability to enforce our patents also depends on the laws of individual countries and each country’s practices regarding the enforcement of intellectual property rights. The loss of patent protection or regulatory exclusivity on innovative medicines could materially impact our business, results of operations, financial condition and prospects.
We also rely on trade secrets, unpatented proprietary know-how, trademarks, regulatory exclusivity and continuing technological innovation that we seek to protect, in part by confidentiality agreements with licensees, suppliers, employees and consultants. These measures may not provide adequate protection for our unpatented technology. If these agreements are breached, it is possible that we will not have adequate remedies. Disputes may arise concerning the ownership of intellectual property or the applicability of confidentiality agreements. Furthermore, our trade secrets and proprietary technology may otherwise become known or be independently developed by our competitors or we may not be able to maintain the confidentiality of information relating to such products. If we are unable to adequately protect our technology, trade secrets or proprietary know-how, or enforce our intellectual property rights, our results of operations, financial condition and cash flows could suffer.
Risks related to our substantial indebtedness
We have substantial debt of $21,212 million as of December 31, 2022, 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.
Our consolidated debt was $21,212 million at December 31, 2022, compared to $23,043 million at December 31, 2021. If we are unable to meet our debt service obligations and other financial obligations, we could be forced to restructure or refinance our indebtedness and other financial transactions, seek additional debt or equity capital or sell our assets. We might then be unable to obtain such financing or capital or sell our assets on satisfactory terms, if at all. Any refinancing of our indebtedness could be at significantly higher interest rates, incur significant transaction fees or include more restrictive covenants. See “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity” and note 9 to our consolidated financial statements for a detailed discussion of our outstanding indebtedness.
We may have lower-than-anticipated cash flows in the future, which could further reduce our available cash. Although we believe that we will have access to cash sufficient to meet our business objectives and capital needs, this reduced availability of cash could constrain our ability to grow our business. Our unsecured syndicated sustainability-linked revolving credit facility (“RCF”) contains certain covenants, including certain limitations on incurring liens and indebtedness and maintenance of certain financial ratios, including a maximum leverage ratio, which becomes more restrictive over time. Under specified circumstances, including non-compliance with any of the covenants and the unavailability of any waiver, amendment or other modification thereto, we will not be able
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to borrow under the RCF. Additionally, violations of the covenants, under certain circumstances, would result in an event of default in all borrowings under the RCF and, when greater than a specified threshold amount as set forth in each series of senior notes and sustainability-linked senior notes is outstanding, could lead to an event of default under our senior notes and sustainability-linked senior notes due to cross acceleration provisions.
As of December 31, 2022, we were in compliance with all applicable financial ratios. We continue to take steps to reduce our debt levels and improve profitability to ensure continual compliance with the financial maintenance covenants. If such covenants will not be met, we believe we will be able to renegotiate and amend the covenants, or refinance the debt with different repayment terms to address such situation as circumstances warrant. Although we have successfully negotiated amendments to our loan agreements in the past, we cannot guarantee that we will be able to amend such agreements on terms satisfactory to us, or at all, if required to maintain compliance in the future. If we experience lower than required earnings and cash flows to continue to maintain compliance and efforts could not be successfully completed on commercially acceptable terms, we may curtail additional planned spending, may divest additional assets in order to generate enough cash to meet our debt requirements and all other financial obligations.
Our substantial net debt could also have other important consequences to our business, including, but not limited to:
• | making it more difficult for us to satisfy our obligations; |
• | limiting our ability to borrow additional funds and increasing the cost of any such borrowing; |
• | increasing our vulnerability to, and reducing our flexibility to respond to, general adverse economic and industry conditions; |
• | limiting our flexibility in planning for, or reacting to, changes in our business and the industry in which we operate; |
• | placing us at a competitive disadvantage as compared to our competitors, to the extent that they are not as highly leveraged; and |
• | restricting us from pursuing certain business opportunities. |
Additionally, if macroeconomic pressures continue to impact our business and financial results for an extended period of time, our credit losses, liquidity and cash resources could be negatively impacted. We may be required to draw down funds from our RCF or pursue additional sources of financing to fund our operations, such as secured financing. If we seek secured financing in excess of the limitation in our debt instruments, we may have to secure our current outstanding debt as well. Capital and credit markets, which have been disrupted by such macroeconomic pressures, have experienced increased volatility. As a result, access to additional financing may be challenging and is largely dependent upon evolving market conditions and other factors, which could materially impact our business, results of operations, financial condition and prospects.
We may need to raise additional funds in the future, which may not be available on acceptable terms or at all.
We may consider issuing additional debt or equity securities in the future to refinance existing debt or for general corporate purposes, including to fund potential acquisitions or investments. If we issue ordinary equity, convertible preferred equity or convertible debt securities to raise additional funds, our existing shareholders may experience dilution, and the new equity or debt securities may have rights, preferences and privileges senior to those of our existing shareholders. If we incur additional debt, it may increase our leverage relative to our earnings or to our equity capitalization, requiring us to pay additional interest and potentially lowering our credit ratings. We may not be able to market such issuances on favorable terms, or at all, in which case, we may not be able to develop or enhance our products, execute our business plan, take advantage of future opportunities or respond to competitive pressures or unanticipated customer requirements.
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If our credit ratings are further downgraded by leading rating agencies, we may not be able to raise debt or borrow funds in amounts or on terms that are favorable to us, if at all.
Our credit ratings impact the cost and availability of future borrowings and, accordingly, our cost of capital. Our ratings at any time will reflect each rating agency’s then opinion of our financial strength, operating performance and ability to meet our debt obligations. In the past, we have been subject to downgrades in our credit ratings by various ratings agencies. Most recently, Standard and Poor’s Financial Services LLC (“Standard and Poor’s”) downgraded our rating from BB to BB- due to rising litigation risks. Subsequently, on July 29, 2022, following our announcement of reaching an agreement in principle on the financial terms of a nationwide settlement of the opioids litigation, Standard and Poor’s revised our rating outlook to positive, reflecting our continued solid competitive position and robust free cash flow generation. However, there is no assurance that we will not be subject to ratings downgrades or negative outlooks by any of the ratings agencies in the future.
Any downgrade of our ratings by the rating agencies limits our ability to borrow at interest rates consistent with the interest rates that were available to us prior to such downgrades. This may limit our ability to sell additional debt securities or borrow money in the amounts, at the times or interest rates, or upon the terms and conditions that would have been available to us if our previous credit ratings had been maintained.
Additional risks related to our business and operations
Global economic conditions may negatively affect us and may magnify certain risks that affect our business.
In recent months, record levels of inflation have resulted in significant volatility and disruptions in the global economy. In response to rising inflation, central banks in the markets in which we operate, including the United States Federal Reserve, have tightened their monetary policies and raised interest rates, and such measures may continue if there is a period of sustained heightened inflation. Higher interest rates and volatility in financial markets could lead to additional economic uncertainty or recession. Increased inflation rates have increased our and our suppliers’ operating costs, including labor costs, raw materials costs, manufacturing costs, freight costs and R&D costs. There is no assurance that we will be able to promptly increase our pricing to offset our increased costs, or that our operations will not be materially impacted by rising inflation and its broader effects on the markets in which we operate in the future. In addition to rising inflation, the global economy has also been impacted by fluctuating foreign exchange rates and geopolitical tensions, such as the ongoing conflict between Russia and Ukraine, which has spurred rising energy costs and exacerbated disruptions to the global supply chain caused by the COVID-19 pandemic and the government and societal responses to the pandemic. Supply chain disruptions could continue to result in delays in our production and distribution processes, R&D initiatives and our ability to timely respond to consumer demand. 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. We have implemented certain measures in response to such macroeconomic pressures, including maintaining multiple supply sources for certain of our raw materials and employing various derivative financial instruments and hedging strategies to manage our exposure to exchange rate risks, which measures may mitigate, but do not eliminate, such economic pressures and their impact on us. We are continuing to monitor the effects of rising inflation, foreign exchange rate fluctuations, geopolitical tensions and other macroeconomic headwinds on our business performance and financial condition. However, the duration and extent of such macroeconomic developments are uncertain and we cannot accurately predict whether we will be able to effectively and timely mitigate their impact on our business.
The widespread outbreak of an illness or any other communicable disease, or any other public health crisis, such as the COVID-19 pandemic and the governmental and societal responses thereto, could adversely affect our business, results of operations and financial condition.
Widespread outbreaks of disease or other public health crises, such as the COVID-19 pandemic and responses thereto have in the past and may in the future negatively impact the global economy, disrupt global
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supply chains and create significant volatility and disruption of financial markets. Since it began in 2019, the COVID-19 pandemic has spread globally, including to countries and regions where we manufacture most of our products and conduct our clinical trials. In response to the COVID-19 pandemic, we temporarily closed certain of our facilities and faced other protectionist measures and restrictions imposed by government authorities to control the pandemic which inhibited our employees’ access to our facilities, and caused certain delays and disruptions in our materials, supply. More recently, the disruption from the COVID-19 pandemic has decreased and in 2022, we did not experience material delays in the production and distribution of medicines caused by the COVID-19 pandemic.
However, we experienced delays in some clinical trials in 2022 due to slowdowns in recruitment for studies and suspended regulatory inspections, delays in regulatory approvals of new products due to reduced capacity or re-prioritization of regulatory agencies and delays in pre-commercial launch activities. Additionally, the COVID-19 pandemic continued to have an impact to a certain extent on markets and on customer stocking and purchasing patterns. The new working environment that has emerged as a result of the COVID-19 pandemic, with many employees working remotely, has also increased the exposure of many companies, including us, to cyber-attacks and data security breaches. If such breach were to occur, it may have a material adverse effect on our business, operations and reputation.
We have taken precautionary measures, and may take additional measures, intended to minimize the risks of the COVID-19 pandemic to our employees and operations. While we expect to be able to continue our operations and to satisfy the demand for our products, while protecting the health and safety of our employees and customers, the uncertainty surrounding the full economic implications of the pandemic may result in business disruption and it is possible that we will continue to see variable demand in future periods. Though availability of vaccines and reopening of economies has improved the outlook for recovery from the COVID-19 pandemic’s impacts, the impact of other new, more contagious or lethal variants that may emerge, the effectiveness of COVID-19 vaccines against such variants or the related responses by governments, including reinstated government-imposed lockdowns or other measures, cannot be predicted at this time. Any disruptions caused by the COVID-19 pandemic, or any new outbreaks of disease that may emerge in the future, could have a material adverse impact on our operational and financial performance, including our ability to execute our business strategies in the expected time frame or at all.
Implementation of ongoing optimization efforts may adversely affect our business, financial condition and results of operations.
We may face wrongful termination, discrimination or other legal claims from employees affected by ongoing changes in our workforce. We may incur substantial costs defending against such claims, regardless of their merits, and such claims may significantly increase our severance costs. Additionally, we may see variances in the estimated severance costs depending on the category of employees and locations in which severance is incurred.
Upon the proposed divestiture of any facility in connection with our ongoing plant optimization, we may not be able to divest such facility at a favorable price or in a timely manner. Any divestiture that we are unable to complete may cause additional costs associated with retaining the facility or closing and disposing of the impacted businesses.
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. We cannot guarantee that, following such efficiency measures, our business will be more efficient or effective.
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.
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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. 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. Changes in our management as a result of the appointment or departure of members of management and other key employees, such as the recent appointment of our new President and Chief Executive Officer, may also cause disruptions to our business and result in the loss of key personnel with institutional knowledge of our business, negative impacts on our relationships with existing employees and customers and increased operating costs related to integrating new personnel. Any difficulty in recruiting, hiring, integrating, retaining and motivating talented and skilled members of our organization may delay or prevent the achievement of major business objectives.
Manufacturing or quality control problems may damage our reputation for quality production, demand costly remedial activities and negatively impact our financial results.
As a pharmaceutical company, we are subject to substantial regulation by various governmental authorities. 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. Failure to strictly and promptly comply with these regulations and requirements may damage our reputation and lead to financial penalties, compliance expenditures associated with remediation efforts, the recall or seizure of products, total or partial suspension of production and/or distribution, suspension of the applicable regulator’s review of our submissions, enforcement actions, injunctions and criminal prosecution.
We must register our facilities, whether located in the United States or elsewhere, with the FDA for products sold in the United States, and with other regulators outside the United States for products sold outside of the United States. Our products must be produced in a manner consistent with cGMP, or similar quality and compliance standards in each territory in which we manufacture. In addition, the FDA and other agencies periodically inspect our manufacturing facilities. Following an inspection, an agency may issue a notice listing conditions that are believed to violate cGMP or other regulations, or take other regulatory action, including issuing a warning letter for violations of “regulatory significance” that may result in enforcement action if not promptly and adequately corrected.
In recent years, regulatory agencies around the world have increased their scrutiny of pharmaceutical manufacturers. This has resulted in requests for product recalls, temporary plant shutdowns to address specific issues and other remedial actions. Our manufacturing facilities, as well as those of our vendors and manufacturing partners, have also been the subject of increased regulatory oversight, leading to increased expenditures required to ensure compliance with new or more stringent production and quality control regulations. For information regarding significant regulatory events, see note 15 to our consolidated financial statements.
These regulatory actions have and may adversely impact our ability to supply various products around the world and to obtain approvals for new products manufactured at the affected facilities. If any regulatory body were to require one or more of our significant manufacturing facilities to cease or limit production, or to halt the approval of new or pending regulatory applications, our business and reputation could be adversely affected. In addition, because regulatory approval to manufacture a drug is site-specific, the delay and cost of remedial actions or obtaining approval to manufacture at a specific facility could have a material adverse effect on our business, financial condition and results of operations.
The manufacture of our products is highly complex, and an interruption in our supply chain or problems with internal or third party information technology systems could adversely affect our results of operations.
Our products are either manufactured at our own facilities or obtained through supply agreements with third parties. Many of our products are the result of complex manufacturing processes, and some require highly
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specialized raw materials. Problems may arise during manufacturing for a variety of reasons, including equipment malfunction, failure to follow specific protocols and procedures, problems with or shortages of raw materials, natural disasters, and environmental factors. For some of our key raw materials, we have only a single, source of supply, and alternate sources of supply may not be readily available. If our supply of certain raw materials or finished products is interrupted from time to time, or proves insufficient to meet demand, our cash flows and results of operations could be adversely impacted. Additionally, any such supply interruption could result in a supply shortage to patients depending on the number of competitors able to meet the supply needs. Moreover, the streamlining of our manufacturing network may result in our product supply becoming more dependent on a smaller number of specific manufacturing plants. 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 are working diligently across our supply chain to ensure continuous and stable supply. Many European countries are implementing legal and regulatory measures, such as mandatory stockpiling and high penalties in order to prevent supply disruptions. Such measures may lead to substantial monetary losses in case we experience long-term supply disruptions in the relevant territories.
We also rely on complex shipping arrangements to and from the various facilities of our supply chain. Customs clearance and shipping by land, air or sea routes rely on and may be affected by factors that are not in our full control or are hard to predict.
A significant portion of our costs is comprised of raw materials for our products as well as energy, transportation and labor costs for our manufacturing and operations. We have experienced increases in prices of raw materials, energy, labor and transportation, in part due to macroeconomic pressures, including as a result of geopolitical tensions and conflicts such as the ongoing conflict between Russia and Ukraine. 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. Our ability to increase our pricing may be limited or delayed by regulatory restrictions and we may only be able to increase our pricing to the extent our competitors also increase their prices, as any increase in our pricing exceeding that of our competitors could negatively impact our competitive position. Any failure to effectively and timely pass along our increased costs to our customers may adversely impact our results of operations and financial condition.
Significant disruptions of our information technology systems could adversely affect our business.
We rely extensively on information technology systems in order to conduct business, including some systems that are managed by third-party service providers. These systems include, but are not limited to, programs and processes relating to internal and external communications, ordering and managing materials from suppliers, converting materials to finished products, shipping products to customers, processing transactions, summarizing and reporting results of operations, and complying with regulatory, legal or tax requirements. These information technology systems could be damaged or cease to function properly due to the poor performance or failure of third-party service providers, catastrophic events, power outages, network outages, failed upgrades or other similar events. If our business continuity plans do not effectively resolve such issues on a timely basis, we may suffer significant interruptions in conducting our business, which may adversely impact our business, financial condition and results of operations.
Furthermore, our systems and networks have been, and are expected to continue to be, the target of increasing advanced 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. As cybersecurity threats rapidly evolve in sophistication and become more prevalent, we are continually increasing our attention to these threats. We assess potential threats and vulnerabilities and make investments seeking to address them, including ongoing monitoring and updating of networks and systems, increasing
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specialized information security skills, deploying employee security training and updating our security policies. However, because the techniques, tools and tactics used in cyber-attacks frequently change and may be difficult to detect for periods of time, we may face difficulties in anticipating and implementing adequate preventative measures or fully mitigating harms after such an attack. In addition, hardware, software or applications we develop or procure from third parties may contain defects in design or manufacture or other problems that could unexpectedly compromise information security. We outsource administration of certain functions to vendors that could be targets of cyber-attacks. Any theft, loss and/or fraudulent use of customer, employee or proprietary data as a result of a cyber-attack targeting us or one of our third-party service providers could subject us to significant litigation, liability and costs, as well as adversely impact our reputation with customers and regulators, among others. A cyber-attack on our information technology systems may lead to substantial interruptions in our business, legal claims and liability, regulatory investigations and penalties, and reputational damage, which could have a material adverse effect on our business, financial condition and results of operations. 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.
A data security breach could adversely affect our business and reputation.
In the ordinary course of our business, we collect and store sensitive data, including intellectual property, proprietary business information and personally identifiable information (including of our employees, customers, suppliers and business partners). 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. Additionally, we expect that new privacy and cybersecurity laws and regulations will be proposed and adopted in the U.S. and other jurisdictions in which we operate. Our failure, or the failure of our third-party vendors, to comply with applicable laws and regulations and our involvement or the involvement of any of our third-party vendors in any cybersecurity incidents could result in legal claims and liability, obligations to report incidents to governmental agencies, regulatory investigations and penalties, and reputational damage, which could have a material adverse effect on our business, financial condition and results of operations.
We have procedures in place to detect and respond to cyber-attacks, data breaches, security incidents, and compromises of personal information. 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.
Because our facilities are located throughout the world, we are subject to varying intellectual property laws that may adversely affect our ability to manufacture our products.
We are subject to intellectual property laws in all countries where we have manufacturing facilities. Modifications of such laws or court decisions regarding such laws may adversely affect us and may impact our ability to produce and export products manufactured in any such country in a timely fashion. Additionally, the existence of third-party patents in such countries, with the attendant risk of litigation, may cause us to move production to a different country (potentially leading to significant production delays) or otherwise adversely affect our ability to export certain products from such countries.
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We have significant operations globally, including in countries that may be adversely affected by political or economic instability, major hostilities or acts of terrorism, which exposes us to risks and challenges associated with conducting business internationally.
We are a global pharmaceutical company with worldwide operations. Although a majority of our sales in 2022 were in the United States and Western Europe, an increasing portion of our sales and operational network are located in other regions, such as Latin America, Central and Eastern Europe and Asia, which may be more susceptible to political and economic instability, such as the ongoing conflict between Russia and Ukraine, that could result in a loss of sales in such regions. We have no manufacturing or R&D facilities in Russia or Ukraine. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the current conflict between Russia and Ukraine, rising tensions in Asia and the Middle East and other geopolitical conflicts that may arise in the future, cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets. Other countries and regions, such as the United States and Western Europe, also face potential instability due to political and other developments. In addition, in the United States, the executive administration has discussed, and in some cases implemented, changes with respect to certain trade policies, tariffs and other government regulations affecting trade between the United States and other countries. As a company that manufactures most of its products outside the United States, a “border adjustment tax” or other restriction on trade, if enacted, may have a material adverse effect on our business, financial condition and results of operations. In addition, given that a significant portion of our business is conducted in the European Union and the U.K., the formal change in the relationship between the U.K. and the European Union caused by the U.K. referendum to leave the European Union, referred to as “Brexit,” may pose certain implications to our research, commercial and general business operations in the U.K. and the European Union, including the approval and supply of our products. On December 24, 2020, the United Kingdom and European Union agreed on a new Trade and Cooperation Agreement and on December 31, 2020, the United Kingdom formally left the European Union. The Trade and Cooperation Agreement is comprehensive, but does not cover all areas of regulation pertinent to the pharmaceutical industry, so certain complexities remain. This finalization of the long-term relationship between the United Kingdom and the European Union will dictate how both jurisdictions will be impacted and may result in an impact on our business operations in Europe.
Significant portions of our operations are conducted outside the markets in which our products are sold, and accordingly we often import a substantial number of products into such markets. 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. In addition, certain countries have put regulations in place requiring local manufacturing of goods, while foreign-made products are subject to pricing penalties or even bans from participation in public procurement auctions.
We face additional risks inherent in conducting business internationally, including compliance with laws and regulations of many jurisdictions that apply to our international operations. These laws and regulations include data privacy requirements, labor relations laws, tax laws, competition regulations, import and trade restrictions, economic sanctions, export requirements, the Foreign Corrupt Practices Act (“FCPA”), the UK Bribery Act 2010 and other similar local laws that prohibit corrupt payments to governmental officials or certain payments or remunerations and provisions of things of value to customers and, in some cases, other private sector counterparties. Given the high level of complexity of these laws, there is a risk that some provisions may be breached by us, for example through fraudulent or negligent behavior of individual employees (or third parties acting on our behalf), our failure to comply with certain formal documentation requirements, or otherwise. Actions by our employees, or by third-party intermediaries acting on our behalf, in violation of such laws, whether carried out in the United States or elsewhere in connection with the conduct of our business have exposed us, and may further expose us, to significant liability for violations of the FCPA or other anti-corruption laws. In 2016, we paid a monetary fine for FCPA violations and entered into a three year deferred prosecution
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agreement with the DOJ, which included retaining an independent compliance monitor. The FCPA also requires us to keep and maintain accurate books and records and systems of internal controls to prevent bribery and corruption. 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. Any such violation could include prohibitions on our ability to offer our products in one or more countries and could materially damage our reputation, our brand, our ability to attract and retain employees, our business, our financial condition and our results of operations.
Our corporate headquarters and a sizable portion of our manufacturing activities are located in Israel. Our Israeli operations are dependent upon materials imported from outside Israel. 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.
We are subject to extensive pharmaceutical regulation, which can be costly and subject our business to disruption, delays and potential penalties.
We are subject to extensive regulation by the FDA and various other U.S. federal and state authorities, the EMA and other foreign regulatory authorities. 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. 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. For example, in the last three years, we experienced delays in obtaining anticipated approvals for various generic and innovative medicines, and during 2020 and 2021 the COVID-19 pandemic caused some delays in approvals due to travel and work restrictions. During 2022, we experienced delays in regulatory approvals of new products due to reduced capacity or re-prioritization of regulatory agencies and delays in pre-commercial launch activities. We may continue to experience similar delays.
In addition, no assurance can be given that we will remain in compliance with applicable FDA and other regulatory requirements once approval or marketing authorization has been obtained for a product. These requirements include, among other things, regulations regarding manufacturing practices, product labeling, and advertising and post marketing reporting, including adverse event reports and field alerts due to manufacturing quality concerns. Our facilities are subject to ongoing regulation, including periodic inspection by the FDA and other regulatory authorities, and we must incur expense and expend effort to ensure compliance with these complex regulations. In addition, we are subject to regulations in various jurisdictions, including the Federal Drug Supply Chain Security Act in the U.S., the Falsified Medicines Directive in the European Union and many other such regulations in other countries that require us to develop electronic systems to serialize, track, trace and authenticate units of our products through the supply chain and distribution system. Compliance with these regulations may result in increased expenses for us or impose greater administrative burdens on our organization, and failure to meet these requirements could result in fines or other penalties.
Failure to comply with all applicable regulatory requirements may subject us to operating restrictions and criminal prosecution, monetary penalties and other disciplinary actions, including, sanctions, warning letters, product seizures, recalls, fines, injunctions, suspension, shutdown of production, revocation of approvals or the inability to obtain future approvals, or exclusion from future participation in government healthcare programs. Any of these events could disrupt our business and have a material adverse effect on our revenues, profitability and financial condition.
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Healthcare reforms, and related reductions in pharmaceutical pricing, reimbursement and coverage, by governmental authorities and third-party payers may adversely affect our business.
The continuing increase in expenditures for healthcare has been the subject of considerable government attention almost everywhere we conduct business. Private health insurers and government health authorities continue to seek ways to reduce or contain healthcare costs, including by reducing or eliminating coverage for certain products and lowering reimbursement levels. The focus on reducing or containing healthcare costs has been fueled by controversies, political debate and publicity about prices for pharmaceutical products that some consider excessive, including Congressional and other inquiries into drug pricing, including with respect to our innovative medicines, which could have a material adverse effect on our reputation. In most of the countries and regions where we operate, including the United States, Western Europe, Israel, Russia, Japan, certain countries in Central and Eastern Europe and several countries in Latin America, pharmaceutical prices are subject to new government policies designed to reduce healthcare costs, and may be subject to additional regulatory efforts, funding restrictions, legislative proposals, policy interpretations, investigations and legal proceedings regarding pricing practices. These changes frequently adversely affect pricing and profitability and may cause delays in market entry, or decisions to forgo or discontinue development programs for our products. 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. Private third-party payers, such as health plans, increasingly challenge pharmaceutical product pricing, which could result in lower prices, lower reimbursement rates and a reduction in demand for our products. 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. Congress and various state legislatures in the United States continue to propose and enact legislative reforms to limit or reduce the cost of healthcare and regulate drug pricing practices. For example, the IRA introduced certain measures that, among other things, limit the price increases of prescription drugs and authorize the Medicare program to negotiate pricing for certain high-cost drugs, including physician-administered and self-administered drugs, that have been on the market for a minimum amount of time without generic competition. The IRA also includes reforms to Medicare benefit design, increasing a manufacturer’s coverage liability for applicable products. As the IRA was only recently enacted, we cannot accurately predict the impact it will have on the profitability of our products or our research and development initiatives. A number of state legislatures have also begun considering legislation that would implement IRA-like frameworks for state regulated insurance markets.
The pharmaceutical industry faces uncertainty regarding future pharmaceutical pricing changes. For example, on November 27, 2020 the CMS published an Interim Final Rule (“IFR”) that would have imposed a mandatory Most Favored Nation (“MFN”) pricing model on the fifty single-source drugs and biologics (including biosimilars) with the highest annual Medicare Part B spending for seven years, beginning January 1, 2021. The MFN model would have ultimately based payment for each of the fifty drugs on the lowest-available, gross domestic product (“GDP”)-adjusted drug price available in any Organization for Economic Co-operation and Development (“OECD”) country that meets minimum GDP requirements. Pharmaceutical and biotechnology industry organizations as well as several patient support groups filed litigation to enjoin implementation of the IFR. On December 28, 2020, the U.S. District Court for the Northern District of California imposed a nationwide preliminary injunction on implementation of the IFR pending CMS’s completion of regulatory notice-and-comment rulemaking by CMS. On December 29, 2021, CMS published a final rule that rescinded the IFR, effective February 28, 2022, to address the procedural issues acknowledged in the preliminary injunction. Although the IFR as published will not go into effect, CMS could propose future pharmaceutical pricing changes similar to the IFR, albeit with the required notice and opportunity for stakeholders to participate in the regulatory process.
Increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private sector beneficiaries may result in increased pricing pressure by influencing the reimbursement policies of third-party
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payers. Healthcare reform legislation has increased the number of patients who have insurance coverage for our products, but provisions such as the assessment of a branded pharmaceutical manufacturer fee and an increase in the amount of rebates that manufacturers pay for coverage of their drugs by Medicaid programs may have an adverse effect on us. It is uncertain how current and future reforms in these areas will influence the future of our business operations and financial condition. In addition, “tender systems” for generic pharmaceuticals have been implemented (by both public and private entities) in a number of significant markets in which we operate, including in some European markets, in an effort to lower prices. Under such tender systems, manufacturers submit bids that establish prices for generic pharmaceutical products. These measures impact marketing practices and reimbursement of drugs and may further increase pressure on reimbursement margins. Certain other countries may consider the implementation of a tender system. Failing to win tenders or our withdrawal from participating in tenders, or the implementation of similar systems in other markets leading to further price declines, could have a material adverse effect on our business, financial position and results of operations.
A significant portion of our revenues is derived from sales to a limited number of customers.
A significant portion of our revenues is derived from sales to a limited number of customers. If we were to experience a significant reduction in or loss of business with one or more such customers, or if one or more such customers were to experience difficulty in paying us on a timely basis, our business, financial condition and results of operations could be materially adversely affected. For a description of our revenue from our main customers, see note 19 to our consolidated financial statements.
We may not be able to find or successfully bid for suitable acquisition targets or licensing opportunities, or consummate and integrate future acquisitions.
We may evaluate or pursue potential acquisitions, strategic alliances, joint ventures, private equity, third-party financing and licenses, among other transactions, as part of our business strategy. Relying on acquisitions, licensing agreements and other transactions as sources of new innovative medicines, biosimilar and other products, or as a means of growth, involves risks that could adversely affect our future revenues and operating results. We may not be successful in seeking or consummating appropriate opportunities to enable us to execute our business strategy. We may not be able to pursue relevant acquisitions and licensing opportunities due to financial capacity constraints, and we may not be able to obtain necessary regulatory approvals, including those of competition authorities, and as a result, or for other reasons, we may fail to consummate an announced acquisition. 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. In addition, partners for which we may enter into licensing or other collaboration agreements may not be able to perform their responsibilities challenging the ability to monetize opportunities related to them.
We may decide to sell assets, which could adversely affect our prospects and opportunities for growth.
We may from time to time consider selling certain assets if we determine that such assets are not critical to our strategy or we believe the opportunity to monetize the asset is attractive or for various other reasons, including for the reduction of indebtedness. We closed or divested a significant number of manufacturing plants and R&D facilities in connection with our restructuring plan and may close or divest additional plants and facilities as part of our ongoing efforts regarding network consolidation activities. We have explored and may continue to explore the sale of certain assets. We may fail to identify appropriate opportunities to divest assets on terms acceptable to us or may fail to transition employees and continuing operations from disposed businesses efficiently. If divestiture opportunities are found, consummation of any such divestiture may be subject to closing conditions, including obtaining necessary regulatory approvals, including those of competition authorities, and as a result, or for other reasons, we may fail to consummate an anticipated divestiture. Although our expectation is to engage in asset sales only if they advance or otherwise support our overall strategy, any such sale could reduce the size or scope of our business, the capabilities or durability of our manufacturing network, our market share in particular markets or our opportunities with respect to certain markets.
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Compliance, regulatory and litigation risks
Our operations are subject to complex legal and regulatory environments. If we fail to comply with applicable laws and regulations we may suffer legal consequences that may have a material effect on our business, operations or reputation.
We operate around the world in complex legal and regulatory environments. Any failure to comply with applicable laws, rules and regulations may result in civil and/or criminal legal proceedings and lead to fines, damages, mandatory compliance programs and other sanctions and remedies that may materially affect our business and operations as well as our reputation. In addition, as rules and regulations change or as interpretations of those rules and regulations evolve, our prior conduct may be investigated.
Examples of rules and regulations impacting our operations include rules and regulations applicable to the sales and marketing of our products, competition laws, pricing laws, economic sanctions, export controls, import and trade laws and regulations, anti-bribery laws, privacy laws, compliance with cGMP, labor laws, safety and laws regarding manufacturing practices, product labeling, advertising and post marketing reporting including adverse event reports and field alerts due to manufacturing quality concerns, tax and financial reporting laws and environmental laws.
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 and corporate governance and environmental matters. These investigations and litigations are costly and involve a significant diversion of management attention. Such proceedings are unpredictable and may develop over lengthy periods of time. An 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, which can be expensive and disruptive to operations.
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. This could increase our premiums, reduce the scope and capacity of our coverage, and adversely affect our ability to maintain and renew our existing insurance policies on favorable terms or at all. While we continue to maintain insurance coverage intended to address certain risks, such coverage may be insufficient to cover claims and losses we face.
Public concern over the abuse of opioid medications, increased legal and regulatory action and any delay in our ability to obtain sufficient participation of plaintiffs for the nationwide settlement to take effect, could negatively affect our business.
Certain governmental and regulatory agencies are focused on the abuse of opioid medications in the United States. U.S. federal, state and local governmental and regulatory agencies are conducting investigations of us, other pharmaceutical manufacturers and other supply chain participants with regard to the manufacture, sale, marketing and distribution of opioid medications. We currently are litigating civil claims and administrative actions brought by various states and political subdivisions as well as private claimants, against various manufacturers, distributors and retail pharmacies throughout the United States in connection with our manufacture, marketing, sale and distribution of opioids. In November 2022, we finalized the documentation of our nationwide settlement, which is contingent upon reaching sufficient participation by states and subdivisions. There is no assurance as to when or whether such sufficient participation can be obtained, and based on experience with the nationwide settlements of other defendants in these matters, we do not expect 100 percent participation by all states and subdivisions. Additionally, once finalized, settlement payments that we will be required to make, 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
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version of Narcan® (naloxone hydrochloride nasal spray) in the amounts and at the times required under the terms of our nationwide settlement. Moreover, if we are unable to reach an agreement with any remaining states and subdivisions, we will continue to litigate these cases and may face a material adverse judgment. For further information, see “Opioids Litigation” in note 12b to our consolidated financial statements.
Additionally, we are defending claims and putative class action lawsuits in Canada in relation to the manufacture, sale, marketing and distribution of opioid medications. The loss or settlement of any such claims related to opioids could have a material adverse impact on our liquidity.
In addition to the costs and potential consequences associated with defending the governmental investigations and legal proceedings, legislative, regulatory or industry measures to address the misuse of prescription opioid medications may also affect our business in ways that we are not able to predict. For example, a number of states, including New York, have enacted legislation that requires the payment of assessments or taxes on the sale or distribution of opioid medications in those states. If other states or local jurisdictions successfully enact similar legislation and we are not able to mitigate the impact on our business through operational changes or commercial arrangements, such legislation in the aggregate may have a material adverse effect on our business, financial condition and results of operations.
Furthermore, we utilize controlled substances in certain of our current products and products in development, and therefore must meet the requirements of the Controlled Substances Act of 1970 and related regulations administered by the DEA in the U.S., as well as the requirements of similar laws and regulations in other countries where we operate, relating to the manufacture, importation, shipment, storage, sale, and use of controlled substances. We are committed to compliance and have robust compliance systems in place; however, risks associated with these laws and regulations cannot be entirely eliminated by policies and procedures. For example, violations of the Controlled Substances Act of 1970 and related laws and regulations by third-party intermediaries (such as distributors and wholesalers) may expose us to liability and penalties and could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or share price. In addition, prescription drug abuse and the diversion of opioids and other controlled substances are the frequent subject of public attention, including, for example, recent media reports over the appropriateness of prescription of medications used to treat attention deficit hyperactivity disorder (ADHD). The occurrence of any of the above risks could have a material adverse effect on our business, financial condition, results of operations, cash flows, and/or share price.
The pharmaceutical sector is facing increased government scrutiny from competition and pricing authorities around the world, which may expose us to significant damages and commercial restrictions that can materially and adversely affect our business.
We are required to comply with competition laws in the territories where we do business around the world. Compliance with these laws has been the subject of increasing focus and activity by regulatory authorities, both in the United States and Europe, in recent years. Alleged actions by our employees, in violation of such laws, or evolving interpretations of competition law as applicable to certain practices, have exposed us, and may further expose us, to investigations and legal proceedings, which may result in significant liability for violations of competition laws, which may have a material adverse effect on our reputation, business, financial condition and results of operations.
We are subject to a DOJ civil investigation and a criminal indictment charging Teva USA with criminal felony Sherman Act violations, that, if resulting in a conviction or guilty plea, could have a material adverse effect on our business, including monetary penalties, debarment from federally funded health care programs and reputational harm. In addition, we are a party to numerous civil claims brought by state officials and private plaintiffs alleging that Teva, together with other pharmaceutical manufacturers, engaged in conspiracies to fix prices and/or allocate market share of generic products in the United States. For further information, see “Government Investigations and Litigation Relating to Pricing and Marketing” in note 12b to our consolidated financial statements.
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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. Accordingly, we may receive formal or informal requests from competition law authorities around the world for information about a particular settlement agreement, and there is a risk that governmental authorities, customers, other downstream purchasers or others may commence actions against us alleging violations of antitrust laws based on our settlement agreements. 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. 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. For example, the State of California has enacted legislation that prohibits, with certain exceptions and safe harbors, various types of patent litigation settlements, and imposes substantial monetary penalties on companies and individuals who do not comply. The enforcement of this law has been preliminarily enjoined as likely violating the U.S. 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.
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. Congressional investigations regarding both our innovative medicines and generic medicines, the European Commission’s inquiry into COPAXONE, and litigation concerning the U.K. Competition and Markets Authority’s inquiry regarding hydrocortisone. For example, in September 2020, the U.S. House Committee on Oversight and Reform held a hearing focused on pricing of branded medications, which focused in part on historic pricing of COPAXONE in the U.S., and subsequently issued a report with respect to COPAXONE’s pricing. Additionally, on October 10, 2022, the European Commission issued a Statement of Objections, which sets forth its preliminary allegations that Teva had engaged in anti-competitive practices relating to COPAXONE. It is not possible to predict the ultimate outcome of any such investigations, claims or proceedings or what other investigations or lawsuits or regulatory responses may result from such assertions, which could 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.
Third parties may claim that we infringe their intellectual property rights and we may have sold or may in the future elect to sell products prior to the final resolution of outstanding intellectual property litigation, and, as a result, we may be prevented from manufacturing and selling some of our products and could be subject to liability for damages in the United States, Europe and other markets where we do business.
Our ability to introduce new products depends in large part upon the success of our challenges to patent rights held by third parties or our ability to develop non-infringing products. Based upon a variety of legal and commercial factors, we may elect to sell a product even though patent litigation is still pending, either before any court decision is rendered or while an appeal of a lower court decision is pending. The outcome of such patent litigation could, in certain cases, materially adversely affect our business. For further information, see “Intellectual Property Litigation” in note 12b to our consolidated financial statements.
If we sell products prior to a final court decision, and such decision is adverse to us, we could be required to cease selling the infringing products, causing us to lose future sales revenue from such products and we could face substantial liabilities for patent infringement, in the form of either payment for the innovator’s lost profits or a royalty on our sales of the infringing products. These damages may be significant and could materially
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adversely affect our business. In the United States, in the event of a finding of willful infringement, the damages assessed may be up to three times the profits lost by the patent owner. 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. 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. As our portfolio of available products expands, particularly with new innovative medicines, we may experience increases in product liability claims asserted against us.
We maintain an insurance program, which may include commercial insurance, self-insurance (including direct risk retention), or a combination of both approaches, in amounts and on terms that it believes are reasonable and prudent in light of its business and related risks. We sell, and will continue to sell, pharmaceutical products that are not covered by its product liability insurance. In addition, we may be subject to claims for which insurance coverage is denied, as well as claims that exceed our policy limits. Product liability coverage for pharmaceutical companies is becoming more expensive and increasingly difficult to obtain. 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.
Any failure to comply with the complex reporting and payment obligations under the Medicare and Medicaid programs may result in further litigation or sanctions, in addition to those that we have announced in previous years.
The U.S. laws and regulations regarding Medicare and/or Medicaid reimbursement and rebates and other governmental programs are complex. 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 under these programs are subject to review and challenge, and it is possible that such reviews could result in material changes. In addition, the U.S. government has alleged violations of the federal Anti-Kickback Statute, and related causes of action under the federal False Claims Act and state law in connection with Teva’s donations to patient assistance programs. Such allegations could, if proven or settled, result in additional monetary penalties (beyond the lawsuits we have already settled) and possible exclusion from Medicare, Medicaid and other programs. In addition, we are notified from time to time of governmental investigations regarding drug reimbursement or pricing issues. For further information, see “Government Investigations and Litigation Relating to Pricing and Marketing” in note 12b to our consolidated financial statements. Certain parts of Medicare benefits are under scrutiny, as the U.S. Congress looks for ways to reduce government spending on prescription medicines.
Sanctions and trade control laws create the potential for significant liabilities, penalties and reputational harm.
As a company with global operations, we may be subject to national laws as well as international treaties and conventions controlling imports, exports, re-export, transfer and diversion of goods (including finished goods, materials, APIs, packaging materials, other products and machines), services and technology. These include import and customs laws, export controls, trade embargoes and economic sanctions, restrictions on sales to parties that are listed on (or are owned or controlled by one or more parties listed on) denied party watch lists and anti-boycott measures (collectively “Customs and Trade Controls”). Applicable Customs and Trade Controls are administered by Israel’s Ministry of Finance, the U.S. Treasury’s Office of Foreign Assets Control, the U.S. Department of Commerce, other U.S. agencies and multiple other agencies of other jurisdictions around the
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world where we do business. Customs and Trade Controls relate to a number of aspects of our business, including most notably the sales of finished goods and API as well as the licensing of our intellectual property. Compliance with Customs and Trade Controls has been the subject of increasing focus and activity by regulatory authorities, both in the United States and elsewhere, in recent years, and requirements under applicable Customs and Trade Controls in general, change frequently. Sanctions imposed with respect to the ongoing conflict between Russia and Ukraine have been particularly dynamic and future geopolitical conflicts involving other jurisdictions may result in further changes to the sanctions environment. Any such changes to the sanctions environment may require us to withdraw from or limit our exposure to certain markets or to terminate certain business relationships in order to remain in compliance with applicable laws. Although we have policies and procedures designed to address compliance with Customs and Trade Controls, actions by our employees, by third-party intermediaries (such as distributors and wholesalers) or others acting on our behalf in violation of relevant laws and regulations may expose us to liability and penalties for violations of Customs and Trade Controls and accordingly may have a material adverse effect on our reputation and our business, financial condition and results of operations.
Our failure to comply with applicable environmental, health and safety laws and regulations worldwide could adversely impact our business and results of operations.
We are subject to laws and regulations concerning the environment, safety matters, regulation of chemicals and product safety in the countries where we manufacture and sell our products or otherwise operate our business. These requirements include regulation of the handling, manufacture, transportation, storage, use and disposal of materials, including the discharge of pollutants and pharmaceutical residues into the environment. If we fail to comply with these laws and regulations, we may be subject to enforcement proceedings including fines and penalties. 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. Under certain laws, we may be required to remediate contamination at certain properties, regardless of whether the contamination was caused by us or by previous occupants or users of the property. 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. These more stringent requirements could increase our costs of sourcing, production, and transportation, as well as have negative reputational impacts if we fail to meet such requirements. While we have validated Science-Based Targets for GHG reductions, failure to respond to risks regarding climate change may have a material adverse effect on our business, financial condition, results of operations and reputation. The consequences of climate change, such as extreme weather and water scarcity, could pose risks to our facilities and disruption of our activities.
Natural disasters and extreme weather events resulting from climate change, such as floods, heatwaves, blizzards, hurricanes, wildfires, the rise of sea level, and water stress, could impact our business activities and our ability to deliver our products to customers. We evaluate these risks in our supply planning, loss prevention and business continuity planning. 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. We have been placing increased attention on water management, implementing a scarcity-focused approach to water conservation to align with community needs and advance toward sustainable operations. If our planning and risk management regarding natural disasters and extreme weather events fail, our facilities could be impacted and our activities could be significantly disrupted.
Our business could be negatively impacted by ESG issues.
In recent years, there has been an increased focus from certain investors, employees, consumers, regulators (including the SEC), and other stakeholders concerning ESG matters. These matters can contribute to the long-
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term sustainability of companies’ performance and an inability to successfully perform on ESG matters can result in negative impacts to our reputation, recruitment, retention, operations, financial results, the price of our shares, and our ability to attract or retain certain types of customers and investors. 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. 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. Such failures could be due to changes in our business or evolving regulations in the countries in which we operate, and any such failures or perceived failures could expose us to negative impacts, including government enforcement actions or private litigation. We have also issued sustainability-linked senior notes with targets that include improving access to medicines in low- and middle-income countries and reducing GHG emissions, and failure to achieve such targets could negatively impact our reputation and also result in increased payments to holders of such senior notes.
A variety of organizations measure performance on ESG topics, including on topics such as the cost, even if unintended, of our actions on climate change and inequality in society. We could be criticized for the scope of such initiatives or goals or perceived as not acting responsibly or far enough in connection with these matters. Any such ESG matters could have a material adverse effect on our reputation, business, financial condition and results of operations. Additionally, companies across a variety of industries, including the pharmaceutical industry, are experiencing increased shareholder activism regarding ESG matters. If we are required to respond to actions by activist shareholders, we could incur disruptions to the operation of our business and our management’s attention could be diverted. While we monitor a broad range of ESG issues, there can be no certainty that we will manage such issues successfully, or that we will successfully meet the expectations of investors, employees, consumers and other stakeholders.
Moreover, our selection of disclosure frameworks that seek to align with various reporting standards may change from time to time and may result in lack of meaningful or comparative data from period to period. Our interpretation of reporting standards may differ from those of others and such standards may change over time, any of which could result in significant revisions to our goals or reported progress in achieving such goals. 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. Inadequate processes to collect and review this data and information prior to disclosure could be subject to potential liability related to such information.
Additional financial risks
Because we have substantial international operations, our sales, profits and cash flow may be adversely affected by currency fluctuations and restrictions as well as credit risks.
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 2022, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar. As a result, we are subject to significant foreign currency risks, including repatriation restrictions in certain countries, and may face heightened risks as we enter new markets. A substantial proportion of our sales, particularly in Latin America, Central and Eastern European countries and Asia, are recorded in local currencies, which exposes us to the direct risk of devaluations, hyperinflation or exchange rate fluctuations. In addition, although the majority of our operating costs are recorded in, or linked to, the U.S. dollar, in 2022, 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. Moreover, the strengthening of the U.S. dollar versus other currencies in which we operate, negatively impacted our revenues, results of operations, profits and cash flows.
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We use derivative financial instruments and “hedging” techniques, such as issuance of debt in non-U.S. dollar currencies, to manage our balance sheet and income statement exposure to currency exchange rate fluctuations in the major foreign currencies in which we operate. However, not all of our potential exposure is covered, and some elements of our consolidated financial statements, such as our equity position, are not protected against foreign currency exposures. Therefore, our exposure to exchange rate fluctuations could have a material adverse effect on our financial results.
The imposition of price controls or restrictions on the conversion of foreign currencies could also have a material adverse effect on our financial results. In addition, operating internationally exposes us to credit risks of customers and other counterparties in a number of jurisdictions. Some of these customers and other counterparties may have lesser creditworthiness than others and the legal system for enforcing collections in such jurisdictions may be less well-developed.
Our long-lived assets may continue to lead to significant impairments in the future.
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. The amount of goodwill, identifiable intangible assets and property, plant and equipment on our consolidated balance sheet may increase following acquisitions or other collaboration agreements. Changes in market conditions, including further increases in discount rates, exchange rate fluctuations, or other changes in the future outlook of value may lead to further impairments in the future. In addition, the potential divestment of assets, including the closure or divestment of manufacturing plants and R&D facilities, headquarters and other office locations, may lead to additional impairments. Future events or decisions may lead to asset impairments and/or related charges. For assets that are not impaired, we may adjust the remaining useful lives. Certain non-cash impairments may result from a change in our strategic goals, business direction or other factors relating to the overall business environment. Any significant impairment could have a material adverse effect on our results of operations. See notes 6 and 7 in our consolidated financial statements, for descriptions of impairments of intangible assets and goodwill in recent periods.
Our tax liabilities could be larger than anticipated.
We are subject to tax in many jurisdictions, and significant judgment is required in determining our provision for income taxes. Likewise, we are subject to audit by tax authorities in many jurisdictions. In such audits, our interpretation of tax legislation may be challenged and tax authorities in various jurisdictions may disagree with, and subsequently challenge, the amount of profits taxed in such jurisdictions under our inter-company agreements.
Although we believe our estimates are reasonable, the ultimate outcome of such audits and related litigation could be different from our provision for taxes and may have a material adverse effect on our consolidated financial statements and cash flows. For additional information see note 13 to our consolidated financial statements.
The base erosion and profit shifting (“BEPS”) project undertaken by the OECD may have adverse consequences to our tax liabilities. The BEPS project contemplates changes to numerous international tax principles, as well as national tax incentives, and these changes, when adopted by individual countries, could adversely affect our provision for income taxes. The first wave of BEPS recommendations has been implemented by countries in specific national tax laws, and the OECD is currently working on further initiatives that may further change current international tax principles. On December 12, 2022, the EU Council announced that EU member states had reached an agreement to implement at EU level the minimum taxation component of 15% (“Pillar Two”) of the OECD’s reform of international taxation. We are currently monitoring the new rules and awaiting further guidance and country agreements, however it remains difficult to predict the magnitude of the effect of such new rules on our financial results.
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The termination or expiration of governmental programs or tax benefits, or a change in our business, could adversely affect our overall effective tax rate.
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. 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. 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. Additionally, some of these programs and the related tax benefits are available to us for a limited number of years, and these benefits expire from time to time.
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. |
Equity ownership risks
Shareholder rights and responsibilities as a shareholder are governed by Israeli law, which differs in some material respects from the rights and responsibilities of shareholders of U.S. companies.
The rights and responsibilities of the holders of our ordinary shares are governed by our articles of association and by Israeli law. These rights and responsibilities differ in some material respects from the rights and responsibilities of shareholders of U.S. corporations. In particular, a shareholder of an Israeli company has a duty to act in good faith and in a customary manner in exercising his or her rights and performing his or her obligations towards the company and other shareholders, and to refrain from abusing his or her power in the company, including, among other things, in voting at a general meeting of shareholders on matters such as amendments to a company’s articles of association, increases in a company’s authorized share capital, mergers and acquisitions and related party transactions requiring shareholder approval. 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. There is limited case law available to assist in understanding the nature of this duty or the implications of these provisions. These provisions may be interpreted to impose additional obligations and liabilities on holders of our ordinary shares that are not typically imposed on shareholders of U.S. corporations.
Provisions of Israeli law and our articles of association may delay, prevent or make difficult an acquisition of us, prevent a change of control and negatively impact our share 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 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. For example, Israeli tax law may subject a shareholder who exchanges his or her ordinary shares for shares in a foreign corporation to taxation before disposition of the investment in the foreign corporation. These provisions of Israeli law may delay, prevent or make difficult an acquisition of our company, which could prevent a change of control and, therefore, depress the price of our shares.
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In addition, our articles of association contain certain provisions that may make it more difficult to acquire us, such as provisions that provide for a classified board of directors and that our Board of Directors may issue preferred shares. These provisions may have the effect of delaying or deterring a change in control of us, thereby limiting the opportunity for shareholders to receive a premium for their shares and possibly affecting the price that some investors are willing to pay for our securities.
Our ADSs and ordinary shares are traded on different stock exchanges and this may result in price variations.
Our ADSs have been traded in the United States since 1982, and on the New York Stock Exchange (the “NYSE”) since 2012, and our ordinary shares have been listed on the TASE since 1951. Trading in our securities on these markets takes place in different currencies (our ADSs are traded in U.S. dollars and our ordinary shares are traded in New Israeli Shekels), and at different times (resulting from different time zones, different trading days and different public holidays in the United States and Israel). As a result, the trading prices of our securities on these two markets may differ due to these factors. In addition, any decrease in the price of our securities on one of these markets could cause a decrease in the trading price of our securities on the other market.
It may be difficult to enforce non-Israeli judgments in Israeli courts against us, our officers and our directors.
We are incorporated in Israel. Certain of our executive officers and directors and our outside auditors are not residents of the United States, and a substantial portion of our assets and the assets of these persons are located outside the United States. Therefore, it may be difficult for an investor, or any other person or entity, to file or enforce an action against us or any of those persons under non-Israeli law in an Israeli court. In addition, an Israeli court may be deemed forum non conveniens for such legal proceedings. 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.
ITEM 2. PROPERTIES
We own or lease 78 manufacturing and R&D facilities, occupying approximately 19 million square feet. As of December 31, 2022, 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 |
20 | 3,200 | ||||||
Europe |
35 | 10,000 | ||||||
International Markets |
23 | 5,800 | ||||||
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|||||
Worldwide Total Manufacturing and R&D Facilities |
78 | 19,000 |
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.
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.
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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.
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.
ITEM 3. LEGAL PROCEEDINGS
Information pertaining to legal proceedings can be found in “Item 8 Financial Statements—Note 12b Contingencies” and is incorporated by reference herein.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
PART II
ITEM 5. MARKET FOR THE COMPANY’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
American Depositary Shares (“ADSs”)
Our ADSs, which have been traded in the United States since 1982, were admitted to trade on the Nasdaq National Market in October 1987 and were subsequently traded on the Nasdaq Global Select Market. On May 30, 2012, we transferred the listing of our ADSs to the New York Stock Exchange (the “NYSE”). The ADSs are quoted under the symbol “TEVA.” Citibank, N.A. serves as depositary for the ADSs. Each ADS represents one ordinary share.
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, 2022 was 2,161.
The number of record holders of ordinary shares at December 31, 2022 was 169.
The number of record holders is based upon the actual number of holders registered on our books at such date and does not include holders of shares in “street names” or persons, partnerships, associations, corporations or other entities identified in security position listings maintained by depository trust companies.
Dividends
We have not paid dividends on our ordinary shares or ADSs since December 2017.
Unregistered Sales of Equity Securities and Use of Proceeds
None.
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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, 2018, 2019, 2020, 2021 and 2022, of $100 invested on December 31, 2017 in the Company’s ADSs, the Standard & Poor’s 500 Index and the Dow Jones U.S. Pharmaceuticals Index.
* | $100 invested on December 31, 2017 in stock or index – including reinvestment of dividends. Indexes calculated on month-end basis. |
ITEM 6. [RESERVED]
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ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Business Overview
We are a global pharmaceutical company, committed to helping patients around the world to access affordable medicines and benefit from innovations to improve their health. Our mission is to be a global leader in generics, innovative medicines and biopharmaceuticals, improving the lives of patients.
We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Our key strengths include our world-leading generic medicines expertise and portfolio, focused innovative medicines portfolio and global infrastructure and scale.
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. Each business segment manages our entire product portfolio in its region, including generics, which includes biosimilars and OTC products, as well as innovative medicines. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.
In addition to these three segments, we have other activities, primarily the sale of API to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis.
Macroeconomic Environment
In recent months, the global economy has been impacted by fluctuating foreign exchange rates. Approximately 47% of our revenues are denominated in currencies other than the U.S. dollar. The strengthening of the U.S. dollar versus other currencies in which we operate, negatively impacts our revenues, results of operations, profits and cash flows. We also manufacture largely outside of the United States, which may to varying degrees result in lower expenses. Additionally, high levels of inflation have recently resulted in significant economic volatility and monetary tightening by central banks. The global economy has also been impacted by the ongoing conflict between Russia and Ukraine, which has spurred rising energy costs and caused disruptions to the global and the Company’s internal supply chain. Supply chain disruptions and rising energy costs could continue to result in delays in our production and distribution processes, R&D initiatives and our ability to timely respond to consumer demand. See also discussion under “—International Markets segment” below.
We have implemented certain measures in response to such macroeconomic pressures and are continually considering various initiatives, including price adjustments, enhanced inventory management and alternative sourcing strategies for our raw material supply, to allow us to partially mitigate and offset the impact of these macroeconomic factors. However, although inflationary and other macroeconomic pressures may ease, the higher costs we have experienced during the recent period have already impacted our operations and will likely continue to have an effect on our financial results.
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Highlights
Significant highlights of 2022 included:
• | Our revenues in 2022 were $14,925 million, a decrease of 6% in U.S. dollars, or 1% in local currency terms, compared to 2021, mainly due to lower revenues from COPAXONE and certain respiratory products in our North America and Europe segments, generic products as well as BENDEKA and TREANDA in our North America segment, partially offset by higher revenues from generic products in our Europe and International Markets segments, and from our innovative products – AUSTEDO and AJOVY, and Anda. |
• | Our North America segment generated revenues of $7,452 million and profit of $1,993 million in 2022. Revenues decreased by 5%, compared to 2021. Profit decreased by 10% compared to 2021. |
• | Our Europe segment generated revenues of $4,525 million and profit of $1,496 million in 2022. Revenues decreased by 7% in U.S. dollars. In local currency terms, revenues increased by 4% compared to 2021. Profit was flat compared to 2021. |
• | Our International Markets segment generated revenues of $1,903 million and profit of $479 million in 2022. Revenues decreased by 6% in U.S. dollars. In local currency terms, revenues increased by 3% compared to 2021. Profit decreased by 9% compared to 2021. |
• | Our revenues from other activities in 2022 were $1,045 million, a decrease of 9% in U.S. dollars, or 6% in local currency terms, compared to 2021. |
• | Impairments of identifiable intangible assets were $355 million and $424 million in the years ended December 31, 2022 and 2021, respectively. See note 6 to our consolidated financial statements. |
• | 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. |
• | We recorded expenses of $414 million for other asset impairments, restructuring and other items in 2022, compared to expenses of $341 million in 2021. See note 15 to our consolidated financial statements. |
• | In 2022, we recorded expenses of $2,082 million in legal settlements and loss contingencies, compared to expenses of $717 million in 2021. See note 11 to our consolidated financial statements. |
• | Operating loss was $2,099 million in 2022, compared to an operating income of $1,716 million in 2021. |
• | Financial expenses, net were $966 million in 2022, compared to $1,058 million in 2021. See note 17 to our consolidated financial statements. |
• | In 2022, we recognized a tax benefit of $638 million, or 21%, on a pre-tax loss of $3,065 million. In 2021, we recognized a tax expense of $211 million, or 32%, on a pre-tax income of $658 million. See note 13 to our consolidated financial statements. |
• | As of December 31, 2022, our debt was $21,212 million, compared to $23,043 million as of December 31, 2021. See note 9 to our consolidated financial statements. |
• | Cash flow generated from operating activities in 2022 was $1,590 million, compared to $798 million in 2021. The increase in 2022 resulted mainly from the sale of accounts receivables under our U.S. securitization facility entered into in November 2022, and lower collections remitted to the owner of the receivables under our EU securitization program mainly due to exchange rate fluctuations, partially offset by an increase in inventory levels, as well as higher payments of legal settlements in connection with the opioids litigation. For further information on our securitization facilities see note 10f to our consolidated financial statements. |
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• | 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 in proceeds from divestitures of businesses and other 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 2021, we generated free cash flow of $2,196 million. The increase in 2022 resulted mainly from an increase in cash flow generated from operating activities, partially offset by lower beneficial interest collected in exchange for securitized accounts receivables under our EU securitization program mainly due to exchange rate fluctuations, as well as lower proceeds from divestitures of businesses and other assets. For further information on our securitization facilities see note 10f to our consolidated financial statements. |
Results of Operations
The discussion that follows includes a comparison of our results of operations and liquidity and capital resources for fiscal years 2022 and 2021. For a comparison of our results of operations and financial condition for fiscal years 2021 and 2020, see “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations” of our 2021 Annual Report on Form 10-K, filed with the SEC on February 9, 2022.
Segment Information
North America Segment
The following table presents revenues, expenses and profit for our North America segment for the past two years:
Year ended December 31, | ||||||||||||||||
2022 | 2021 | |||||||||||||||
(U.S. $ in millions /% of Segment Revenues) | ||||||||||||||||
Revenues |
$ | 7,452 | 100% | $ | 7,809 | 100% | ||||||||||
Gross profit |
3,926 | 52.7% | 4,226 | 54.1% | ||||||||||||
R&D expenses |
532 | 7.1% | 618 | 7.9% | ||||||||||||
S&M expenses |
941 | 12.6% | 988 | 12.7% | ||||||||||||
G&A expenses |
474 | 6.4% | 427 | 5.5% | ||||||||||||
Other income |
(15 | ) | § | (31 | ) | § | ||||||||||
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Segment profit* |
$ | 1,993 | 26.7% | $ | 2,224 | 28.5% | ||||||||||
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* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
North America Revenues
Our North America segment includes the United States and Canada. Revenues from our North America segment in 2022 were $7,452 million, a decrease of $357 million, or 5%, compared to 2021, mainly due to a decline in revenues from generic products, COPAXONE and BENDEKA and TREANDA, partially offset by higher revenues from our innovative products—AUSTEDO and AJOVY, as well as Anda.
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Revenues by Major Products and Activities
The following table presents revenues for our North America segment by major products and activities for the past two years:
Year ended December 31, | Percentage Change 2022-2021 |
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2022 | 2021 | |||||||||||
(U.S. $ in millions) | ||||||||||||
Generic products |
$ | 3,549 | $ | 3,769 | (6 | %) | ||||||
AJOVY |
218 | 176 | 24 | % | ||||||||
AUSTEDO |
963 | 802 | 20 | % | ||||||||
BENDEKA and TREANDA |
316 | 385 | (18 | %) | ||||||||
COPAXONE |
387 | 577 | (33 | %) | ||||||||
Anda |
1,471 | 1,323 | 11 | % | ||||||||
Other* |
549 | 777 | (29 | %) | ||||||||
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Total |
$ | 7,452 | $ | 7,809 | (5 | %) | ||||||
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* | Other revenues in 2022 decreased mainly due to reduction in sales of certain innovative respiratory products. On October 1, 2022, we discontinued marketing ProAir HFA. |
Generic products revenues in our North America segment (including biosimilars) in 2022 decreased by 6% to $3,549 million, compared to 2021, mainly due to increased competition to parts of our portfolio, as well as supply disruptions including the closure of the Irvine, CA site, partially offset by revenues from generic launches in 2022.
Among the most significant generic products we sold in North America in 2022 were Truxima® (the biosimilar to Rituxan®), lenalidomide capsules (the generic version of Revlimid®), epinephrine injectable solution (the generic equivalent of EpiPen® and EpiPen Jr.®), albuterol sulfate inhalation aerosol (our ProAir authorized generic), and lidocaine transdermal patch (the generic equivalent of Lidoderm Patch®).
On March 7, 2022 we announced the launch of the first generic version of Revlimid® (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States. These lenalidomide capsules are a prescription medicine used in adults for the treatment of (i) multiple myeloma in combination with the medicine dexamethasone, (ii) certain myelodysplastic syndromes, and (iii) mantle cell lymphoma following specific prior treatment.
For more information on our generic products, including biosimilars, see “Item 1—Business—Our Product Portfolio and Business Offering—Generic Medicines.”
In 2022, our total prescriptions were approximately 306 million (based on trailing twelve months), representing 8.2% of total U.S. generic prescriptions according to IQVIA data.
AJOVY revenues in our North America segment in 2022 increased by 24% to $218 million, compared to 2021, mainly due to growth in volume and favorable net pricing. In 2022, AJOVY’s exit market share in the United States in terms of total number of prescriptions was 26%, compared to 21.4% in 2021.
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 2022 increased by 20% to $963 million, compared to 2021, mainly due to growth in volume.
For more information on AUSTEDO, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—AUSTEDO.”
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BENDEKA and TREANDA combined revenues in our North America segment in 2022 decreased by 18% to $316 million, compared to 2021, mainly due to the availability of alternative therapies and intense competition. In December 2022, the orphan drug exclusivity that had attached to bendamustine products expired. To-date we are aware of one generic TREANDA product on the market.
For more information on BENDEKA and TREANDA, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—Oncology.”
COPAXONE revenues in our North America segment in 2022 decreased by 33% to $387 million, compared to 2021, mainly due to generic competition in the United States and a decrease in glatiramer acetate market share due to availability of alternative biologic therapies.
For more information on COPAXONE, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—COPAXONE.”
Anda revenues from third parties in our North America segment in 2022 increased by 11% to $1,471 million, compared to 2021, mainly due to higher demand.
Product Launches and Pipeline
In 2022, we launched the generic version of the following branded products in the United States:
Product Name |
Brand Name | Launch Date |
Total Annual U.S. Branded Sales at Time of Launch (U.S. $ in millions (IQVIA))* |
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Fluticasone Propionate and Salmeterol Inhalation Powder, USP |
Advair Diskus® | March | $ | 2,940 | ||||||
Lenalidomide Capsules, 5, 10, 15, & 25 mg |
Revlimid® | March | $ | 2,143 | ||||||
Diclofenac Potassium Capsules |
Zipsor® | March | $ | 20 | ||||||
Pirfenidone Tablets 267mg & 801mg |
Esbriet® | May | $ | 570 | ||||||
Scopolamine Transdermal System 1mg/3 days |
Transderm Scop® | May | $ | 88 | ||||||
Dalfampridine Extended-release Tablets 10mg |
Ampyra® | May | $ | 81 | ||||||
Lanthanum Carbonate Chewable Tablets 500mg, 750mg, 1000mg |
Fosrenol® | May | $ | 35 | ||||||
Pemetrexed Injection 100mg/4mL, 500mg/20mL, 1g/40mL** |
N/A | May | No Data | |||||||
Vilazodone Hydrochloride Tablets 10mg, 20mg, 40mg |
Viibryd® | June | $ | 569 | ||||||
Mycophenolate Mofetil for Oral Suspension, USP, 200mg/mL |
CellCept® | June | $ | 55 | ||||||
Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg and 300 mcg |
Synthroid® | September | $ | 2,035 | ||||||
Tacrolimus Ointment |
Protopic® | September | $ | 80 | ||||||
Pantoprazole Sodium for Injection |
Protonix® | September | $ | 77 | ||||||
Mycophenolate Mofetil Tablets 500mg |
CellCept® | September | $ | 68 |
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Product Name |
Brand Name | Launch Date |
Total Annual U.S. Branded Sales at Time of Launch (U.S. $ in millions (IQVIA))* |
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Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) 100mg |
Macrobid® | September | $ | 55 | ||||||
Icosapent Ethyl Capsules 500mg |
Vascepa® | September | $ | 21 | ||||||
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5% |
Combigan® | October | $ | 457 | ||||||
Penciclovir Cream 1% |
Denavir® | November | $ | 22 | ||||||
Naproxen Sodium ER Tablets 375mg, 500mg & 750mg |
Naprelan® | November | $ | 10 | ||||||
Icosapent Ethyl Capsules 1g |
Vascepa® | December | $ | 1,373 | ||||||
Tasimelteon Capsules 20mg*** |
Hetlioz® | December | No Data |
* | The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch. |
** | Teva’s Pemetrexed is a 505(b)(2) product, was filed as an NDA and is not bioequivalent to a brand product. |
*** | Marketed through Specialty Pharmacy that does not report to IQVIA. |
As of December 31, 2022, our generic products pipeline in the United States includes 171 product applications awaiting FDA approval, including 73 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended September 30, 2022 of approximately $113 billion, according to IQVIA. Approximately 71% of pending applications include a paragraph IV patent challenge and we believe we are first to file with respect to 68 of these products, or 97 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first to file opportunities represent over $81 billion in U.S. brand sales for the twelve months ended September 30, 2022, according to IQVIA.
IQVIA reported brand sales are one of the many indicators of future potential value of a launch, but equally important are the mix and timing of competition, as well as cost effectiveness. The potential advantages of being the first filer with respect to some of these products may be subject to forfeiture, shared exclusivity or competition from so-called “authorized generics,” which may ultimately affect the value derived.
In 2022, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications. A “tentative approval” indicates that the FDA has substantially completed its review of an application and final approval is expected once the relevant patent expires, a court decision is reached, a 30-month regulatory stay lapses or a 180-day exclusivity period awarded to another manufacturer either expires or is forfeited.
Generic Name |
Brand Name | Total U.S. Annual Branded Market (U.S. $ in millions (IQVIA))* |
||||
Dasatinib Tablets, 20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg |
Sprycel® | $ | 1,569 | |||
Cabozantanib Tablets, 20, 40 and 60 mg |
Cabometyx® | $ | 1,136 | |||
Valbenazine Capsules, 40 mg and 80 mg |
Ingrezza® | $ | 1,041 | |||
Canagliflozin Tabs |
Invokana® | $ | 900 | |||
Dapagliflozin/ Metformin Tablets |
Xigduo XR® | $ | 560 | |||
Linaclotide Capsules, 72 mcg |
Linzess® | $ | 457 |
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Generic Name |
Brand Name | Total U.S. Annual Branded Market (U.S. $ in millions (IQVIA))* |
||||
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL) |
Mozobil® | $ | 192 | |||
Lisdexamfetamine Dimesylate Chewable Tablets (CII) 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg |
Vyvanse® | $ | 144 | |||
Methylnaltrexone Bromide Tablets, 150 mg |
Relistor® | $ | 131 | |||
Methylphenidate Hydrochloride Extended-Release Chewable Tablets, 20 mg, 30 mg and 40 mg |
Quillichew ER® | $ | 118 | |||
Midostaurin Capsules, 25 mg |
Rydapt® | $ | 88 | |||
Naltrexone Hydrochloride and Bupropion Hydrochloride Extended-Release Tablets, 8 mg/90 mg |
Contrave® | $ | 71 | |||
Oxymetazoline Hydrochloride Cream, 1% |
Rhofade® | $ | 25 | |||
Riociguat Tablets |
Adempas® | $ | 12 | |||
Gefitinib Tablets, 250 mg |
Iressa® | $ | 6 | |||
Paclitaxel Protein-Bound Particles for Injectable Suspension, 100 mg/vial ** |
N/A | No Data | ||||
Eltrombopag Choline Tablets, Eq. to 9 mg, 18 mg, 36 mg, and 54 mg*** |
Promacta® | No Data |
* | The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch. |
** | Teva’s Paclitaxel is a 505(b)(2) product, was filed as an NDA and is not bioequivalent to a brand product. |
*** | Teva’s Eltrombopag Choline Tablets is a 505(b)(2) product, is not bioequivalent to a brand product. |
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 2022 was $3,926 million, a decrease of 7% compared to $4,226 million in 2021, mainly due to lower revenues as discussed above.
Gross profit margin for our North America segment in 2022 decreased to 52.7%, compared to 54.1% in 2021. This decrease was mainly due to lower revenues from COPAXONE and an unfavorable mix of generic products.
North America R&D Expenses
R&D expenses relating to our North America segment in 2022 were $532 million, a decrease of 14% compared to $618 million in 2021.
For a description of our R&D expenses in 2022, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
North America S&M Expenses
S&M expenses relating to our North America segment in 2022 were $941 million, a decrease of 5% compared to $988 million in 2021, mainly due to cost efficiencies.
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North America G&A Expenses
G&A expenses relating to our North America segment in 2022 were $474 million, an increase of 11% compared to $427 million in 2021.
For a description of our G&A expenses in 2022, see “—Teva Consolidated Results—General and Administrative (G&A) Expenses” below.
North America Profit
Profit from our North America 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 North America segment in 2022 was $1,993 million, a decrease of 10% compared to $2,224 million in 2021. This decrease was mainly due to lower revenues, partially offset by lower operating expenses, as discussed above.
Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the past two years:
Year ended December 31, | ||||||||||||||||
2022 | 2021 | |||||||||||||||
(U.S. $ in millions /% of Segment Revenues) | ||||||||||||||||
Revenues |
$ | 4,525 | 100% | $ | 4,886 | 100% | ||||||||||
Gross profit |
2,700 | 59.7% | 2,823 | 57.8% | ||||||||||||
R&D expenses |
213 | 4.7% | 244 | 5.0% | ||||||||||||
S&M expenses |
748 | 16.5% | 846 | 17.3% | ||||||||||||
G&A expenses |
246 | 5.4% | 244 | 5.0% | ||||||||||||
Other (income) expense |
(3 | ) | § | (5 | ) | § | ||||||||||
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|
|
|
|
|
|
|||||||||
Segment profit* |
$ | 1,496 | 33.1% | $ | 1,494 | 30.6% | ||||||||||
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|
|
|
|
|
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
Europe Revenues
Our Europe segment includes the European Union, the United Kingdom and certain other European countries. Revenues from our Europe segment in 2022 were $4,525 million, a decrease of $361 million, or 7%, compared to 2021. In local currency terms, revenues increased by 4%, mainly due to higher demand of generic and OTC products resulting from new product launches and from the removal of restrictions related to doctor and hospital visits by patients previously implemented in response to the COVID-19 pandemic, as well as higher sales of cough and cold products and higher revenues from AJOVY, partially offset by lower revenues from COPAXONE and certain other respiratory products.
In 2022, revenues were negatively impacted by exchange rate fluctuations of $550 million, including hedging effects, compared to 2021. Revenues in 2022 included $17 million from a positive hedging impact, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.
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Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the past two years:
Year ended December 31, | Percentage Change 2022-2021 |
|||||||||||
2022 | 2021 | |||||||||||
(U.S. $ in millions) |
|
|||||||||||
Generic products |
$ | 3,466 | $ | 3,569 | (3 | %) | ||||||
AJOVY |
124 | 87 | 43 | % | ||||||||
COPAXONE |
268 | 391 | (31 | %) | ||||||||
Respiratory products |
273 | 356 | (23 | %) | ||||||||
Other |
393 | 483 | (19 | %) | ||||||||
|
|
|
|
|||||||||
Total |
$ | 4,525 | $ | 4,886 | (7 | %) | ||||||
|
|
|
|
Generic products revenues (including OTC and biosimilar products) in our Europe segment in 2022 decreased by 3% to $3,466 million, compared to 2021. In local currency terms, revenues increased by 9%, mainly due to higher demand of generic and OTC products, resulting from new product launches and from the removal of restrictions related to doctor and hospital visits by patients previously implemented in response to the COVID-19 pandemic, as well as higher sales of cough and cold products.
AJOVY revenues in our Europe segment in 2022 increased by 43% to $124 million, compared to 2021. In local currency terms, revenues increased by 61%, mainly due to launches and reimbursements in additional European countries and growth in existing countries.
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 2022 decreased by 31% to $268 million, compared to 2021. In local currency terms, revenues decreased by 23%, mainly due to price reductions and a decline in volume 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 2022 decreased by 23% to $273 million, compared to 2021. In local currency terms, revenues decreased by 14% mainly due to net price reductions and lower volumes.
Product Launches and Pipeline
As of December 31, 2022, our generic products pipeline in Europe included 751 generic approvals relating to 89 compounds in 189 formulations, no EMA approvals received during 2022. In addition, approximately 1,162 marketing authorization applications pending approval in 37 European countries, relating to 102 compounds in 211 formulations. Two applications are pending with the EMA.
For a description of our innovative medicines pipeline, see “Item 1—Business—Research and Development” above.
Europe Gross Profit
Gross profit from our Europe segment in 2022 was $2,700 million, a decrease of 4% compared to $2,823 million in 2021. This decrease was mainly due to exchange rate fluctuations.
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Gross profit margin for our Europe segment in 2022 increased to 59.7%, compared to 57.8% in 2021, mainly due to our network consolidation activities and a favorable mix of products.
Europe R&D Expenses
R&D expenses relating to our Europe segment in 2022 were $213 million, a decrease of 13% compared to $244 million in 2021.
For a description of our R&D expenses in 2022, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe S&M Expenses
S&M expenses relating to our Europe segment in 2022 were $748 million, a decrease of 12% compared to $846 million in 2021. This decrease was mainly due to exchange rate fluctuations and cost efficiencies.
Europe G&A Expenses
G&A expenses relating to our Europe segment in 2022 were $246 million, an increase of 1% compared to $244 million in 2021.
For a description of our G&A expenses in 2022, see “—Teva Consolidated Results—General and Administrative (G&A) Expenses” below.
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 2022 was $1,496 million, flat compared to $1,494 million in 2021.
International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the past two years:
Year ended December 31, | ||||||||||||||||
2022 | 2021 | |||||||||||||||
(U.S. $ in millions /% of Segment Revenues) | ||||||||||||||||
Revenues |
$ | 1,903 | 100% | $ | 2,032 | 100% | ||||||||||
Gross profit |
1,033 | 54.3% | 1,118 | 55.0% | ||||||||||||
R&D expenses |
72 | 3.8% | 68 | 3.3% | ||||||||||||
S&M expenses |
405 | 21.3% | 417 | 20.5% | ||||||||||||
G&A expenses |
119 | 6.3% | 109 | 5.4% | ||||||||||||
Other (income) expense |
(43 | ) | (2.2% | ) | (5 | ) | § | |||||||||
|
|
|
|
|
|
|
|
|||||||||
Segment profit* |
$ | 479 | 25.2% | $ | 529 | 26.0% | ||||||||||
|
|
|
|
|
|
|
|
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
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International Markets Revenues
Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical market. The countries in our International Markets segment include highly regulated, pure generic markets, such as Israel, branded generics oriented markets, such as Russia and certain Latin American markets, and hybrid markets, such as Japan.
In February 2022, Russia launched an invasion of Ukraine. As of the date of this Annual Report on Form 10-K, sustained conflict and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results. We have no manufacturing or R&D facilities in these markets. During the year ended December 31, 2022, the impact of this conflict on our International Markets segment’s results of operations and financial condition was immaterial. Consistent with our foreign exchange risk management hedging programs, we entered into hedges to hedge our exposure to currency exchange rate fluctuations with respect to our balance sheet assets, revenues and expenses. However, as of the end of 2022, we were unable to renew certain of our expiring hedging positions due to the liquidity situation in the market for Russian rubles. Prior to and since the escalation of the conflict, we have been taking measures to reduce our operational cash balances in Russia and Ukraine. We have been monitoring the solvency of our customers in Russia and Ukraine and have taken measures, where practicable, to mitigate our exposure to risks related to the conflict in the region. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the conflict cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets.
On February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.
Revenues from our International Markets segment in 2022 were $1,903 million, a decrease of $129 million, or 6%, compared to 2021. In local currency terms, revenues increased by 3% compared to 2021, mainly due to higher revenues from generic products in most markets, partially offset by lower sales in Japan resulting from the divestment mentioned above. Revenues in 2021 included a milestone payment of $35 million.
In 2022, revenues were negatively impacted by exchange rate fluctuations of $181 million including hedging effects, compared to the year end of 2021. Revenues in 2022, included $11 million from a negative hedging impact, compared to $6 million from a positive hedging impact in 2021, which are included in “Other” in the table below. See note 10d to our consolidated financial statements.
Revenues by Major Products and Activities
The following table presents revenues for our International Markets segment by major products and activities for the past two years:
Year ended December 31, | Percentage Change 2022-2021 |
|||||||||||
2022 | 2021 | |||||||||||
(U.S. $ in millions) | ||||||||||||
Generic products |
$ | 1,586 | $ | 1,649 | (4% | ) | ||||||
AJOVY |
35 | 50 | (30% | ) | ||||||||
COPAXONE |
36 | 37 | (3% | ) | ||||||||
Other |
246 | 295 | (17% | ) | ||||||||
|
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|
|
|
|
|||||||
Total |
$ | 1,903 | $ | 2,032 | (6% | ) | ||||||
|
|
|
|
|
|
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Generic products revenues in our International Markets segment in 2022, which include OTC products, decreased by 4% to $1,586 million, compared to 2021. In local currency terms, revenues increased by 5%, due to higher revenues in most markets, as well as price increases largely as a result of rising costs due to inflationary pressure, partially offset by lower revenues in Japan resulting from regulatory price reductions, the divestment mentioned above, and generic competition to off-patented products.
AJOVY was launched in certain markets in our International Markets segment, including in Japan during the third quarter of 2021. We are moving forward with plans to launch AJOVY in other markets. AJOVY revenues in our International Markets segment in 2022 were $35 million compared to $50 million in 2021. Revenues in 2021 included a milestone payment of $35 million received from Otsuka related to the launch of AJOVY in Japan.
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 2022 decreased by 3% to $36 million, compared to 2021. In local currency terms, revenues increased by 15%.
For more information on COPAXONE, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—COPAXONE.”
AUSTEDO was launched in early 2021 in China for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia, and was also launched in Israel during 2021. During the third quarter of 2022, AUSTEDO was launched in Brazil. We continue with additional submissions in various other markets.
For more information on AUSTEDO, see “Item 1—Business—Our Product Portfolio and Business Offering—Innovative Medicines—AUSTEDO.”
International Markets Gross Profit
Gross profit from our International Markets segment in 2022 was $1,033 million, a decrease of 8% compared to $1,118 million in 2021.
Gross profit margin for our International Markets segment in 2022 decreased to 54.3%, compared to 55.0% in 2021. 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 rising costs due to inflationary pressure and a favorable mix of products sold.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in 2022 were $72 million, an increase of 6% compared to $68 million in 2021.
For a description of our R&D expenses in 2022, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
International Markets S&M Expenses
S&M expenses relating to our International Markets segment in 2022 were $405 million, a decrease of 3% compared to $417 million in 2021, mainly due to exchange rate fluctuations and cost efficiencies.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in 2022 were $119 million, an increase of 9% compared to $109 million in 2021.
For a description of our G&A expenses in 2022, see “—Teva Consolidated Results—General and Administrative (G&A) Expenses” below.
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International Markets Other Income
Other income relating to our International Markets segment in 2022 was $43 million, compared to $5 million in 2021. Other income in 2022 was mainly the result of settlement proceeds.
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 2022 was $479 million a decrease of 9% compared to $529 million in 2021. This decrease was mainly due to lower gross profit, as discussed above.
Other Activities
We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an out-licensing platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments described above.
Our revenues from other activities in 2022 were $1,045 million, a decrease of 9% in U.S. dollars, or 6% in local currency terms, compared to 2021.
API sales to third parties in 2022 were $675 million, a decrease of 9% in both U.S. dollars and local currency terms.
Teva Consolidated Results
Revenues
Revenues in 2022 were $14,925 million, a decrease of 6%, in U.S. dollars or 1% in local currency terms, compared to 2021, mainly due to lower revenues from COPAXONE and certain respiratory products in our North America and Europe segments, generic products as well as BENDEKA and TREANDA in our North America segment, partially offset by higher revenues from generic products in our Europe and International Markets segments, and from our innovative products – AUSTEDO and AJOVY, and Anda. See “—North America Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.
Exchange rate movements during 2022, including hedging effects, negatively impacted revenues by $780 million, compared to 2021. See note 10d to our consolidated financial statements.
Gross Profit
Gross profit in 2022 was $6,973 million, a decrease of 8% compared to 2021.
Gross profit margin was 46.7% in 2022, compared to 47.8% in 2021.
This decrease in gross profit margin was mainly due to lower revenues from COPAXONE and certain respiratory products in our North America and Europe segments, partially offset by higher revenues from AUSTEDO in North America and a favorable mix of generic products in our Europe segment.
Research and Development (R&D) Expenses
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.
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Our R&D activities for innovative medicines and biosimilar products in each of our segments include costs of discovery research, preclinical development, drug formulation, early- and late-clinical development and product registration costs. These expenditures are reported net of contributions received from collaboration partners. Our spending takes place throughout the development process, including (i) early-stage projects in both discovery and preclinical phases; (ii) middle-stage projects in clinical programs up to phase 3; (iii) late-stage projects in phase 3 programs, including where a new drug application is currently pending approval; (iv) post-approval studies for marketed products; and (v) indirect expenses, such as costs of internal administration, infrastructure and personnel.
Our R&D expenses in 2022 were $838 million, a decrease of 13% compared to 2021.
Our lower R&D expenses in 2022, compared to 2021, were mainly due to a decrease in several neuroscience projects (in the pain and migraine and headache therapeutic areas) and immunology (in the respiratory therapeutic area), as well as a decline in various generics projects, and an adjustment in payments pursuant to a contract with one of our R&D partners in 2022, partially offset by higher R&D expenses related to our biosimilar products pipeline.
R&D expenses as a percentage of revenues were 5.6% in 2022, compared to 6.1% in 2021.
Selling and Marketing (S&M) Expenses
S&M expenses in 2022 were $2,265 million, a decrease of 7% compared to 2021. Our S&M expenses were primarily the result of the factors discussed above under “—North America Segment— S&M Expenses” and “—Europe Segment— S&M Expenses.”
S&M expenses as a percentage of revenues were 15.2% in 2022, compared to 15.3% in 2021.
General and Administrative (G&A) Expenses
G&A expenses in 2022 were $1,180 million, an increase of 7% compared to 2021. This increase was related to proceeds received from Teva’s insurance carriers pursuant to a settlement reached on a derivative proceeding in the second quarter of 2021 related to the acquisition of Actavis Generics, as well as higher litigation fees in the second quarter of 2022.
G&A expenses as a percentage of revenues were 7.9% in 2022, compared to 6.9% in 2021.
Identifiable Intangible Asset Impairments
We recorded expenses of $355 million for identifiable intangible asset impairments in 2022, compared to expenses of $424 million in 2021. See note 6 to our consolidated financial statements.
Goodwill Impairment
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.
Other Asset Impairments, Restructuring and Other Items
We recorded expenses of $414 million for other asset impairments, restructuring and other items in 2022, compared to expenses of $341 million in 2021. For further details, as well as a description of significant regulatory and other events, see note 15 to our consolidated financial statements.
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Legal Settlements and Loss Contingencies
In 2022, we recorded expenses of $2,082 million in legal settlements and loss contingencies, compared to expenses of $717 million in 2021. See note 11 to our consolidated financial statements.
Other Income
Other income in 2022 was $107 million, compared to $98 million in 2021. See note 16 to our consolidated financial statements.
Operating Income (Loss)
Operating loss was $2,099 million in 2022, compared to operating income of $1,716 million in 2021.
Operating loss as a percentage of revenues was 14.1% in 2022, compared to operating income as a percentage of revenues of 10.8% in 2021. Operating loss in 2022 was mainly affected by goodwill impairment charges and legal settlements and loss contingencies.
Financial Expenses, Net
Financial expenses, net were $966 million in 2022, compared to $1,058 million in 2021. Financial expenses in 2022 were mainly comprised of interest expenses and other bank charges of $930 million.
Financial expenses in 2021 were mainly comprised of interest expenses and other bank charges of $891 million and loss on revaluations of marketable securities of $90 million.
The following table presents a reconciliation of our segment profits to Teva’s consolidated operating income (loss) and to consolidated income (loss) before income taxes for the past two years:
Year ended December 31, |
||||||||
2022 | 2021 | |||||||
(U.S. $ in millions) | ||||||||
North America profit |
$ | 1,993 | $ | 2,224 | ||||
Europe profit |
1,496 | 1,494 | ||||||
International Markets profit |
479 | 529 | ||||||
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|
|
|
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Total reportable segments profit |
3,968 | 4,246 | ||||||
Profit of other activities |
172 | 154 | ||||||
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|
|
|||||
Total segments profit |
4,140 | 4,401 | ||||||
Amounts not allocated to segments: |
||||||||
Amortization |
732 | 802 | ||||||
Other assets impairments, restructuring and other items |
414 | 341 | ||||||
Goodwill impairment |
2,045 | — | ||||||
Intangible assets impairments |
355 | 424 | ||||||
Legal settlements and loss contingencies |
2,082 | 717 | ||||||
Other unallocated amounts |
610 | 402 | ||||||
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|
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Consolidated operating income (loss) |
(2,099 | ) | 1,716 | |||||
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|
|||||
Financial expenses, net |
966 | 1,058 | ||||||
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|
|||||
Consolidated income (loss) before income taxes |
$ | (3,065 | ) | $ | 658 | |||
|
|
|
|
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Income Taxes
In 2022, we recognized a tax benefit of $638 million, or 21%, on a pre-tax loss of $3,065 million.
In 2021, we recognized a tax expense of $211 million, or 32%, on a pre-tax income of $658 million. See note 13 our consolidated financial statements.
Share In (Profits) Losses of Associated Companies, Net
Share in profits of associated companies, net was $21 million in 2022, compared to $9 million in 2021. Share in profits of associated companies, net in 2022 was mainly related to the difference between the book value of our investment in Novetide and its fair value as of the date we completed its acquisition in January 2022.
Net Income (Loss) Attributable to Teva
Net loss was $2,353 million in 2022, compared to a net income of $417 million in 2021. Net loss in 2022 was mainly affected by goodwill impairment charges and legal settlements and loss contingencies, partially offset by a tax benefit, all as discussed above.
Diluted Shares Outstanding and Earnings (Loss) Per Share
The weighted average diluted shares outstanding used for the fully diluted share calculation for 2022 and 2021 was 1,110 million and 1,107 million shares, respectively.
In computing diluted loss per share for the year ended December 31, 2022, no account was taken of the potential dilution that could occur upon the exercise of options and non-vested restricted share units (“RSUs” and performance share units (“PSUs”) granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
In computing diluted earnings per share for the year ended December 31, 2021, basic earnings per share were adjusted to take into account the potential dilution that could occur upon the exercise of options and non-vested RSUs and PSUs granted under employee stock compensation plans. No account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
Diluted loss per share was $2.12 for the year ended December 31, 2022, compared to diluted earnings per share of $0.38 for the year ended December 31, 2021.
Share Count for Market Capitalization
We calculate share amounts using the outstanding number of shares (i.e., excluding treasury shares) plus shares that would be outstanding upon the exercise of options and vesting of RSUs and PSUs and the conversion of our convertible senior debentures, in each case, at period end.
As of December 31, 2022 and 2021, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,143 million and 1,128 million, respectively.
Impact of Currency Fluctuations on Results of Operations
In 2022, approximately 47% of our revenues were denominated in currencies other than the U.S. dollar. 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.
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During 2022, 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 Turkish lira by 47%, the Argentinian peso by 25%, the Hungarian forint by 18%, the Japanese yen by 16%, the Ukraine hryvna by 15%, the Swedish krona by 15% and the Polish zloty by 13%. The following main currencies relevant to our operations increased in value against the U.S. dollar: the Russian ruble by 9%, the Brazilian real by 5% and the Mexican peso by 1%.
As a result, exchange rate movements during 2022, including hedging effects, negatively impacted overall revenues by $780 million and operating income by $247 million in comparison with 2021.
In 2022, a positive hedging impact of $11 million was recognized under revenues, and a negative impact of $7 million was recognized under cost of sales. In 2021, a positive impact of $31 million was recognized under revenues and a minimal negative impact was recognized under cost of sales.
Hedging transactions against future projected revenues and expenses are recognized on the balance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. See note 10d to our consolidated financial statements.
Commencing the third quarter of 2018, the cumulative inflation in Argentina exceeded 100% or more over a 3-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.
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.
Liquidity and Capital Resources
Total balance sheet assets were $44,006 million as of December 31, 2022, compared to $47,666 million as of December 31, 2021.
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 $119 million as of December 31, 2022, compared to positive $787 million as of December 31, 2021. This decrease was mainly a result of lower accounts receivables balances, net of SR&A, due to the securitization facility entered into in November 2022, partially offset by timing of sale cycle in the fourth quarter of 2022, an increase in accrued expenses mainly related to an update to the estimated settlement provision recorded in connection with the remaining opioid cases and an increase in accounts payables.
Cash investment in property, plant and equipment in 2022 was $548 million, compared to $562 million in 2021. Depreciation was $576 million in 2022, compared to $528 million in 2021.
Cash and cash equivalents and short-term and long-term investments, as of December 31, 2022, were $2,817 million compared to $2,191 million as of December 31, 2021.
Our cash on hand that is not used for ongoing operations is generally invested in bank deposits, as well as liquid securities that bear fixed and floating rates.
Teva’s principal sources of short-term liquidity are its cash on hand, existing cash investments, liquid securities and available credit facilities, primarily its $1.8 billion unsecured syndicated sustainability-linked revolving credit facility, entered into in April 2022, which was amended in February 2023 (“RCF”). See note 9 to our consolidated financial statements.
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2022 Debt Balance and Movements
As of December 31, 2022, our debt was $21,212 million, compared to $23,043 million as of December 31, 2021. This decrease was mainly due to $1,369 million of senior notes repaid at maturity and $484 million of exchange rate fluctuations.
In April 2022, Teva repaid $296 million of its 3.25% senior notes at maturity.
In July 2022, Teva repaid $365 million of its 0.50% senior notes at maturity.
In December 2022, Teva repaid $713 million of its 2.95% senior notes at maturity.
Our debt as of December 31, 2022 was effectively denominated in the following currencies: 62% in U.S. dollars, 36% in euros and 2% in Swiss francs.
The portion of total debt classified as short-term as of December 31, 2022 was 10%, compared to 6% as of December 31, 2021, mainly due to repayment of debt, partially offset by a reclassification of upcoming maturities in 2022.
Our financial leverage, which is the ratio between our debt and the sum of our debt and equity, was 71% as of December 31, 2022, compared to 67% as of December 31, 2021.
Our average debt maturity was approximately 5.8 years as of December 31, 2022, compared to 6.4 years as of December 31, 2021.
For further information, see note 9 to our consolidated financial statements.
2021 Debt Balance and Movements
On February 1, 2021, $491 million of our 0.25% convertible senior debentures, due 2026 were redeemed by holders.
In July 2021, we repaid $1,475 million of our 2.2% senior notes at maturity.
In November 2021, we completed debt issuances for an aggregate principal amount of $5,013 million, comprised of 1,500 million euro principal amount of 4.38% sustainability-linked senior notes due in 2030, 1,100 million euro principal amount of 3.75% sustainability-linked senior notes due in 2027, $1,000 million principal amount of 4.75% sustainability-linked senior notes due in 2027 and $1,000 million principal amount of 5.13% sustainability-linked senior notes due in 2029.
In November 2021, we completed a cash tender offer, which resulted in debt reduction of: $4,008 million from our 1.13% 1,500 million euro senior notes due in October 2024, 1.25% 1,300 million euro senior notes due in March 2023, 3.25% 700 million euro senior notes due in April 2022, 2.8% $3,000 million senior notes due in July 2023 and 2.95% $1,300 million senior notes due in December 2022.
In November 2021, we repaid $613 million and $588 million of our 3.65% senior notes at maturity.
During 2021, we borrowed up to $500 million under our RCF, which was fully repaid before year end.
Total Equity
Total equity was $8,691 million as of December 31, 2022, compared to $11,244 million as of December 31, 2021. This decrease was mainly due to a net loss of $2,406 million and a negative impact of $356 million from exchange rate fluctuations.
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Exchange rate fluctuations affected our balance sheet, as approximately 66% 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, 2021, changes in currency rates had a negative impact of $356 million on our equity as of December 31, 2022. The following main currencies decreased in value against the U.S. dollar: Chilean peso by 12%, Polish zloty by 11%, Japanese yen by 9%, euro by 8%, Croatian kuna by 8%, Bulgarian lev by 8%, British pound by 8%, Swiss franc by 5%, and the Peruvian nuevo sol by 4%. The Russian ruble increased in value against the U.S. dollar by 28%. All comparisons are on a year-end to year-end basis.
Cash Flow
We seek to continually improve the efficiency of our working capital management. From time to time, as part of our cash and commercial relationship management activities, we may 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, having the effect of increasing or decreasing cash from operations in an individual period. Such decisions may have an impact on our annual operating cash flow measurement, as well as on our quarterly results.
Cash flow generated from operating activities in 2022 was $1,590 million, compared to $798 million in 2021. The increase in 2022 resulted mainly from the sale of accounts receivables under our U.S. securitization facility entered into in November 2022, and lower cash collections remitted to the owner of the receivables under our EU securitization program mainly due to exchange rate fluctuations, partially offset by an increase in inventory levels, as well as higher payments of legal settlements in connection with the opioids litigation. For further information on our securitization facilities see note 10f to our consolidated financial statements.
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 divestitures of businesses and other 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 2021, we generated free cash flow of $2,196 million, which we define as comprising $798 million in cash flow generated from operating activities, $1,648 million in beneficial interest collected in exchange for securitized accounts receivables and $311 million in proceeds from divestitures of businesses and other assets, partially offset by $562 million in cash used for capital investments. The increase in 2022 resulted mainly from an increase in cash flow generated from operating activities, partially offset by lower beneficial interest collected in exchange for securitized accounts receivables under our EU securitization program mainly due to exchange rate fluctuations, as well as lower proceeds from divestitures of businesses and other assets. For further information on our securitization facilities see note 10f to our consolidated financial statements.
Dividends
We have not paid dividends on our ordinary shares or ADSs since December 2017.
Commitments
In addition to financing obligations under short-term debt and long-term senior notes and loans, debentures and convertible debentures, our major contractual obligations and commercial commitments include royalty payments, contingent payments pursuant to acquisition agreements and participation in joint ventures associated with R&D activities.
In October 2021, Teva announced a license agreement with Modag that will provide Teva an exclusive global license to develop, manufacture and commercialize Modag’s lead compound (TEV-56286) and a related compound (TEV-56287). TEV-56286 was initially developed for the treatment of MSA and Parkinson’s disease,
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and has the potential to be applied to other treatments for neurodegenerative disorders, such as Alzheimer’s disease. A phase 1b clinical trial is currently being completed for TEV-56286. In the fourth quarter of 2021, Teva made an upfront payment of $10 million to Modag that was recorded as an R&D expense. Modag may be eligible for future development milestone payments, totaling an aggregate amount of up to $40 million, as well as future commercial milestones and royalties.
In August 2020, Teva entered into an agreement with biopharmaceutical company Alvotech for the exclusive commercialization in the U.S. of five biosimilar product candidates. The initial pipeline for this collaboration contains biosimilar candidates addressing multiple therapeutic areas, including a proposed biosimilar to Humira® and Stelara®. Under the terms of the agreement, Alvotech is responsible for the development, registration and supply of the biosimilar product candidates and Teva will exclusively commercialize the products in the United States. Teva made an upfront payment in the third quarter of 2020 and additional upfront and milestone payments in the second quarter of 2021, which were recorded as an R&D expense. Teva also made a milestone payment in January 2023 which was recorded as R&D expenses in the fourth quarter of 2022. Additional development and commercial milestone payments of up to $398 million, as well as royalty payments, may be payable by Teva over the next few years. Teva and Alvotech will share profit from the commercialization of these biosimilars. Alvotech was previously involved in litigation involving certain IP and trade secrets claims filed by Abbvie in relation to Alvotech’s proposed biosimilar to Humira®, all of which were settled on March 8, 2022. Pursuant to that settlement, Alvotech and Teva may sell Alvotech’s proposed biosimilar to Humira® in the United States beginning on July 1, 2023, provided that U.S. regulatory approval is obtained by that date. In September 2022, Alvotech announced they received a CRL from the FDA with respect to Alvotech’s proposed biosimilar to Humira® and an additional CRL was received in December 2022. In January 2023, the FDA accepted for review a Biologic License Application (“BLA”) for Alvotech’s proposed biosimilar Stelara®.
In September 2016, Teva and Regeneron entered into a collaborative agreement to develop and commercialize Regeneron’s pain medication product, fasinumab. Teva and Regeneron share in the global commercial rights to this product (excluding Japan, Korea and nine other Asian countries), as well as ongoing associated R&D costs of approximately $1 billion. Teva made an upfront payment of $250 million to Regeneron in the third quarter of 2016 and additional payments for achievement of development milestones in an aggregate amount of $120 million were paid during 2017 and 2018. In October 2022, development of fasinumab for the treatment of osteoarthritic pain was discontinued.
In November 2013, Teva entered into an agreement with MedinCell for the development and commercialization of multiple LAI products. The lead product candidate selected was risperidone LAI (TV-46000) suspension for subcutaneous use for the treatment of schizophrenia. In August 2021, the FDA accepted the new drug application (“NDA”) for risperidone LAI, based on phase 3 data from two pivotal studies. Teva leads the clinical development and regulatory process and is responsible for commercialization of this product candidate. MedinCell may be eligible for future commercial milestones of up to $112 million in respect of risperidone LAI. Teva will also pay MedinCell royalties on net sales. In April 2022, the FDA issued a CRL regarding the NDA for risperidone LAI. Teva resubmitted the NDA in October 2022 and awaits the FDA’s response.
The second selected product candidate is TEV-44749, a LAI for the treatment of schizophrenia. In the third quarter of 2022, Teva decided to progress development of the product to phase 3, as a result of which a $3 million milestone payment was paid to MedinCell which was recognized as R&D expenses. MedinCell may become eligible for further milestones and royalties on sales of TEV-44749.
We are committed to pay royalties to owners of know-how, partners in alliances and certain other arrangements, and to parties that financed R&D at a wide range of rates as a percentage of sales of certain products, as defined in the agreements. In some cases, the royalty period is not defined; in other cases, royalties will be paid over various periods not exceeding 20 years.
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In connection with certain development, supply and marketing, and research and collaboration or services agreements, we are required to indemnify, in unspecified amounts, the parties to such agreements against third-party claims relating to (i) infringement or violation of intellectual property or other rights of such third party; or (ii) damages to users of the related products. Except as described in our financial statements, we are not aware of any material pending action that may result in the counterparties to these agreements claiming such indemnification.
Aggregated Contractual Obligations
The following table summarizes our material contractual obligations and commitments as of December 31, 2022:
Payments Due by Period | ||||||||||||||||||||
Total | Less than 1 year |
1-3 years |
3-5 years |
More than 5 years |
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(U.S. $ in millions) | ||||||||||||||||||||
Long-term debt obligations, including estimated interest* |
$ | 26,903 | $ | 2,967 | $ | 6,785 | $ | 7,424 | $ | 9,726 | ||||||||||
Purchase obligations (including purchase orders) |
1,996 | 1,624 | 301 | 55 | 16 | |||||||||||||||
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Total |
$ | 28,899 | $ | 4,591 | $ | 7,086 | $ | 7,479 | $ | 9,742 | ||||||||||
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* | 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. |
The total gross amount of unrecognized tax benefits for uncertain tax positions was $638 million at December 31, 2022. 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. Correspondingly, it is difficult to ascertain whether we will pay any significant amount related to these obligations within the next year.
We have committed to make potential future milestone payments to third parties under various agreements. These payments are contingent upon the occurrence of certain future events and, given the nature of these events, it is unclear when, if ever, we may be required to pay such amounts. As of December 31, 2022, 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 $26 million. Additional contingent payments are owed upon achievement of product approval or launch milestones.
We have committed to pay royalties to owners of know-how, partners in alliances and other certain arrangements and to parties that financed research and development, at a wide range of rates as a percentage of sales or of the gross margin of certain products, as defined in the underlying agreements.
Due to the uncertainty of the timing of these payments, these amounts, and the amounts described in the previous paragraph, are not included in the table above.
Off-Balance Sheet Arrangements
Except for securitization transactions, which are disclosed in note 10f to our consolidated financial statements, we do not have any material off-balance sheet arrangements.
Non-GAAP Net Income and Non-GAAP EPS Data
We present non-GAAP net income and non-GAAP earnings per share (“EPS”) as management believes that such data provide useful information to investors because they are used by management and our Board of Directors, in conjunction with other performance metrics, to evaluate our operational performance, to prepare and evaluate our work plans and annual budgets and ultimately to evaluate the performance of management,
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including annual compensation. While other qualitative factors and judgment also affect annual compensation, the principal quantitative element in the determination of such compensation are performance targets tied to the work plan, which are based on these non-GAAP measures.
Non-GAAP financial measures have no standardized meaning and accordingly have limitations in their usefulness to investors. Investors are cautioned that, unlike financial measures prepared in accordance with U.S. GAAP, non-GAAP measures may not be comparable with the calculation of similar measures for other companies. These non-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using non-GAAP financial measures as performance measures are that they provide a view of our results of operations without including all events during a period and may not provide a comparable view of our performance to other companies in the pharmaceutical industry. Investors should consider non-GAAP net income and non-GAAP EPS in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP.
In preparing our non-GAAP net income and non-GAAP EPS data, we exclude items that either have a non-recurring impact on our financial performance or which, in the judgment of our management, are items that, either as a result of their nature or size, could, were they not excluded, potentially cause investors to extrapolate future performance from an improper base that is not reflective of our underlying business performance. Certain of these items are also excluded because of the difficulty in predicting their timing and scope. The items excluded from our non-GAAP net income and non-GAAP EPS include:
• | amortization of purchased intangible assets; |
• | legal settlements and material litigation fees and/or loss contingencies, due to the difficulty in predicting their timing and scope; |
• | impairments of long-lived assets, including intangibles, property, plant and equipment and goodwill; |
• | restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to the rationalization of our plants or to certain other strategic activities, such as the realignment of R&D focus or other similar activities; |
• | acquisition- or divestment- related items, including changes in contingent consideration, integration costs, banker and other professional fees and inventory step-up; |
• | expenses related to our equity compensation; |
• | significant one-time financing costs, amortization of issuance costs and terminated derivative instruments, and marketable securities investment valuation gains/losses; |
• | unusual tax items; |
• | other awards or settlement amounts, either paid or received; |
• | other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as impacts due to changes in accounting, significant costs for remediation of plants, or other unusual events; and |
• | corresponding tax effects of the foregoing items. |
Commencing the first quarter of 2022, we no longer exclude IPR&D acquired in development arrangements from our non-GAAP financial measures. In our comparable non-GAAP financial measures for the year ended December 31, 2021 we excluded $15 million IPR&D acquired in development arrangements. We are not recasting the non-GAAP presentation for the year ended December 31, 2021 since the adjustment is not significant. We made this change to our presentation of non-GAAP financial measures to improve the comparability of our non-GAAP presentation to those of other companies in the pharmaceutical industry that made a similar change to their presentations beginning in the first quarter of 2022.
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The following tables present our non-GAAP net income and non-GAAP EPS for the years ended December 31, 2022 and 2021, as well as reconciliations of each measure to their nearest GAAP equivalents:
Year ended December 31, |
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2022 | 2021 | |||||||||
($ in millions except per share amounts) |
||||||||||
Net income (loss) attributable to Teva |
($) | (2,353) | 417 | |||||||
Increase (decrease) for excluded items: |
||||||||||
Amortization of purchased intangible assets |
732 | 802 | ||||||||
Legal settlements and loss contingencies |
2,082 | 717 | ||||||||
Goodwill impairment |
2,045 | — | ||||||||
Impairment of long-lived assets |
402 | 584 | ||||||||
Other R&D expenses |
— | 15 | ||||||||
Restructuring costs |
146 | 133 | ||||||||
Costs related to regulatory actions taken in facilities |
7 | 23 | ||||||||
Equity compensation |
124 | 118 | ||||||||
Contingent consideration |
163 | 7 | ||||||||
Gain on sale of business |
(47 | ) | (51 | ) | ||||||
Accelerated depreciation |
117 | 18 | ||||||||
Financial expenses |
61 | 128 | ||||||||
Share in profits (losses) of associated companies – net |
(22 | ) | (1 | ) | ||||||
Items attributable to non-controlling interests |
(96 | ) | (15 | ) | ||||||
Other non-GAAP items* |
465 | 318 | ||||||||
Corresponding tax effects and unusual tax items |
(1,016 | ) | (360 | ) | ||||||
Non-GAAP net income attributable to Teva |
($) | 2,812 | 2,855 | |||||||
Diluted earnings (loss) per share attributable to Teva |
($) | (2.12) | 0.38 | |||||||
EPS difference** |
4.64 | 2.20 | ||||||||
Diluted Non-GAAP EPS attributable to Teva** |
($) | 2.52 | 2.58 | |||||||
Non-GAAP weighted average number of shares (in millions)** |
1,115 | 1,107 |
* | 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, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants, material litigation fees and other unusual events. |
** | EPS difference and diluted non-GAAP EPS are calculated by dividing our non-GAAP net income attributable to Teva by our non-GAAP diluted weighted average number of shares. |
Trend Information
The following factors are expected to have a significant effect on our 2023 results:
• | ongoing impact of macroeconomic headwinds, including global supply chain disruptions, increases in prices of raw materials, labor, transportation as well as exchange rate fluctuations on our results of operations. For further details, see “—Macroeconomic Environment” above; |
• | continued success of our innovative medicines AUSTEDO and AJOVY; |
• | success of clinical trials and approval of risperidone LAI; |
• | ability to successfully execute key generic launches in a timely manner; |
• | ability to successfully develop and launch new biosimilar products; |
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• | continued decline in sales of COPAXONE and other innovative medicines due to potential loss of exclusivity, generic competition and/or availability of alternative therapies; |
• | we expect continued competition for our generic products where multiple similar generic products have been launched, resulting in pricing pressure in the generics markets. We do, however, also see certain generic segments in which opportunities exist to grow our business, our portfolio of new drug applications and our portfolio of approved complex products; our disciplined cash management and debt repayment schedule; |
• | our non-investment grade credit rating may increase the cost of any new borrowing; |
• | ongoing evaluation to further network consolidation activities to achieve additional operational efficiencies, which may affect our business and operations; and |
• | continued efforts towards achieving our long-term financial goals. |
For additional information, please see “Item 1—Business” above and elsewhere in this Item 7.
Critical Accounting Policies
For a description of our significant accounting policies, see note 1 to our consolidated financial statements.
The preparation of our consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions in certain circumstances that affect the amounts reported in the accompanying consolidated financial statements and related footnotes. Actual results may differ from these estimates. We base our judgments on our experience and on various assumptions that we believe to be reasonable under the circumstances.
Of our policies, the following are considered critical to an understanding of our consolidated financial statements as they require the application of subjective and complex judgment, involving critical accounting estimates and assumptions impacting our consolidated financial statements. We have applied our policies and critical accounting estimates consistently across our businesses.
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 sales allowances to wholesalers, retailers and government agencies with respect to our pharmaceutical products. Those deductions represent estimates of rebates and discounts related to gross sales for the reporting period and, as such, knowledge and judgment of market conditions and practice are required when estimating the impact of these revenue deductions on gross sales for a reporting period.
Historically, our changes of estimates reflecting actual results or updated expectations, have not been material to our overall business. Product-specific rebates, however, may have a significant impact on year-over-
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year individual product growth trends. If any of our ratios, factors, assessments, experiences or judgments are not indicative or accurate predictors of our future experience, our results could be materially affected. The sensitivity of our estimates can vary by program, type of customer and geographic location. However, estimates associated with governmental allowances, U.S. Medicaid and other performance-based contract rebates are most at risk for material adjustment because of the extensive time delay between the recording of the accrual and its ultimate settlement, an interval that can generally range up to one year. Because of this time lag, in any given quarter, our adjustments to actual can incorporate revisions of several prior quarters. See also “Revenue recognition” in note 1 to the consolidated financial statements.
Income Taxes
The provision for income tax is calculated based on our assumptions as to our entitlement to various benefits under the applicable tax laws in the jurisdictions in which we operate. The entitlement to such benefits depends upon our compliance with the terms and conditions set out in these laws.
Accounting for uncertainty in income taxes requires that it be more likely than not that the tax benefits recognized in the financial statements be sustained based on technical merits. The amount of benefits recorded for these positions is measured as the largest benefit more likely than not to be sustained. Significant judgment is required in making these determinations.
Deferred taxes are determined utilizing the asset and liability method based on the estimated future tax effects of differences between the financial accounting and tax bases of assets and liabilities under the applicable tax laws. Valuation allowances are provided if, based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. In the determination of the appropriate valuation allowances, we have considered the most recent projections of future business results and prudent tax planning alternatives that may allow us to realize the deferred tax assets. Taxes which would apply in the event of disposal of investments in subsidiaries have not been taken into account in computing deferred taxes, as it is our intention to hold these investments rather than realize them.
Taxes have not been provided for tax-exempt income, as the Company intends to permanently reinvest these earnings and does not currently foresee a need to distribute dividends out of these earnings. In addition, the Company announced a suspension of dividend distribution on ordinary shares and ADSs in 2017. Furthermore, deferred taxes have not been provided for the retained earnings of the Company’s foreign subsidiaries because the Company does not expect these subsidiaries to distribute taxable dividends in the foreseeable future, as their earnings and excess cash are used to pay down the group’s external liabilities, and the Company expects to have sufficient resources in the Israeli companies to fund its cash needs in Israel. An assessment of the tax that would have been payable had the Company’s foreign subsidiaries distributed their income to the Company is not practicable because of the multiple levels of corporate ownership and multiple tax jurisdictions involved in each hypothetical dividend distribution.
For a discussion of the valuation allowance, deferred tax and valuation allowance estimates see notes 1 and 13 to our consolidated financial statements.
Contingencies
From time to time, Teva and/or its subsidiaries are subject to claims for damages and/or equitable relief arising in the ordinary course of business. In addition, in large part as a result of the nature of its business, Teva is frequently subject to litigation, governmental investigations and other legal proceedings. Except for income tax contingencies or contingent consideration acquired in a business combination, Teva records a provision in its financial statements to the extent that it concludes that a contingent liability is probable and the amount thereof is reasonably estimable. When accruing these costs, Teva will recognize an accrual in the amount within a range of loss that is the best estimate within the range. When no amount within the range is a better estimate than any
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other amount, Teva accrues for the minimum amount within the range. Teva records anticipated recoveries under existing insurance contracts at the gross amount that is expected to be collected when they are considered probable to occur.
Teva reviews the adequacy of the accruals on a periodic basis and, although it believes that its present reserves are adequate, changes in facts and circumstances in the future may lead to adjustments to reserve estimates and could have a material impact on Teva’s results of operations, cash flows and financial condition in the period that reserve estimates are adjusted or paid. As such accruals are based on management’s judgment as to the probability of losses and, where applicable, actuarially determined estimates, accruals may materially differ from actual verdicts, settlements or other agreements made with regards to such contingencies. Litigation outcomes and contingencies are unpredictable and excessive verdicts can occur. 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. 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. The provisions of the accounting standard for goodwill allow us to first assess qualitative factors to determine whether it is necessary to perform the next goodwill impairment quantitative test.
Examples of events or circumstances that may be indicative of impairment include, but are not limited to: macroeconomic and industry conditions, overall financial performance and adverse changes in legal, regulatory, market share and other relevant entity specific events.
The Company estimates the fair values of all reporting units using a discounted cash flow model which utilizes Level 3 unobservable inputs. 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.
The carrying value of each reporting unit is determined by assigning the assets and liabilities, including the existing goodwill, to those reporting units.
When necessary, we record charges for impairments of goodwill for the amount by which the carrying amount exceeds the fair value of these assets.
See note 7 and note 19 to our consolidated financial statements for further details on the goodwill impairments recognized in 2022 and 2020, and Teva’s operating and reporting segments.
Identifiable Intangible Assets
Identifiable intangible assets are comprised of definite life intangible assets and indefinite life intangible assets.
Definite life intangible assets consist mainly of acquired product rights and other rights relating to products for which marketing approval was received from the FDA or the equivalent agencies in other countries. These assets are amortized using mainly the straight-line method over their estimated period of useful life, or based on
80
economic benefit models, if more appropriate, which is determined by identifying the period and manner in which substantially all of the cash flows are expected to be generated. Amortization of acquired developed products is recorded under cost of sales. Amortization of marketing and distribution rights is recorded under selling and marketing expenses when separable.
Indefinite life intangible assets are mainly comprised of IPR&D assets. Teva monitors these assets for items such as research and development milestones and progress to identify any triggering events.
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.
Whenever impairment indicators are identified for definite life intangible assets, Teva reconsiders the asset’s estimated life, calculates the undiscounted value of the asset’s or asset group’s cash flows and then calculates, if required, the discounted value of cash flow by applying an appropriate discount rate to the undiscounted cash flow streams. Teva then compares such value against the asset’s or asset group’s carrying amount. If the carrying amount is greater, Teva records an impairment loss for the excess of carrying value over fair value based on the discounted cash flows.
For indefinite life intangible assets Teva performs an impairment test annually in the second quarter and whenever events or changes in circumstances indicate the carrying value of an asset may not be recoverable. Teva determines the fair value of the asset annually or when triggering events are present, based on discounted cash flows and records an impairment loss if book value exceeds fair value.
Examples of events or circumstances that may be indicative of impairment include:
• | A projection or forecast that indicates losses or reduced profits associated with an asset. This could result, for example, from a change in the competitive landscape modifying our assumptions about market share or pricing prospectively, a government reimbursement program that results in an inability to sustain projected product revenues and profitability, or lack of acceptance of a product by patients, physicians or payers limiting our projected growth. |
• | A significant adverse change in legal factors or in the business climate that could affect the value of the asset. 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. For example, restrictions imposed by the FDA or other regulatory authorities could affect our ability to manufacture or sell a product. |
• | For IPR&D projects, this could result from, among other things, a change in outlook affecting assumptions around competition or timing of entry such as approval success or the related timing of approval, clinical trial data results, other delays in the projected launch dates or additional expenditures required to commercialize the product. |
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. Additionally, for IPR&D assets the risk of failure has been factored into the fair value measure.
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While all intangible assets other than goodwill can face events and circumstances that can lead to impairment, in general, intangible assets other than goodwill that are most at risk of impairment include IPR&D assets and newly acquired or recently impaired indefinite-lived brand assets. IPR&D assets are high-risk assets, as R&D is an inherently risky activity. Consequently, IPR&D assets could be determined to be no longer commercially viable. Newly acquired and recently impaired indefinite-lived assets are more vulnerable to impairment as the assets are recorded at fair value and are then subsequently measured at the lower of fair value or carrying value annually or when triggering events are present. 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.
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ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
General
The objective of our financial risk management measures is to minimize the impact of risks arising from foreign exchange and interest rate fluctuations. To reduce these risks, we take various operational measures in order to achieve a natural hedge and may enter, from time to time, into financial derivative instruments. Our derivative transactions are executed through global banks. We believe that due to our diversified derivatives portfolio, the credit risk associated with any of these banks is minimal. No derivative instruments are entered into for trading purposes.
Exchange Rate Risk Management
We operate our business worldwide and, as such, we are subject to foreign exchange risks on our results of operations, our monetary assets and liabilities and our foreign subsidiaries’ net assets. For further information on currencies in which we operate, see “Item 7— Management’s Discussion and Analysis of Financial Condition and Results of Operations—Impact of Currency Fluctuations on Results of Operations.”
We generally prefer to borrow in U.S. dollars; however, from time to time we borrow funds in other currencies, such as the euro, Swiss franc and new Israeli shekel, in order to benefit from same currency revenues in relation to same currency costs and same currency assets in relation to same currency liabilities.
Cash Flow Exposure
Our total revenues were $14,925 million in 2022. Of these revenues, approximately 47% were denominated in currencies other than the U.S. dollar, of which 21% in euros, 4% in British pound and the rest in other currencies, none of which accounted for more than 4% of total revenues in 2022. In most currencies, we record corresponding expenses.
In certain currencies, primarily the euro, our revenues generally exceed our expenses. Conversely, in other currencies, primarily the new Israeli shekel and the Indian rupee, our expenses generally exceed our revenues.
We enter into financial derivatives to hedge part of those currencies which do not have a sufficient natural hedge, in order to reduce the impact of foreign exchange fluctuations on our operating results.
As of December 31, 2022, we hedged part of our expected operating results for 2023 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.
In certain cases, we may hedge exposure arising from a specific transaction, executed in a currency other than the functional currency, by entering into forward contracts and/or by using plain-vanilla and exotic option strategies. We generally limit the term of hedging transactions to a maximum of eighteen months.
Balance Sheet Exposure
With respect to our monetary assets and liabilities, the exposure arises when the monetary assets and/or liabilities are denominated in currencies other than the functional currency of our subsidiaries. We strive to limit our exposure through natural hedging. The remaining exposure is hedged almost in full by entering into financial derivative instruments. To the extent possible, the hedging activity is carried out on a consolidated level.
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The table below presents exposures exceeding $50 million in absolute values:
Net exposure as of December 31, 2022 |
||||
Liability/Asset | (U.S. $ in millions) | |||
CHF/EUR |
360 | |||
USD/JPY |
225 | |||
GBP/EUR |
177 | |||
EUR/BGN |
150 | |||
GBP/USD |
130 | |||
INR /USD |
110 | |||
ILS/USD |
100 | |||
EUR/RUB |
85 | |||
CAD/EUR |
53 |
Outstanding Foreign Exchange Hedging Transactions
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, 2021, we had outstanding derivatives, primarily forwards and currency option contracts with corresponding notional amounts of approximately $2.1 billion and $0.4 billion, respectively.
The table below presents the net notional and fair values of the financial derivatives entered into as of December 31, 2022 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.
Currency (sold) |
Cross Currency (bought) |
Net Notional Value | Fair Value | 2022 Weighted Average Cross Currency Prices or Strike Prices |
||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||
(U.S. $ in millions) | ||||||||||||||||||||||||
Forward: |
||||||||||||||||||||||||
EUR |
CHF | 354 | * | (3 | ) | — | 0.98 | |||||||||||||||||
EUR |
USD | 252 | 98 | (8 | ) | 4 | 0.96 | |||||||||||||||||
JPY |
USD | 246 | 313 | (17 | ) | 4 | 139.06 | |||||||||||||||||
EUR |
GBP | 179 | * | (4 | ) | — | 0.87 | |||||||||||||||||
USD |
INR | 151 | 95 | (1 | ) | 1 | 82.51 | |||||||||||||||||
PLN |
USD | 122 | * | (8 | ) | — | 4.70 | |||||||||||||||||
CAD |
USD | 79 | 76 | 2 | 1 | 1.31 | ||||||||||||||||||
CHF |
USD | 58 | 509 | (18 | ) | (4 | ) | 0.94 | ||||||||||||||||
USD |
GBP | 58 | 133 | 1 | (1 | ) | 1.20 | |||||||||||||||||
CLP |
USD | 52 | * | (5 | ) | — | 943.05 | |||||||||||||||||
EUR |
CAD | 50 | * | (2 | ) | — | 1 | |||||||||||||||||
MXN |
USD | * | 96 | — | (4 | ) | 19 | |||||||||||||||||
Options: |
||||||||||||||||||||||||
EUR |
USD | 132 | 73 | (3 | ) | 1 | 0.99 | |||||||||||||||||
GBP |
USD | 86 | * | (2 | ) | — | 1.13 | |||||||||||||||||
USD |
ILS | 68 | * | (2 | ) | — | 3.25 | |||||||||||||||||
CAD |
USD | * | 53 | — | — | — | ||||||||||||||||||
CHF |
USD | * | 51 | (1 | ) | — | — |
* | Represents net notional value of less than $50 million. |
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Foreign Subsidiaries Net Assets
Under certain market conditions, we may hedge against possible fluctuations in foreign subsidiaries’ net assets (“net investment hedge”). In these cases, we may use cross currency swaps and forward contracts.
Interest Rate Risk Management
We are subject to interest rate risk on our investments and on our borrowings. We manage interest rate risk in the aggregate, while focusing on our immediate and intermediate liquidity needs.
We raise capital through various debt instruments including senior notes and sustainability-linked senior notes that bear a fixed or variable interest rate, unsecured syndicated sustainability-linked revolving credit facility that bears a fixed or variable interest rate and convertible debentures that bear a fixed and variable interest rate. In some cases, as described below, we have swapped from a fixed to a variable interest rate (“fair value hedge”), from a variable to a fixed interest rate and from a fixed to a fixed interest rate with an exchange from a currency other than the functional currency (“cash flow hedge”), reducing overall interest expenses or hedging risks associated with interest rate fluctuations.
In certain cases, we may hedge, in whole or in part, against exposure arising from a specific transaction, such as debt issuances related to an acquisition or debt refinancing, by entering into forward and interest rate swap contracts and/or by using options.
The table below presents the aggregate outstanding debt by currencies and maturities as of December 31, 2022:
Currency |
Total Amount |
Interest Rate Ranges |
2023 | 2024 | 2025 | 2026 | 2027 | 2028 & thereafter |
||||||||||||||||||||||||||||
(U.S. dollars in millions) | ||||||||||||||||||||||||||||||||||||
Fixed Rate: |
||||||||||||||||||||||||||||||||||||
USD |
13,220 | 2.80 | % | 7.13 | % | 1,250 | 1,000 | 3,497 | 1,000 | 1,250 | 3,770 | |||||||||||||||||||||||||
Euro |
7,667 | 1.13 | % | 6.00 | % | 670 | 2,034 | — | 1,925 | 799 | 1,606 | |||||||||||||||||||||||||
CHF |
379 | 1.00 | % | 1.00 | % | — | 379 | — | — | — | — | |||||||||||||||||||||||||
USD convertible debentures* |
23 | 0.25 | % | 0.25 | % | — | — | — | — | — | — | |||||||||||||||||||||||||
Variable Rate: |
||||||||||||||||||||||||||||||||||||
Others |
1 | — | — | |||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Total: |
21,290 | $ | 1,920 | $ | 3,413 | $ | 3,497 | $ | 2,925 | $ | 2,049 | $ | 5,376 | |||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||||||
Less debt issuance costs |
(78 | ) | ||||||||||||||||||||||||||||||||||
|
|
|||||||||||||||||||||||||||||||||||
Total: |
$ | 21,212 | ||||||||||||||||||||||||||||||||||
|
|
* | Classified under short-term debt. |
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Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Net revenues |
$ | 14,925 | $ | 15,878 | $ | 16,659 | ||||||
Cost of sales |
7,952 | 8,284 | 8,933 | |||||||||
Gross profit |
6,973 | 7,594 | 7,726 | |||||||||
Research and development expenses, net |
838 | 967 | 997 | |||||||||
Selling and marketing expenses |
2,265 | 2,429 | 2,498 | |||||||||
General and administrative expenses |
1,180 | 1,099 | 1,173 | |||||||||
Intangible assets impairments |
355 | 424 | 1,502 | |||||||||
Goodwill impairment |
2,045 | — | 4,628 | |||||||||
Other asset impairments, restructuring and other items |
414 | 341 | 479 | |||||||||
Legal settlements and loss contingencies |
2,082 | 717 | 60 | |||||||||
Other income |
(107 | ) | (98 | ) | (40 | ) | ||||||
Operating (loss) income |
(2,099 | ) | 1,716 | (3,572 | ) | |||||||
Financial expenses – net |
966 | 1,058 | 834 | |||||||||
Income (loss) before income taxes |
(3,065 | ) | 658 | (4,406 | ) | |||||||
Income taxes (benefit) |
(638 | ) | 211 | (168 | ) | |||||||
Share in (profits) losses of associated companies – net |
(21 | ) | (9 | ) | (138 | ) | ||||||
Net income (loss) |
(2,406 | ) | 456 | (4,099 | ) | |||||||
Net income (loss) attributable to non-controlling interests |
(53 | ) | 39 | (109 | ) | |||||||
Net income (loss) attributable to Teva |
(2,353 | ) | 417 | (3,990 | ) | |||||||
Earnings (loss) per share attributable to ordinary shareholders: |
||||||||||||
Basic |
$ | (2.12 | ) | $ | 0.38 | $ | (3.64 | ) | ||||
Diluted |
$ | (2.12 | ) | $ | 0.38 | $ | (3.64 | ) | ||||
Weighted average number of shares (in millions): |
||||||||||||
Basic |
1,110 | 1,102 | 1,095 | |||||||||
Diluted |
1,110 | 1,107 | 1,095 | |||||||||
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Net income (loss) |
$ | (2,406 | ) | $ | 456 | $ | (4,099 | ) | ||||
Other comprehensive income (loss), net of tax: |
||||||||||||
Currency translation adjustment |
(356 | ) | (462 | ) | (69 | ) | ||||||
Unrealized gain (loss) on derivative financial instruments, net |
29 | 39 | 57 | |||||||||
Unrealized gain (loss) on defined benefit plans, net |
57 | 32 | (18 | ) | ||||||||
|
|
|
|
|
|
|||||||
Total other comprehensive income (loss) |
(270 | ) | (391 | ) | (30 | ) | ||||||
|
|
|
|
|
|
|||||||
Total comprehensive income (loss) |
(2,676 | ) | 65 | (4,129 | ) | |||||||
Comprehensive income (loss) attributable to non-controlling interests |
(169 | ) | (68 | ) | (53 | ) | ||||||
|
|
|
|
|
|
|||||||
Comprehensive income (loss) attributable to Teva |
$ | (2,507 | ) | $ | 133 | $ | (4,076 | ) | ||||
|
|
|
|
|
|
Teva shareholders’ equity |
||||||||||||||||||||||||||||||||||||
Ordinary shares |
||||||||||||||||||||||||||||||||||||
Number of shares (in millions) |
Stated value |
Additional paid-in capital |
Retained earnings (accumulated deficit) |
Accumulated other comprehensive income (loss) |
Treasury shares |
Total Teva share- holders’ equity |
Non-controlling interests |
Total equity |
||||||||||||||||||||||||||||
(U.S. dollars in millions) |
||||||||||||||||||||||||||||||||||||
Balance at January 1, 2020 |
1,198 | 56 | 27,312 | (6,956 | ) |
(2,312 | ) |
(4,128 | ) |
13,972 | 1,091 | 15,063 | ||||||||||||||||||||||||
Changes during 2020: |
||||||||||||||||||||||||||||||||||||
Net income (loss) |
(3,990 | ) |
(3,990 | ) |
(109 | ) |
(4,099 | ) | ||||||||||||||||||||||||||||
Other comprehensive income (loss) |
(86 | ) |
(86 | ) |
56 | (30 | ) | |||||||||||||||||||||||||||||
Issuance of shares |
4 | * |
* |
1 | 1 | |||||||||||||||||||||||||||||||
Stock-based compensation expense |
129 | 129 | 129 | |||||||||||||||||||||||||||||||||
Transactions with non-controlling interests |
(2 | ) |
(2 | ) | ||||||||||||||||||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||||
Balance at December 31, 2020 |
1,202 | 57 | 27,443 | (10,946 | ) |
(2,399 | ) |
(4,128 | ) |
10,026 | 1,035 | 11,061 | ||||||||||||||||||||||||
Changes during 2021: |
||||||||||||||||||||||||||||||||||||
Net income (loss) |
417 | 417 | 39 | 456 | ||||||||||||||||||||||||||||||||
Other comprehensive income (loss) |
(283 | ) |
(283 | ) |
(107 | ) |
(391 | ) | ||||||||||||||||||||||||||||
Issuance of Shares |
7 | * | * |
* | ||||||||||||||||||||||||||||||||
Stock-based compensation expense |
119 | 119 | 119 | |||||||||||||||||||||||||||||||||
Transactions with non-controlling interests |
(2 | ) |
(2 | ) | ||||||||||||||||||||||||||||||||
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|
|
|
|
|
|
|
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|
|
|
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Balance at December 31, 2021 |
1,209 | 57 | 27,561 | (10,529 | ) |
(2,683 | ) |
(4,128 | ) |
10,278 | 966 | 11,244 | ||||||||||||||||||||||||
Changes during 2022: |
||||||||||||||||||||||||||||||||||||
Net income (loss) |
(2,353 | ) |
(2,353 | ) |
(53 | ) |
(2,406 | ) | ||||||||||||||||||||||||||||
Other comprehensive income (loss) |
(154 | ) |
(154 | ) |
(116 | ) |
(270 | ) | ||||||||||||||||||||||||||||
Issuance of Shares |
8 | * | 1 | 1 | 1 | |||||||||||||||||||||||||||||||
Stock-based compensation expense |
124 | 124 | 124 | |||||||||||||||||||||||||||||||||
Transactions with non-controlling interests |
(2 | ) |
(2 | ) | ||||||||||||||||||||||||||||||||
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|
|
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|
|
|
|
|
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|
|
|
|||||||||||||||||||
Balance at December 31, 2022 |
1,217 | $ |
57 | $ |
27,688 | $ |
(12,882 | ) |
$ |
(2,838 | ) |
$ |
(4,128 | ) |
$ |
7,897 | $ |
794 | $ |
8,691 | ||||||||||||||||
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|
|
* | Represents an amount less than $ 0.5 million. |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Operating activities: |
||||||||||||
Net income (loss) |
$ | (2,406 | ) | $ | 456 | $ | (4,099 | ) | ||||
Adjustments to reconcile net income (loss) to net cash provided by operations: |
||||||||||||
Impairment of goodwill, long-lived assets and assets held for sale |
2,447 | 584 | 6,546 | |||||||||
Depreciation and amortization |
1,308 | 1,330 | 1,557 | |||||||||
Net change in operating assets and liabilities |
1,257 | (1,701 | ) | (2,188 | ) | |||||||
Deferred income taxes — net and uncertain tax positions |
(1,059 | ) | (120 | ) | (696 | ) | ||||||
Stock-based compensation |
124 | 119 | 129 | |||||||||
Other items |
(91 | ) | 16 | 100 | ||||||||
Research and development in process |
— | 10 | 80 | |||||||||
Net loss (gain) from investments and from sale of business and long lived assets |
10 | 104 | (213 | ) | ||||||||
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|
|
|
|
|||||||
Net cash provided by (used in) operating activities |
1,590 | 798 | 1,216 | |||||||||
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|
Investing activities: |
||||||||||||
Beneficial interest collected in exchange for securitized trade receivables |
1,140 | 1,648 | 1,405 | |||||||||
Proceeds from sale of business and long lived assets |
68 | 311 | 67 | |||||||||
Purchases of property, plant and equipment |
(548 | ) | (562 | ) | (578 | ) | ||||||
Purchases of investments and other assets |
(1 | ) | (47 | ) | (55 | ) | ||||||
Proceeds from sale of investments |
4 | 172 | 12 | |||||||||
Other investing activities |
— | 1 | 12 | |||||||||
Acquisitions of businesses, net of cash acquired |
(7 | ) | — | — | ||||||||
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|
|
|
|
|||||||
Net cash provided by (used in) investing activities |
656 | 1,523 | 863 | |||||||||
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|
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|
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|
|
Financing activities: |
||||||||||||
Repayment of senior notes and loans and other long term liabilities |
(1,369 | ) | (6,649 | ) | (1,871 | ) | ||||||
Proceeds from senior notes, net of issuance costs |
— | 4,974 | — | |||||||||
Proceeds from short term debt |
— | 700 | 550 | |||||||||
Repayment of short term debt |
— | (700 | ) | (559 | ) | |||||||
Redemption of convertible debentures |
— | (491 | ) | — | ||||||||
Other financing activities |
(118 | ) | (6 | ) | (5 | ) | ||||||
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|
|
|
|
|
|||||||
Net cash provided by (used in) financing activities |
(1,487 | ) | (2,172 | ) | (1,885 | ) | ||||||
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|
|
|
|
|
|||||||
Translation adjustment on cash and cash equivalents |
(123 | ) | (128 | ) | 8 | |||||||
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|
|
|
|
|
|||||||
Net change in cash, cash equivalents and restricted cash |
636 | 21 | 202 | |||||||||
Balance of cash, cash equivalents and restricted cash at beginning of year |
2,198 | 2,177 | 1,975 | |||||||||
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|
|||||||
Balance of cash, cash equivalents and restricted cash at end of year |
$ | 2,834 | $ | 2,198 | $ | 2,177 | ||||||
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Reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheet: |
||||||||||||
Cash and cash equivalents |
2,801 | 2,165 | 2,177 | |||||||||
Restricted cash included in other current assets |
33 | 33 | — | |||||||||
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|
|
|
|||||||
Total cash, cash equivalents and restricted cash shown in the statement of cash flows |
2,834 | 2,198 | 2,177 | |||||||||
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|
|
|
|
|
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Supplemental cash flow information: |
||||||||||||
Non-cash financing and investing activities: |
||||||||||||
Beneficial interest obtained in exchange for securitized trade receivables |
$ | 1,189 | $ | 1,635 | $ | 1,397 | ||||||
Cash paid during the year for: |
||||||||||||
Interest |
$ | 948 | $ | 913 | $ | 846 | ||||||
Income taxes, net of refunds |
$ | 543 | $ | 495 | $ | 709 |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
Other current assets |
$ | (828 | ) | $ | (2,271 | ) | $ | (1,473 | ) | |||
Trade payables, accrued expenses, employee-related obligations and other liabilities |
1,914 | 764 | (463 | ) | ||||||||
Trade receivables net of sales reserves and allowances |
334 | (574 | ) | (293 | ) | |||||||
Inventories |
(163 | ) | 380 | 41 | ||||||||
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|
|
|
|||||||
$ | 1,257 | $ | (1,701 | ) | $ | (2,188 | ) | |||||
|
|
|
|
|
|
b. |
New accounting pronouncements |
c. |
Acquisitions: |
d. |
Collaborative arrangements: |
e. |
Equity investments: |
f. |
Fair value measurement: |
g. |
Cash and cash equivalents: |
h. |
Restricted cash: |
i. |
Accounts Receivables: |
j. |
Concentration of credit risks: |
k. |
Inventories: |
l. |
Long-lived assets: |
1. |
An initial qualitative assessment may be performed to determine whether it is more likely than not that the fair value of the reporting unit is less than its carrying amount. |
2. |
If the Company concludes it is more likely than not that the fair value of the reporting unit is less than its carrying mount, a quantitative fair value test is performed. An impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value is recognized. |
m. |
Contingencies: |
n. |
Treasury shares: |
o. |
Stock-based compensation: |
p. |
Deferred income taxes: |
1. |
Taxes that would apply in the event of disposal of investments in subsidiaries, as it is generally the Company’s intention to hold these investments, not to realize them. The determination of the amount of related unrecognized deferred tax liability is not practicable. |
2. |
Amounts of tax-exempt income generated from the Company’s current Approved Enterprises and unremitted earnings from foreign subsidiaries retained for reinvestment in the Group. See note 13f. |
q. |
Uncertain tax positions: |
r. |
Derivatives and hedging: |
s. |
Revenue recognition: |
t. |
Research and development: |
u. |
Shipping and handling costs: |
v. |
Advertising costs: |
w. |
Restructuring: |
x. |
Segment reporting: |
(a) | North America segment, which includes the United States and Canada. |
(b) | Europe segment, which includes the European Union, the United Kingdom and certain other European countries. |
(c) | International Markets segment, which includes all countries in which Teva operates other than those in the North America and Europe segments. |
y. |
Earnings per share: |
z. |
Securitization |
aa. |
Divestitures |
bb. |
Debt instruments |
cc. |
Leases |
December 31, 2022 |
December 31, 2021 |
|||||||
(U.S. $ in millions) |
||||||||
Inventories |
2 | 2 | ||||||
Property, plant and equipment, net and others |
18 | 86 | ||||||
Goodwill |
— | 7 | ||||||
Adjustments of assets held for sale to fair value |
(10 | ) | (76 | ) | ||||
|
|
|
|
|||||
Total assets of the disposal group classified as held for sale in the consolidated balance sheet |
$ | 10 | $ | 19 | ||||
|
|
|
|
|||||
Total liabilities of the disposal group classified as held for sale in the consolidated balance sheet, recorded under accrued expenses and other long-term liabilities |
$ | — | $ | (43 | ) | |||
|
|
|
|
Year ended December 31, 2022 |
||||||||||||||||||||
North America |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||
Sale of goods |
5,834 | 4,455 | 1,806 | 671 | 12,766 | |||||||||||||||
Licensing arrangements |
139 | 51 | 19 | 4 | 212 | |||||||||||||||
Distribution |
1,471 | 1 | 46 | — | 1,519 | |||||||||||||||
Other |
8 | 18 | 33 | 370 | 428 | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
$ | 7,452 | $ | 4,525 | $ | 1,903 | $ | 1,045 | $ | 14,925 | |||||||||||
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2021 |
||||||||||||||||||||
North America |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||
Sale of goods |
6,394 | 4,807 | 1,889 | 739 | 13,829 | |||||||||||||||
Licensing arrangements |
92 | 50 | 13 | 4 | 160 | |||||||||||||||
Distribution |
1,323 | 1 | 65 | — | 1,390 | |||||||||||||||
Other |
(1 | ) | 27 | 65 | 408 | 500 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
$ | 7,809 | $ | 4,886 | $ | 2,032 | $ | 1,151 | $ | 15,878 | |||||||||||
|
|
|
|
|
|
|
|
|
|
Year ended December 31, 2020 |
||||||||||||||||||||
North America |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||
Sale of goods |
6,902 | 4,736 | 1,946 | 772 | 14,354 | |||||||||||||||
Licensing arrangements |
84 | 32 | 9 | 4 | 129 | |||||||||||||||
Distribution |
1,462 | 3 | 30 | — | 1,495 | |||||||||||||||
Other |
§ | (14 | ) | 169 | 527 | 680 | ||||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
$ | 8,447 | $ | 4,757 | $ | 2,154 | $ | 1,302 | $ | 16,659 | |||||||||||
|
|
|
|
|
|
|
|
|
|
§ |
Represents an amount less than $1 million. |
Sales Reserves and Allowances |
||||||||||||||||||||||||||||||||
Reserves included in Accounts Receivable, net |
Rebates |
Medicaid and other governmental allowances |
Chargebacks |
Returns |
Other |
Total reserves included in Sales Reserves and Allowances |
Total |
|||||||||||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||||||||||||||
Balance at January 1, 2022 |
$ |
68 | $ | 1,655 | $ | 854 | $ | 1,085 | $ | 535 | $ | 112 | $ | 4,241 | $ |
4,309 | ||||||||||||||||
Provisions related to sales made in current |
363 |
3,823 |
871 |
7,819 | 317 |
85 |
12,915 | 13,278 | ||||||||||||||||||||||||
Provisions related to sales made in prior |
— |
(69 |
) |
(35 |
) |
(44 |
) |
(3 |
) |
(51 | ) | (202 | ) | (202 | ) | |||||||||||||||||
Credits and payments |
(364 |
) |
(3,798 |
) |
(1,023 |
) |
(7,861 |
) |
(390 |
) |
(77 | ) | (13,149 | ) | (13,513 | ) | ||||||||||||||||
Translation differences |
— |
(36 |
) |
(4 |
) |
(8 |
) |
(4 |
) |
(3 | ) | (55 | ) | (55 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at December 31, 2022 |
$ | 67 | $ | 1,575 | $ | 663 | $ | 991 | $ | 455 | $ | 66 | $ | 3,750 | $ | 3,817 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales Reserves and Allowances |
||||||||||||||||||||||||||||||||
Reserves included in Accounts Receivable, net |
Rebates |
Medicaid and other governmental allowances |
Chargebacks |
Returns |
Other |
Total reserves included in Sales Reserves and Allowances |
Total |
|||||||||||||||||||||||||
(U.S.$ in millions) |
||||||||||||||||||||||||||||||||
Balance at January 1, 2021 |
$ | 80 | $ | 2,054 | $ | 828 | $ | 1,108 | $ | 686 | $ | 148 | $ | 4,824 | $ | 4,904 | ||||||||||||||||
Provisions related to sales made in current year period |
382 | 4,030 | 852 | 7,967 | 263 | 314 | 13,426 | 13,808 | ||||||||||||||||||||||||
Provisions related to sales made in prior periods |
(9 | ) | (125 | ) | (51 | ) | (47 | ) | (60 | ) | (26 | ) | (309 | ) | (318 | ) | ||||||||||||||||
Credits and payments |
(385 | ) | (4,275 | ) | (768 | ) | (7,937 | ) | (350 | ) | (321 | ) | (13,651 | ) | (14,036 | ) | ||||||||||||||||
Translation differences |
— | (29 | ) | (7 | ) | (6 | ) | (4 | ) | (3 | ) | (49 | ) | (49 | ) | |||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||||||
Balance at December 31, 2021 |
$ | 68 | $ | 1,655 | $ | 854 | $ | 1,085 | $ | 535 | $ | 112 | $ | 4,241 | $ | 4,309 | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Finished products |
$ | 1,987 | $ | 1,932 | ||||
Raw and packaging materials |
1,059 | 1,136 | ||||||
Products in process |
555 | 587 | ||||||
Materials in transit and payments on account |
232 | 163 | ||||||
$ | 3,833 | $ | 3,818 | |||||
December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Machinery and equipment |
$ | 5,026 | $ | 5,098 | ||||
Buildings |
2,463 | 2,568 | ||||||
Computer equipment and other assets |
2,323 | 2,261 | ||||||
Assets under construction and payments on account |
1,199 | 1,034 | ||||||
Land |
246 | 262 | ||||||
11,257 | 11,223 | |||||||
Less—accumulated depreciation |
(5,518 | ) | (5,241 | ) | ||||
$ | 5,739 | $ | 5,982 | |||||
Gross carrying amount net of impairment |
Accumulated amortization |
Net carrying amount |
||||||||||||||||||||||
December 31, |
||||||||||||||||||||||||
2022 |
2021 |
2022 |
2021 |
2022 |
2021 |
|||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||
Product rights |
$ | 18,067 | $ | 18,815 | $ | 12,630 | $ | 12,318 | $ | 5,437 | $ | 6,497 | ||||||||||||
Trade names |
577 | 590 | 231 | 198 | 346 | 392 | ||||||||||||||||||
In-process research and development (IPR&D) |
487 | 577 | — | — | 487 | 577 | ||||||||||||||||||
Total |
$ | 19,131 | $ | 19,982 | $ | 12,861 | $ | 12,516 | $ | 6,270 | $ | 7,466 | ||||||||||||
(a) | Identifiable product rights of $310 million due to: (i) $256 million related to updated market assumptions regarding price and volume of products, and (ii) $54 million related to a change in Teva’s commercial plans regarding a certain program, as part of portfolio optimization efforts, which also included an inventory write-off of $108 million; and |
(b) | IPR&D assets of $45 million, due to generic pipeline products resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape and launch date). |
(a) | Identifiable product rights and trade names of $297 million due to: (i) $267 million, mainly related to updated market assumptions regarding price and volume of products acquired from Actavis Generics that are primarily marketed in the United States, and, (ii) $30 million related to lenalidomide (generic equivalent of Revlimid ® ), resulting from modified competition assumptions as a result of settlements between the innovator and other generic filers; and |
(b) | IPR&D assets of $127 million, mainly due to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date) in the United States. |
(a) | IPR&D assets of $797 million, mainly due to: (i) $300 million related to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date) in the United States; (ii) $262 million related to lenalidomide (generic equivalent of Revlimid ® ), due to modified competition assumptions as a result of settlements between the innovator and other generic filers; and (iii) $211 million related to AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States following clinical trial results, received in February 2020, which failed to meet their primary endpoints; and |
(b) | Identifiable product rights of $705 million, mainly due to: (i) $398 million related to updated market assumptions regarding price and volume of products acquired from Actavis Generics that are primarily marketed in the United States; (ii) $165 million in Japan in connection with ongoing regulatory pricing reductions and generic competition; and (iii) $110 million related to a change in the assumptions regarding competition for the expected relaunch of metformin tablets. |
North America |
Europe |
International Markets |
Other |
Total |
||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||
Balance as of December 31, 2020 (1) |
$ |
6,473 |
$ |
9,102 |
$ |
2,362 |
$ |
2,687 |
$ |
20,624 |
||||||||||
Changes during the period: |
||||||||||||||||||||
Goodwill reclassified as assets held for sale |
— |
(7 |
) |
— |
(11 |
) |
(18 |
) | ||||||||||||
Translation differences |
1 |
(551 |
) |
(34 |
) |
18 |
(566 |
) | ||||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2021 (1) |
$ |
6,474 |
$ |
8,544 |
$ |
2,328 |
$ |
2,694 |
$ |
20,040 |
||||||||||
Changes during the period: |
||||||||||||||||||||
Goodwill impairment |
— |
— |
(979 |
) |
(1,066 |
) |
(2,045 |
) | ||||||||||||
Goodwill acquired |
— |
— |
— |
12 |
12 |
|||||||||||||||
Translation differences |
(24 |
) |
(242 |
) |
(10 |
) |
(98 |
) |
(374 |
) | ||||||||||
|
|
|
|
|
|
|
|
|
|
|||||||||||
Balance as of December 31, 2022 (1) (*) |
$ |
6,450 |
$ |
8,302 |
$ |
1,339 |
$ |
1,542 |
$ |
17,633 |
||||||||||
|
|
|
|
|
|
|
|
|
|
(1) |
Accumulated goodwill impairment as of December 31, 2022, December 31, 2021 and December 31, 2020 was approximately $27.6 billion, $25.6 billion and $25.6 billion, respectively. |
(*) |
As of December 31, 2022, “Other” includes $1,293 million goodwill balance related to Teva’s API reporting unit. |
Year ended December 31, |
Year ended December 31, |
Year ended December 31, |
||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
(U.S. $ in millions) |
(U.S. $ in millions) |
||||||||||
Operating lease cost: |
||||||||||||
Fixed payments and variable payments that depend on an index or rate |
$ | 142 | $ | 135 | $ | 148 | ||||||
Variable lease payments not included in the lease liability |
4 | 4 | 4 | |||||||||
Short-term lease cost |
2 | 2 | 3 | |||||||||
|
|
|
|
|
|
|||||||
$ | 148 | $ | 141 | $ | 155 | |||||||
|
|
|
|
|
|
Year ended December 31, |
Year ended December 31, |
Year ended December 31, |
||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
(U.S. $ in millions) |
(U.S. $ in millions) |
||||||||||
Cash paid for amounts included in the measurement of lease liabilities: |
||||||||||||
Operating cash flows from operating leases |
$ | 140 | $ | 143 | $ | 151 | ||||||
Right-of-use (non-cash): |
||||||||||||
Operating leases |
$ | 81 | $ | 81 | $ | 211 |
December 31, |
December 31, |
|||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
(U.S. $ in millions) |
|||||||
Operating leases: |
||||||||
Operating lease ROU assets |
$ | 419 | $ | 495 | ||||
Other current liabilities |
93 | 109 | ||||||
Operating l e l ies |
349 | 416 | ||||||
Total operating lease liabilities |
$ | 442 | $ | 525 | ||||
|
|
|
|
December 31, |
December 31, |
|||||||
2022 |
2021 |
|||||||
Weighted average remaining lease term |
|
|
|
|
|
|
|
|
Operating leases |
6.8 years | 7.3 years | ||||||
Weighted average discount rate |
|
|
|
|
|
|
|
|
Operating leases |
5.6 | % | 5.4 | % |
December 31, |
||||
2022 |
||||
(U.S. $ in millions) |
||||
202 3 |
116 | |||
202 4 |
94 | |||
202 5 |
79 | |||
202 6 |
66 | |||
202 7 and thereafter |
188 | |||
|
|
|||
Total operating lease payments |
$ | 543 | ||
|
|
|||
Less: imputed interest |
101 | |||
|
|
|||
Present value of lease liabilities |
$ | 442 | ||
|
|
a. |
Short-term debt: |
December 31, |
||||||||||||||||
Weighted average interest rate as of December 31, 2022 |
Maturity |
2022 |
2021 |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Convertible debentures |
0.25 | % | 2026 | 23 | 23 | |||||||||||
Current maturities of long-term liabilities |
2,086 | 1,403 | ||||||||||||||
|
|
|
|
|||||||||||||
Total short term debt |
$ | 2,109 | $ | 1,426 | ||||||||||||
|
|
|
|
b. |
Long-term debt: |
Weighted average interest rate as of December 31, 2022 |
Maturity |
December 31, 2022 |
December 31, 2021 |
|||||||||||||
% |
(U.S. $ in millions) |
|||||||||||||||
Senior notes EUR 1,500 million |
1.13 | % | 2024 | 670 | 708 | |||||||||||
Sustainability-linked senior notes EUR 1,500 million (1)(*) |
4.38 | % | 2030 | 1,606 | 1,699 | |||||||||||
Senior notes EUR |
1.25 | % | 2023 | 633 | 670 | |||||||||||
Sustainability-linked senior notes EUR 1,100 million (2)(*) |
3.75 | % | 2027 | 1,177 | 1,246 | |||||||||||
Senior notes EUR 1,000 million |
6.00 | % | 2025 | 1,070 | 1,134 | |||||||||||
Senior notes EUR 900 million |
4.50 | % | 2025 | 963 | 1,020 | |||||||||||
Senior notes EUR |
1.63 | % | 2028 | 800 | 844 | |||||||||||
Senior notes EUR 700 million (3) |
3.25 | % | 2022 | — | 307 | |||||||||||
Senior notes EUR 700 million |
1.88 | % | 2027 | 748 | 792 | |||||||||||
Senior notes USD 3,500 million |
3.15 | % | 2026 | 3,496 | 3,496 | |||||||||||
Senior notes USD 3,000 million |
2.80 | % | 2023 | 1,453 | 1,453 | |||||||||||
Senior notes USD 2,000 million |
4.10 | % | 2046 | 1,986 | 1,986 | |||||||||||
Senior notes USD 1,250 million |
6.00 | % | 2024 | 1,250 | 1,250 | |||||||||||
Senior notes USD 1,250 million |
6.75 | % | 2028 | 1,250 | 1,250 | |||||||||||
Senior notes USD 1,000 million |
7.13 | % | 2025 | 1,000 | 1,000 | |||||||||||
Sustainability-linked senior notes USD 1,000 million (2)(*) |
4.75 | % | 2027 | 1,000 | 1,000 | |||||||||||
Sustainability-linked senior notes USD 1,000 million (1)(*) |
5.13 | % | 2029 | 1,000 | 1,000 | |||||||||||
Senior notes USD 844 million (5) |
2.95 | % | 2022 | — | 715 | |||||||||||
Senior notes USD 789 million |
6.15 | % | 2036 | 783 | 783 | |||||||||||
Senior notes CHF 350 million (4) |
0.50 | % | 2022 | — | 382 |
Weighted average interest rate as of December 31, 2022 |
Maturity |
December 31, 2022 |
December 31, 2021 |
|||||||||||||
% |
(U.S. $ in millions) |
|||||||||||||||
Senior notes CHF 350 million |
1.00 | % | 2025 | 382 | 383 | |||||||||||
|
|
|
|
|||||||||||||
Total senior notes |
21,266 | 23,118 | ||||||||||||||
Other long-term debt |
1 | 2 | ||||||||||||||
Less current maturities |
(2,086 | ) | (1,403 | ) | ||||||||||||
Less debt issuance costs |
(78 | ) | (100 | ) | ||||||||||||
|
|
|
|
|||||||||||||
Total senior notes and loans |
$ | 19,103 | $ | 21,617 | ||||||||||||
|
|
|
|
(1) | If Teva fails to achieve certain sustainability performance targets, the interest rate shall increase by 0.125%-0.375% per annum, from and including May 9, 2026. |
(2) | If Teva fails to achieve certain sustainability performance targets, a one-time premium payment of 0.15%-0.45% out of the principal amount will be paid at maturity or upon earlier redemption, if such redemption is on or after May 9, 2026. |
(3) | In April 2022, Teva repaid $296 million of its 3.25% senior notes at maturity. |
(4) | In July 2022, Teva repaid $365 million of its 0.50% senior notes at maturity. |
(5) | In December 2022, Teva repaid $713 million of its 2.95% senior notes at maturity. |
(*) | Interest rate adjustments and a potential one-time premium payment related to the sustainability-linked bonds are treated as bifurcated embedded derivatives. See note 10c. |
December 31, 2022 |
||||
(U.S. $ in millions) |
||||
2024 |
$ | 1,921 | ||
2025 |
3,412 | |||
2026 * |
3,523 | |||
2027 |
2,927 | |||
2028 and thereafter |
7,448 | |||
|
|
|||
$ | 19,231 | |||
|
|
* | I ncluding $23 million convertible notes. See note 9a. |
a. |
Foreign exchange risk management: |
b. |
Interest risk management: |
c. |
Bifurcated embedded derivatives: |
d. |
Derivative instrument outstanding: |
Fair value |
||||||||
Not designated as hedging instruments |
||||||||
December 31, 2022 |
December 31, 2021 |
|||||||
Reported under |
(U.S. $ in millions) |
|||||||
Asset derivatives: |
||||||||
Other current assets: |
||||||||
Option and forward contracts |
$ | 29 | $ | 30 | ||||
Liability derivatives: |
||||||||
Other current liabilities: |
||||||||
Option and forward contracts |
$ | (101 | ) | $ | (23 | ) |
Reported under |
Financial expenses, net |
Other comprehensive income (loss) |
||||||||||||||||||||||
Year ended December 31, |
Year ended December 31, |
|||||||||||||||||||||||
2022 |
2021 |
2020 |
2022 |
2021 |
2020 |
|||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||
Line items in which effects of hedges are recorded |
$ | 966 | $ | 1,058 | $ | 834 | $ | (270 | ) | $ | (391 | ) | $ | (30 | ) | |||||||||
Cross-currency swaps—net investment hedge (1) |
— | — | (2 | ) | — | — | (21 | ) |
Financial expenses, net |
Net revenues |
|||||||||||||||||||||||
Year ended December 31, |
Year ended December 31, |
|||||||||||||||||||||||
2022 |
2021 |
2020 |
2022 |
2021 |
2020 |
|||||||||||||||||||
Reported under |
(U.S. $ in millions) |
|||||||||||||||||||||||
Line items in which effects of hedges are recorded |
$ | 966 | $ | 1,058 | $ | 834 | $ | (14,925 | ) | $ | (15,878 | ) | $ | (16,659 | ) | |||||||||
Option and forward contracts ( 2 ) |
(12 | ) | (45 | ) | 130 | — | — | — | ||||||||||||||||
Option and forward contracts ( 3 ) |
— | — | — | (11 | ) | (31 | ) | * |
* |
Represents an amount less than $0.5 million. |
(1) |
In each of the first and second quarters of 2017, Teva entered into a cross currency swap agreement with a notional amount of $500 million maturing in 2020. These cross currency swaps were designated as a net investment hedge of Teva’s foreign subsidiaries euro denominated net assets, in order to reduce the risk of adverse exchange rate fluctuations. With respect to these cross currency swap agreements, Teva recognized gains which mainly reflect the differences between the float-for-float |
(2) |
Teva uses foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, Teva recognizes gains or losses that offset the revaluation of the balance sheet items also recorded under financial expenses, net. |
(3) |
Teva entered into option and forward contracts designed to limit the exposure of foreign exchange fluctuations on projected revenues and expenses recorded in euro, Swiss franc, Japanese yen, British pound, Canadian dollar, Polish zloty and some other currencies to protect its projected operating results for 2022 and 2023. These derivative instruments do not meet the criteria for hedge accounting, however, they are accounted for as an economic hedge. These derivative instruments, which may include hedging transactions against future projected revenues and expenses, are recognized on the b alance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. In 2022, the positive impact from these derivatives recognized under was $11 million. In 2021, the positive impact from these derivatives recognized under revenues was $31 million. Changes in the fair value of the derivative instruments are recognized in the same line item in the statements of income as the underlying exposure being hedged. The cash flows associated with these derivatives are reflected as cash flows from operating activities in the consolidated statements of cash flows. |
e. |
Amortizations due to terminated derivative instruments: |
f. |
Securitization: |
As of and for the year ended December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Sold receivables at the beginning of the year |
$ | 685 | $ | 734 | ||||
Proceeds from sale of receivables |
4,653 | 5,139 | ||||||
Cash collections (remitted to the owner of the receivables) |
(4,665 | ) | (5,152 | ) | ||||
Effect of currency exchange rate changes |
(37 | ) | (36 | ) | ||||
Sold receivables at the end of the year |
$ | 636 | $ | 685 | ||||
a. |
Commitments: |
b. |
Contingencies: |
a. |
Income (loss) before income taxes: |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Parent Company and its Israeli subsidiaries |
$ | (119 |
) |
$ | 126 | $ | 947 | |||||
Non-Israeli subsidiaries |
(2,946 | ) |
532 | (5,353 | ) | |||||||
$ | (3,065 | ) | $ | 658 | $ | (4,406 | ) | |||||
b. |
Income taxes: |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Income (loss) before income taxes |
$ | (3,065) | $ | 658 | $ | (4,406) | ||||||
Statutory tax rate in Israel |
23% | 23% | 23% | |||||||||
Theoretical provision for income taxes |
$ | (705) | $ | 151 | $ | (1,013) | ||||||
Increase (decrease) in the provision for income taxes due to: |
||||||||||||
The Parent Company and its Israeli subsidiaries - Tax benefits arising from reduced tax rates under benefit programs |
15 | (12) | (153) | |||||||||
Mainly nondeductible items and prior year tax |
35 | 20 | (30) | |||||||||
Non-Israeli subsidiaries, including impairments (*) |
924 | 117 | 1,369 | |||||||||
Worthless stock deduction (**) |
(909) |
— |
— |
|||||||||
Increase (decrease) in other uncertain tax positions—net |
2 | (65) | (341) | |||||||||
Effective consolidated income taxes |
$ | (638) | $ | 211 | $ | (168) | ||||||
* |
In 2022 and 2020, loss before income taxes includes goodwill impairment in non-Israeli subsidiaries that did not have a corresponding tax effect. |
** |
In 2022, one of Teva’s U.S. subsidiaries was determined to be insolvent for tax purposes (i.e., its liabilities exceeded the fair market value of its assets), mainly in light of its accumulated operational losses. Consequently, Teva will recognize on its 2022 tax return, a worthless stock deduction of approximately $4.2 billion, with related tax benefit of approximately $909 million. |
c. |
Deferred income taxes: |
December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Deferred tax assets (liabilities), net: |
||||||||
Inventory related |
$ | 125 |
$ | 104 | ||||
Sales reserves and allowances |
89 | 136 | ||||||
Provision for legal settlements |
703 | 360 | ||||||
Intangible assets (*) |
(567 | ) |
(814 | ) | ||||
Carryforward losses and deductions and credits (**) |
2,850 | 2,093 | ||||||
Property, plant and equipment |
(238 | ) |
(215 | ) | ||||
Deferred interest |
800 | 617 | ||||||
Provisions for employee related obligations |
82 | 95 | ||||||
Other |
133 | 159 | ||||||
3,977 | 2,535 | |||||||
Valuation allowance—in respect of carryforward losses and deductions that may not be utilized |
(3,072 | ) |
(2,723 | ) | ||||
$ | 905 | $ | (188 | ) | ||||
(*) | The decrease in deferred tax liability is mainly due to impairment and amortization. |
(**) | The amounts are shown following a reduction for unrecognized tax benefits of $1 million and $10 million as of December 31, 2022 and 2021, respectively. |
d. |
Uncertain tax positions: |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Balance at the beginning of the year |
$ | 672 | $ | 888 | $ | 1,223 | ||||||
Increase (decrease) related to prior year tax positions, net |
(46 | ) |
(106 | ) | (238 | ) | ||||||
Increase related to current year tax positions |
42 | 7 | 10 | |||||||||
Decrease related to settlements with tax authorities and lapse of applicable statutes of limitations |
(31 | ) | (115 | ) | (105 | ) | ||||||
Other |
1 | (2 | ) | (2 | ) | |||||||
Balance at the end of the year |
$ | 638 | $ | 672 | $ | 888 | ||||||
|
|
|
|
|
|
e. |
Tax assessments: |
f. |
Basis of taxation: |
• |
Investment of at least 7% of income, or at least NIS 75 million (approximately $22 million) in R&D activities; and |
• |
One of the following: |
a. | At least 20% of the workforce (or at least 200 employees) are employed in R&D; |
b. | A venture capital investment approximately equivalent to at least $2 million was previously made in the company; or |
c. | Growth in sales or workforce by an average of 25% over the three years preceding the tax year. |
a. |
Ordinary shares and ADSs |
b. |
Stock-based compensation plans |
Year ended December 31, |
||||||||||||||||||||||||
2022 |
2021 |
2020 |
||||||||||||||||||||||
Number (in thousands) |
Weighted average exercise price |
Number (in thousands) |
Weighted average exercise price |
Number (in thousands) |
Weighted average exercise price |
|||||||||||||||||||
Balance outstanding at beginning of year |
29,015 | $ | 36.96 | 35,234 | $ | 37.27 | 40,064 | $ | 37.90 | |||||||||||||||
Changes during the year: |
||||||||||||||||||||||||
Forfeited |
(2,378 | ) | 33.77 | (3,644 | ) | 36.09 | (3,610 | ) | 40.24 | |||||||||||||||
Expired |
(2,518 | ) | 41.26 | (2,575 | ) | 42.40 | (1,220 | ) | 49.35 | |||||||||||||||
Balance outstanding at end of year |
24,119 | 36.83 | 29,015 | 36.96 | 35,234 | 37.27 | ||||||||||||||||||
Balance exercisable at end of year |
24,119 | 36.83 | 26,989 | 38.30 | 28,556 | 40.56 | ||||||||||||||||||
Year ended December 31, |
||||||||||||||||||||||||
2022 |
2021 |
2020 |
||||||||||||||||||||||
Number (in thousands) |
Weighted average grant date fair value |
Number (in thousands) |
Weighted average grant date fair value |
Number (in thousands) |
Weighted average grant date fair value |
|||||||||||||||||||
Balance outstanding at beginning of year |
24,412 | $ | 11.58 | 20,720 | $ | 13.81 | 15,977 | $ | 16.49 | |||||||||||||||
Granted |
18,755 | 7.42 | 12,748 | 10.42 | 10,848 | 11.42 | ||||||||||||||||||
Vested |
(7,571 | ) | 13.02 | (6,818 | ) | 15.60 | (4,324 | ) | 19.49 | |||||||||||||||
Forfeited |
(3,293 | ) | 9.81 | (2,238 | ) | 12.18 | (1,781 | ) | 18.18 | |||||||||||||||
Balance outstanding at end of year |
32,302 | 9.11 | 24,412 | 11.58 | 20,720 | 13.81 | ||||||||||||||||||
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Employee stock options |
$ | 2 | $ | 16 | $ | 30 | ||||||
RSUs and PSUs |
122 | 103 | 99 | |||||||||
Total stock-based compensation expense |
124 | 119 | 129 | |||||||||
Tax effect on stock-based compensation expense |
9 | 12 | 14 | |||||||||
Net effect |
$ | 115 | $ | 107 | $ | 115 | ||||||
c . |
Dividends |
d . |
Accumulated other comprehensive loss |
Net Unrealized Gains/(Losses) |
Benefit Plans |
|||||||||||||||
Foreign currency translation adjustments |
Derivative financial instruments |
Actuarial gains/(losses) and prior service (costs)/credits |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Balance as of January 1, 2020 |
$ | (1,794 | ) | (420 | ) | (98 | ) | (2,312 | ) | |||||||
Other comprehensive income/(loss) before reclassifications |
(190 | ) | 22 | (7 | ) | (175 | ) | |||||||||
Amounts reclassified to the statements of income |
— | 35 | (12 | ) | 23 | |||||||||||
Net other comprehensive income/(loss) before tax |
(190 | ) | 57 | (19 | ) | (152 | ) | |||||||||
Corresponding income tax |
65 | — | 1 | 66 | ||||||||||||
Net other comprehensive income/(loss) after tax* |
(125 | ) | 57 | (18 | ) | (86 | ) | |||||||||
Balance as of December 31, 2020 |
(1,919 | ) | (363 | ) | (117 | ) | (2,399 | ) | ||||||||
Other comprehensive income/(loss) before reclassifications |
(386 | ) | — | 18 | (368 | ) | ||||||||||
Amounts reclassified to the statements of income |
— | 39 | 18 | 57 | ||||||||||||
Net other comprehensive income/(loss) before tax |
(386 | ) | 39 | 36 | (311 | ) | ||||||||||
Corresponding income tax |
31 |
— |
(4 |
) |
27 |
|||||||||||
Net other comprehensive income/(loss) after tax* |
(355 |
) |
39 |
32 |
(284 |
) | ||||||||||
Balance as of December 31, 2021 |
(2,274 |
) |
(324 |
) |
(85 |
) |
(2,683 |
) | ||||||||
Other comprehensive income/(loss) before reclassifications |
(223 |
) |
— |
40 |
(183 |
) | ||||||||||
Amounts reclassified to the statements of income |
— |
29 |
27 |
56 |
||||||||||||
Net other comprehensive income/(loss) before tax |
(223 |
) |
29 |
67 |
(127 |
) | ||||||||||
Corresponding income tax |
(17 |
) |
— |
(10 |
) |
(27 |
) | |||||||||
Net other comprehensive income/(loss) after tax* |
(240 |
) |
29 |
57 |
(154 |
) | ||||||||||
Balance as of December 31, 2022 |
$ |
(2,514 |
) |
$ |
(295 |
) |
$ |
(28 |
) |
$ |
(2,838 |
) | ||||
* | Amounts do not include foreign currency translation adjustments attributable to non-controlling interests of $116 million loss in 2022, $107 million loss in 2021 and $56 million gain in 2020. |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
I t of long-lived tangible assets (1) |
$ | 47 | $ | 160 | $ | 416 | ||||||
Contingent consideration (see note 20) |
163 | 7 | (81 | ) | ||||||||
Restructuring |
146 | 133 | 120 | |||||||||
Other |
57 | 41 | 24 | |||||||||
Total |
$ | 414 | $ | 341 | $ | 479 | ||||||
(1) |
Including impairments related to exit and disposal activities. |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Restructuring |
||||||||||||
Employee termination |
$ | 117 | $ | 117 | $ | 71 | ||||||
Other |
29 | 16 | 49 | |||||||||
Total |
$ | 146 | $ | 133 | $ | 120 | ||||||
Employee termination costs |
Other |
Total |
||||||||||
(U.S. $ in millions ) |
||||||||||||
Balance as of January 1, 2020 |
$ | (208 | ) | $ | (7 | ) | $ | (215 | ) | |||
Provision |
(71 | ) | (49 | ) | (120 | ) | ||||||
Utilization and other* |
164 | 49 | 213 | |||||||||
Balance as of January 1, 2021 |
$ | (115 | ) | $ | (7 | ) | $ | (122 | ) | |||
Provision |
(117 | ) | (16 | ) | (133 | ) | ||||||
Utilization and other* |
101 | 16 | 117 | |||||||||
Balance as of December 31, 2021 |
$ | (131 | ) | $ | (7 | ) | $ | (138 | ) | |||
Provision |
(117 | ) | (29 | ) | (146 | ) | ||||||
Utilization and other* |
136 | 29 | 165 | |||||||||
Balance as of December 31, 2022 |
$ | (112 | ) | (7 | ) | (119 | ) | |||||
* |
Includes adjustments for foreign currency translation. |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Gain on divestitures, net of divestitures related costs (1) |
$ | 46 | 51 | 8 | ||||||||
Section 8 and similar payments (2) |
13 | 19 | — | |||||||||
Gain (loss) on sale of assets |
18 | 7 | 11 | |||||||||
Other, net (3) |
31 | 22 | 20 | |||||||||
Total other income |
$ | 107 | $ | 98 | $ | 40 | ||||||
(1) |
In 2022, mainly related to the divestment of several activities in North America and International Markets. In 2021, mainly due to capital gains related to the sale of certain OTC assets. In 2020, mainly related to the divestment of several activities in International Markets. |
(2) |
Section 8 of the Patented Medicines (Notice of Compliance) Regulation relates to recoveries of lost revenue related to patent infringement proceedings in Canada. |
(3) |
In 2022, mainly the result of settlement proceeds related to the International Markets segment. |
Year ended December, 31 |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Interest expenses and other bank charges |
930 | 891 | 901 | |||||||||
(Income) loss from investments (1) |
(10 | ) | 90 | (104 | ) | |||||||
Foreign exchange (gains) losses, net |
(16 | ) | 7 | (26 | ) | |||||||
Other, net (2) |
61 | 71 | 62 | |||||||||
Total finance expense, net |
$ | 966 | $ | 1,058 | $ | 834 | ||||||
(1) |
(Income) loss from investments in 2021 and 2020 comprised mainly of revaluation gains and loss of Teva’s investment in American Well Corporation (“American Well”). |
(2) |
Amortization of issuance costs and terminated derivative instruments. |
Year ended December, 31 |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions, except share data) |
||||||||||||
Net income (loss) used for the computation of basic and diluted earnings (loss) per share |
(2,353 | ) | $ | 417 | $ | (3,990 | ) | |||||
Weighted average number of shares used in the computation of basic earnings (loss) per share |
1,110 | 1,102 | 1,095 | |||||||||
Weighted average number of shares used in the computation of diluted earnings (loss) per share |
1,110 | 1,107 | 1,095 | |||||||||
(a) | North America segment, which includes the United States and Canada. |
(b) | Europe segment, which includes the European Union, the United Kingdom and certain other European countries. |
(c) |
International Markets segment, which includes all countries other than those in the North America and Europe segments. |
Year ended December 31, |
||||||||||||
2022 |
||||||||||||
North America |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | 7,452 | $ | 4,525 | $ | 1,903 | ||||||
Gross profit |
3,926 | 2,700 | 1,033 | |||||||||
R&D expenses |
532 | 213 | 72 | |||||||||
S&M expenses |
941 | 748 | 405 | |||||||||
G&A expenses |
474 | 246 | 119 | |||||||||
Other income |
(15 | ) | (3 | ) | (43 | ) | ||||||
Segment profit |
$ | 1,993 | $ | 1,496 | $ | 479 | ||||||
Year ended December 31, |
||||||||||||
2021 |
||||||||||||
North America |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | 7,809 | $ | 4,886 | $ | 2,032 | ||||||
Gross profit |
4,226 | 2,823 | 1,118 | |||||||||
R&D expenses |
618 | 244 | 68 | |||||||||
S&M expenses |
988 | 846 | 417 | |||||||||
G&A expenses |
427 | 244 | 109 | |||||||||
Other income |
(31 | ) | (5 | ) | (5 | ) | ||||||
Segment profit |
$ | 2,224 | $ | 1,494 | $ | 529 | ||||||
Year ended December 31, |
||||||||||||
2020 |
||||||||||||
North America |
Europe |
International Markets |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | 8,447 | $ | 4,757 | $ | 2,154 | ||||||
Gross profit |
4,489 | 2,666 | 1,096 | |||||||||
R&D expenses |
622 | 247 | 70 | |||||||||
S&M expenses |
1,013 | 830 | 427 | |||||||||
G&A expenses |
443 | 261 | 136 | |||||||||
Other income |
(10 | ) | (3 | ) | (11 | ) | ||||||
Segment profit |
$ | 2,421 | $ | 1,331 | $ | 474 | ||||||
Year ended |
||||||||||||
December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
North America profit |
$ | 1,993 | $ | 2,224 | $ | 2,421 | ||||||
Europe profit |
1,496 | 1,494 | 1,331 | |||||||||
International Markets profit |
479 | 529 | 474 | |||||||||
Total reportable segments profit |
3,968 | 4,246 | 4,225 | |||||||||
Profit of other activities |
172 | 154 | 163 | |||||||||
Total segments profit |
4,140 | 4,401 | 4,388 | |||||||||
Amounts not allocated to segments: |
||||||||||||
Amortization |
732 | 802 | 1,020 | |||||||||
Other assets impairments, restructuring and other items |
414 | 341 | 479 | |||||||||
Goodwill impairment |
2,045 | — | 4,628 | |||||||||
Intangible asset impairments |
355 | 424 | 1,502 | |||||||||
Legal settlements and loss contingencies |
2,082 | 717 | 60 | |||||||||
Other unallocated amounts |
610 | 402 | 271 | |||||||||
Consolidated operating income (loss) |
(2,099 | ) | 1,716 | (3,572 | ) | |||||||
Financial expenses, net |
966 | 1,058 | 834 | |||||||||
Consolidated income (loss) before income taxes |
$ | (3,065 | ) | $ | 658 | $ | (4,406 | ) | ||||
b. |
Segment revenues by major products and activities: |
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Generic products |
$ | 3,549 | $ | 3,769 | $ |
4,010 | ||||||
AJOVY |
218 | 176 | 134 | |||||||||
AUSTEDO |
963 | 802 | 637 | |||||||||
BENDEKA and TREANDA |
316 | 385 | 415 | |||||||||
COPAXONE |
387 | 577 | 884 | |||||||||
Anda |
1,471 | 1,323 | 1,462 | |||||||||
Other |
549 | 777 | 905 | |||||||||
Total |
$ | 7,452 | $ | 7,809 | $ |
8,447 | ||||||
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Generic products |
$ | 3,466 | $ | 3,569 | $ |
3,513 | ||||||
AJOVY |
124 | 87 | 31 | |||||||||
COPAXONE |
268 | 391 | 400 | |||||||||
Respiratory products |
273 | 356 | 353 | |||||||||
Other |
393 | 483 | 459 | |||||||||
Total |
$ | 4,525 | $ | 4,886 | $ |
4,757 | ||||||
Year ended December 31, |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Generic products |
$ | 1,586 | $ | 1,649 | $ | 1,792 | ||||||
AJOVY |
35 | 50 | 18 | |||||||||
COPAXONE |
36 | 37 | 53 | |||||||||
Other |
246 | 295 | 291 | |||||||||
Total |
$ | 1,903 | $ | 2,032 | $ | 2,154 | ||||||
c. |
Supplemental data—major customers: |
Percentage of Third Party Net Sales |
||||||||||||
2022 |
2021 |
2020 |
||||||||||
McKesson Corporation |
10 | % | 11 | % | 12 | % | ||||||
AmerisourceBergen Corporation |
10 | % | 11 | % | 12 | % |
d. |
Property, plant and equipment—by geographical location were as follows: |
December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Israel |
$ | 1,401 | $ | 1,543 | ||||
Germany |
1,143 | 1,045 | ||||||
United States |
625 | 692 | ||||||
Croatia |
445 | 481 | ||||||
Czech republic |
318 | 324 | ||||||
Hungary |
294 | 321 | ||||||
Ireland |
268 | 269 | ||||||
Other |
1,245 | 1,307 | ||||||
Total property, plant and equipment |
$ | 5,739 | $ | 5,982 | ||||
December 31, 2022 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money markets |
$ | 1,222 | — | — | $ | 1,222 | ||||||||||
Cash, deposits and other |
1,579 | — | — | 1,579 | ||||||||||||
Investment in securities: |
||||||||||||||||
Equity securities |
9 | — | — | 9 | ||||||||||||
Other |
5 | — | 1 | 6 | ||||||||||||
Restricted cash |
33 | — | — | 33 | ||||||||||||
Derivatives: |
||||||||||||||||
: O ptions and forward contracts |
— | 29 | — | 29 | ||||||||||||
: |
— | |||||||||||||||
Options and forward contracts |
— | (101 | ) | — | (101 | ) | ||||||||||
Bifurcated embedded derivatives |
— | — | § | — | ||||||||||||
Contingent consideration* |
— | — | (153 | ) | (153 | ) | ||||||||||
Total |
$ | 2,848 | $ | (73 | ) | $ | (152 | ) | $ | 2,624 | ||||||
§ |
Represents an amount less than 0.5 million |
* |
Contingent consideration represents liabilities recorded at fair value in connection with acquisitions.. |
§ | Represents an amount less than $0.5 million. |
* | Contingent consideration represents liabilities recorded at fair value in connection with acquisitions. |
December 31, 2022 |
December 31, 2021 |
|||||||
(U.S. $ in millions) |
||||||||
Fair value at the beginning of the period |
$ | (175 | ) | $ | (258 | ) | ||
Redemption of debt securities |
— | (9 | ) | |||||
Bifurcated embedded derivatives |
§ | § | ||||||
Adjustments to provisions for contingent consideration: |
||||||||
Actavis Generics transaction |
(142 | ) | 15 | |||||
Eagle transaction |
(21 | ) | (23 | ) | ||||
Settlement of contingent consideration: |
||||||||
Actavis Generics transaction |
109 | 100 | ||||||
Eagle transaction |
88 | — | ||||||
Additional contingent consideration resulting from Novetide acquisition* |
(11 | ) | — | |||||
Fair value at the end of the period |
$ | (152 | ) | $ | (175 | ) | ||
§ | Represents an amount less than 0.5 million. |
* | In January 2022, Teva acquired 100% ownership of Novetide Ltd. (“Novetide”), which was previously accounted for as “investment in associated companies”. This transaction was accounted for as a business combination. Total consideration for the transaction included cash and certain contingent royalty payments through 2034. As part of the transaction, Teva recognized a gain under “Share in (profits) losses of associated companies, net”, reflecting the difference between the book value of its investment in Novetide and its fair value as of the date Teva completed its acquisition. |
Estimated fair value* |
||||||||
December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Senior notes and sustainability-linked senior notes included under senior notes and loans |
$ | 16,694 | $ | 21,477 | ||||
Senior notes and convertible senior debentures included under short-term debt |
2,075 | 1,426 | ||||||
Total |
$ | 18,769 | $ | 22,903 | ||||
* |
The fair value was estimated based on quoted market prices. |
a. |
Long-term employee-related obligations consisted of the following: |
December 31, |
||||||||
2022 |
2021 |
|||||||
(U.S. $ in millions) |
||||||||
Accrued severance obligations |
$ | 74 | $ | 83 | ||||
Defined benefit plans |
58 | 142 | ||||||
Total |
$ | 132 | $ | 225 | ||||
b. |
Terms of arrangements: |
Column A |
Column B |
Column C |
Column D |
Column E |
||||||||||||||||
Balance at beginning of period |
Charged to costs and expenses |
Charged to other accounts |
Deductions |
Balance at end of period |
||||||||||||||||
Allowance for doubtful accounts: |
||||||||||||||||||||
Year ended December 31, 2022 |
164 |
8 |
(2 |
) |
(8 |
) |
162 |
|||||||||||||
Year ended December 31, 2021 |
$ |
200 |
$ |
(8 |
) |
$ |
— |
$ |
(28 |
) |
$ |
164 |
||||||||
Year ended December 31, 2020 |
$ |
209 |
$ |
(11 |
) |
$ |
2 |
$ |
— |
$ |
200 |
|||||||||
Allowance in respect of carryforward tax losses and deductions that may not be utilized: |
||||||||||||||||||||
Year ended December 31, 2022 |
$ |
2,723 |
$ |
443 |
$ |
— |
$ |
(93 |
) |
$ |
3,072 |
|||||||||
Year ended December 31, 2021 |
$ |
2,547 |
$ |
336 |
$ |
— |
$ |
(160 |
) |
$ |
2,723 |
|||||||||
Year ended December 31, 2020 |
$ |
1,974 |
$ |
670 |
$ |
— |
$ |
(97 |
) |
$ |
2,547 |
|||||||||
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Not Applicable.
ITEM 9A. | CONTROLS AND PROCEDURES |
Disclosure Controls and Procedures
Teva maintains “disclosure controls and procedures” (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) that are designed to provide reasonable assurance that information required to be disclosed in Teva’s reports filed or submitted under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Teva’s management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.
After evaluating the effectiveness of our disclosure controls and procedures as of December 31, 2022, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, Teva’s disclosure controls and procedures were effective at the reasonable assurance level.
Report of Teva Management on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act, as amended. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of Teva’s internal control over financial reporting as of December 31, 2022. In making this assessment, it used the criteria established in Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). Based on such assessment, management has concluded that, as of December 31, 2022, Teva’s internal control over financial reporting was effective.
Attestation Report of the Registered Public Accounting Firm
Our internal control over financial reporting as of December 31, 2022 has been audited by Kesselman & Kesselman, an independent registered public accounting firm in Israel and a member of PricewaterhouseCoopers International Limited (“PwC”), as stated in their report which is included under “Item 8—FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA.”
Changes in Internal Control over Financial Reporting
During the quarter ended December 31, 2022, there were no changes in internal control over financial reporting that materially affected or are reasonably likely to materially affect Teva’s internal control over financial reporting.
170
ITEM 9B. OTHER INFORMATION
Revolving Credit Agreement Amendment
On April 29, 2022, Teva and certain of its subsidiaries entered into a $1.8 billion senior unsecured sustainability-linked revolving credit agreement (the “Revolving Credit Agreement”) with a syndicate of banks, arranged by Bank of America Europe Designated Activity Company, as Documentation Agent and Sustainability Coordinator, Bank of America Europe DAC, BNP Paribas, Citibank, N.A., Goldman Sachs Bank USA, HSBC Bank Plc, Intesa San Paolo S.P.A, J.P. Morgan S.E., Mizuho Bank, LTD. and PNC Bank, National Association, as Bookrunners and Mandated Lead Arrangers, and Bank of America, N.A., as Administrative Agent and Bank of America Europe Designated Activity Company, as Sustainability Coordinator.
On February 6, 2023, Teva and certain of its subsidiaries entered into an Amendment to the Revolving Credit Agreement (the “Revolving Credit Agreement Amendment”) with Bank of America, N.A., as administrative agent, and the Required Lenders (as defined in the Revolving Credit Agreement). The terms of the Revolving Credit Agreement were amended to update the Company’s maximum leverage ratio under the Revolving Credit Agreement for certain periods. Under the terms of the Revolving Credit Agreement, as amended, the Company’s leverage ratio shall not exceed 4.25x in the fourth quarter of 2022 and in the first, second and third quarters of 2023, 4.00x in the fourth quarter of 2023 and in the first, second and third quarters of 2024, and 3.50x in the fourth quarter of 2024 and onwards.
The foregoing description of the Revolving Credit Agreement Amendment does not purport to be complete and is qualified in its entirety by reference to the Revolving Credit Agreement Amendment, which is filed as Exhibit 10.3 hereto and is incorporated herein by reference.
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
PART III
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Reference is made to Teva’s 2023 Proxy Statement, which will be filed no later than 120 days after the close of the registrant’s fiscal year ended December 31, 2022, with respect to Teva’s directors, executive officers and corporate governance, which is incorporated herein by reference and made a part hereof in response to the information required by Item 10.
ITEM 11. EXECUTIVE COMPENSATION
Reference is made to Teva’s 2023 Proxy Statement, which will be filed no later than 120 days after the close of Teva’s fiscal year ended December 31, 2022, with respect to Teva’s executive compensation, which is incorporated herein by reference and made a part hereof in response to the information required by Item 11.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS
Reference is made to Teva’s 2023 Proxy Statement, which will be filed no later than 120 days after the close of Teva’s fiscal year ended December 31, 2022, with respect to the security ownership of certain beneficial owners and management and related stockholder matters of Teva, which is incorporated herein by reference and made a part hereof in response to the information required by Item 12.
171
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
Reference is made to Teva’s 2023 Proxy Statement, which will be filed no later than 120 days after the close of Teva’s fiscal year ended December 31, 2022, with respect to certain relationships and related transactions, and director independence of Teva, which is incorporated herein by reference and made a part hereof in response to the information required by Item 13.
ITEM 14. | PRINCIPAL ACCOUNTING FEES AND SERVICES |
Reference is made to Teva’s 2023 Proxy Statement, which will be filed no later than 120 days after the close of Teva’s fiscal year ended December 31, 2022, with respect to principal accountant fees and services provided to Teva, which is incorporated herein by reference and made a part hereof in response to the information required by Item 14.
172
PART IV
ITEM 15. EXHIBITS, FINANCIAL STATEMENT SCHEDULES
(a) | The following financial statements are filed as part of this Annual Report on Form 10-K: |
page | ||||
87 | ||||
Consolidated Financial Statements: |
||||
Balance Sheets |
91 | |||
92 | ||||
93 | ||||
94 | ||||
95 | ||||
97 | ||||
Financial Statement Schedule: |
||||
169 |
Exhibits
(b) The information called for by this Item is incorporated herein by reference to the Exhibit Index in this Form 10-K.
173
174
175
176
177
101.SCH | Inline XBRL Taxonomy Extension Schema Document | |
101.CAL | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |
101.DEF | Inline XBRL Taxonomy Extension Definition Linkbase Document | |
101.LAB | Inline XBRL Taxonomy Extension Labels Linkbase Document | |
101.PRE | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |
104 | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* | Filed herewith. |
(1) | English translation or summary from Hebrew original, which is the official version. |
ITEM 16. FORM 10-K SUMMARY
None.
178
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED | ||
By: | /s/ Richard D. Francis | |
Name: | Richard D. Francis | |
Title: | President and Chief Executive Officer | |
Dated: | February 10, 2023 |
POWER OF ATTORNEY
KNOW ALL PERSONS BY THESE PRESENT, that each of the undersigned directors and/or officers of Teva Pharmaceutical Industries Limited, a corporation organized under the laws of Israel, hereby constitutes and appoints Richard D. Francis, Eli Kalif, David M. Stark and Amir Weiss, and each of them, his or her true and lawful attorneys-in-fact and agents, with full power of substitution, for him or her and in his or her name, place and stead, in any and all capacities, to sign, execute and deliver with the U.S. Securities and Exchange Commission any and all amendments to this Annual Report on Form 10-K, with all exhibits thereto, and other documents in connection therewith, granting unto said attorneys-in-fact and agents, and each of them, full power and authority to do and perform each and every act and thing requisite and necessary to be done in connection therewith, as fully to all intents and purposes as he or she might or could do in person, hereby ratifying and confirming that all said attorneys-in-fact and agents, or any of them or their or his or her substitute or substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this annual report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated.
Name |
Title |
Date | ||||
By: |
/s/ Dr. Sol J. Barer Dr. Sol J. Barer |
Chairman of the Board of Directors |
February 10, 2023 | |||
By: | /s/ Richard D. Francis Richard D. Francis |
President and Chief Executive Officer and Director | February 10, 2023 | |||
By: | /s/ Eli Kalif Eli Kalif |
Executive Vice President, Chief Financial Officer (Principal Financial Officer) |
February 10, 2023 | |||
By: | /s/ Amir Weiss Amir Weiss |
Senior Vice President, Chief Accounting Officer (Principal Accounting Officer) |
February 10, 2023 | |||
By: | /s/ Rosemary A. Crane Rosemary A. Crane |
Director | February 10, 2023 | |||
By: | /s/ Amir Elstein Amir Elstein |
Director | February 10, 2023 |
179
Name |
Title |
Date | ||||
By: | /s/ Jean-Michel Halfon Jean-Michel Halfon |
Director | February 10, 2023 | |||
By: | /s/ Gerald M. Lieberman Gerald M. Lieberman |
Director | February 10, 2023 | |||
By: | /s/ Roberto A. Mignone Roberto A. Mignone |
Director | February 10, 2023 | |||
By: | /s/ Dr. Perry D. Nisen Dr. Perry D. Nisen |
Director | February 10, 2023 | |||
By: | /s/ Nechemia (Chemi) J. Peres Nechemia (Chemi) J. Peres |
Director | February 10, 2023 | |||
By: | /s/ Prof. Ronit Satchi-Fainaro Prof. Ronit Satchi-Fainaro |
Director | February 10, 2023 | |||
By: | /s/ Janet S. Vergis Janet S. Vergis |
Director | February 10, 2023 | |||
By: | /s/ Dr. Tal Zaks Dr. Tal Zaks |
Director | February 10, 2023 |
180
Exhibit 10.3
AMENDMENT TO SENIOR UNSECURED SUSTAINABILITY-LINKED
REVOLVING CREDIT AGREEMENT
This AMENDMENT to the Senior Unsecured Sustainability-Linked Revolving Credit Agreement, dated as of February 6, 2023 (this Amendment), is made and entered into by and among TEVA PHARMACEUTICAL INDUSTRIES LIMITED, an Israeli company registered under no 52-0013-954, the registered address of which is at Dvora HaNevia St. 124, Tel Aviv, Israel (the Company or Parent), TEVA PHARMACEUTICALS USA, INC., a Delaware corporation, the principal office of which is at 400 Interpace Parkway, Building A, Parsippany, New Jersey 07054, United States of America (Teva USA or the US Borrower), TEVA PHARMACEUTICAL FINANCE NETHERLANDS II B.V., a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) incorporated under the laws of the Netherlands, with its official seat (statutaire zetel) in Amsterdam, the Netherlands, having its office at Piet Heinkade 107, 1019GM Amsterdam, the Netherlands and registered with the Dutch trade register under number 59012161 (the Dutch II Borrower) and TEVA PHARMACEUTICAL FINANCE NETHERLANDS III B.V., a a private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) incorporated under the laws of the Netherlands, with its official seat (statutaire zetel) in Amsterdam, the Netherlands, having its office at Piet Heinkade 107, 1019GM Amsterdam, the Netherlands and registered with the Dutch trade register under number 64156729 (the Dutch III Borrower and together with the Dutch II Borrower, Dutch Borrowers and each a Dutch Borrower and, together with the Parent and Teva USA, the Borrowers) and BANK OF AMERICA, N.A., (the Administrative Agent).
W I T N E S S E T H:
Reference is made to the Senior Unsecured Sustainability-Linked Revolving Credit Agreement dated as of April 29, 2022 (as amended from time to time, the Credit Agreement), between, amongst others, the Parent, the Borrowers, the Lenders named therein and the Administrative Agent.
WHEREAS, the Loan Parties (as defined in the Credit Agreement) and the Administrative Agent (with the consent of the Required Lenders (as defined in the Credit Agreement)) have agreed to amend certain provisions of the Credit Agreement as provided for herein;
NOW, THEREFORE, in consideration of the mutual conditions and agreements set forth herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
ARTICLE I
Defined Terms
Section 1.1 Defined Terms. Each capitalized term used in this Amendment, unless otherwise defined herein, shall have the meaning ascribed to such term in the Credit Agreement.
1
ARTICLE II
Amendments
Section 2.1 Amendments. Subject to the occurrence of the Amendment Effective Date: Section 6.04 of the Credit Agreement is hereby amended by deleting the grid contained therein and replacing it with the grid below:
Column 1 |
Column 2 | |
Four-quarter Test Period ending with the quarters below | ||
Q1 2022 | No greater than 4.50x | |
Q2 2022 | No greater than 4.50x | |
Q3 2022 | No greater than 4.50x | |
Q4 2022 | No greater than 4.25x | |
Q1 2023 | No greater than 4.25x | |
Q2 2023 | No greater than 4.25x | |
Q3 2023 | No greater than 4.25x | |
Q4 2023 | No greater than 4.00x | |
Q1 2024 | No greater than 4.00x | |
Q2 2024 | No greater than 4.00x | |
Q3 2024 | No greater than 4.00x | |
Q4 2024 and thereafter | No greater than 3.50x |
ARTICLE III
Representations and Warranties
Section 3.1 Representations and Warranties to the Amendment Effective Date. Each Loan Party hereby represents and warrants as of the Amendment Effective Date as follows:
(a) all of the representations and warranties set forth in the Credit Agreement are true and correct on and as of such date, as if made on such date, except to the extent that such representations and warranties specifically relate to an earlier date, in which case such representations and warranties shall have been true and correct on and as of such earlier date (it being understood that references therein to the Credit Agreement shall be deemed to refer to the Credit Agreement as amended by this Amendment and after giving effect to the amendments set forth herein);
(b) the execution, delivery and performance by each Loan Party of this Amendment have been duly authorized by all necessary corporate or other organizational action, as applicable, of such Loan Party;
(c) this Amendment has been duly executed and delivered by such Loan Party; and
(d) no Default or Event of Default has occurred, is continuing or would exist after giving effect to this Amendment.
2
ARTICLE IV
Effectiveness
Section 4.1 Effective Date. This Amendment shall become effective on the date (the Amendment Effective Date) on which:
(i) the Administrative Agent shall have received counterparts to this Amendment duly executed and delivered by facsimile transmission or electronic mail (in pdf or similar format) by each Loan Party and the Administrative Agent.
Section 4.2 Fees. The Loan Parties shall pay or cause to be paid to the Administrative Agent, for the account of each Lender that consents to this Amendment on or before February 6, 2023 (each, a Consenting Lender) an amendment fee (the Amendment Fee) equal to 0.10% of the sum of such Consenting Lenders (a) outstanding Loans and (b) undrawn Commitments under the Credit Agreement as of the Amendment Effective Date ((a) and (b) together, the Consenting Lender Loans and Commitments) which Amendment Fee, shall be earned on the Amendment Effective Date and due and payable within 2 Business Days of the Amendment Effective Date; provided that upon any assignment or transfer of any Consenting Lender Loans and Commitments; the assignee or transferee shall become the Consenting Lender with respect to such Consenting Lender Loans and Commitments.
Section 4.3 Expenses. The Loan Parties shall pay all reasonable and documented out-of-pocket expenses incurred by the Administrative Agent and the Lenders, including the reasonable fees, charges and disbursements of counsel for the Administrative Agent and the Lenders, in connection with this Amendment.
Section 4.4 Notification. The Administrative Agent shall notify the Loan Parties and the Lenders of the Amendment Effective Date and such notice shall be conclusive and binding.
ARTICLE V
Miscellaneous
Section 5.1 Effect of Amendment. Except as modified pursuant hereto, no other changes or modifications to the Credit Agreement or Loan Documents are intended or implied and in all other respects the Credit Agreement and Loan Documents are hereby specifically ratified, restated and confirmed by all parties hereto as of the effective date hereof. To the extent of conflict between the terms of this Amendment and the Loan Documents, the terms of this Amendment shall control. The Credit Agreement and this Amendment shall be read and construed as one agreement.
Section 5.2 Further Assurances. The parties hereto shall execute and deliver such additional documents and take such additional action as may be reasonably necessary or desirable to effectuate the provisions and purposes of this Amendment.
Section 5.3 Binding Effect. This Amendment shall be binding upon and inure to the benefit of each of the parties hereto and their respective successors and assigns.
Section 5.4 Severability. Any provisions of this Amendment that is prohibited or unenforceable in any jurisdiction shall, as to such jurisdiction, be ineffective to the extent of such prohibition or unenforceability without invalidating the remaining provisions hereof, and any such prohibition or unenforceability in any jurisdiction shall not invalidate or render unenforceable such provision in any other jurisdiction.
Section 5.5 Reference to the Effect on the Loan Documents. Upon the effectiveness of this Amendment, (a) each reference in the Credit Agreement to this Agreement, hereunder, hereof, herein or words of similar import and (b) each reference in any other Loan Document to the Credit Agreement, shall mean and be a reference to the Credit Agreement as amended by this Amendment.
3
Section 5.6 Headings. The headings listed herein are for convenience only and do not constitute matters to be construed in interpreting this Amendment.
Section 5.7 Counterparts; Electronic Signatures. This Amendment may be in the form of an Electronic Record and may be executed using Electronic Signatures (including, without limitation, facsimile and .pdf) and shall be considered an original, and shall have the same legal effect, validity and enforceability as a paper record. For the avoidance of doubt, the authorization under this Section may include, without limitation, use or acceptance by the Administrative Agent of a manually signed paper communication which has been converted into electronic form (such as scanned into PDF format), or an electronically signed communication converted into another format, for transmission, delivery and/or retention. Notwithstanding anything contained herein to the contrary, the Administrative Agent is under no obligation to accept an Electronic Signature in any form or in any format unless expressly agreed to by the Administrative Agent pursuant to procedures approved by it; provided, further, without limiting the foregoing, (a) to the extent the Administrative Agent has agreed to accept such Electronic Signature, the Administrative Agent shall be entitled to rely on any such Electronic Signature without further verification and (b) upon the request of the Administrative Agent any Electronic Signature shall be promptly followed by a manually executed, original counterpart. For purposes hereof, Electronic Record and Electronic Signature shall have the meanings assigned to them, respectively, by 15 USC §7006, as it may be amended from time to time. This Amendment may be executed by one or more parties to this Amendment on any number of separate counterparts, and all of said counterparts taken together shall be deemed to constitute one and the same instrument. Delivery of an executed signature page of this Amendment by facsimile transmission or electronic mail (in .pdf or similar format) shall be effective as of delivery a manually executed counterpart hereof.
Section 5.8 Governing Law; Jurisdiction; Consent to Service of Process.
(a) This Amendment and the rights and obligations of the parties under this Amendment shall be governed by, and construed and interpreted in accordance with, the law of the State of New York without regard to conflict of law principles that would result in the application of any law other than the law of the State of New York.
(b) Each party hereto hereby irrevocably and unconditionally submits, for itself and its property, to the exclusive jurisdiction of the Supreme Court of the State of New York sitting in New York County and of the United States District Court of the Southern District of New York, and any appellate court from any thereof, in any action or proceeding arising out of or relating to this Amendment, or for recognition or enforcement of any judgment, and each of the parties hereto hereby irrevocably and unconditionally agrees that all claims in respect of any such action or proceeding may be heard and determined in such New York State or, to the extent permitted by law, in such federal court. To the extent that any Loan Party has or hereafter may acquire any immunity from jurisdiction of any court or from any legal process (whether through service or notice, attachment prior to judgment, attachment in aid of execution, execution or otherwise) with respect to itself or its property, such Loan Party hereby irrevocably waives such immunity in respect of its obligations under this Amendment. Each of the parties hereto agrees that a final judgment in any such action or proceeding shall be conclusive and may be enforced in other jurisdictions by suit on the judgment or in any other manner provided by law. Nothing in this Amendment shall affect any right that the Administrative Agent or any Lender may otherwise have to bring any action or proceeding relating to this Amendment against any Loan Party or any of their respective properties in the courts of any jurisdiction to enforce a judgment obtained in accordance with this Section.
(c) Each Loan Party hereby irrevocably and unconditionally waives, to the fullest extent it may legally and effectively do so, any objection which it may now or hereafter have to the laying of venue of any suit, action or proceeding arising out of or relating to this Amendment in any court referred to in paragraph (b) of this Section. Each of the parties hereto hereby irrevocably waives, to the fullest extent permitted by law, the defense of an inconvenient forum to the maintenance of such action or proceeding in any such court.
(d) Each party to this Amendment irrevocably consents to service of process in the manner provided for notices in Section 11.01 of the Credit Agreement. In addition, each Loan Party (other than Teva USA) hereby irrevocably designates, appoints and empowers Teva USA (the Process Agent), in the case of any suit, action or proceeding brought in the United States as its designee, appointee and agent to receive, accept and acknowledge for and on its behalf, and in respect of its property, service of any kind and all legal process, summons, notices and documents that may be served in any action or proceeding arising out of or in connection with this Amendment or any other Loan Document. By executing this Amendment, Teva USA hereby
4
irrevocably accepts such designation, appointment and agency, which shall remain in full force and effect until such time as Teva USA ceases to be a Borrower under the Credit Agreement (at which time each Loan Party shall designate a replacement Process Agent satisfactory to the Administrative Agent (and deliver the appropriate documentation in respect thereof as reasonably requested by the Administrative Agent)). Such service may be made by mailing (by registered or certified mail, postage prepaid) or delivering a copy of such process to such Person in care of the Process Agent at the Process Agents above address, and such Person hereby irrevocably authorizes and directs the Process Agent to accept such service on its behalf. As an alternative method of service, each Loan Party irrevocably consents to the service of any and all process in any such action or proceeding by the mailing (by registered or certified mail, postage prepaid) of copies of such process to the Process Agent or such Person at its address specified in Section 11.01 of the Credit Agreement. Nothing in this Amendment will affect the right of any party to this Amendment to serve process in any other manner permitted by law.
Section 5.9 WAIVER OF JURY TRIAL. EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN ANY LEGAL PROCEEDING DIRECTLY OR INDIRECTLY ARISING OUT OF OR RELATING TO THIS AMENDMENT OR ANY OTHER LOAN DOCUMENT OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY (WHETHER BASED ON CONTRACT, TORT OR ANY OTHER THEORY). EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THE FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO ENTER INTO THIS AMENDMENT BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION.
[Remainder of this page intentionally left blank]
5
IN WITNESS WHEREOF, the parties hereto have caused this Amendment to be executed and delivered by their respective duly authorized officers as of the date first above written.
TEVA PHARMACEUTICAL INDUSTRIES LIMITED | ||
Name: | /s/ Eli Kalif | |
Title: | Executive Vice President and Chief Financial Officer | |
Name: | /s/ Stephen D. Harper | |
Title: | Senior Vice President, Corporate Treasurer, Head of Insurance & Risk Management | |
TEVA PHARMACEUTICALS USA, INC. | ||
Name: | /s/ Dr. Sven Dethlefs | |
Title: | President and Chief Executive Officer | |
Name: | /s/ Debra Peterson | |
Title: | Treasurer | |
TEVA PHARMACEUTICAL FINANCE NETHERLANDS II B.V. | ||
Name: | /s/ Stephen D. Harper | |
Title: | Managing Director | |
Name: | /s/ David Vrhovec | |
Title: | Managing Director | |
TEVA PHARMACEUTICAL FINANCE NETHERLANDS III B.V. | ||
Name: | /s/ Stephen D. Harper | |
Title: | Managing Director | |
Name: | /s/ David Vrhovec | |
Title: | Managing Director |
[Signature Page to RCF Amendment]
BANK OF AMERICA, N.A., as Administrative Agent | ||
Name: | /s/ Henry Pennell | |
Title: | Vice President |
[Signature Page to RCF Amendment]
Exhibit 10.6
EXECUTION VERSION
EMPLOYMENT AGREEMENT
This Employment Agreement (this Agreement) is entered on this 21st day of November 2022, and is made by and between TEVA PHARMACEUTICAL INDUSTRIES LTD., an Israeli corporation located at 124 Dvora HaNevia Street, Tel Aviv, Israel, Company No. 52-001395-4 (the Company), and Richard Francis (Executive).
WHEREAS, the Company wishes to employ Executive as its President and Chief Executive Officer (President and CEO), and Executive wishes to be so employed; and
WHEREAS, the parties have agreed on the terms pursuant to which Executive shall serve as President and CEO, and wish to set forth such terms in this Agreement.
NOW, THEREFORE, THE PARTIES HAVE AGREED AS FOLLOWS:
1. | Term; Positions and Duties; Location |
1.1 | The Company agrees to employ Executive, and Executive agrees to serve the Company and its affiliates, subject to the terms and conditions of this Agreement, for the period commencing on January 1, 2023 (the date Executives service to the Company commences, Effective Date) and ending on the date that Executives employment lawfully terminates (the Term) of which the period ending on the third (3rd) anniversary of the Effective Date shall be a fixed term (the Fixed Term). Unless previously terminated, the Fixed Term shall be automatically extended for consecutive periods of one (1) year (each such period an Extension Period) unless either party provides written notice to the other party of non-renewal of the Fixed Term or Extension Period as the case may be in accordance with Section 26 not less than six (6) months prior to the end of the Fixed Term or Extension Period as then in effect, in which case for the avoidance of doubt the date of termination of employment shall be the expiry of the Fixed Term or Extension Period as the case may be. |
Notwithstanding the foregoing provisions of this Section 1.1, (a) upon the occurrence of a Change in Control (as described in the Compensation Policy (as defined below)), the Fixed Term or the Extension Period (whichever is in effect at the time the Change in Control occurs) shall automatically be extended until the second (2nd) anniversary of the date such Change in Control occurs (except that if the Change in Control occurs during the first year of the Fixed Term then such extension shall not apply) and, in the case of such an extension, the expression Fixed Term or Extension Period, as applicable, as used herein shall be construed to include such extension; and (b) during the Fixed Term or the Extension Period (as extended upon the occurrence of a Change in Control as contemplated by sub-clause (a) above, if applicable), Section 9 will apply to the termination of Executives employment.
1.2 | Executive shall report directly to the Board of Directors of the Company (the Board). All executive officers of the Company shall report directly to Executive (unless otherwise determined by Executive, or as required by Law (as defined below) or the principles of good corporate governance). In addition, Executive shall serve as President and CEO and have all of the duties, authorities and responsibilities customarily exercised by an individual serving as the president and chief executive officer of a company the size and nature of the Company, and such other duties, authorities and responsibilities, consistent with the foregoing, as may reasonably be assigned to him from time to time by the Board. |
1.3 | During the Term, Executive shall devote his full business time, energy, business judgment, knowledge and skill to the performance of his duties with the Company; provided that the foregoing shall not prevent Executive from (a) reasonably participating in charitable, civic, educational, professional, community or industry affairs, and (b) managing his own personal investments, in each case, so long as such activities in the aggregate do not interfere or conflict with Executives duties hereunder or create a potential business or fiduciary conflict. Executive shall not serve on the board of directors or similar body of a for-profit entity without the express written consent of the Chairman of the Board (such consent not to be unreasonably withheld and on the basis that consent has been given for the positions that Executive will hold at the Effective Date as disclosed by the Executive to the Company prior to the date hereof). |
1.4 | During the Term, Executive may be required to serve as a director, officer or committee member of the Company and/or another entity of any type in which the Company holds, directly or indirectly, at least 25% of the means of control (as such term is defined in the Securities Law, 1968) (collectively, the Company Group), and the fulfillment of such position shall not constitute an employer-employee relationship between Executive and any such entity (other than the Company), and notwithstanding any such position, Executive shall only be considered to be an employee of the Company and shall not receive any additional compensation for serving in such additional position other than those amounts expressly set forth herein; provided that the Companys D&O insurance shall cover Executive and the Indemnification and Release Agreement attached hereto as Exhibit B shall fully cover Executive in all such positions. |
1.5 | Executives principal place of employment during the Term shall be at the Companys principal offices in Israel and his principal private residence will be in the United Kingdom, from which he will also work. Executive acknowledges and agrees that he shall be required to travel abroad extensively on Company business. Executives working time shall be allocated among the various applicable work locations as necessary and appropriate to support performance of his duties as President and CEO, with such allocation to be mutually agreed from time to time between Executive and the Chairman of the Board. Notwithstanding anything to the contrary and subject to the terms of Section 21 of this Agreement, Executive agrees to comply with the guidelines set forth in Section 21.4 of this Agreement. |
1.6 | Executive acknowledges and agrees that no collective and/or special bargaining agreement that might apply to the Companys employees shall apply to Executive in his capacity as an employee of the Company, unless required by applicable Law. |
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1.7 | This Agreement and all compensation and benefits payable hereunder are subject to the Companys compensation policies applicable to senior officers in effect on the Effective Date and the terms and conditions of this Agreement, including the Companys Compensation Policy for Executive Officers and Directors adopted by the shareholders at the 2022 annual general meeting of shareholders, held on June 23, 2022 (collectively, the Compensation Policy). |
1.8 | The Company may, in its discretion and subject to Executives consent, decide to employ Executive indirectly through a wholly owned subsidiary of the Company, in which case, the Company and Executive shall cooperate and use commercially reasonable efforts to establish Executives employment with such subsidiary. Such an employment arrangement would in no event alter (a) Executives position as President and CEO, (b) his reporting relationship, duties, responsibilities, compensation, and benefits, in each case as set forth in this Agreement, or (c) any other substantive provision of this Agreement. For avoidance of any doubt, it is hereby clarified that such an employment arrangement shall not trigger any termination payment pursuant to Section 9 of this Agreement and the Executives employment with a wholly owned subsidiary shall be considered as continued employment. |
2. | Base Salary |
2.1 | During the Term, Executives gross annual base salary shall be not less than $1,600,000 (One Million Six Hundred Thousand United States Dollars) (the Annual Salary). The Annual Salary shall be divided by 12, and each such 1/12 shall constitute Executives monthly salary (the Monthly Salary) payable in arrears in equal monthly installments. The Annual Salary shall be subject to upward only review, at least annually, by the Human Resources & Compensation Committee of the Board (the Compensation Committee) for possible increase, subject to the requirements of applicable Law, including any requirement of shareholder approval. |
2.2 | Executive hereby acknowledges and agrees that in light of his position and areas of responsibility, which require a special degree of trust, and since he is part of the Companys senior management, the provisions of the Hours of Work and Rest Law, 1951, shall not apply to his employment. |
2.3 | It is hereby agreed that only the Monthly Salary payable to Executive pursuant to Section 2.1 shall constitute the basis for the calculation of all social benefits (or their equivalent) paid to Executive pursuant to this Agreement (including any payments or contributions related to the Severance Contribution and Pension Benefit) and for any other purpose or benefit plan for which such payments are calculated based on a percentage of Executives salary. |
2.4 | The parties hereby acknowledge and agree that the compensation terms set forth in this Agreement constitute fair consideration to Executive, given, inter alia, his managerial responsibilities and obligations towards the Company. |
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3. | Cash Awards |
3.1 | Sign-on Cash Award. Executive shall be granted a cash award of $5,000,000 (Five Million United States Dollars) (the Sign-on Cash Award), which shall vest and be paid (a) in three installments: (i) with the first installment, equal to $1,500,000, to be paid on the first business day following the Effective Date; (ii) the second installment, equal to $1,500,000, to be paid on the first business day following the first anniversary of the Effective Date; and (iii) the third installment, equal to $2,000,000, to be paid on the first business day following the third anniversary of the Effective Date, in each case, subject to Executives continued employment with the Company through the applicable vesting date identified in clauses (ii) and (iii) above or (b) upon such earlier vesting date as may be provided for, if at all, under Section 9. |
3.2 | Annual Bonus. During the Term, for each fiscal year of the Company commencing with the fiscal year in which the Effective Date occurs, Executive shall be considered for an annual bonus (the Annual Bonus) in accordance with the terms of the Companys executive annual bonus plan as in effect from time to time. Executive shall have a target Annual Bonus opportunity of 150% of Annual Salary if performance goals are achieved at 100% (the Target Bonus) and a maximum Annual Bonus opportunity of 200% of Annual Salary if performance goals are achieved at 120% or more, the actual amount of which shall be determined in good faith by the Compensation Committee and the Board, based on their determination of the attainment of performance measures established by the Compensation Committee and the Board. The performance measures and thresholds applicable to Executive shall be no less favorable to Executive than those applicable to other executive officers of the Company and shall be established by the Compensation Committee and the Board after consultation with Executive. The Annual Bonus shall be paid in a lump sum in cash not later than April 1 of the year immediately following the fiscal year to which such Annual Bonus relates. The Annual Bonus shall not be prorated in respect of the fiscal year in which the Effective Date occurs, and Executive shall be eligible for a full years Annual Bonus in respect of such fiscal year. Except as expressly provided in Section 9 of the Agreement and except in the case of non-renewal of this Agreement pursuant to Section 1.1, Executive shall not be entitled to an annual bonus in respect of a fiscal year if he is not employed by the Company Group on the payment date. |
4. | Equity Awards |
4.1 | Sign-on Awards. On the Effective Date (or, if the Company is subject to a blackout on the Effective Date, the seventh day after the blackout period ends), Executive shall be granted (the date on which such grant occurs, the Grant Date) awards (the Sign-on Awards) in respect of ordinary shares of the Company (Shares) pursuant to the Companys 2020 Plan and award agreements thereunder, which shall be allocated, and have terms and conditions, as follows: |
4.1.1 | Sign-on RSU Award. Executive shall be granted a restricted share unit award (the Sign-on RSU Award) covering a number of Shares having a total grant date fair value of $5,000,000 (Five Million United States Dollars). The Sign-on RSU Award shall vest and settle in equal installments on the first (1st), second (2nd) and third (3rd) anniversaries of the Grant Date, subject, except as provided in Section 9, to Executives continued employment with the Company on, in each case, the applicable vesting date. The Sign-on RSU Award shall include other terms and conditions described in this Agreement and other terms and conditions consistent with restricted share unit (RSU) awards granted by the Company generally. |
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Sign-on PSU Award. Executive shall be granted a performance
share unit (PSU) award (the Sign-on PSU Award), the target number of Shares subject to such award having a total grant date fair value of $5,000,000 (Five Million United
States Dollars). The Sign-on PSU Award shall provide that the number of Shares earned thereunder shall be determined based on achievement of stretch performance goals to be established by the Committee in
consultation with Executive prior to the Companys 2023 annual shareholders meeting. Annual Equity Awards. For the fiscal year in which employment commences and for each of the subsequent
fiscal years during the Term, Executive shall be granted equity awards with a target grant date fair value of $9,000,000 (Nine Million United States Dollars) per year (not pro-rated in respect of the first
fiscal year in which employment commences), with 70% of each such award to be granted as PSUs and 30% of each such award to be granted as RSUs, the grant date being not later than the end of the first quarter of the applicable fiscal year to which
the awards relate, in each case subject to the terms of the 2020 Plan (or any successor thereto). All such awards shall otherwise be subject to the same vesting terms as the corresponding Share awards granted to other senior executives of the
Company generally. Executive Benefits Generally. During the Term, Executive (and, to the extent eligible, his dependents and Beneficiaries (as
defined below)) shall be entitled to participate in any and all health, medical, dental, group insurance (including life insurance), welfare, pension, fringe benefits, perquisites and other employee benefit plans, programs and arrangements that are
generally available from time to time to similarly situated senior executives of the Company and their dependents and Beneficiaries (the Executive Benefits), such participation in each case to be on terms and conditions that are
commensurate with Executives position and responsibilities at the Company and that are no less favorable to Executive than those that apply to senior executives of the Company with an equivalent international role. International Assignment. During the Term, Executive shall be covered by, and shall be provided
relocation benefits as set forth in, the Companys Long Term International Assignment Policy (including reimbursement of reasonable tax advice and legal assistance) and, in addition, Executive will receive up to (a) $12,000 (USD) per month (pro-rated for partial calendar months) (grossed up for tax and social security contributions in accordance with Company policy) for reimbursement of housing (including hotel), utilities, other accommodation
expenses in Israel, and air travel, and (b) up to $100,000 (USD) (grossed up for tax and social security contributions in accordance with Company policy) in the aggregate per year personal travel expenses of Executive and/or his spouse and
children, subject in each case to Executives presentation of appropriate supporting documentation. 5
Reimbursement for Certain Costs and Expenses Business Expenses. The Company shall pay or reimburse Executive for all
out-of-pocket business expenses incurred by Executive during the Term in performing his duties under this Agreement, promptly upon presentation of appropriate supporting
documentation and in accordance with the expense reimbursement policy of the Company. Business Equipment. During the Term, the Company shall provide, and pay or reimburse Executive for all
expenses incurred in connection with acquiring, maintaining and using, in each such case a land-line telephone in his residence, a laptop, a cellular telephone or other similar hand-held device, and a car benefit suitable for the chief executive
officer of a company of the size and nature of the Company, in each case, to the extent applicable, promptly upon presentation of appropriate supporting documentation and in accordance with the expense reimbursement policy of the Company.
Tax and Financial Advisory Expenses. In addition to the tax preparation services provided under the
Companys Long Term International Assignment Policy which will be provided to Executive during the Term, with respect to each year occurring during the Term for which information regarding any salary, compensation or benefits hereunder are
required to be included in tax returns, the Company shall pay or reimburse Executive for ongoing financial counseling and tax advisory fees incurred by Executive with an adviser of his choice, promptly upon presentation of appropriate supporting
documentation and in accordance with the expense reimbursement policy of the Company up to $15,000 (USD) annually. For the avoidance of doubt the tax preparation services provided to Executive under the Companys Long Term International
Assignment Policy will be no less favorable than is provided to other senior executives who are on assignment and covered by such policy. Vacation; Sick Leave; Recreation Pay Vacation. Executive shall be entitled to twenty (20) paid vacation working days per calendar year
and all Israeli public holidays fully paid, which shall accrue in accordance with Company policy. Executive shall be entitled to take such vacation on UK public holidays should he so choose (save that he will demonstrate flexibility on such days to
accommodate business need). Executive shall be required to utilize at least five (5) consecutive days every calendar year, and may accumulate the remaining vacation days in accordance with the Companys policy. The dates of
Executives annual vacation shall be coordinated in advance with the Chairman of the Board. Executive shall be entitled to redeem the aforesaid accumulated vacation days upon termination of Executives employment. Sick Leave. Executive shall be entitled to thirty (30) paid sick working days per calendar year
during the Term (without any reduction in the compensation or benefits or bonus payable hereunder), which may accumulate during the Term in accordance with the Companys practice or policy, as in effect from time to time. The sick pay shall
include the Monthly Salary and all other amounts and benefits to which Executive is entitled under this Agreement, as if Executive worked at the Company during the period of his illness (in respect of the period for which he is
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Recreation Pay. Executive shall be entitled to fifteen (15) paid recreation days per calendar year
during the Term (without any reduction in the compensation or benefits payable hereunder). The amount of recreation pay per recreation day, the payment conditions and any other conditions governing recreation pay shall be in accordance with
applicable Law and the Companys policy in effect at the applicable time with respect to its employees generally. Pension Executive shall receive from the Company on a monthly basis a pension benefit equal to 7.5% of Monthly Salary
(the Pension Benefit). The Pension Benefit shall be paid directly to the Executive into a bank account designated by him. For the avoidance of doubt, the Pension Benefit shall not be grossed up and shall be subject to all
applicable taxes. Executive confirms that during the Term he shall pay an amount equal to £4,000 per annum as a pension contribution to a UK registered defined contribution pension scheme designated by the Executive (or such lesser amount as
is the maximum that can be paid by law without breaching any allowances applicable to tax free pension contributions) and he shall use reasonable endeavours to arrange critical illness cover for himself at a cost of at least £100 per month.
It is hereby acknowledged and agreed that the Pension Benefit payment shall not be deemed part of the Executives
Monthly Salary for any purpose, including without derogating from the foregoing, for the purpose of payment of severance and any other entitlement calculated as a percentage of Executives Monthly Salary, and no additional current or future
cost or expense, directly or indirectly shall be imposed on the Company as a result of such Pension Benefit. In addition to the Pension Benefit the Company shall contribute and deposit, on a monthly basis, an additional
sum equal to 8.33% of the Monthly Salary on account of pension contribution to an interest-bearing bank account in Israel that shall be opened for such purpose, in accordance with applicable Law (such contributions cumulatively and all earnings
thereon, the Severance Contribution). The Severance Contribution is to be paid out along with the last salary payment. For the avoidance of doubt, the Severance Payment and any severance entitlements payable under applicable Law
(whether arising during or after the Term) shall be reduced (but not below $0) by the amount of the Severance Contribution. 7
Executive acknowledges that the Pension Benefit pursuant to this Section 8 is intended to be in lieu of
the Companys obligation under applicable Law to insure the Executive under a pension plan. In light of the fact that the arrangement pursuant to this Section 8 is per Executives request:
Executive hereby represents that (i) Executive has considered the above and is aware of the consequences
of this Section 8 with respect to the Pension Benefit, and (ii) since the aforementioned is being done pursuant to his request, and for his benefit, he does not and shall not have a cause of action with respect to any other pension
insurance coverage to which he is entitled by Law (Pension Insurance Coverage). Without derogating from the foregoing, Executive hereby explicitly waives any and all claim and/or demand
and/or lawsuit of any kind with respect to the scope of the Pension Insurance Coverage. Executive undertakes to indemnify the Company for any damage and/or cost and/or expense incurred by the Company as a result of any demand and/or lawsuit filed by
him and/or on his behalf in connection with this Section 8. Executive shall be entitled to cancel the arrangement specified in this Section 8 and the Company shall
accept such request and thereafter the Pension Benefit shall be made in full in Israel pursuant to applicable Law. Termination of Employment General. Executives employment with the Company shall terminate upon the earliest to occur of
(a) Executives death, (b) a termination by reason of a Disability, (c) a termination by the Company with or without Cause, and (d) a termination by Executive with or without Good Reason. The date on which employment
hereunder terminates shall be referred to in this Agreement as the Date of Termination. Upon any termination of Executives employment for any reason, except as may otherwise be requested by the Company in writing and agreed
upon in writing by Executive, Executive shall be deemed to have resigned, effective immediately, from any and all directorships, committee memberships, and any other positions Executive holds with any member of the Company Group. If for any reason
this Section 9.1 is deemed to be insufficient to effectuate the resignations contemplated by the immediately preceding sentence, then Executive shall without incurring any costs on him, upon the Companys request, execute any documents or
instruments that the Company may deem necessary or desirable to effectuate such resignations. In addition, Executive hereby designates the Secretary or any Assistant Secretary of the Company to execute any such documents or instruments as
Executives attorney-in-fact to effectuate such resignations if execution by the Secretary or any Assistant Secretary of the Company is deemed by the Company to be
a more expedient means to effectuate such resignation or resignations. 8
Termination Due to Death or Disability. Executives employment shall terminate automatically upon
his death. The Company may terminate Executives employment immediately upon the occurrence of a Disability (as defined in Section 9.9.4), such termination to be effective upon Executives receipt of written notice of such
termination. Upon Executives death or in the event that Executives employment is terminated due to his Disability, Executive or his estate or his Beneficiaries, as the case may be, shall be entitled to: The Accrued Obligations, including the Severance Contribution; Any portion of the Severance Payment required to be paid pursuant to applicable Law, which shall be paid in
accordance with the requirements of applicable Law; provided, however, that such payment shall be reduced (but not below $0) by the amount of the Severance Contribution; Any portion of the Sign-on Cash Award that is unvested as of the Date
of Termination shall vest and be paid in a lump sum on the next regular payroll date immediately following the thirtieth (30th) day after the Date of Termination if not payable earlier according to Section 3.1; The Equity Benefits; If the Date of Termination occurs on or following the first (1st) anniversary of the Effective Date, the
Prorated Annual Bonus, which shall be payable at the same time bonuses are paid to other senior executives of the Company; and Solely in the case of Executives termination due to his Disability, the
Non-Compete Payment. Notwithstanding the foregoing provisions of this
Section 9.2, the payments and benefits described in this Section 9.2 (other than the components of the Accrued Obligations and any portion of the Severance Payment required to be paid pursuant to applicable Law) (a) are subject to
Executives execution and non-revocation or that of a duly authorized person on behalf of his estate or a person having legal power of attorney over his affairs (as the case may be) of the Release of
Claims in accordance with Section 9.7 and (b) shall immediately terminate, and the Company shall have no further obligations to Executive with respect thereto, in the event that Executive wilfully and materially breaches any provision of
Sections 11, 12, 13 or 14. Termination by the Company for Cause. The Company may terminate Executives employment at any time for Cause. In the event that the Company
terminates Executives employment for Cause, he shall be entitled only to Accrued Obligations (which for purposes of this Section 9.3 shall be deemed to include only the payments and benefits set forth in clause (a) and clause
(d) thereof, and the right to Company reimbursement of any unreimbursed business expenses pursuant to clause (c) thereof). Following such termination of Executives employment by the Company for Cause, except as set forth in this
Section 9.3, Executive shall have no further rights to any compensation or any benefits under this Agreement. 9
No termination of Executives employment for Cause shall be effective unless the Company shall have
complied with the provisions of this Section 9.3.2 and applicable Law. In the event that the Company believes that the Executive may have engaged in conduct that constitutes Cause, Executive shall be given written notice by the Company (the
Cause Notice) of its intention to terminate Executives employment for Cause. The Cause Notice shall state in detail the particular circumstances that constitute the grounds on which the proposed termination for Cause is
based and all relevant documentation and the Executive shall be given a reasonable opportunity (and no less than 30 days) to make representations to the Board, either at a hearing in person with his legal adviser in attendance or in writing. Any
such hearing shall be held on a date mutually convenient to the Executive and the Board. The Company shall consider the Executives representations in good faith before making its decision as to whether to terminate the Executives
employment for Cause and if it decides to so terminate, it shall give written reasons to the Executive for such decision. In the case of Cause based on circumstances that the Executive is capable of curing (as reasonably determined by the Company),
the Executive must be given a period of thirty (30) days from receipt of the Cause Notice to cure the circumstances specified in such Cause Notice. If such circumstances are cured, then Cause shall not exist on the basis of such circumstances.
Termination by the Company without Cause. The Company may terminate Executives employment at any
time without Cause, effective one hundred and eighty (180) days following the date of Executives receipt of written notice of such termination (the Company Notice Period); provided, however, that
the Company and Executive may mutually agree to reduce the Company Notice Period. In the event that such notice is given by the Company, any intervening termination for any reason (other than a termination of Executives employment by the
Company for Cause), including death or Disability, prior to the expiration of the Company Notice Period shall not alter the Companys obligations under this Section 9.4. The Company may, in its sole and absolute discretion and by written
notice, place Executive on garden leave during the Company Notice Period on the condition that the Company pays Executive the Monthly Salary and any other compensation and benefits to which Executive would have been entitled had the Executive not
been placed on garden leave during the Company Notice Period (including but not limited to Annual Bonus and continued vesting of equity awards). If the Company and Executive mutually agree to reduce the Company Notice Period to less than one hundred
and eighty (180) days, the Company may provide, in its sole and absolute discretion, that outstanding equity awards continue to vest for up to the one hundred and eighty (180)-day period following Executives receipt of written notice of
termination. In the event that Executives employment is terminated by the Company without Cause (other than due to death or Disability), Executive shall be entitled to: 10
The Accrued Obligations, including the Severance Contribution; The Severance Payment, which shall be paid in a lump sum on the thirtieth (30th) day after the Date of
Termination, other than those components of the Severance Payment required by Law to be paid earlier, which components shall be paid in accordance with the requirements of applicable Law; provided, however, that the amount of the
Severance Payment shall be reduced (but not below $0) by the amount of the Severance Contribution; Any portion of the Sign-on Cash Award that is unvested as of the Date
of Termination shall vest and be paid in a lump sum on the thirtieth (30th) day after the Date of Termination if not payable earlier in accordance with Section 3.1; The Equity Benefits; If the Date of Termination occurs on or following the first (1st) anniversary of the Effective Date, the
Prorated Annual Bonus, which shall be payable at the same time bonuses are paid to other senior executives of the Company; The Non-Compete Payment; and If such termination occurs within one (1) year following the date of a Change in Control (as
described in the Compensation Policy), then, in addition to the payments and benefits set forth in Sections 9.4.1 through 9.4.6, Executive shall be entitled to be paid the Merger Amount (as defined below), which shall be paid in a lump sum on the
thirtieth (30th) day after the Date of Termination. Notwithstanding the foregoing, the payments and benefits described
in this Section 9.4 (other than the components of the Accrued Obligations and the portion of the Severance Payment required to be paid pursuant to applicable Law) (a) are subject to Executives execution and non-revocation of the Release of Claims in accordance with Section 9.7 and (b) shall immediately terminate, and the Company shall have no further obligations to Executive with respect thereto, in the event
that Executive wilfully and materially breaches any provision of Section 11, 12, 13 or 14. Termination by Executive with or without Good Reason. Executive may terminate his employment with or
without Good Reason by providing the Company one-hundred eighty (180) days prior written notice of such termination (the Executive Notice Period); provided,
however, that the Company and Executive may mutually agree to reduce the Executive Notice Period. In the event that such notice is given by Executive, any intervening termination for any reason (other than a termination of Executives
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In the event of a termination of employment by Executive for Good
Reason, Executive shall be entitled to the same payments and benefits as provided in Section 9.4 for a termination by the Company without Cause, subject to the same conditions on payment and benefits as described in Section 9.4 (including
execution and non-revocation of the Release of Claims in accordance with Section 9.7 and not having wilfully or materially breached Sections 11, 12, 13 and 14). Notwithstanding the above, the Company may
terminate the employment of Executive with or without Cause in accordance with Sections 9.3 and 9.4 after receipt of the Good Reason Notice (as defined below). In the event of a termination of employment by Executive without Good Reason, Executive shall be entitled to only (a) the Accrued
Obligations, and (b) subject to the same conditions on payment and benefits as described in Section 9.4 (including execution and non-revocation of the Release of Claims in accordance with
Section 9.7 and not having wilfully or materially breached Sections 11, 12, 13 and 14), the Non-Compete Payment. Termination Upon Non-Renewal. In the event that Executives
employment terminates on non-renewal of this Agreement by either the Company or Executive pursuant to Section 1.1, Executive shall be entitled to only (a) the Accrued Obligations and (b) subject
to the same conditions on payment and benefits as described in Section 9.4 (including execution and non-revocation of the Release of Claims in accordance with Section 9.7 and not having wilfully or
materially breached Sections 11, 12, 13 and 14), the Non-Compete Payment and the Prorated Annual Bonus. Release. Notwithstanding any provision in this Agreement to the contrary, the payment of any amount or
provision of any benefit pursuant to Sections 9.2 through 9.6 (other than the components of the Accrued Obligations and those components of the Severance Payment required to be paid pursuant to applicable Law) (collectively, the Severance
Benefits) shall be conditioned upon Executives execution, delivery to the Company, and non-revocation of the Release of Claims within fourteen (14) days following the Date of Termination.
If Executive fails to 12
Full Settlement. Without prejudice to Executives entitlements in respect of vested equity under
the 2020 Plan (or any successor plan) the payments and benefits provided under this Section 9 shall be in full satisfaction of all obligations of the Company Group to Executive under this Agreement or any other agreement, plan, arrangement or
policy of the Company Group in connection with his termination of employment. For the avoidance of doubt, Executives sole and exclusive remedy upon a termination of employment shall be receipt of the payments and benefits specified in this
Section 9. Definitions. For purposes of this Agreement, the following terms have the following meanings:
Accrued Obligations means (a) any unpaid Monthly Salary earned through the Date of
Termination, and any unused vacation days and recreation days accrued through the Date of Termination, which amounts shall be paid on the next regular payroll date immediately following the Date of Termination, (b) any earned and unpaid Annual
Bonus for the fiscal year immediately preceding the Date of Termination, which shall be paid at the time that annual bonuses for such fiscal year are paid to other senior executives of the Company, and (c) any other payment to which Executive
is entitled under the applicable terms of any applicable plan, program, agreement, corporate governance document or arrangement of the Company or its affiliates, including Company reimbursement of any unreimbursed business expenses, to be made in a
timely manner in accordance with the terms of such arrangements, and (d) rights to any Company indemnification and Company-provided officers liability insurance as set forth in Section 10. Beneficiaries means, subject to applicable Law, the executors or personal representatives of
Executives estate. Cause means (a) Executives material violation of the policies of the Company or
any of its affiliates, including, but not limited to, those relating to sexual harassment, corruption, the disclosure or misuse of confidential information, which violation has resulted, or could reasonably be expected to result, in material injury
to the business or 13
Notwithstanding the foregoing, without prejudice to clause 9.3.2, in the event that the Board reasonably believes that
Executive may have engaged in conduct that constitutes Cause, the Board may, subject to applicable Law, suspend Executive from performing his duties hereunder for a period of up to sixty (60) days, and provided the Company is acting in good
faith in no event shall any such suspension constitute an event pursuant to which Executive may terminate employment for Good Reason; provided that no such suspension shall alter the Companys obligations under this Agreement (including
but not limited to its obligations to provide Executive compensation and benefits and Annual Bonus and equity vesting in the usual way) during such period of suspension. For the avoidance of doubt, such equity vesting means Executive shall continue
to earn vesting credit with respect to equity awards during the suspension period, and that Executives eligibility to earn a full years Annual Bonus means that the amount of the Annual Bonus shall not be negatively impacted by such
suspension. Disability means that Executive, due to a physical or mental disability, has been unable to
perform his duties under this Agreement for a continuous period of one hundred and eighty (180) days or longer; Equity Benefits means vesting of the Sign-on Awards
solely in accordance with clauses (a) and (b) below, and the annual equity awards granted pursuant to Section 4.2 solely in accordance with clause (c) below: Sign-on RSU Award. The portion of the Sign-on RSU Award that is unvested as of the Date of Termination shall vest and be settled on the later of (i) the Date of Termination and (ii) the first (1st) anniversary of the grant date of the Sign-on RSU Award; Sign-on PSU Award. If the Date of Termination is during a Performance Period, then the
Sign-on PSU Award shall be eligible for vesting and settlement, at the end of the applicable Performance Period based on actual performance through the entire Performance Period; 14
If the Date of Termination occurs following the expiration of an applicable Performance Period (but prior to
the date the Sign-on PSU is otherwise settled in accordance with its terms), then the portion of the applicable Sign-on PSU Award earned based on actual performance
during the Performance Period shall immediately vest and be settled; Annual Equity Awards. In the event of termination of employment hereunder by reason of death or
Disability, any equity awards granted pursuant to Section 4.2 will be subject to accelerated vesting as provided for in the 2020 Plan (or any successor thereto). Good Reason means a termination by Executive if (a) any of the following events occurs
without Executives express prior written consent, (b) Executive notifies the Company in writing that such event has occurred within ninety (90) days after Executive learns of the occurrence of such event, describing such event in
reasonable detail and demanding cure, (the Good Reason Notice), (c) such event is not substantially cured within thirty (30) days after Executive delivers the Good Reason Notice to the Company, and (d) the Date of
Termination occurs within one hundred eighty (180) days after the failure of the Company to so cure and relates to: (i) any failure to continue Executive as the President and CEO after the Effective Date (other than by reason of a
termination of Executives employment by the Company with or without Cause or due to death, Disability or by Executive without Good Reason); (ii) a material diminution in Executives duties, responsibilities or authorities;
(iii) any material diminution of Executives Annual Salary or Target Bonus or maximum Annual Bonus opportunity; (iv) any change in the reporting structure so that Executive is required to report to anyone other than the Board;
(v) any material breach by the Company or any of its affiliates of any obligation under this Agreement; or (vi) without the Executives written consent, the relocation of the Executives principal place of employment as specified
in Section 1.5 above by more than 50 miles. Law means any Israeli law, rule or regulation, and the regulations of any securities
exchange on which the Companys securities are listed, or any applicable judgment, order, writ, decree, permit or license of any governmental authority. Merger Amount means an amount equal to the Annual Salary in effect immediately prior to the
Date of Termination (without taking into account any reduction in Annual Salary that gives rise to, or could have given rise to, a claim for Good Reason). 15
Prorated Annual Bonus means an Annual Bonus for the fiscal year of the Company in which the
Date of Termination occurs, prorated based on the number of days elapsed in the fiscal year as of the Date of Termination, and determined based on actual performance as of the end of the fiscal year and in exercising discretion to determine the
Prorated Annual Bonus payable to Executive, the Company (and where applicable, the Compensation Committee and the Board) shall disregard the fact that Executives employment is expected to terminate or has terminated. Release of Claims means the release of claims in favor of the Company and its affiliates
substantially in the form attached hereto as Exhibit A. Severance Payment means an amount equal to two (2) times the Annual Salary in
effect immediately prior to the Date of Termination (without taking into account any reduction in Annual Salary that gives rise to, or could have given rise to, a claim for Good Reason). Indemnification In accordance with and subject to the provisions of applicable Law and the applicable provisions of the
Companys Articles of Association and the Compensation Policy then in effect, Executive shall be indemnified and released by the Company in accordance with the provisions of the Indemnification and Release Agreement attached hereto as
Exhibit B, the terms of which shall be incorporated by reference herein. An officers liability insurance policy (or policies) shall be kept in place, during the Term and
thereafter until the seventh (7th) anniversary of the Date of Termination, providing coverage to Executive that is no less favorable to Executive in any respect than the coverage then being provided to any other present or former senior executive of
the Company. Confidentiality and Disclosure of Information Executive shall execute the Confidentiality, Disclosure of Information and Assignment of Inventions Agreement attached hereto as Exhibit
C concurrently with the execution of this Agreement and agrees to abide by the terms thereof, which shall be deemed incorporated into this Section 11. Non-Competition Executive hereby agrees, during the Non-Competition Restriction Period (as defined below), not to
engage, directly or indirectly, anywhere in the world, in any activity, business or any other engagement in the pharmaceutical industry or any other industry that the Company Group enters under Executives authority or direction, in each case,
which competes with the business of any member of the Company Group as of the Date of Termination (including any business that any member of the Company Group is actively planning to enter as of the Date of Termination), including as a consultant or
as a director, 16
except with the Companys prior written approval. Notwithstanding anything to the contrary contained in this Section 12, the foregoing shall not prevent Executive from acquiring for his
own personal investment not more than 1% of the outstanding voting securities of any publicly traded corporation and continuing to hold such investments and/or appointments as have been approved during his employment hereunder pursuant to
Section 1.3. For purposes of this Agreement, the term Non-Competition Restriction Period means the Term and a period of twelve (12) months following the Date of Termination.
It is hereby agreed and clarified that, when determining the above non-competition undertaking,
the parties took into account the entire consideration provided to Executive pursuant to this Agreement and the payment to which Executive is entitled pursuant to Section 15, which is being made in consideration, inter alia, for such
undertaking. For the avoidance of doubt, this Section 12 shall apply to Executive following a termination of employment that occurs on the expiration of the Fixed Term or any Extension Period. Non-Solicitation Executive hereby agrees, during the Non-Solicitation Restriction Period (as defined below), not to,
directly or indirectly, entice, solicit or encourage anyone known to him to be an employee, consultant, customer, vendor or supplier of the Company Group and/or its affiliates and with whom he had during the preceding six (6) months (or during
the six (6) months preceding the Date of Termination, in the case of actions taken by Executive after the Date of Termination) contact (other than incidental contact) and/or in respect of whom he had confidential information (or any prospective
employee consultant, customer, vendor or supplier with whom the Company Group has had material contact or taken material steps to engage or retain) to cease doing business with the Company Group, reduce its relationship with the Company Group or
refrain from establishing or expanding a relationship with the Company Group or in any other way interfere with the Company Groups relationships with such employees, consultants, customers, vendors or suppliers. Executive further agrees and
undertakes that during the Non-Solicitation Restriction Period, Executive shall not, directly or indirectly, including personally or in any business in which he is an officer, director or shareholder, for any
purpose or in any place, hire or engage any key employee (Executive Committee member or direct report of an Executive Committee member) employed by the Company Group on the date of such termination or during the preceding six (6) months.
Executive shall not violate this provision by making a general solicitation that is not directed at employees or consultants of the Company Group, by providing a reference for an employee or consultant of the Company Group, or by making a passive
investment in any company provided that such investment represents less than 5% of the outstanding equity interests of such company. For purposes of this Agreement, the term Non-Solicitation
Restriction Period means the Term and a period of twenty-four (24) months following the Date of Termination. It is
hereby agreed and clarified that, when determining the above non-solicitation undertaking, the parties took into account the entire consideration provided to Executive pursuant to this Agreement and the
payment to which Executive is entitled pursuant to Section 15, which is being made in consideration, inter alia, for such undertaking. For the avoidance of doubt, this Section 13 shall apply to Executive following a termination of
employment that occurs on the expiration of the Fixed Term or any Extension Period. 17
Non Disparagement Neither the Company Group nor Executive shall make disparaging or otherwise detrimental comments to any person or entity concerning the other,
or the circumstances surrounding Executives engagement and/or separation of engagement from the Company, unless such party can demonstrate that the comments were made in private circumstances and that it or he intended that the comments not be
published. In addition, Executive shall not make disparaging or otherwise detrimental comments to any person or entity concerning the Company Groups officers, directors or employees; the products, services or programs provided or to be
provided by the Company Group; the business affairs, operation, management or the financial condition of the Company Group, unless Executive can demonstrate that the comments were made in private circumstances and that he intended that the comments
not be published. The obligations set forth in this Section 14 shall apply both during and ten (10) years after the Term. Nothing herein shall prevent Executive or the Company Group from (i) testifying truthfully in any legal
proceeding and to any governmental or regulatory body; or (ii) as may otherwise be required by applicable Law or regulatory authority. It is hereby agreed and clarified that, when determining the above non-disparagement undertaking, the
parties took into account the entire consideration provided to Executive pursuant to this Agreement and the payment to which Executive is entitled pursuant to Section 15, which is being made in consideration, inter alia, for such
undertaking. Any claim in respect of breach of this clause by either party must be based on direct evidence that a breach has occurred and such evidence should be disclosed in full when making any allegation of breach. Non-Competition/Non-Solicitation/Non-Disparagement
Payment In consideration for Executives undertaking set forth in Sections 11, 12, 13
and 14 and subject to compliance therewith, following the Date of Termination Executive shall receive an amount equal to twelve (12) times the Monthly Salary (without taking into account any reduction in Monthly Salary that gives rise to, or
could have given rise to, a claim for Good Reason), to be paid in twelve (12) equal monthly installments commencing seven days after the Date of Termination (the Non-Compete Payment).
The Non-Compete Payment shall not be subject to offset by any income Executive derives from non-competitive employment or self-employment. Notwithstanding the foregoing, in the event that Executives employment is terminated by the Company for Cause, Executive shall remain
subject to Sections 11, 12, 13 and 14 and any other non-compete obligations, but the Company shall not be required to pay the Non-Compete Payment and the entire
compensation paid to the Executive pursuant to this Agreement shall constitute consideration for the Executives undertaking set forth in Sections 11, 12, 13 and 14. In the event of Executives death, the undertakings set forth in Sections
11, 12, 13 and 14 shall not apply and consequently the Company shall not be required to pay the Non-Compete Payment. 18
Cooperation During the Term and at all times thereafter, Executive agrees to cooperate (in respect of matters of which he has knowledge) with the Company
and its attorneys in connection with any matter related to the period he was employed by the Company and/or his services to any other member of the Company Group, including but not limited to any threatened, pending, and/or subsequent litigation,
government investigation, or other formal inquiry against any member of the Company Group, and shall make himself available upon reasonable notice to prepare for and appear at any deposition, hearing, arbitration, mediation, or trial in connection
with any such matters. Such cooperation will include willingness to be interviewed by representatives of the Company and to participate in legal proceedings by deposition or testimony. To the extent reasonably practicable, the Company shall
coordinate with Executive to minimize scheduling conflicts with Executives business and personal commitments. The Company shall reimburse Executive for any reasonable
out-of-pocket expenses (including travel expenses) incurred in connection with providing such assistance; provided that the reimbursement of fees related to any
legal counsel retained by Executive in connection with such assistance shall be subject to the terms of the Indemnification and Release Agreement. No-Hedging Policy;
No-Pledging Policy; Stock Ownership Guidelines Executive acknowledges and
agrees to adhere to the Companys No-Hedging Policy, No-Pledging Policy and Stock Ownership Guidelines applicable to executive officers of the Company, as each may
be amended from time to time in the Companys sole discretion. Return of Car, Equipment and Documents As of no later than the Date of Termination or as soon as reasonably practicable thereafter, Executive shall return to the Company the car,
cell phone (or other hand-held device), laptop, credit card(s) and any other company equipment, if any, provided to Executive, and any other confidential or proprietary information of the Company that remains in Executives possession;
provided, however, that nothing in this Agreement or elsewhere shall prevent Executive from retaining and utilizing documents relating to his personal benefits, defense of claims under this Agreement, entitlements and obligations;
documents relating to his personal tax obligations; his desk calendar, personal contact list, and the like; and such other records and documents as may reasonably be approved by the Board (such approval not to be unreasonably withheld or delayed).
Executive shall confirm such return in writing to the Company promptly upon Companys written request, together with confirmation that Executive no longer has any Company property or confidential or proprietary information of the Company in his
possession or control. No Other Post-Employment Restrictions There shall be no contractual, or similar, restrictions on Executives right to terminate his employment with the Company, or on his
post-employment activities, other than as expressly set forth in this Agreement. Assignability; Binding Nature This Agreement shall inure to the benefit of, and be binding on and enforceable by, the parties and each of their respective successors and
personal representatives (in Executives case) and assigns, except that the obligation of Executive to provide services under this Agreement is personal to Executive and may not be imposed on any other individual. No rights or obligations of
the Company under this Agreement may be assigned or transferred 19
by the Company, except that such rights and obligations may be assigned or transferred pursuant to a merger or consolidation, or the sale or liquidation of all or substantially all of the
business and assets of the Company; provided that the assignee or transferee is the successor to all or substantially all of the business and assets of the Company and such assignee or transferee contractually assumes the liabilities,
obligations and duties of the Company, as contained in this Agreement. For the avoidance of doubt, the Company shall be entitled to discuss this Agreement and any matters relating to it with any persons who satisfactorily identify themselves as
Executives personal representatives as if they were Executive. Tax Payments; Clawback Tax and Social Security Payments. Executive hereby acknowledges and agrees that the payments and
benefits granted to him under this Agreement shall be subject to income tax deductions and other mandatory tax deductions which the Company is required to deduct by applicable Law, and further represents that, except as specifically set forth in
this Agreement or the Companys Long Term International Assignment Policy, nothing in this Agreement shall be construed as imposing on the Company the obligation to pay taxes or any other obligatory payment imposed on Executive due to any
payment or benefit. For the avoidance of doubt, the Company Group shall be responsible for the employer portion of all social security taxes or contributions payable in respect of compensation or benefits paid to Executive by the Company Group.
Clawback. Notwithstanding anything to the contrary herein, all compensation and benefits provided under
this Agreement (including for the avoidance of doubt, the Sign-on Awards) shall be subject to clawback by the Company in accordance with the Compensation Policy. By signing this Agreement, Executive grants the
Company a power of attorney to deduct from the Monthly Salary, Annual Bonus, Sign-on Cash Award and/or any other payments due to Executive by the Company, any amounts owed by him, in accordance with applicable
Law and any Company clawback provisions in the Compensation Policy. Tax Protection. Notwithstanding anything contained in the Companys Long-Term International
Assignment Policy, Executive will be entitled to tax protection benefits in accordance with the terms of this Agreement. The scope of the tax protection benefit will be as follows: Exclusively with respect to Executives compensation income from the Company (including Monthly Salary,
Annual Bonus, Sign-on Cash Award, Sign-on Equity Awards, and annual equity awards) during the Term (collectively, the Compensation Income), Executive
is expected to pay no more income taxes and social security contributions than he would have paid if he were working exclusively in the United Kingdom for a United Kingdom tax resident employer (collectively, the Expected Tax
Amount). Any income taxes and social security contributions that Executive becomes obligated to pay in any jurisdiction other than the United Kingdom that are in addition to the Expected Tax Amount will be paid directly by the Company or
fully reimbursed to 20
Subject to the tax protection provisions as set out in the this Agreement, Executive agrees that Executive will
pay actual taxes owed on the Compensation Income in the United Kingdom and in Israel, on the basis of the calibrated withholding amount provided in this Section 21.3, and Executive and/or his tax advisers agree to cooperate with the Company to
prepare and promptly file Executives personal tax returns in the United Kingdom and Israel and any other filing required to be made pursuant to any tax ruling. The terms of the Companys Long-Term International Assignment Policy under the Home Approach
with respect to Outside/Personal Income, Tax Preparation Services, Penalties, and Refunds shall apply to the tax protection benefit provided to Executive under this Section 21.3. The Company and Executive shall cooperate and use reasonable best efforts to obtain relevant tax rulings or
other agreements with respect to Executives employment and the provision of services by Executive, including, without limitation, from the tax authorities in Israel and the United Kingdom. The Company agrees to take all action reasonably necessary to ensure that Executive recognizes income for
Israeli tax purposes on equity awards granted to Executive by the Company (including the Sign-On Awards) at the same time that Executive is required to recognize income for United Kingdom tax purposes on such
equity awards, including to provide instructions to remove the securities subject to such equity awards from the Section 102 trustee immediately upon the vesting of such equity awards (and Executive agrees to sign an authorization letter
requesting such removal upon request by the Company). Certain Guidelines. The Company and Executive will cooperate in good faith during the Term in order to
ensure compliance with the Companys corporate tax practices and policies in the jurisdictions in which Executive is performing services. In order to help avoid unintended and adverse tax consequences, the Company and Executive hereby agree
that, notwithstanding anything to the contrary, the following guidelines shall apply to Executive during the Term: 21
To the maximum extent possible, Executive shall not negotiate or sign any contracts on behalf of the Company
while he is not physically present in Israel. Executives office at the Companys principal offices in Israel shall be his exclusive dedicated
office space at any premises owned by the Company or any of its subsidiaries. To the extent that Executive works from his office within his personal residence in the United Kingdom, he shall not be entitled to reimbursement of related office
expenses. The Company and the Executive intend that the Executive shall not be physically present in the United Kingdom,
the United States, or any other jurisdiction other than Israel for more than a total of three months (per jurisdiction) in each calendar year. For the avoidance of doubt, any breach (whether material or otherwise) of this Section 21 by the Executive
shall not constitute grounds for termination of the Executives employment by the Company (whether for Cause or otherwise). Residence and Work Permit The Company Group shall assist Executive in obtaining a residency permit and work permit in Israel and shall pay all fees incurred by
Executive in obtaining such permits and, if requested, all fees incurred by Executives spouse in obtaining a residency permit in Israel. The Company and Executive shall cooperate in obtaining a work permit as soon as possible and in the event
the work permit is not obtained prior to the Effective Date, the Company and Executive shall agree as to a temporary place of employment. Representations. Executive represents that (a) he has provided to the Company complete and accurate
information regarding the terms of all contracts, arrangements, agreements, policies or understandings applicable to Executive, with prior employers or otherwise, which include post-employment covenants (including those relating to competition or
solicitation of third parties), and (b) he is not subject to (or has been released from all restrictive covenants under) any contract, arrangement, agreement, policy or understanding that in any way impacts his ability to enter into or fully
perform his obligations under this Agreement. Executive and the Company each represent and warrant (i) that such party is not otherwise unable to enter into and fully perform such partys obligations under this Agreement; and
(ii) that, upon the execution and delivery of this Agreement by both parties, this Agreement shall be such partys valid and binding obligation, enforceable against such party in accordance with its terms, except to the extent that
enforceability may be limited by applicable bankruptcy, insolvency or similar laws affecting the enforcement of creditors rights generally, or otherwise as may be limited by applicable Laws. Notwithstanding any portion of this Agreement to the
contrary, if any of Executives representations under this Section 23 prove to be inaccurate, the Company may immediately declare this Agreement null and void and Executives employment with the Company shall terminate immediately
without obligation of any sort by the Company, including pursuant to any equity or other award previously issued to Executive. 22
Dispute Resolution Subject to clause 24.4, any dispute arising out of or in connection with this contract, including any question
regarding its existence, validity or termination, shall be referred to and finally resolved by arbitration under the LCIA Rules, which Rules are deemed to be incorporated by reference into this clause. The number of arbitrators shall be three. The seat, or legal place, of arbitration shall be London, England. The language to be used in the arbitral proceedings shall be English. The governing law of the contract shall be the substantive law of Israel. The governing law of the arbitration
agreement shall be the law of England & Wales. Parties shall not be required to submit to arbitration any claim or complaint for any remedy pursuant to
legislation in Israel or England (as the case may be) that is required to be brought only in the Israel Labor Courts or the Employment Tribunals in England. Notwithstanding the foregoing, any claim by the Company Group for injunctive relief in accordance with
Section 25 may be sought before any court of competent jurisdiction. The Company shall reimburse Executive for all reasonable legal fees and expenses incurred by Executive in seeking to obtain or enforce any right or benefit provided under
this Agreement, provided that Executive substantially prevails on at least one material issue in any such dispute. Further the Company Group shall pay the costs of the arbitrator and if necessary the appeal-arbitrator. Remedies and Injunctive Relief Executive acknowledges that his wilful and material breach of any of the provisions of Sections 11, 12, 13 or 14 would cause irreparable
damage to the Company Group in an amount that would be material but not readily ascertainable, and that any remedy at law (including the payment of damages) would be inadequate. Accordingly, Executive agrees that, notwithstanding any provision of
this Agreement to the contrary, in addition to any other damages it is able to show, in the event of a willful, material and continued violation by Executive of any of the covenants contained in Sections 11, 12, 13 or 14, the Company Group shall be
entitled (without the necessity of showing economic loss or other actual damage) to (a) cease payment of the compensation and benefits contemplated by Sections 9 or 15 to the extent not previously paid or provided (including ceasing vesting of
outstanding equity awards), (b) the prompt return by Executive of any portion of such compensation and the value of such benefits previously paid or provided (including forfeiture of any equity awards that vested pursuant to Section 9 or
the repayment of the value of any equity incentive awards that vested pursuant to Section 9 that have been settled) and (c) injunctive relief (including temporary restraining orders, preliminary injunctions and permanent injunctions),
without posting a bond, in any court of competent jurisdiction for any actual or threatened breach of any of the covenants set forth in Sections 11, 12, 13 or 14 in addition to any other legal or equitable remedies it may have. The preceding
sentence shall not be construed as a waiver of the rights that may have for 23
damages under this Agreement or otherwise, and all such rights shall be unrestricted. The Non-Compete Restriction Period and the Non-Solicitation Restriction Period shall be tolled during (and shall be deemed automatically extended by) any period during which Executive is in violation of the provisions of Section 12 or 13, as applicable.
In the event that a court of competent jurisdiction determines that any provision of Sections 11, 12, 13 or 14 is invalid or more restrictive than permitted under the governing law of such jurisdiction, then, only as to enforcement of such provision
within the jurisdiction of such court, such provision shall be interpreted and enforced as if it provided for the maximum restriction permitted under such governing law. Notices Any notice or other communication required or permitted to be delivered under this Agreement shall be (a) in writing; (b) delivered
personally, by email received by the intended receiver of such email, by facsimile, by courier service or by certified or registered mail, first class postage prepaid and return receipt requested; (c) deemed to have been received on the date of
delivery or, if so mailed, on the third business day after the mailing thereof; and (d) addressed as follows (or to such other address as the party entitled to notice shall hereafter designate in accordance with the terms hereof): If to the Company: to the Companys headquarters, Attn: Chairman of the Board; With a copy (which shall not constitute notice) to: Wachtell, Lipton, Rosen & Katz 51 W 52nd Street New York, NY
10019 Facsimile:
+1-212-403-2000 Attn: Adam O. Emmerich, Esq. and to Tulchinsky, Marciano,
Cohen, Levitski & Co. Law Offices 4 Berkowitz Street Tel Aviv 64238 Facsimile: +972
(3) 6075050 Attn: Menachem Tulchinsky, Adv. If to Executive: to the last address on file with the Company; and With a copy (which shall not constitute notice) to: Withers LLP 20 Old Bailey London EC4M 7AN Attn: Elaine
Aarons 24
Miscellaneous Entire Agreement. This Agreement shall constitute the entire agreement between the parties with respect
to the subject matter hereof, and this Agreement (including the agreements attached hereto as Exhibits) shall supersede all prior representations, agreements and understandings (including any prior course of dealings), both written and oral, between
the parties with respect to the subject matter hereof. Amendment or Waiver. No provision in this Agreement may be amended unless such amendment is set forth in
a writing that expressly refers to the provision of this Agreement that is being amended and that is signed by Executive and by an authorized officer of the Company. No waiver by either party of any breach of any condition or provision contained in
this Agreement shall be deemed a waiver of any similar or dissimilar condition or provision at the same or any prior or subsequent time. To be effective, any waiver must be set forth in a writing signed by the waiving party and must specifically
refer to the condition(s) or provision(s) of this Agreement being waived. Inconsistencies. Subject to applicable Law and Section 1.6, in the event of any inconsistency
between any provision of this Agreement and any provision of any applicable plan, program, agreement, corporate governance document or arrangement of the Company or its affiliates, the provisions of this Agreement shall prevail unless Executive and
the Company otherwise agree in writing. Headings; Construction. The headings of the sections and
sub-sections contained in this Agreement are for convenience only and shall not be deemed to control or affect the meaning or construction of any provision of this Agreement. For purposes of this Agreement,
the term including shall mean including, without limitation. Survivorship. The provisions of this Agreement that by their terms call for performance subsequent to
the termination of either Executives employment or this Agreement (including the terms of Sections 9, 10, 11, 12, 13, 14, 24 and 25) shall survive such termination in accordance with their applicable terms. Governing Law; Severability. This Agreement shall be governed by the laws of the State of Israel,
without regard to its conflict of laws rules. Whenever possible, each provision or portion of any provision of this Agreement shall be interpreted in such manner as to be effective and valid under Law but the invalidity or unenforceability of any
provision or portion of any provision of this Agreement in any jurisdiction shall not affect the validity or enforceability of the remainder of this Agreement in that jurisdiction or the validity or enforceability of this Agreement, including that
provision or portion of any provision, in any other jurisdiction. In addition, should a court or arbitrator determine that any provision or portion of any provision of this Agreement, is not reasonable or valid, either in period of time,
geographical area, or otherwise, the parties agree that such provision should be interpreted and enforced to the maximum extent which such court or arbitrator deems reasonable or valid. No Mitigation/No Offset. Executive shall be under no obligation to seek other employment or to otherwise
mitigate the obligations of the Company under this Agreement, and there shall be no offset against amounts or benefits due to Executive under this Agreement or otherwise on account of any claim (other than any preexisting debts then due in
accordance with their terms) the Company or its affiliates may have against him or any remuneration or other benefit earned or received by Executive after such termination. 25
Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be
deemed an original, but all such counterparts shall together constitute one and the same instrument. Signatures delivered by facsimile, or by PDF sent via email, or by other electronic method, shall be effective for all purposes.
Board Approvals. Any reference made in this Agreement to an approval required of the Board or a
committee of the Board shall also include any approval of the Board or any committee of the Board as may be required by Law, the Compensation Policy or the Companys corporate documents. Legal and Accounting Fee Reimbursement. The Company shall reimburse or pay directly any legal or
accounting fees incurred by Executive in connection with the negotiation and execution of this Agreement, up to a maximum amount of USD $100,000 (One Hundred Thousand United States Dollars) (exclusive of any value added tax). Any invoice for such
fees that is delivered directly to the Company shall be sent to the attention of the Companys SVP GC Corporate Affairs. Payment or reimbursement will be made within thirty (30) days following receipt of the invoice by the Company.
Execution of this Agreement. This Agreement shall be signed by the Company following the necessary Board
approvals and shall immediately thereafter be signed by Executive. Signature page follows 26
IN WITNESS WHEREOF, the parties have executed this Agreement in one or more
counterparts as of the Effective Date. /s/ Sol J. Barer [Signature Page]
/s/ Richard Francis [Signature Page]
Exhibit A Form of Release Agreement This Release
Agreement (this Release Agreement) is dated as of [_____________] and is entered into by Richard Francis (Executive, Me or I) and TEVA PHARMACEUTICAL INDUSTRIES LTD.
(the Company) in connection with the termination of Executives employment with the Company. 1. General Release. (a) In consideration for the receipt of those payments that are in excess of the amounts required to be paid to Me by Law (as detailed in the
settlement of account attached hereto), I, on behalf of myself and my family, agents, representatives, heirs, executors, trustees, administrators, successors and assigns (the Releasors), hereby irrevocably and unconditionally
(i) represent and warrant that I have received in a timely manner full and complete payment of all amounts due to Me under my employment agreement with the Company dated November 21, 2022 (the Employment Agreement) or
under any applicable law and/or in connection with the termination of my employment, both at law and pursuant to the terms of the Employment Agreement (other than any amounts that are contingent on me signing this Release Agreement, which by the
terms of my Employment Agreement will not be provided until after this Release Agreement is effective (such payments, the Contingent Payments), and (ii) save in respect of any claims to enforce the payment of the Contingent
Payments release, settle, cancel, acquit, discharge and acknowledge to be fully satisfied, and covenant not to sue the Company and each of its respective past and/or present subsidiaries, affiliates, successors and assigns, and each of their
respective predecessors, and past and/or present stockholders, partners, members, directors, managers, officers, employees, agents or other representatives, and employee benefit plans of the Company or its affiliates, including, but not limited to,
trustees and administrators of these plans, in each case, in their individual and/or representative capacities (collectively, the Releasees) from any and all claims, contractual or otherwise, demands, costs, rights, causes of
action, charges, debts, liens, promises, obligations, complaints, losses, damages and all liability of whatever kind and nature, whether known or unknown, and hereby waive any and all rights that I, he, she or it may have, from the beginning of time
up to and including the time of signing this Release Agreement, in respect of my employment or separation from employment with the Company, or is in any way connected with or related to any applicable compensatory or benefit plan, program, policy or
arrangement, including, but not limited to, any claims relating to salaries, benefits, bonuses, compensation, fringe benefits, social benefits according to any law or agreement, amounts of pension fund, overtime, severance pay, sick pay, recreation
payments, vacation payments, prior notice payments, options or other securities, reimbursement of expenses and/or any other payments or benefits due to Me by any of the Releasees, or claims under any policy, agreement, understanding or promise,
written or oral, formal or informal, between the Company and any of its affiliates and myself, now or hereafter recognized, including claims for wrongful discharge, slander and defamation, as well as all claims for counsel fees and costs;
provided that such released claims shall not include any claims to enforce my rights under or with respect to any post-termination obligations of the Company expressly undertaken by the Company under my Employment Agreement (including but not
limited to vested accrued benefits and compensation under the Companys employee benefit plans and arrangements as set forth in Section 9 in my Employment Agreement), rights as a shareholder of the Company and rights to indemnification and
liability insurance coverage. A-1
(b) The Releasors agree not to bring any action, suit or proceeding whatsoever (including
the initiation of governmental proceedings or investigations of any type) against any of the Releasees hereto for any matter or circumstance concerning which the Releasors have released the Releasees under this Release Agreement. Further, the
Releasors agree not to encourage any other person or suggest to any other person that he, she or it institute any legal action against the Releasees, and I hereby declare, confirm and undertake that, if the Releasors or anyone else in their name
should deliver a claim as mentioned above, I shall reimburse the Releasees and anyone else on their behalf to the full extent of the sum of the legal expenses and legal fees incurred by them as a result of any such claim; and in the event that
Releasors prevail in such legal action, then the Releasees shall reimburse such sum to Me or the Releasors. The Releasors hereby agree to waive the right to any relief (monetary or otherwise) in any action, suit or proceeding I may bring in
violation of this Release Agreement. (c) This Release Agreement shall constitute a dismissal and compromise notice for the purposes of
Section 29 of the Severance Pay Law 5713-1963. 2. Legal Advice, Reliance. I represent and acknowledge that (a) I have been given
adequate time to consider this Release Agreement and have been advised to discuss all aspects of this Release Agreement with my private attorney, (b) I have carefully read and fully understand all the provisions of this Release Agreement,
(c) I have voluntarily entered into this Release Agreement, without duress or coercion, and (d) I have not heretofore assigned or transferred or purported to assign or transfer, to any person or entity, any of the claims described in
Section 1(a), any portion thereof or any interest therein. I understand that if I request additional time to review the terms of this Release Agreement, a reasonable extension of time shall be granted. 3. Miscellaneous. (a) No Violation of
Law. I agree and acknowledge that this Release Agreement is not and shall not be construed to be an admission by the Company of any violation of any applicable laws of Israel, or of any duty owed by the Company to Me. (b) Governing Law; Severability. This Release Agreement shall be governed by the laws of the State of Israel, without regard to its
conflict of laws rules. In the event that any one or more of the provisions of this Release Agreement is held to be invalid, illegal or unenforceable, the validity, legality and enforceability of the remaining provisions shall not in any way be
affected or impaired thereby. Any dispute arising under or relating to this Agreement or any transactions contemplated herein shall be resolved in accordance with Section 24 of my Employment Agreement. (c) Revocation. I may revoke this Release Agreement within seven (7) days after the date on which I sign this Release Agreement. I
understand that this Release Agreement is not binding or enforceable until such seven (7) day period has expired. Any such revocation must be made in a signed letter executed by Me and received by the Company at its headquarters no later than
5:00 p.m., Tel Aviv time, on the seventh day after I have executed this Release Agreement. I understand that if I revoke this Release Agreement, I shall not be entitled to any severance benefits under my Employment Agreement. A-2
(d) Counterparts. This Release Agreement may be executed in one or more counterparts,
each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. * * * * * A-3
Exhibit B Indemnification Agreement Indemnification and Release Agreement This Indemnification and Release Agreement (this Indemnification Agreement) is being entered into effective as of
January 1, 2023, pursuant to the resolutions of the Board of Directors (the Board) of Teva Pharmaceutical Industries Ltd., a company organized under the laws of the State of Israel (the Company), dated
July 31, 2012 and the resolutions of the Human Resources and Compensation Committee of the Board, and the Audit Committee of the Board, each dated July 30, 2012. It is in the best interest of the Company to retain and attract as office holders the most capable persons available and such persons are
becoming increasingly reluctant to serve in companies unless they are provided with adequate protection through insurance, exemption and indemnification in connection with such service. You are or have been appointed as an office holder of the Company, and in order to enhance your service to the Company in an effective manner,
the Company desires to provide for your indemnification to the fullest extent permitted by law and the Companys Articles of Association (the Articles of Association). In consideration of your service to the Company, the
Company hereby agrees as follows: 1. The Company hereby undertakes to indemnify you to the maximum extent permitted by the
Articles of Association and the Israeli Companies Law, 5759-1999, as amended from time to time (the Companies Law), the Israeli Securities Law, 5728-1968, as amended from time to time (the Securities Law), and
any other applicable law, in respect of the following expenses or liabilities imposed on, or incurred by, you in consequence of any act performed or omission committed by you in your capacity as an Office Holder (such term shall bear the
meaning assigned to it in the Companies Law) of the Company (including your service, at the request of the Company, as an officer, director, employee or board observer of any other company controlled directly or indirectly by the Company (a
Subsidiary) or in which the Company holds shares (an Affiliate)). 1.1 any monetary liability
imposed on you in favor of another person by a court judgment, including a settlement or an arbitrators award which was approved by court; 1.2 reasonable litigation expenses, including attorneys fees, actually incurred by you in connection with an investigation or
proceeding that was conducted against you by a competent authority which has been Terminated Without the Filing of an Indictment (as such term is defined in the Companies Law) against you and without the Imposition on you of a Monetary
Liability In Lieu of a Criminal Proceeding (as such term is defined in the Companies Law), or which has been Terminated Without the Filing of an Indictment against you but with the Imposition on you of a Monetary Liability in Lieu of a
Criminal Proceeding in respect of a crime which does not require the proof of mens rea (criminal intent) or in connection with a monetary sanction; B-1
1.3 reasonable litigation expenses, including attorneys fees, actually incurred
by you or charged to you by a court, in a proceeding instituted against you by the Company or on its behalf or by another person, or in any criminal proceeding in which you were acquitted, or in any criminal proceedings in which you were convicted
of a crime which does not require the proof of mens rea (criminal intent); and 1.4 payment which you are obligated to make
to an injured party as set forth in Section 52(54)(a)(1)(a) of the Securities Law, and expenses actually incurred by you in connection with a proceeding under Chapters H3, H4, or I1 of the Securities Law, including reasonable
legal expenses, which term includes attorneys fees or in connection with Article D of Chapter Four of Part Nine of the Companies Law. For the purpose of this Indemnification Agreement, expenses shall include, without limitation, attorneys fees and all other
costs, expenses and obligations paid or incurred by you in connection with investigating, defending, being a witness in or participating in (including on appeal), or preparing to defend, be a witness in or participate in any claim relating to any
matter for which indemnification hereunder may be provided, and expenses paid or incurred by you in successfully enforcing this Indemnification Agreement. Expenses shall be considered paid or incurred by you at such time as you are required to pay
or incur such cost or expenses, including upon receipt of an invoice or payment demand. 2. Notwithstanding the forgoing provisions
of Section 1, except to the extent permitted by applicable law, the Company will not indemnify you for any amount you may be obligated to pay in respect of: 2.1 A breach of your duty of loyalty to the Company or a Subsidiary or Affiliate, unless committed in good faith and with reasonable
grounds to believe that such act would not prejudice the interests of the Company or a Subsidiary or Affiliate; 2.2 A breach of
your duty of care to the Company or a Subsidiary or an Affiliate committed intentionally or recklessly; 2.3 An action or omission
taken by you with the intent of unlawfully realizing personal gain; 2.4 A fine, monetary sanction, forfeit or penalty imposed upon
you; or 2.5 With respect to proceedings or claims initiated or brought voluntarily by you against the Company or a Subsidiary or
an Affiliate, other than by way of defense, by way of third party notice to the Company or a Subsidiary or an Affiliate, or by way of countersuit in connection with claims brought against you. 3. To the fullest extent permitted by law, the Company will, following receipt by the Company of your written request therefor, make
available all amounts payable to you in accordance with Section 1 above on the date on which such amounts are first payable by you (Time of Indebtedness), and with respect to items referred to in Sections 1.2, 1.3 and 1.4
above, even prior to the time on which the applicable court renders its decision, provided, however, that advances given to cover legal expenses will be repaid by you to the Company if it is determined that you are not
lawfully entitled to such indemnification. B-2
As part of the aforementioned undertaking, the Company will make available to you any
security or guarantee that you may be required to post in accordance with an interim decision given by a court or an arbitrator, including for the purpose of substituting liens imposed on your assets. 4. The Company will indemnify you and advance expenses in accordance with this Indemnification Agreement even if at the relevant Time
of Indebtedness you are no longer an Office Holder of the Company or a Subsidiary or an Affiliate, provided that the obligations with respect to which you will be indemnified hereunder are in respect of actions taken or omissions
committed by you while you were an Office Holder of the Company or such Subsidiary or such Affiliate as aforesaid, and in such capacity. 5. The undertaking of the Company set forth in Section 1.1 shall be limited as follows: 5.1 to matters that are connected or otherwise related to those events or circumstances set forth in Schedule A hereto. 5.2 the maximum amount for which the Company undertakes to indemnify you for the matters and circumstances described in Section 1.1,
jointly and in the aggregate, shall not exceed US $200 million according to the representative rate of exchange, or any other official rate of exchange that may replace it, at the Time of Indebtedness calculated with respect to each Office
Holder of the Company. Such amount has been determined by the Board to be reasonable under the circumstances. 6. Subject to the
limitations of Section 5 above and Section 7 below, the indemnification hereunder will, in each case, cover all sums of money that you will be obligated to pay, in those circumstances for which indemnification is permitted under the law,
under the Articles of Association and under this Indemnification Agreement. 7. Notwithstanding anything to the contrary herein,
the Company will not indemnify you for any liability with respect to which you have received payment by virtue of an insurance policy or another indemnification agreement, including, without limitation, an indemnification undertaking provided by a
Subsidiary or an Affiliate, other than for amounts which are in excess of the amounts actually paid to you pursuant to any such insurance policy or other indemnity agreement (including deductible amounts not covered by insurance policies), all
within the limits set forth in Section 5 above. In order to eliminate any duplication of benefits, the Company will be entitled to receive any amount collected by you from a third party in connection with liabilities actually indemnified
hereunder, up to the amount actually paid to you by the Company as indemnification hereunder, to be transferred by you to the Company within fifteen (15) days following the receipt of said amount. In the event of payment by the Company pursuant to this Indemnification Agreement, the Company shall be subrogated to the extent of such
payment to all of your rights of recovery, and you shall execute all documents required, and shall do everything that may be necessary, to secure such rights, including the execution of such documents necessary to enable the Company effectively to
bring suit to enforce such rights. 8. In all indemnifiable circumstances, indemnification will be subject to the following: B-3
8.1 You shall promptly notify the Company in writing of any legal proceedings
initiated against you and of all possible or threatened legal proceedings for which you may seek indemnification hereunder, without delay, and in any event within seven (7) days following your first becoming aware thereof,
provided, however, that your failure to notify the Company as aforesaid shall not derogate from your right to be indemnified as provided herein except and to the extent that such failure to provide notice prejudices the
Companys ability to defend against such action or to conduct any related legal proceeding. You shall deliver to the Company, or to such person as it shall advise you, without delay, all documents you receive in connection with these
proceedings or possible or threatened proceedings. Notice to the Company shall be directed to the Chairman of the Board, and in the event you are the Chairman of the Board, to the Chairman of the Audit Committee, at the address of the Companys
principal office (or at such other address as the Company shall advise you). 8.2 Other than with respect to proceedings that have
been initiated against you by the Company or in its name, the Company shall be entitled to undertake the conduct of your defense in respect of such legal proceedings and/or to hand over the conduct thereof to any attorney which the Company may
choose for that purpose, except to an attorney who is not, upon reasonable grounds, acceptable to you. In such case, the fees and expenses of such counsel shall be paid by the Company. The Company shall notify you of any such decision to defend
within ten (10) calendar days of receipt of notice of any such proceeding. The Company or the attorney as aforesaid shall be
entitled, within the context of the conduct as aforesaid, to conclude such proceedings, all as they shall see fit, including by way of settlement. Notwithstanding the foregoing, in the case of criminal proceedings, the Company or the attorneys as aforesaid will not have the right to plead
guilty in your name or to agree to a plea-bargain in your name without your consent. Furthermore, in a civil proceeding (whether before a court or as a part of a compromise arrangement), the Company and/or its attorneys will not have the right to
admit to any occurrences that are not indemnifiable pursuant to this Indemnification Agreement and/or pursuant to law, without your consent. However, the aforesaid will not prevent the Company or its attorneys as aforesaid, with the approval of the
Company, to come to a financial arrangement with a plaintiff in a civil proceeding or to consent to the entry of any judgment against you or enter into any settlement, arrangement or compromise, in each case without your consent, so long as such
arrangement, judgment, settlement or compromise: (i) does not include an admission of your fault, (ii) is fully indemnifiable pursuant to this Indemnification Agreement and pursuant to law and (iii) further provides, as an
unconditional term thereof, the full release of you from all liability in respect of such proceeding. This paragraph shall not apply to a proceeding brought by you under Section 8.7 below. 8.3 You will fully cooperate with the Company and/or any attorney as aforesaid in every reasonable way as may be required of you within
the context of their conduct of such legal proceedings, including but not limited to the execution of power(s) of attorney and other documents required to enable the Company or its attorney as aforesaid to conduct your defense in your name, and to
represent you in all matters connected therewith, in accordance with the aforesaid and will give the Company all information and access to documents, files and your advisors and representatives as shall be within your power, in every reasonable way
as may be required by the Company with respect to any such legal proceedings, provided that the Company shall cover all reasonable costs incidental thereto such that you will not be required to pay the same or to finance the same
yourself, and provided, further, that you shall not be required to take any action that would reasonably prejudice your defense in connection with any indemnifiable proceeding. B-4
8.4 Notwithstanding the provisions of Sections 8.2 and 8.3 above, (i) if in
a proceeding to which you are a party by reason of your status as an Office Holder of the Company or any Subsidiary or Affiliate, the named parties to any such proceeding include both you and the Company or any Subsidiary or Affiliate, and joint
representation is inappropriate under applicable standards of professional conduct due to a conflict of interest or potential conflict of interest (including the availability to the Company and its Subsidiary or Affiliate, on the one hand, and you,
on the other hand, of different or inconsistent defenses or counterclaims) that exists between you and the Company, or (ii) if the Company fails to assume the defense of such proceeding in a timely manner, or (iii) if the Company refers
the conduct of your defense to an attorney who is not, upon reasonable grounds, acceptable to you, you shall be entitled to be represented by separate legal counsel, which may represent other persons similarly situated, of the Companys choice
and reasonably acceptable to you and such other persons, at the sole expense of the Company. In addition, if the Company fails to comply with any of its material obligations under this Indemnification Agreement or in the event that the Company or
any other person takes any action to declare this Indemnification Agreement void or unenforceable, or institutes any action, suit or proceeding to deny or to recover from you the benefits intended to be provided to you hereunder, except with respect
to such actions, suits or proceedings brought by the Company that are resolved in favor of the Company, you shall have the right to retain counsel of your choice, reasonably acceptable to the Company and at the expense of the Company, to represent
you in connection with any such matter. 8.5 If, in accordance with Section 8.2 (but subject to Section 8.4), the Company
has taken upon itself the conduct of your defense, you shall have the right to employ counsel in any such action, suit or proceeding, who shall fully update, and be fully updated by, the Company on the defense procedure and shall consult with, and
be consulted with by, the Company and the attorney conducting the legal defense on behalf of the Company, but the fees and expenses of such counsel, incurred after the assumption by the Company of the defense thereof, shall be at your expense and
the Company will have no liability or obligation pursuant to this Indemnification Agreement or the above resolutions to indemnify you for any legal expenses, including any legal fees, that you may incur in connection with your defense, unless the
Company shall agree to such expenses; in which event all reasonable fees and expenses of your counsel shall be borne by the Company to the extent so agreed to by the Company. 8.6 The Company will have no liability or obligation pursuant to this Indemnification Agreement to indemnify you for any amount
expended by you pursuant to any compromise or settlement agreement reached in any suit, demand or other proceeding as aforesaid without the Companys consent to such compromise or settlement, which consent shall not be unreasonably withheld.
8.7 The Board and/or applicable committee(s) thereof and/or any other person(s) authorized by the Board will consider the request
for indemnification and the amount thereof and will determine if you are entitled to indemnification and the amount thereof. In the event that you make a request for payment of an amount of indemnification hereunder or a request for an advancement
of indemnification expenses hereunder and the Company fails to timely determine your right to indemnification hereunder or fails to timely make such payment or advancement in B-5
whole or in part, you may request that a determination with respect to your entitlement thereto shall be made in the specific case by an Independent Counsel agreed upon by the Company and you,
and in the absence of such agreement, appointed by the head of the Israeli Bar Association. The Company agrees to pay the reasonable fees of the Independent Counsel referred to above and to fully indemnify such counsel against any and all expenses,
claims, liabilities and damages arising out of or relating to this Indemnification Agreement or its engagement pursuant hereto, provided, however, that you shall reimburse the Company for any such fees, expenses, claims,
liabilities and damages in the event the matter is resolved in favor of the Company. Independent Counsel means a law firm, or a member of a law firm, that is experienced in matters of Israeli corporate law and neither presently
is, nor in the past five years has been, retained to represent: (i) the Company, an interested party (as defined in the Companies Law) of the Company or you in any matter material to either such party (other than in the capacity of
Independent Counsel with respect to this Indemnification Agreement or similar indemnification agreements of the Company), or (ii) any other party to the proceeding giving rise to a claim for indemnification hereunder. Notwithstanding the
foregoing, the term Independent Counsel shall not include any person who, under the applicable standards of professional conduct then prevailing, would have a conflict of interest in representing either the Company or you in an action to
determine your rights under this Indemnification Agreement. 8.8 Neither the Company nor any of its agents, employees, directors or
officers shall make any statement to the public or to any other person regarding any settlement of claims made pursuant to this Indemnification Agreement against you that would in any manner cast any negative light, inference or aspersion against
you. 8.9 By signing this Indemnification Agreement you hereby accept that you shall not make any statement to the public or to any
other person regarding any settlement of claims made pursuant to this Indemnification Agreement against you or the Company that would in any manner cast any negative light, inference or aspersion against the Company, and that you will keep the terms
of such settlement confidential. 9. The Company hereby exempts you, to the fullest extent permitted by law and the Articles of
Association, from any liability for damages caused as a result of a breach of your duty of care to the Company, provided that in no event shall you be exempt with respect to any actions listed in Section 2 above or for a breach of
your duty of care in connection with a Distribution (as defined in the Companies Law). 10. Subject to Section 20
below, if any act, resolution, approval or other procedure is required for the validation of any of the undertakings in this Indemnification Agreement, the Company undertakes to cause them to be done or adopted in a manner which will enable the
Company to fulfill all its undertakings as aforesaid. 11. To the fullest extent permitted by law and the Articles of Association
(as stated above), nothing contained in this Indemnification Agreement shall derogate from the Companys right (but in no way shall the Company be obligated) to indemnify you post factum for any amounts which you may be obligated to pay
as set forth in Section 1 above without regard to the limitations set forth in Section 5 above. Your rights of indemnification hereunder shall not be deemed exclusive of any other rights you may have under the Articles of Association or
applicable law or otherwise. B-6
12. If any undertaking included in this Indemnification Agreement is held invalid or
unenforceable, such invalidity or unenforceability will not affect any of the other undertakings which will remain in full force and effect. Furthermore, if such invalid or unenforceable undertaking may be modified or amended so as to be valid and
enforceable as a matter of law, such undertaking will be deemed to have been modified or amended, and any competent court or arbitrator is hereby authorized to modify or amend such undertaking, so as to be valid and enforceable to the maximum extent
permitted by law. 13. This Indemnification Agreement and the agreements herein shall be governed by and construed and enforced in
accordance with the laws of the State of Israel, without regard to the rules of conflict of laws, and any dispute arising from or in connection with this Indemnification Agreement is hereby submitted to the sole and exclusive jurisdiction of the
competent courts in Tel Aviv, Israel. 14. This Indemnification Agreement cancels and replaces any preceding letter of
indemnification or arrangement for indemnification that may have been issued to you by the Company. Notwithstanding the foregoing, the indemnification obligation set forth in this Indemnification Agreement will also apply, subject to the terms,
conditions and limitations set forth in this Indemnification Agreement, with respect to actions performed, or omissions committed, in your capacity as an Office Holder of the Company or a Subsidiary or an Affiliate, during the period prior to the
date of this Indemnification Agreement. 15. Neither the settlement nor termination of any proceeding nor the failure of the
Company to award indemnification or to determine that indemnification is payable shall create an adverse presumption that you are not entitled to indemnification hereunder. In addition, the termination of any proceeding by judgment or order (unless
such judgment or order provides so specifically) or settlement shall not create a presumption that you did not act in good faith and in a manner which you reasonably believed to be in or not opposed to the best interests of the Company or, with
respect to any criminal action or proceeding, that you had reasonable cause to believe that your action was unlawful. 16. This
Indemnification Agreement shall be (a) binding upon all successors and assigns of the Company (including any transferee of all or a substantial portion of the business, stock and/or assets of the Company and any direct or indirect successor by
merger or consolidation or otherwise by operation of law), and (b) binding on and shall inure to the benefit of your heirs, personal representatives, executors and administrators. This Indemnification Agreement shall continue for your benefit
and your heirs, personal representatives, executors and administrators benefit after you cease to be an Office Holder of the Company. 17. The obligations of the Company according to this Indemnification Agreement shall be interpreted broadly and in a manner that shall
facilitate its execution, to the extent permitted by law, and for the purposes for which it was intended. In the event of a conflict between any provision of this Indemnification Agreement and any provision of the law which cannot be conditioned
upon, changed or added to, the said provision of the law shall supersede the specific provision in this Indemnification Agreement, but shall not limit or diminish the validity of the remaining provisions of this Indemnification Agreement. B-7
18. Subject to Section 20 below, the Company hereby agrees to indemnify and
exempt you to the fullest extent permitted by law, notwithstanding that such indemnification or exemption is not specifically authorized by the other provisions of this Indemnification Agreement. In the event of any change after the date of this
Indemnification Agreement in any applicable law, statute or rule which expands the right of an Israeli company to indemnify Office Holders, it is the intent of the parties hereto that you shall enjoy by this Indemnification Agreement the greater
benefits afforded by such change and such changes shall to the extent permitted by applicable law be, ipso facto, within the purview of your rights and the Companys obligations pursuant to this Indemnification Agreement. 19. Subject to Section 5 above and notwithstanding anything else to the contrary herein, in the event of any change in the
Articles of Association after the date of this Indemnification Agreement which narrows the Companys right to indemnify you under this Agreement, such change shall apply only with respect to actions performed, or omissions committed, by you in
your capacity as an Office Holder of the Company, of a Subsidiary or of an Affiliate, after the date of such change, to the extent permitted by applicable law. 20. Notwithstanding anything to the contrary herein, nothing in this Indemnification Agreement shall require or obligate the Company to
amend its Articles of Association, or take any action with respect thereto. 21. No waiver of any of the provisions of this
Indemnification Agreement shall be deemed or shall constitute a waiver of any other provisions of this Indemnification Agreement (whether or not similar), nor shall such waiver constitute a continuing waiver. Any waiver shall be in writing. 22. All notices and other communications required or permitted under this Indemnification Agreement shall be in writing, shall be
effective (i) if mailed, three (3) business days after mailing (unless mailed abroad, in which case it shall be effective five (5) business days after mailing), (ii) if by air courier, two (2) business days after delivery to the
courier service, (iii) if sent by messenger, upon delivery, (iv) if sent via facsimile, upon transmission and electronic (or other) confirmation of receipt or (if transmitted and received on a
non-business day) on the first business day following transmission and electronic (or other) confirmation of receipt and (iv) if sent by email, on the date of transmission or (if transmitted and received
on a non-business day) on the first business day following transmission, except where a notice is received stating that such mail has not been successfully delivered. 23. This Indemnification Agreement shall continue in effect regardless of whether you continue to serve as an Office Holder of the
Company. 24. This Indemnification Agreement may be executed in any number of counterparts, each of which shall be deemed an
original and enforceable against the parties actually executing such counterpart, and all of which together shall constitute one and the same instrument; it being understood that parties need not sign the same counterpart. The exchange of an
executed Agreement (in counterparts or otherwise) by facsimile or by electronic delivery in pdf format shall be sufficient to bind the parties to the terms and conditions of this Indemnification Agreement, as an original. The Board has determined, based on the current activity of the Company, that the amount stated in Section 5 is reasonable under the
circumstances, and that those events and circumstances specified in Schedule A are foreseeable in light of the Companys activities as of the date hereof. B-8
Kindly sign and return the enclosed copy of this Indemnification Agreement to acknowledge
your agreement to the contents hereof. [Signature Page to Follow] B-9
/s/ Sol J. Barer / Chairman of the Board /s/ Richard Francis
Schedule A All references in this schedule to the Company shall be deemed to refer to a Subsidiary or Affiliate as well, to the extent
that your service as an office holder, director, employee or board observer of the Subsidiary or Affiliate is at the request of the Company in the circumstances described in the preface of Section 1 to the Indemnification Agreement. 1. The offering of securities by the Company and/or by a shareholder to the public and/or to private investors or the offer by the Company to
purchase securities from the public and/or from private investors or other holders pursuant to a prospectus, agreement, notice, report, tender and/or other proceeding, whether in Israel, the United States or abroad; 2. Occurrences resulting from the Companys public filings or omissions to make a public filing, delisting of shares, or buy-back of Companys securities; 3. Occurrences in connection with investments the Company makes
in other corporations whether before and/or after the investment is made, entering into the transaction, the execution, development and monitoring thereof, including without limitation, actions taken by you in the name of the Company as an Office
Holder and/or board observer of the corporation which is the subject of the transaction and the like; 4. The sale, purchase and holding of
negotiable securities or other investments for or in the name of the Company; 5. Actions in connection with an actual or anticipated
change in ownership, control or structure of the Company, its reorganization, dissolution, including without limitation, a merger, sale or acquisition of shares, or change in capital; 6. Actions in connection with any actual or proposed transaction not in the ordinary course of business of the Company, including without
limitation, the sale, lease or purchase of any assets, subsidiary, operations and/or business, or part thereof, of the Company; 7. Actions
concerning the approval of transactions of the Company with officers and/or directors and/or holders of controlling interests in the Company, and any other transactions referred to in Section 270 of the Companies Law; 8. Without derogating from the generality of the above, actions in connection with the purchase or sale of companies, legal entities, business,
securities or assets, and the division or consolidation thereof, including without limitation, any Tender Offer, Forced Sale of Shares, Arrangement and Compromise (as such capitalized terms are defined in the Companies Law) or any reorganization,
merger or consolidation of whatever kind or nature within the meaning of any law applicable to such claim or demand; 9. Actions taken in
connection with labor relations and/or employment matters in the Company and trade relations of the Company, including without limitation, with employees, independent contractors, customers, suppliers and various service providers; S-A-1
10. Actions in connection with products or services developed and/or commercialized by the
Company, including without limitation, the performance of pre-clinical and clinical trials on such products, whether performed by the Company or by third parties on behalf of the Company, and/or in connection
with the certification, distribution, sale, license or use of such products, including without limitation in connection with professional liability and product liability claims and/or in connection with the procedure of obtaining regulatory or other
approvals regarding such products, whether in Israel or abroad and including without limitation, liabilities arising out of advertising or marketing, including without limitation, misrepresentations regarding the Companys products and
unlawful distribution of emails; 11. Actions taken in connection with the intellectual property of the Company, and its protection,
including without limitation, the registration or assertion of rights to intellectual property and the defense of claims related to intellectual property, including without limitation, any assertion that the Companys products violate,
infringe, misappropriate or misuse the intellectual property rights of any third party; 12. Actions taken pursuant to or in accordance
with the policies and procedures of the Company (including without limitation, tax policies and procedures), whether such policies and procedures are published or not; 13. Approval of corporate actions, in good faith, including without limitation, the approval of the acts of the Companys management,
their guidance and their supervision; 14. Claims of failure to exercise business judgment and a reasonable level of proficiency, expertise
and care in regard of the Companys business; 15. Violations of laws requiring the Company to obtain regulatory and governmental
licenses, permits and authorizations in any jurisdiction; 16. Claims in connection with publishing or providing any information, including
without limitation, any filings with governmental authorities, on behalf of the Company in the circumstances required under applicable laws; 17. Any claim or demand made under any securities laws of any jurisdiction or by reference thereto, or related to the failure to disclose any
information in the manner or time such information is required to be disclosed pursuant to any securities authority or any stock exchange disclosure or other rules, or any other claims relating to relationships with investors, debt holders,
shareholders and the investment community; or related to inadequate or improper disclosure of information to investors, debt holders, shareholders and the investment community, claims relating to or arising out of financing arrangements, any breach
of financial covenants or other obligations towards lenders or debt holders of the Company, class actions, violations of laws requiring the Company to obtain regulatory and governmental licenses, permits and authorizations in any jurisdiction;
actions taken in connection with the issuance of any type of securities of Company, including without limitation, the grant of options to purchase any of the same, or related to the purchase, holding or disposition of securities of the Company or
any other investment activity involving or effected by such securities, including, without limitation, any offering of the Companys securities to private investors or to the public, and listing of such securities, or the offer by the Company
to purchase securities from the public or from private investors or other holders, and any undertakings, representations, warranties and other obligations related to any such offering, listing or offer or to the Companys status as a public
company or as an issuer of securities; S-A-2
18. Any claim or demand made by any lenders or other creditors or for monies borrowed by, or
other indebtedness of, the Company; 19. Any claim or demand made directly or indirectly in connection with complete or partial failure, by
the Company, or their respective directors, officers and employees, to pay, report, keep applicable records or otherwise, any state, municipal, federal, county, local, city or foreign taxes or other mandatory payments of any nature whatsoever,
including, without limitation, income, sales, use, transfer, excise, value added, registration, severance, stamp, occupation, customs, duties, real property, personal property, capital stock, social security, unemployment, disability, payroll or
employee withholding or other withholding, including without limitation, any interest, penalty or addition thereto, whether disputed or not; 20. Any claim or demand arising out of dealings by the Company with third parties, including without limitation, agents, employees, customers,
suppliers, creditors or others; 21. Any claim or demand arising out of presentations or reports submitted or delivered (or not submitted
or delivered) to shareholders (whether current or prospective), customers or creditors of the Company or to any governmental entity or agency, including without limitation, relevant securities authorities or commissions; 22. Any claim or demand made by purchasers, holders, lessors or other users of products of the Company, or individuals treated with or exposed
to such products, for damages or losses related to such use or treatment; 23. Review, approval and actions taken in connection with the
financial and tax reports of the Company, including without limitation, any action, consent or approval related to or arising from the foregoing, including without limitation, execution of certificates for the benefit of third parties related to the
financial statements; 24. Claims in connection with anti-competitive laws and regulations and laws and regulation of commercial
wrongdoing; 25. Claims in connection with breach of confidentiality obligations, acts in regard of invasion of privacy, including with
respect to databases, and acts in connection with slander and defamation; 26. Claims or demands made by any third party suffering any
personal injury and/or bodily injury and/or property damage to business or personal property through any act or omission attributed to the Company, or its employees, agents or other persons acting or allegedly acting on their behalf; 27. Any administrative, regulatory or judicial actions, orders, decrees, suits, demands, demand letters, directives, claims, liens,
investigations, proceedings or notices of noncompliance or violation by any governmental entity, including without limitation, the Office of the Chief Scientist or the Investments Center of the Israeli Ministry of Industry, Trade and Labor, the
Israeli Antitrust Authority, the Israel Securities Authority, the United States Securities and Exchange Commission, or other person alleging the failure to comply with any statute, law, ordinance, rule, regulation, order or decree of any
governmental entity applicable to the Company, or any of its businesses, subsidiaries, assets or operations, or the terms and conditions of any operating certificate or licensing agreement; S-A-3
28. Any action or decision regarding Distribution; 29. An announcement, a statement, including without limitation, a position taken, or an opinion made in good faith by an Office Holder in the
course of his duties and in conjunction with his duties, including without limitation, during a meeting of the Board or one of the committees of the Board; 30. An act or omission undertaken in contradiction to the Companys Memorandum of Association or Articles of Association; 31. Any action or decision in relation to work safety and/or working conditions; 32. An act or omission undertaken in negotiating, signing and performing an insurance policy or any claim relating to a failure to maintain
appropriate insurance and/or adequate safety measures; 33. Any claim or demand made by a customer, supplier, contractor or other third
party transacting any form of business with the Company, in the ordinary course of their business, relating to the negotiations or performance of such transaction, or representations or inducements provided in connection therewith or otherwise. 34. Any administrative, regulatory, civil or judicial actions, orders, decrees, suits, demands, demand letters, directives, claims, liens,
investigations, proceedings or notices of noncompliance or violation by any governmental entity or other person alleging potential responsibility or liability (including without limitation, potential responsibility or liability for costs of
enforcement, investigation, cleanup, governmental response, removal or remediation, for natural resources damages, property damage, personal injuries, or penalties or for contribution, indemnification, cost recovery, compensation, or injunctive
relief) arising out of, based on or related to (x) the presence of release, spill, emission, leaking, dumping, pouring, deposit, disposal, discharge, leaching or migration into the environment (each a Release) or threatened Release
of, or exposure to, any hazardous, toxic, explosive or radioactive substances, wastes or other pollutants and all other substances or wastes of any nature regulated pursuant to any environmental law, at any location, whether or not owned, operated,
leased or managed by the Company, or any of its subsidiaries, or (y) circumstances forming the basis of any violation of any environmental law, environmental permit, license, registration or other authorization required under applicable
environmental and/or public health law. S-A-4
Exhibit C Confidentiality, Disclosure of Information and Assignment of Inventions Agreement To:
Teva Pharmaceutical Industries Ltd. and its subsidiaries and affiliates (the Company) Re: Proprietary Information, Non-Disclosure and Assignment of Inventions Agreement The undersigned (Executive)
hereby acknowledges that he will have access to, certain proprietary information, inventions, commercial secrets and other confidential information of the Company and may participate in the development, planning or marketing of the Companys
products, in connection with Executives employment under the Employment Agreement entered into between the Company and Executive dated November 21, 2022 (hereinafter, the Employment Agreement). In relation to such
confidential information, Executive hereby undertakes as follows, in full knowledge that the force of this undertaking is in no way dependent upon the force of the Employment Agreement, is entirely independent from said agreement, does not in any
way constitute a concurrent obligation with the obligations defined in the Employment Agreement and has been a material part of the consideration of his engagement by the Company: 1. Proprietary Information and Non-Disclosure Executive acknowledges and agrees that he will have access to or be involved in the planning, making or
development of, confidential and proprietary information concerning the business and financial activities of the Company or its property, business, dealings, clients, suppliers, people or entities that come into contact with them, their operational
methods, research or manufacturing process, plans and strategies, business plans, research projects, employees, marketing plans, supplier lists, customers, data, trade secrets, test results, formulas, processes, data and know-how, improvements, inventions, patents, application for patents, copyrights, trademarks, engineering specifications, product designs, technical information discoveries, studies, techniques, specifications,
computer programs (in source and object code), databases, products (actual or planned) and information contained in computers, preservation of information methods, disks, diskettes, drawings, plans, communications, prospectuses, reports, prices,
calculations, fees, work conditions in the Company or other agreement conditions which relate to the Company and documents of the Company. All such information, whether in documentary, written, oral or digital format, and whether received by
Executive as a result of his employment with the Company or brought to his attention in any other manner, shall be deemed to be and referred to as Proprietary Information. For purposes of this Confidentiality, Disclosure of
Information and Assignment of Inventions Agreement, the term Company shall include all entities within the Company Group (as defined in the Employment Agreement). Proprietary Information shall be deemed to include any and all proprietary information disclosed by or on behalf of the Company
irrespective of form, but excluding information that (i) was known to Executive prior to his association with the Company and can be so proven by Executive by documentary evidence; (ii) C-1
shall have appeared in any printed publication or patent of a third party or shall have become a part of the public knowledge except as a result of a breach of this Agreement by Executive; or
(iii) shall have been received by Executive from a third party having no obligation to the Company. In addition, the term
Proprietary Information shall include information regarding salaries, bonuses and benefits paid or granted to Executive by the Company under the Agreement to which this Exhibit C is attached. Executive agrees and declares that all Proprietary Information and rights in connection therewith are, and
shall be, the sole property of the Company and its assignees. At all times, both during the term of his engagement with the Company and thereafter, Executive will keep in strict confidence and trust all Proprietary Information, and Executive will
not copy, transmit, reproduce, summarize, quote, publish and/or make any commercial or other use or disclose directly or indirectly any Proprietary Information or anything relating to it without the prior written consent of the Company, except as
may be necessary in the ordinary course of performing Executives duties in his engagement with the Company and in the best interests of the Company. Executive recognizes that the Company received and will receive confidential or proprietary information from
third parties subject to a duty on the Companys part to maintain the confidentiality of such information and to use it only for certain limited purposes. At all times, both during the term of his engagement with the Company and thereafter,
Executive undertakes to hold and maintain all such information in strict confidence, and not to use or disclose any of such information without the prior written consent of the Company, except as may be necessary to perform his duties as an
Executive of the Company and consistent with the Companys agreement with such third party. 2. Assignment of Inventions
Executive understands that the Company is engaged, involved or associated in a continuous program of
investment, research, development, production or marketing in connection with its business and that, as an essential part of his engagement with the Company, he may make new contributions to and create
know-how of value for the Company. During the term of his engagement, Executive undertakes and covenants that he will promptly disclose in
confidence to the Company all inventions, improvements, ideas, themes, designs, original works of authorship, formulas, concepts, techniques, forecasts, test results and documentation, discoveries, models, drawings, tooling, schematics and other
diagrams, instructional material, notes, records, algorithms, operating procedures methods, systems, processes, compositions of matter, computer software programs, databases, mask works, and trade secrets, whether or not patentable, copyrightable or
protectable as trade secrets or under any other intellectual property right, that are made or conceived or first reduced to practice or created by him, either alone or jointly with others, in the course of his engagement with the Company and due to
his engagement with the Company (Inventions). C-2
Executive agrees and represents, that all Inventions will be the sole and exclusive property of the Company
and/or its assignees and undertakes to act with respect to such Inventions in accordance with the Companys applicable corporate policy. To the extent relevant, Executive agrees to keep and maintain adequate and current written records of all
Inventions made by him (solely or jointly with others) during the term of his engagement. The records will be in the form of notes, sketches, drawings and any other format that may be specified by the Company. The records will be available to and
remain the sole property of the Company at all times and will be returned to the Company upon the termination of Executives employment or earlier at the request of the Company. Executive hereby irrevocably transfers and assigns to the Company and/or its assignees and shall in the future
take all reasonable steps (including by way of illustration only, signing all appropriate documents) to assign to Company and/or its assignees without additional consideration to Executive (other than Executives salary and other benefits to
which he is entitled to as an employee of the Company (including without limitation, without any compensation or royalties in accordance with Sections 132 or 134 of the Patent and Design Act of 1967 (the Patent Law)): (a) all
worldwide patents, patent applications, copyrights, mask works, trade secrets and other intellectual property rights, titles and interests, in any Invention, including, without limitation, service inventions under Section 134 of the Patent Law,
and hereby further acknowledges and shall in the future acknowledge Companys full and exclusive ownership in all such Inventions; and (b) any and all Moral Rights (as defined below) that he may have in or with respect to any Invention.
Executive also hereby forever waives and agrees never to assert any and all Moral Rights he may have in or with respect to any Invention, even after termination of his engagement with the Company. Moral Rights mean any rights of
paternity or integrity, any right to claim authorship of an invention, to object to any distortion, mutilation or other modification of, or other derogatory action in relation to, any Invention, whether or not such would be prejudicial to his honor
or reputation, and any similar right, existing under judicial or statutory law of any jurisdiction whatsoever, or under any treaty, regardless of whether or not such right is denominated or generally referred to as a moral right.
Executive expressly waives all economic rights in the Inventions including without limitation any rights to
royalties from any intellectual property right (specifically including patent rights under Section 134 of the Patent Law) and any right to receive any payment or other consideration whatsoever. Executive agrees to assist the Company in every reasonable way to obtain and enforce, for the benefit of the
Company and/or its assignees exclusive and absolute title, right, interest, patents, copyrights, mask work rights, and other legal protections for the Inventions in any and all countries. Executive will execute any documents that may be reasonably
requested of him for use in obtaining or enforcing such patents, copyrights, mask work rights, trade secrets and other legal protections. Executives obligations under this Section 2.7 will survive the termination of his engagement with
the Company; provided that the Company will compensate him at a reasonable rate after such termination for time or expenses actually spent by him at the Companys request on such assistance. After the termination of Executives
engagement with the Company, any assistance C-3
Executive hereby acknowledges and agrees that the salary and other benefits provided to him under his
Employment Agreement constitute appropriate, full and fair consideration in connection with his employment with the Company, including, without limitation, with respect to this Agreement and including with respect to Executives undertakings
under this Section 2, and with respect to any Inventions created, conceived or reduced to practice or that may be created, conceived or reduced to practice by Executive, either alone or jointly with others, in the course of his employment with
the Company, all of which are assigned to the Company in accordance with this Agreement, and Executive hereby unconditionally and irrevocably waives any right that he may have to receive any additional payment or other consideration whatsoever to
which Executive may be entitled with respect to any Invention pursuant to any applicable law, in any jurisdiction, including (but not limited to) pursuant to Section 134 of the Patent Law, or any provision that may supersede it. In the event
that for any reason such right cannot be waived, Executive hereby assigns and transfers to the Company any such right Executive may have to receive any additional payment or other consideration whatsoever with respect to any Invention pursuant to
any applicable law, including the Patent Law, in any jurisdiction. The provisions of this Section 2 shall survive termination or expiration of the Employment Agreement and
shall be and remain in full force and effect at all times thereafter. Executive acknowledges that the Company has entered into the Employment Agreement in reliance on his
undertaking set forth in this Section 2, and that given his access to information regarding the Company, the provisions of this Section 2 are reasonable and necessary to protect the Companys business and rights.
If any one or more of the terms contained in this Proprietary Information, Assignment of Inventions and Non-Disclosure Agreement shall for any reason be held to be excessively broad with regard to time, geographic scope or activity, the term shall be construed in a manner to enable it to be enforced to the extent
compatible with applicable law. C-4
3. Miscellaneous Governing Law. This Agreement shall be governed by and construed according to the laws of the State of
Israel. Any dispute arising under or relating to this Agreement or any transactions contemplated herein shall be resolved in accordance with Section 24 of the Employment Agreement.. Injunctive Relief. Any breach of this Agreement may cause irreparable harm to the Company, for which
damages would not be an adequate remedy, and therefore, the Company will be entitled to injunctive relief from any court of competent jurisdiction as such court so determines, restraining any violation or further violation of this Agreement by
Executive. The Companys right to injunctive relief shall be cumulative and in addition to any other remedies provided by law or equity and without any requirement to post bond. C-5
IN WITNESS WHEREOF, Executive has signed this Proprietary Information,
Non-Disclosure and Assignment of Inventions Agreement as of the date first set forth above. /s/ Richard Francis /s/ Sol J. Barer / Chairman of the Board
4.1.2
4.2
5.
5.1
5.2
6.
6.1
6.2
6.3
7.
7.1
7.2
entitled to receive payment as aforesaid), less any amount that Executive is entitled to and does receive other than from the Company with respect to the aforementioned period of his illness,
including from any pension fund (if applicable); provided that Executive provides the Company with medical confirmation of his illness if requested by the Chairman of the Board. The parties hereto hereby acknowledge and agree that the
payments to Executive set forth in this Section 7.2 and Executives insurance in the pension fund and/or loss of ability to work are meant to also cover the Companys obligations under the Sick Pay Law, 1976.
7.3
8.
8.1
8.2
8.3
8.4
8.4.1
8.4.2
8.4.3
9.
9.1
9.2
9.2.1
9.2.2
9.2.3
9.2.4
9.2.5
9.2.6
9.3
9.3.1
9.3.2
9.4
9.4.1
9.4.2
9.4.3
9.4.4
9.4.5
9.4.6
9.4.7
9.5
employment by the Company for Cause), including death or Disability, prior to the expiration of the Executive Notice Period shall not alter the Companys obligations under this
Section 9.5. The Company may, in its sole and absolute discretion and by written notice, place Executive on garden leave during the Executive Notice Period or accelerate the effective date of such termination of employment; provided that
the Company shall continue to pay Executive the Monthly Salary and any other compensation and benefits to which Executive would have been entitled had he not been placed on garden leave during the Executive Notice Period (including but not limited
to Annual Bonus and continued vesting of equity awards). If the Company and Executive mutually agree to reduce the Company Notice Period to less than one-hundred eighty (180) days, the Company may
provide, in its sole and absolute discretion, that outstanding equity awards continue to vest for up to the one-hundred eighty (180)-day period following the
Companys receipt of written notice of termination.
9.6
9.7
execute the Release of Claims in such a timely manner or revokes the Release of Claims, Executive shall not be entitled to any of the Severance Benefits. For the avoidance of doubt, in the event
of a termination due to Executives death or Disability or Executives death or Disability following a notice of termination of employment without Cause or for Good Reason, Executives obligations herein to execute and not revoke the
Release of Claims may be satisfied on his behalf by his estate or a person having legal power of attorney over his affairs and the Release of Claims will be amended by the Company so as to enable such person on behalf of his estate or a person
having legal power of attorney over his affairs to execute the same so that it has the same effect as if (i) it were executed by Executive; (ii) only Executive or his estate are liable thereunder; and (iii) such persons themselves
will have no personal liability to the Company.
9.8
9.9
9.9.1
9.9.2
9.9.3
reputation of the Company or its affiliates, (b) material breach of this Agreement by Executive, (c) Executive is convicted of, or has entered a plea of nolo contendere to, a
felony, or (d) a wilful and material breach by Executive of the provisions of Section 11, 12, 13 or 14. For the purposes of this clause, no act, or failure to act, on Executives part shall be deemed wilful unless done, or
omitted to be done, by Executive not in good faith and without reasonable belief that his act, or failure to act, was in the best interest of the Company. Any act or failure to act by Executive that is based upon or relies upon the direction or
approval of the Board shall not constitute Cause. For the avoidance of doubt, the termination of Executives employment for any reason other than as contemplated by this Section 9.9.3 shall not constitute Cause.
9.9.4
9.9.5
a.
b.
i.
ii.
c.
9.9.6
9.9.7
9.9.8
9.9.9
9.9.10
9.9.11
10.
10.1
10.2
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
21.1
21.2
21.3
21.3.1
Executive by the Company (including any necessary gross-ups). Such payment or gross up shall include any interest or penalties to any tax authority that
may fall due. The Company anticipates withholdings for tax and social security contributions to be payable by Executive in relation to Compensation Income in the United Kingdom and Israel only. The Company will ensure that, on a monthly basis, the
tax and social security contribution withholding (in both the United Kingdom and Israel) by the Company and its affiliates on Executives Compensation Income is calibrated as closely as reasonably practicable to the Expected Tax Amount, and to
the extent that such withholding in fact exceeds the tax that would have applied with respect to the Expected Tax Amount, the Company will provide a payment to Executive promptly following the end of each calendar year.
21.3.2
21.3.3
21.3.4
21.3.5
21.4
21.4.1
21.4.2
21.4.3
21.5
22.
23.
24.
24.1
24.2
24.3
24.3.1
24.3.2
24.4
24.5
25.
26.
27.
27.1
27.2
27.3
27.4
27.5
27.6
27.7
27.8
27.9
27.10
27.11
TEVA PHARMACEUTICAL INDUSTRIES LTD.
By:
Sol J. Barer
Title:
Chairman of the Board
EXECUTIVE
Richard Francis
Very truly yours,
EXECUTIVE
Name: _______________________
Dated:
ACCEPTED AND AGREED:
TEVA PHARMACEUTICAL INDUSTRIES LTD
By:
Title:
By:
Title:
Sincerely yours,
Teva Pharmaceutical Industries Ltd.
Name: Sol J. Barer
Title: Chairman of the Board
Accepted and agreed
as of the first date written above:
Name: Richard Francis
1.1.
1.2.
1.3.
2.1.
2.2.
2.3.
2.4.
2.5.
2.6.
2.7.
requested by the Company or any of its assignees pursuant to this Section 2.7 shall take into account Executives obligations towards third parties. Executive hereby irrevocably
appoints the Company and/or its duly authorized officers and agents (including, without limitation, the chairman of the Board) as his attorney-in-fact to execute
documents on his behalf for this purpose and agrees that, if the Company is unable because of Executives unavailability, mental or physical incapacity, or for any other reason, to secure Executives signature for the purpose of applying
for or pursuing any application for any Israeli or foreign patents or mask work or copyright registrations covering the Inventions assigned to the Company in this Section 2, to act for and on Executives behalf to execute and file any such
applications and to do all other lawfully permitted acts to further the prosecution and issuance of patents, copyright and mask work registrations with the same legal force and effect as if executed by Executive.
2.8.
2.9.
2.10.
2.11.
3.1.
3.2.
EXECUTIVE
Name: Richard Francis
ACCEPTED AND AGREED:
TEVA PHARMACEUTICAL INDUSTRIES LTD
Name: Sol J. Barer
Title: Chairman of the Board
Exhibit 10.7
EXECUTION VERSION
November 21, 2022
Kåre Schultz
c/o Teva Pharmaceutical Industries Ltd.
124 Dvora HaNevia Street,
Tel Aviv, Israel
Dear Kåre:
This letter memorializes our recent discussions regarding your departure from the position of President and Chief Executive Officer of Teva Pharmaceutical Industries Ltd. (the Company) and the appointment of your successor, who is expected to commence service on January 1, 2023 (the Succession Date). Reference is made to your employment agreement with the Company dated September 7, 2017, as amended on June 9, 2020 (the Employment Agreement). Capitalized terms used and not otherwise defined herein shall have the meanings given to such terms in the Employment Agreement.
Given that the identification of your successor occurred sooner than anticipated and prior to the expiration of the term of the Employment Agreement, your departure will be treated as a termination by the Company without Cause for purposes of the Employment Agreement. As a practical matter, this means that you will continue in your current role until the day prior to the Succession Date, at which time you will cease serving as President and Chief Executive Officer and will cease to be a member of the Board of Directors of the Company. From the Succession Date through the last day of your contractual notice period (which ends 90 days following the signature of both parties on this letter, on February 19, 2023 (the Termination Date)), you will be on garden leave. During the garden leave, you agree that you will be available at the Companys reasonable request to assist with an orderly transition of your duties and responsibilities to your successor.
In connection with your cessation of employment, you will be entitled to the payments and benefits set forth in Section 9.4 of the Employment Agreement, including the Annual Bonus for the fiscal year 2022 and the Prorated Annual Bonus with respect to fiscal year 2023, subject to your compliance with the conditions set forth therein (including your execution and non-revocation of the Release of Claims in accordance with Section 9.7 of the Employment Agreement and your continuous compliance with Sections 11 (Confidentiality and Disclosure of Information), 12 (Non-Competition), 13 (Non-Solicitation) and 14 (No Disparagement) of the Employment Agreement).
For the avoidance of doubt, in addition to the Annual Bonus for 2022 and the Prorated Annual Bonus for 2023 (which for the individual performance component for both years will be paid out at 100%, and for the Company financial performance component, will be paid out based on actual performance for 2022 and at 100% for 2023), you will also be entitled to the following:
The Accrued Obligations, including Severance Contribution.
The Severance Payment, a gross amount equal to USD 2,000,000 which is inclusive of the Severance Contribution, shall be paid, net of applicable tax withholding, as a lump sum on the next regular payroll date immediately following the seventy-fifth day after the Termination Date.
The Equity Benefits (generally consisting of continued vesting of your equity awards over the remainder of the original vesting schedule) meaning that Annual Equity Awards (USD 6,000,000) and the Additional Annual Awards (USD 4,000,000) will continue to vest over the remainder of their original vesting periods, on the same terms and to the same extent as if you had remained employed by the Company in accordance with the terms of the Employment Agreement, with latest vesting occurring in 2027. The Company will continue to provide you with information that is given to other employees in relation to the Equity Benefits until the expiry of the vesting period in 2027. You will also receive the grant of Annual Equity Awards and Additional Annual Awards for 2023, which will be granted to you prior to the expiration of your garden leave and such awards will also vest pursuant to the above provisions.
The Non-Compete Payment, a gross amount equal to USD 4,000,000, to be paid in 24 equal monthly installments without any setting off. The monthly installments of the Non-Compete Payment will be paid to you, net of applicable tax withholding, to the personal bank account, and in the currency, that you identify to the Company in writing in advance of the first payment, with any required currency conversion calculated in accordance with the Companys standard practice.
You are entitled to redeem untaken vacation days and recreation pay accumulated pursuant to Section 7 of the Employment Agreement as of the Termination Date in accordance with Section 9.4.1 of the Employment Agreement.
Applicable tax withholding shall be applied to all payments in accordance with the tax rulings previously obtained with respect to your compensation from the Company.
Kåre, thank you for your contributions to the Company. Please sign and return this letter to indicate that you acknowledge and agree with the terms of your departure as described above.
[Signature Page Follows.]
Sincerely,
TEVA PHARMACEUTICAL INDUSTRIES LTD
By: | /s/ Sol J. Barer | |
Name: Sol J. Barer | ||
Title: Chairman of the Board | ||
ACKNOWLEDGED AND AGREED | ||
/s/ Kåre Schultz | ||
Kåre Schultz |
Exhibit 10.31
December 12, 2022
Private and confidential
To: Eric Drape
Subject: Extension letter to International Assignment as stated in Employment Agreement dated March 12, 2020 (the Agreement)
The parties mutually agree to extend the undersigned international assignment until January 1, 2025 (the Extension Period).
All terms and conditions under the Agreement will remain the same during the Extension Period.
Sincerely Yours,
/s/ Galia Inbar |
Galia Inbar |
Please indicate your agreement by signing below and returning this letter as soon as possible.
I have reviewed the terms of this Extension Period outlined above and by signing below, accept those terms.
Eric Drape |
/s/ Eric Drape |
Dec. 27, 2022 | ||
Name |
Signature |
Date |
Teva Pharmaceutical Industries Ltd.
124 Dvora HaNevia St., Tel Aviv 6944020 Israel | www.tevapharm.com
Exhibit 21
The following is a list of subsidiaries of the Company as of December 31, 2022, omitting some subsidiaries which, considered in the aggregate, would not constitute a significant subsidiary.
Name of Subsidiary |
Jurisdiction of Organization | |
Actavis Group PTC ehf | Iceland | |
Actavis International Limited | Malta | |
Actavis Italy S.p.A | Italy | |
Actavis Pharma Holding ehf | Iceland | |
Actavis U.K. Group Ltd. | United Kingdom | |
Laboratorio Chile, S.A | Chile | |
Medis ehf | Iceland | |
Mepha Schweiz AG | Switzerland | |
Merckle GmbH | Germany | |
Norton Healthcare Ltd. | United Kingdom | |
Norton (Waterford) Ltd. | Ireland | |
Pliva Hrvatska d.o.o. | Croatia | |
Ratiopharm GmbH | Germany | |
Teva API B.V. | Netherlands | |
Teva Canada Limited | Canada | |
Teva Capital Services Switzerland GmbH | Switzerland | |
Teva Czech Industries s.r.o | Czech Republic | |
Teva Health GmbH | Germany | |
Teva Finance Services II B.V. | Curacao | |
Teva Italia S.r.l | Italy | |
Teva Limited Liability Company | Russia | |
Teva Pharma S.L.U | Spain | |
Teva Pharmaceuticals Europe B.V. | Netherlands | |
Teva Pharmaceuticals International GmbH | Switzerland | |
Teva Pharmaceuticals USA, Inc. | United States | |
Teva Pharm. Works Private Ltd. Company | Hungary | |
Teva Operations Poland Sp. Z.o.o. | Poland | |
Teva Santé SAS | France | |
Teva Takeda Pharma Ltd. | Japan | |
Teva UK Limited | United Kingdom | |
Teva Pharmaceutical Finance Netherlands III B.V. | Netherlands |
Exhibit 23
CONSENT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We hereby consent to the incorporation by reference in the Registration Statements on Form S-8 (Nos. 333-168331, 333-206753, 333-212851, 333-214077, 333-220382 and 333-241003) and Form S-3 (No. 333-260519) of Teva Pharmaceutical Industries Limited of our report dated February 10, 2023 relating to the financial statements, financial statement schedule and the effectiveness of internal control over financial reporting, which appears in this Form 10-K.
/s/ Kesselman & Kesselman
Certified Public Accountants (Isr.)
A member of PricewaterhouseCoopers International Limited
Tel-Aviv, Israel
February 10, 2023
Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302
I, Richard D. Francis, certify that:
I have reviewed this annual report on Form 10-K of Teva Pharmaceutical Industries Limited;
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report;
The companys other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have:
a. | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | evaluated the effectiveness of the companys disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | disclosed in this report any change in the companys internal control over financial reporting that occurred during the companys most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the companys internal control over financial reporting; and |
The companys other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the companys auditors and the audit committee of the companys board of directors (or persons performing the equivalent functions):
e. | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the companys ability to record, process, summarize and report financial information; and |
f. | any fraud, whether or not material, that involves management or other employees who have a significant role in the companys internal control over financial reporting. |
Date: February 10, 2023
/s/ Richard D. Francis |
Richard D. Francis |
President and Chief Executive Officer |
Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302
I, Eli Kalif, certify that:
a. | I have reviewed this annual report on Form 10-K of Teva Pharmaceutical Industries Limited; |
b. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
c. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the company as of, and for, the periods presented in this report; |
d. | The companys other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the company and have: |
a. | designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
b. | designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | evaluated the effectiveness of the companys disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | disclosed in this report any change in the companys internal control over financial reporting that occurred during the companys most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the companys internal control over financial reporting; and |
e. | The companys other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the companys auditors and the audit committee of the companys board of directors (or persons performing the equivalent functions): |
e. | all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the companys ability to record, process, summarize and report financial information; and |
f. | any fraud, whether or not material, that involves management or other employees who have a significant role in the companys internal control over financial reporting. |
Date: February 10, 2023
/s/ Eli Kalif |
Eli Kalif |
Executive Vice President, Chief Financial Officer |
Exhibit 32
CERTIFICATION OF THE CHIEF EXECUTIVE OFFICER AND CHIEF FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Annual Report of Teva Pharmaceutical Industries Limited (the Company) on Form 10-K for the period ended December 31, 2022 as filed with the Securities and Exchange Commission on the date hereof (the Report), we, Richard D. Francis, President and Chief Executive Officer of the Company, and Eli Kalif, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to §906 of the Sarbanes-Oxley Act of 2002, that:
(1) | The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Dated: February 10, 2023
/s/ Richard D. Francis |
Richard D. Francis |
President and Chief Executive Officer |
/s/ Eli Kalif |
Eli Kalif |
Executive Vice President, Chief Financial Officer |