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 |
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t Applicable | |
(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 |
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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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1 |
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PART I |
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Item 1. |
2 |
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Item 1A. |
25 |
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Item 1B. |
50 |
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Item 2. |
50 |
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Item 3. |
51 |
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Item 4. |
51 |
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PART II |
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Item 5. |
51 |
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Item 6. |
54 |
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Item 7. |
56 |
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Item 7A. |
92 |
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Item 8. |
96 |
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Item 9. |
184 |
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Item 9A. |
184 |
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Item 9B. |
185 |
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PART III |
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Item 10. |
185 |
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Item 11. |
185 |
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Item 12. |
185 |
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Item 13. |
185 |
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Item 14. |
185 |
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PART IV |
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Item 15. |
186 |
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Item 16. |
191 |
• | our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE ® , our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY® or AUSTEDO® ; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations 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: implementation of our restructuring plan announced in December 2017; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption, sanctions and trade control laws; 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 adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system; |
• | compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; and environmental risks; |
• | other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; 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; |
• | TRUXIMA ® (rituximab). It was approved by the FDA in November 2018 for the treatment of adult patients in three indications: (i) relapsed or refractory, low-grade or follicular, CD20-positive, B-cell Non–Hodgkin’s Lymphoma (NHL) as a single agent, (ii) previously untreated follicular, CD20-positive, B-cell NHL in combination with first line chemotherapy and, in patients achieving a complete or partial response to a rituximab product in combination with chemotherapy, as single-agent maintenance therapy, and (iii) non-progressing (including stable disease), low-grade, CD20-positive, B-cell NHL as a single agent after first-line cyclophosphamide, vincristine, and prednisone (CVP) chemotherapy. In May 2019, the FDA approved TRUXIMA for two additional indications, thus matching all of the reference product’s oncology indications for NHL and CLL. The two additional oncology indications are: (i) previously untreated diffuse large B-cell, CD20-positive NHL in combination with (cyclophosphamide, doxorubicin, vincristine, and prednisone) (CHOP) or other anthracycline-based chemotherapy regimens and (ii) previously untreated and previously treated CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with fludarabine and cyclophosphamide (FC). In December 2019, the FDA further approved TRUXIMA for the treatment of (i) Rheumatoid Arthritis (RA) in combination with methotrexate in adult patients with moderately-to severely-active RA who have inadequate response to one or more TNF antagonist therapies and (ii) Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids. |
• | We entered into an exclusive partnership with Celltrion, Inc. (“Celltrion”) in October 2016 to commercialize TRUXIMA in the United States and Canada. |
• | TRUXIMA, our first oncology biosimilar product in the United States, launched in November 2019 and is the first rituximab biosimilar to be approved in the United States. |
• | We reached an agreement with Genentech, Inc. (“Genentech”) to settle U.S. patent litigation regarding TRUXIMA. Under the terms of the settlement agreement, TRUXIMA became available in the United States with the approved oncology indications on November 11, 2019. In addition, we have a license from Genentech to expand the TRUXIMA label to include the RA and GPA/MPA indications in the second quarter of 2020. |
• | HERZUMA ® (trastuzumab). HERZUMA was initially approved by the FDA in December 2018, with additional indications approved in May 2019, so that HERZUMA’s label now matches all of the reference product’s indications: (i) adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature) breast cancer, as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel, as part of a treatment regimen with docetaxel and carboplatin, or as a single agent following multi-modality anthracycline based therapy, and (ii) in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer, or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease, and (iii) in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. |
• | We entered into an exclusive partnership with Celltrion in October 2016 to commercialize HERZUMA in the United States and Canada. |
• | We reached an agreement with Genentech to settle U.S. patent litigation regarding HERZUMA. Under the terms of the settlement agreement, HERZUMA is expected to be available in the United States in the first quarter of 2020. |
• | COPAXONE |
• | 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. |
• | The FDA approved generic versions of COPAXONE 40 mg/mL in October 2017 and February 2018 and a second generic version of COPAXONE 20 mg/mL in October 2017 in the United States. Hybrid versions of COPAXONE 20 mg/mL and 40 mg/mL were also approved in the European Union. |
• | COPAXONE 40 mg/mL is protected by one European patent expiring in 2030. This patent is being challenged in various European jurisdictions. In October 2017, the U.K. High Court found this patent invalid and our application for permission to appeal this decision was rejected. The patent was upheld by the Opposition Division of the European Patent Office in April 2019. A hearing for an appeal in this case has been set for June 2020. |
• | The market for MS treatments continues to develop, particularly with the approval of generic versions of COPAXONE discussed above, as well as additional generic versions expected to be approved in the future. 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® . |
• | AJOVY |
• | AJOVY was granted a marketing authorization in the European Union by the EMA in a centralized process in April 2019. We commenced launching AJOVY in certain European markets in May 2019 and are moving forward with plans to launch in other European countries. |
• | During 2019, we received marketing authorizations for AJOVY in Israel and Australia and we continue to move forward with submissions in various other countries in our International Markets segment. |
• | On May 12, 2017, we entered into a license and collaboration agreement with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) providing Otsuka with an exclusive license to conduct phase 2 and 3 clinical trials for AJOVY in Japan and, once approved, to commercialize the product in Japan. Results for these trials were received in January 2020, indicating that primary and secondary endpoints were achieved and that no clinically significant adverse events were observed in subjects. |
• | On January 27, 2020, the FDA approved an auto-injector device for AJOVY in the U.S. We have also received approval from the EMA for AJOVY’s auto-injector submission in the EU. |
• | AJOVY is also in clinical development to evaluate safety and efficacy in the treatment of post traumatic headache and fibromyalgia. |
• | 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. An additional patent relating to the use of AJOVY in the treatment of migraine is issued in the United States and will expire in 2035. This patent is also pending in other countries. AJOVY will also be protected by regulatory exclusivity of 12 years from marketing approval in the United States and 10 years from marketing approval in Europe. |
• | We have 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. Lilly has also submitted IPR (inter partes review) petitions to the Patent Trial and Appeal Board, challenging the validity of the nine patents asserted against it in the litigation. The litigation in the district court has been stayed pending resolution of the IPR petitions. The patent office hearing concerning the first six IPRs was held on November 22, 2019 and the hearing concerning the remaining three IPRs was held on January 8, 2020. On February 18, 2020, the Patent Trial and Appeal Board issued decisions on the first six IPRs, finding the six patents invalid as being obvious. We are currently reviewing the possibility of appealing these decisions. In addition, we have entered into separate agreements with Alder Biopharmaceuticals, Inc. (“Alder”) and Lilly, resolving the |
European Patent Office oppositions that they have 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 was approved by the FDA and launched in April 2017 in the United States for the treatment of chorea associated with Huntington disease. In August 2017, the FDA approved AUSTEDO for the treatment of tardive dyskinesia (“TD”) in adults in the United States and we launched AUSTEDO for the treatment of TD in September 2017. TD is a debilitating, often irreversible movement disorder caused by certain medications used to treat mental health or gastrointestinal conditions. |
• | During 2019, we submitted requests for marketing authorizations for AUSTEDO in certain countries in our International Markets segment. We continue to move forward with additional submissions in various other countries around the world. |
• | In September 2017, we entered into a partnership agreement with Nuvelution Pharma, Inc (“Nuvelution”) for the development of AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States. In February 2020, we received results for these clinical trials, which found that the clinical trials failed to meet their primary endpoints. No new safety signals were identified in these studies. |
• | AUSTEDO is protected in the United States by five Orange Book patents expiring between 2031 and 2033 and in Europe by two patents expiring in 2029. |
• | BENDEKA B-cell non-Hodgkin’s lymphoma (“NHL”) that has progressed during or within six months of treatment with rituximab or a rituximab-containing regimen. BENDEKA, which was launched in the United States in January 2016, 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”). 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 increasing the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses. |
• | Eagle launched a ready-to-dilute bendamustine hydrochloride in June 2018, which competes directly with BENDEKA. 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. |
• | There are 15 patents listed in the U.S. Orange Book for BENDEKA with expiry dates between 2026 and 2031. Teva and Eagle received notices of Abbreviated New Drug Application (“ANDA”) filings by Slayback Pharmaceuticals, Fresenius Kabi, Apotex, Mylan, and Lupin Pharmaceuticals, Inc. (“Lupin”) for generic versions of BENDEKA, which all contained Paragraph IV challenges against one or more of the BENDEKA patents. In response, Teva and Eagle filed patent infringement lawsuits against each of the ANDA filers in the U.S. District Court for the District of Delaware, four of which are pending a decision by the court, which could come as early as the first half of 2020. The respective 30-month stays, automatically triggered by the patent infringement lawsuits, began expiring in January 2020. The asserted patents expire in 2031. Additionally, Teva and Eagle received a notification from early 2018 that Hospira, Inc. (“Hospira”) filed a 505(b)(2) new drug application (“NDA”) referencing BENDEKA. In July 2018, Teva and Eagle filed suit against Hospira in the U.S. District Court for the District of Delaware. Hospira’s 30-month stay expires in December 2020. On December 16, 2019, the Delaware District Court dismissed the case against Hospira on all but one of the asserted patents, which expires in 2031. Trial against Hospira on that patent is scheduled to begin on November 15, 2021. |
• | We have U.S. Orange Book patents for TREANDA expiring between 2026 and 2031. One 505(b)(2) NDA was filed for a liquid version of bendamustine and 21 ANDAs were filed for generic versions of the lyophilized form of TREANDA. We have reached final settlements with all 22 filers, providing for the launch of generic versions of TREANDA prior to patent expiration. |
• | In July 2018, Eagle prevailed in its suit against the FDA to obtain seven years of orphan drug exclusivity in the United States for BENDEKA. The FDA has appealed the district court’s decision, but barring a reversal of the decision by the appellate court, drug applications referencing BENDEKA, TREANDA or any other bendamustine product will not be approved by the FDA until the orphan drug exclusivity expires in December 2022. If the decision is reversed, generic versions of TREANDA may be launched immediately. |
• | A breath-actuated inhaler (“BAI”) recently approved in the United States for use with QVAR as QVAR RediHaler ® ; and |
• | Spiromax (EU) or RespiClick (U.S.), a novel inhalation-driven multi-dose dry powder inhaler (“MDPI”). |
• | The ProAir line of products includes ProAir hydrofluoroalkane (“HFA”), ProAir RespiClick ® and ProAir Digihaler® , which are sold only in the United States. |
• | ProAir HFA ® |
• | ProAir Digihaler built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma and COPD. ProAir Digihaler was approved by the FDA on December 21, 2018 for the treatment or prevention of bronchospasm in patients aged four years and older with reversible obstructive airway disease and for prevention of exercise-induced bronchospasm (EIB) in patients aged four years and older. Commercial availability of ProAir Digihaler is planned for 2020 through targeted launch activities. |
• | ProAir RespiClick 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. ProAir RespiClick was approved by the FDA for use in adults and adolescents aged 12 years and older in March 2015 and its label was expanded for use by children 4 to 11 years of age in April 2016. |
• | Three major brands compete with ProAir HFA and ProAir RespiClick in the United States in the short-acting beta agonist market: Ventolin ® HFA (albuterol), Proventil® HFA (albuterol) and Xopenex® HFA (levalbuterol). In addition, an authorized generic version Ventolin® HFA (albuterol) was approved in January 2019. |
• | QVAR |
• | Four major brands compete with QVAR in the mono inhaled corticosteroid segment: Flixotide/Flovent ® (fluticasone), Pulmicort Flexhaler® (budesonide), Asmanex® (mometasone) and Alvesco® (ciclesonide). |
• | QVAR RediHaler |
• | CINQAIR/CINQAERO interleukin-5 antagonist monoclonal antibody for add-on maintenance treatment of adult patients with severe asthma and with an eosinophilic phenotype, received FDA, EMA and Health Canada approval in 2016. This biologic treatment became commercially available to patients in the United States in April 2016, in certain European countries in November 2016 and in Canada in 2017. |
• | Major brands competing with CINQAIR/CINQAERO in the United States, Europe and Canada in the interleukin-5 market are Nucala® (mepolizumab) and Fasenra® (benralizumab). |
• | AirDuo RespiClick |
• | AirDuo RespiClick and its authorized generic have the same active ingredients as Advair ® but are delivered via Teva’s breath-activated, MDPI, RespiClick, which is used with other approved medicines in our respiratory product portfolio |
• | ArmonAir RespiClick ® Diskus. |
• | AirDuo Digihaler built-in sensors which connects to a companion mobile application and provides inhaler use information to people with asthma. AirDuo Digihaler was approved by the FDA on July 12, 2019 for 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/LABA combination. Commercial availability of AirDuo Digihaler is planned for 2020 through targeted launch activities. |
• | BRALTUS ® inhaler, was launched in Europe in August 2016. |
Product |
Potential Indication(s) |
Route of Administration |
Development Phase (date entered phase 3) |
Comments | ||||
CNS, Neurology and Neuropsychiatry |
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AUSTEDO (deutetrabenazine) |
Tourette syndrome |
Oral |
3 (December 2017) |
Teva and Nuvelution entered into a partnership agreement on September 19, 2017 to develop AUSTEDO for the treatment of tics associated with |
Product |
Potential Indication(s) |
Route of Administration |
Development Phase (date entered phase 3) |
Comments | ||||
Tourette syndrome in pediatric patients in the United States. In February 2020, we received results for these clinical trials, which found that the clinical trials failed to meet their primary endpoints. No new safety signals were identified in these studies. | ||||||||
Dyskinesia in cerebral palsy |
Oral |
3 (September 2019) |
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TV-46000 (risperidone LAI) |
Schizophrenia |
Subcutaneous |
3 (April 2018) |
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Migraine and Pain |
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fremanezumab (anti CGRP) |
Post traumatic headache |
Subcutaneous |
2 |
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fibromyalgia |
Subcutaneous |
2 |
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fasinumab |
Osteoarthritis pain |
Subcutaneous |
3 (March 2016) |
Developed in collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”). In August 2018, Regeneron and Teva announced positive topline phase 3 results in patients with chronic pain from osteoarthritis of the knee or hip with the remaining low dose 1mg every month (1mg4W) and 1mg every two months (1mg8W). Fasinumab is protected by patents expiring in 2028 and will also be protected by regulatory exclusivity of 12 years from marketing approval in the United States |
Product |
Potential Indication(s) |
Route of Administration |
Development Phase (date entered phase 3) |
Comments | ||||
and 10 years from marketing approval in Europe. | ||||||||
Respiratory |
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ProAir e-RespiClick ™ |
Bronchospasm and exercise induced bronchitis |
Oral inhalation |
Approved by FDA (December 2018) |
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AirDuo Digihaler |
Treatment of asthma in patients aged 12 years and older |
Oral inhalation |
Approved by FDA (July 2019) |
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ArmonAir DigiHaler |
Treatment of asthma in patients aged 12 years and older |
Oral inhalation |
Under regulatory review |
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GoResp ® DigiHaler / DuoResp DigiHaler |
Treatment of asthma in patients aged 12 years and older and COPD |
Oral inhalation |
Under regulatory review |
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Oncology |
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HERZUMA |
(biosimilar to Herceptin ® US) |
Approved by FDA (December 2018) Approved in Canada (September 2019) |
• | CINQAIR/CINQAERO for severe asthma with eosinophilia; |
• | Fremanezumab (anti CGRP) for episodic cluster headache; and |
• | Fasinumab for chronic lower back pain has been put on hold. |
• | global R&D facilities that enable us to have a broad global generic pipeline and product line, as well as a focused pipeline of specialty products; |
• | 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; |
• | API manufacturing capabilities that offer a stable, high-quality supply of key APIs, vertically integrated with our pharmaceutical operations; and |
• | high-volume, technologically advanced distribution facilities that allow us to deliver new products to our customers quickly and efficiently, providing a cost-effective, safe and reliable supply. |
• | continued the implementation of our global EHS management system, which promotes proactive compliance with applicable EHS requirements, establishes EHS standards throughout our global operations and helps drive continuous improvement in our EHS performance; |
• | provided EHS regulatory monitoring tools in all countries where we have significant operations; and |
• | proactively evaluated EHS compliance through self-evaluation and an internal audit program, addressing non-conformities through appropriate corrective and preventative action. |
December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
United States |
6,390 |
7,056 |
8,807 |
|||||||||
Europe |
18,780 |
19,236 |
22,352 |
|||||||||
International Markets (excluding Israel) |
10,908 |
11,351 |
14,387 |
|||||||||
Israel |
3,961 |
4,893 |
6,245 |
|||||||||
Total |
40,039 |
42,535 |
51,792 |
ITEM 1A. |
RISK FACTORS |
• | AJOVY, which was launched in the United States in September 2018, 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. Also, our auto-injector for AJOVY was just approved by the FDA in January 2020. Until we begin marketing AJOVY with the auto-injector, we are at a competitive disadvantage in our ability to sell and market this product. |
• | Our future success also depends on our ability to maximize the growth and commercial success of AUSTEDO. If our revenues derived from AUSTEDO do not increase as expected, this would have an adverse effect on our results of operations. |
• | pursuing new patents for existing products which may be granted just before the expiration of earlier patents, which could extend patent protection for additional years or otherwise delay the launch of generic competitors; |
• | selling the brand product as their own generic equivalent (an authorized generic), either by the brand company directly, through an affiliate or by a marketing partner; |
• | using the Citizen Petition process to request amendments to FDA standards or otherwise delay generic drug approvals; |
• | seeking changes to U.S. Pharmacopeia, an organization which publishes industry recognized compendia of drug standards; |
• | attempting to use 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 that have the effect of blocking the dispensing of generic products. |
• | 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. |
• | substantial optimization of the generics portfolio globally, and most specifically in the United States, through a more tailored approach to the portfolio with increased focus on profitability; |
• | closure or divestment of a significant number of manufacturing plants in the United States, Europe, Israel and International Markets; |
• | closure or divestment of a significant number of R&D facilities, headquarters and other office locations across all geographies; and |
• | a thorough review of all R&D programs across the Company to prioritize core projects and immediately terminate others. |
• | Following an inspection of our manufacturing plant in Davie, Florida, the FDA issued a Form FDA-483 and in October 2018 notified us that the inspection of the site was classified as “official action indicated” (OAI). On February 5, 2019, we received a warning letter from the FDA that contained four additional enumerated concerns related to production, quality control and investigations at this site. We have been working diligently to address the FDA’s concerns in a manner consistent with cGMP requirements as quickly and as thoroughly as possible. An FDA follow up inspection occurred in January 2020, resulting in some follow up findings. If we are unable to remediate the findings to the FDA’s satisfaction, we may face additional consequences. These would potentially include delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. We expect to generate approximately $230 million in revenues from this site in 2020, assuming remediation or enforcement does not cause |
any unscheduled slowdown or stoppage at the facility or prevent approvals of new products from the site. |
• | We announced the voluntary recall of valsartan and certain combination valsartan medicines in various countries due to the detection of trace amounts of an unexpected nitrosamine impurity in the API provided by our third party supplier in July 2018. Since July 2018, we have been actively engaged with regulatory agencies around the world in reviewing our sartan and other products to determine whether a previously unknown nitrosamine impurity called NDMA and/or other nitrosamine related impurities are present in specific products. Where necessary, we initiated additional voluntary recalls. The aggregate direct impact of this recall on our 2018 and 2019 financial statements was $54 million, primarily related to inventory write-downs and returns. As a result of this loss, we initiated negotiations with Zhejiang Huahai Pharmaceutical Co., Ltd. (“Huahai”), and in December 2019 we reached a settlement with Huahai resolving our claims related to certain sartan API supplied by Huahai to us. Under the settlement agreement, Huahai agreed to compensate Teva for some of the direct losses suffered by Teva and provide Teva prospective cost reductions for API. The settlement does not release Huahai from liability for our future purchases of API, or for any losses we may incur as a result of third party personal injury or product liability claims relating to the sartan API at issue. Although we are permitted to seek indemnification from Huahai for the claims described above, as litigation is inherently uncertain it is possible that we may face challenges when enforcing a judgment against Huahai in China. In addition, multiple lawsuits have been filed in connection with this matter. These may lead to additional customer penalties, impairments, and litigation costs. We expect additional expenses and loss of revenues and profits in connection with this matter going forward. |
• | Appropriate opportunities to enable us to execute our business strategy may not exist, or we may fail to identify them. |
• | Competition in the pharmaceutical industry for target companies and development programs has intensified and has resulted in decreased availability of, or increased prices for, suitable transactions. We may not be able to pursue relevant transactions due to financial capacity constraints. |
• | 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. |
• | The negotiation of transactions may divert management’s attention from our existing business operations, resulting in the loss of key customers and/or personnel and exposing us to unanticipated liabilities. |
• | We may fail to integrate acquisitions successfully in accordance with our business strategy or achieve expected synergies and other results. Integrating the operations of multiple new businesses with that of our own is a complex, costly and time-consuming process, which requires significant management attention and resources. The integration process may disrupt the businesses and, if implemented ineffectively, would preclude realization of the full benefits expected by us. |
• | We may not be able to retain experienced management and skilled employees from the businesses we acquire and, if we cannot retain such personnel, we may not be able to attract new skilled employees and experienced management to replace them. |
• | We may purchase a company that has excessive known or unknown contingent liabilities, including, among others, patent infringement or product liability claims, or that otherwise has significant regulatory or other issues not revealed as part of our due diligence. |
• | 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. |
Business Segment |
Number of Facilities |
Square Feet (in thousands) |
||||||
North America |
19 |
4,442 |
||||||
Europe |
34 |
12,605 |
||||||
International Markets |
37 |
8,226 |
||||||
Worldwide Total Manufacturing and R&D Facilities |
90 |
25,273 |
* | $100 invested on December 31, 2014 in stock or index—including reinvestment of dividends. Indexes calculated on month-end basis |
For the year ended December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
2016 |
2015 |
||||||||||||||||
(U.S. dollars in millions, except share and per share amounts) |
||||||||||||||||||||
Income Statement Data: (a) |
||||||||||||||||||||
Net revenues (b) |
16,887 |
18,271 |
21,853 |
21,464 |
19,303 |
|||||||||||||||
Cost of sales (b) |
9,351 |
9,975 |
11,237 |
9,811 |
8,183 |
|||||||||||||||
Gross profit |
7,537 |
8,296 |
10,615 |
11,653 |
11,120 |
|||||||||||||||
Research and development expenses |
1,010 |
1,213 |
1,778 |
2,077 |
1,525 |
|||||||||||||||
Selling and marketing expenses |
2,614 |
2,916 |
3,395 |
3,583 |
3,242 |
|||||||||||||||
General and administrative expenses |
1,192 |
1,298 |
1,451 |
1,390 |
1,360 |
|||||||||||||||
Intangible assets impairment |
1,639 |
1,991 |
3,238 |
589 |
265 |
|||||||||||||||
Goodwill impairment |
— |
3,027 |
17,100 |
900 |
— |
|||||||||||||||
Other asset impairments, restructuring and other items |
423 |
987 |
1,836 |
830 |
911 |
|||||||||||||||
Legal settlements and loss contingencies |
1,178 |
(1,208 |
) | 500 |
899 |
631 |
||||||||||||||
Other Income |
(76 |
) | (291 |
) | (1,199 |
) | (769 |
) | (166 |
) | ||||||||||
Operating income (loss) |
(443 |
) | (1,637 |
) | (17,484 |
) | 2,154 |
3,352 |
||||||||||||
Financial expenses—net |
822 |
959 |
895 |
1,330 |
1,000 |
|||||||||||||||
Income (loss) before income taxes |
(1,265 |
) | (2,596 |
) | (18,379 |
) | 824 |
2,352 |
||||||||||||
Income taxes (benefit) |
(278 |
) | (195 |
) | (1,933 |
) | 521 |
634 |
||||||||||||
Share in (profits) losses of associated companies—net |
13 |
71 |
3 |
(8 |
) | 121 |
||||||||||||||
Net income (loss) |
(1,000 |
) | (2,472 |
) | (16,449 |
) | 311 |
1,597 |
||||||||||||
Net income (loss) attributable to non-controlling interests |
(2 |
) | (322 |
) | (184 |
) | (18 |
) | 9 |
|||||||||||
Net income (loss) attributable to Teva |
(999 |
) | (2,150 |
) | (16,265 |
) | 329 |
1,588 |
||||||||||||
Accrued dividends on preferred shares |
— |
249 |
260 |
261 |
15 |
|||||||||||||||
Net income (loss) attributable to ordinary shareholders |
(999 |
) | (2,399 |
) | (16,525 |
) | 68 |
1,573 |
||||||||||||
Earnings (loss) per share attributable to ordinary shareholders: |
||||||||||||||||||||
Basic ($) |
(0.91 |
) | (2.35 |
) | (16.26 |
) | 0.07 |
1.84 |
||||||||||||
Diluted ($) |
(0.91 |
) | (2.35 |
) | (16.26 |
) | 0.07 |
1.82 |
||||||||||||
Weighted average number of shares (in millions): |
||||||||||||||||||||
Basic |
1,091 |
1,021 |
1,016 |
955 |
855 |
|||||||||||||||
Diluted |
1,091 |
1,021 |
1,016 |
961 |
864 |
|||||||||||||||
Dividends per ordinary share |
— |
— |
$ | 0.51 |
$ | 1.36 |
$ | 1.36 |
(a) | For a discussion of items that affected the comparability of results for the years 2019, 2018 and 2017, refer to “Item 7—Management’s Discussion and Analysis of Financial Condition and Results of Operations.” |
(b) | The data presented for prior periods (including the years 2015 and 2016) have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b to our consolidated financial statements for additional information. |
As at December 31, |
||||||||||||||||||||
2019 |
2018 |
2017 |
2016 |
2015 |
||||||||||||||||
(U.S. dollars in millions) |
||||||||||||||||||||
Financial assets (cash, cash equivalents and investment in securities) |
2,033 |
1,846 |
1,060 |
1,949 |
8,404 |
|||||||||||||||
Identifiable intangible assets, net |
11,232 |
14,005 |
17,640 |
21,487 |
7,675 |
|||||||||||||||
Goodwill |
24,846 |
24,917 |
28,414 |
44,409 |
19,025 |
|||||||||||||||
Working capital (operating assets minus liabilities) |
74 |
(186 |
) | (384 |
) | 303 |
32 |
|||||||||||||
Total assets |
57,470 |
60,683 |
70,615 |
93,057 |
54,233 |
|||||||||||||||
Short-term debt, including current maturities |
2,345 |
2,216 |
3,646 |
3,276 |
1,585 |
|||||||||||||||
Long-term debt, net of current maturities |
24,562 |
26,700 |
28,829 |
32,524 |
8,358 |
|||||||||||||||
Total debt |
26,908 |
28,916 |
32,475 |
35,800 |
9,943 |
|||||||||||||||
Total equity |
15,063 |
15,794 |
18,745 |
34,993 |
29,927 |
• | Our revenues in 2019 were $16,887 million, a decrease of 8% in U.S. dollar, or 5% in local currency terms, compared to 2018, mainly due to generic competition to COPAXONE, a decline in revenues from our U.S. generics business, BENDEKA/TREANDA and Japan, partially offset by higher revenues from AUSTEDO, AJOVY and QVAR in the United States. The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b to our consolidated financial statements for additional information. |
• | Our North America segment generated revenues of $8,542 million and profit of $2,252 million in 2019. Revenues decreased by 8%, mainly due to a decline in revenues from COPAXONE, our U.S. generics business and certain other specialty products, partially offset by higher revenues from AUSTEDO, our Anda business and AJOVY. Profit decreased by 21%, mainly due to lower revenues from COPAXONE and non-recurrence of other income, partially offset by cost reductions and efficiency measures as part of the restructuring plan. |
• | Our Europe segment generated revenues of $4,795 million and profit of $1,318 million in 2019. Revenues decreased by 8%, or 2% in local currency terms, mainly due to a decline in COPAXONE |
revenues due to competing glatiramer acetate products, lower sales of respiratory products in the United Kingdom and lower revenues from our oncology products due to competing biopharmaceutical products, partially offset by new generic product launches. Profit increased by 4%, mainly due to cost reductions and efficiency measures as part of the restructuring plan. |
• | Our International Markets segment generated revenues of $2,246 million and profit of $464 million in 2019. Revenues decreased by 7%, or 3% in local currency terms, mainly due to lower sales in Japan and certain discontinued activities in Israel. Profit decreased by 7%, mainly due to lower revenues in Japan, partially offset by higher sales in other markets and lower S&M and G&A expenses. The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b to our consolidated financial statements for additional information. |
• | Impairment of identifiable intangible assets were $1,639 million and $1,991 million in the years ended December 31, 2019 and 2018, respectively. See note 6 to our consolidated financial statements. |
• | No goodwill impairment charges were recorded in 2019, compared to a goodwill impairment charge of $3,027 million in 2018. |
• | We recorded expenses of $423 million for other asset impairments, restructuring and other items in 2019, compared to expenses of $987 million in 2018. See note 15 to our consolidated financial statements. |
• | In 2019, we recorded an expense of $1,178 million in legal settlements and loss contingencies, compared to an income of $1,208 million in 2018. The expense in 2019 was mainly related to an estimated settlement provision recorded in connection with the remaining opioid cases. See note 12 to our consolidated financial statements. |
• | Operating loss was $443 million in 2019, compared to an operating loss of $1,637 million in 2018, mainly due to higher impairment charges recorded in 2018. |
• | Financial expenses were $822 million in 2019, compared to $959 million in 2018. Financial expenses in 2019 and 2018 were mainly comprised of interest expenses of $881 million and $920 million, respectively. |
• | In 2019, we recognized a tax benefit of $278 million, or 22%, on a pre-tax loss of $1,265 million. In 2018, we recognized a tax benefit of $195 million, or 8%, on a pre-tax loss of $2,596 million. Our tax rate for 2018 was lower than in 2019, due to one-time legal settlements and divestments that had a low corresponding tax effect. |
• | Exchange rate movements during 2019, in comparison with 2018, negatively impacted revenues by $402 million and operating income by $135 million. |
• | As of December 31, 2019, our debt was $26,908 million, compared to $28,916 million as of December 31, 2018. This decrease was mainly due to senior notes repaid at maturity or prepaid with cash generated during the year. |
• | Cash flow generated from operating activities was $748 million in 2019, a decrease of $1,698 million, or 69%, compared to 2018. This decrease was mainly due to the working capital adjustment with Allergan and the Rimsa settlement in 2018 and lower profit in our North America segment. |
• | During 2019, we generated free cash flow of $2,053 million, which we define as comprising $748 million in cash flow generated from operating activities, $1,487 million in beneficial interest collected in exchange for securitized trade receivables and $343 million in proceeds from sale of property, plant and equipment and intangible assets, partially offset by $525 million in cash used for capital investments. |
Percentage of Net Revenues Year Ended December 31, |
Percentage Change Comparison |
|||||||||||||||||||
2019 |
2018 |
2017 |
2019-2018 |
2018-2017 |
||||||||||||||||
% |
% |
% |
% |
% |
||||||||||||||||
Net revenues |
100.0 |
100.0 |
100.0 |
(8 |
) | (16 |
) | |||||||||||||
Gross profit |
44.6 |
45.4 |
48.6 |
(9 |
) | (22 |
) | |||||||||||||
Research and development expenses |
6.0 |
6.6 |
8.1 |
(17 |
) | (32 |
) | |||||||||||||
Selling and marketing expenses |
15.5 |
16.0 |
15.5 |
(10 |
) | (14 |
) | |||||||||||||
General and administrative expenses |
7.1 |
7.1 |
6.6 |
(8 |
) | (11 |
) | |||||||||||||
Intangible assets impairments |
9.7 |
10.9 |
14.8 |
(18 |
) | (39 |
) | |||||||||||||
Goodwill impairment |
* |
16.6 |
78.3 |
(100 |
) | (82 |
) | |||||||||||||
Other asset impairments, restructuring and other items |
2.5 |
5.4 |
8.4 |
(57 |
) | (46 |
) | |||||||||||||
Legal settlements and loss contingencies |
7.0 |
(6.6 |
) | 2.3 |
n/a |
n/a |
||||||||||||||
Other Income |
(0.5 |
) | (1.6 |
) | (5.5 |
) | (74 |
) | (76 |
) | ||||||||||
Operating (loss) income |
(2.6 |
) | (9.0 |
) | (80.0 |
) | (73 |
) | (91 |
) | ||||||||||
Financial expenses—net |
4.9 |
5.2 |
4.1 |
(14 |
) | 7 |
||||||||||||||
Income (loss) before income taxes |
(7.5 |
) | (14.2 |
) | (84.2 |
) | (51 |
) | (86 |
) | ||||||||||
Income taxes (benefit) |
(1.6 |
) | (1.1 |
) | (8.8 |
) | 42 |
(90 |
) | |||||||||||
Share in (profits) losses of associated companies—net |
0.1 |
0.4 |
* |
(81 |
) | 2,267 |
||||||||||||||
Net income (loss) attributable to non-controlling interests |
* |
(1.8 |
) | * |
(99 |
) | 922 |
|||||||||||||
Net income (loss) attributable to Teva |
(5.9 |
) | (11.8 |
) | (74.4 |
) | (54 |
) | (87 |
) |
* | Represents an amount less than 0.5%. |
Year ended December 31, |
||||||||||||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||||||||||
(U.S. $ in millions / % of Segment Revenues) |
||||||||||||||||||||||||
Revenues |
$ | 8,542 |
100 |
% | $ | 9,297 |
100.0 |
% | $ | 12,141 |
100 |
% | ||||||||||||
Gross profit |
4,350 |
50.9 |
% | 4,979 |
53.6 |
% | 7,322 |
60.3 |
% | |||||||||||||||
R&D expenses |
652 |
7.6 |
% | 713 |
7.7 |
% | 969 |
8.0 |
% | |||||||||||||||
S&M expenses |
1,021 |
12.0 |
% | 1,154 |
12.4 |
% | 1,288 |
10.6 |
% | |||||||||||||||
G&A expenses |
439 |
5.1 |
% | 484 |
5.2 |
% | 533 |
4.4 |
% | |||||||||||||||
Other (income) expense |
(14 |
) | § |
(209 |
) | (2.2 |
%) | (92 |
) | (0.8 |
%) | |||||||||||||
Segment profit* |
$ | 2,252 |
26.4 |
% | $ | 2,837 |
30.5 |
% | $ | 4,624 |
38.1 |
% | ||||||||||||
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
Year ended December 31, |
Percentage Change 2018-2019 |
|||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Generic products |
$ | 3,963 |
$ | 4,056 |
$ | 5,203 |
(2 |
%) | ||||||||
COPAXONE |
1,017 |
1,759 |
3,116 |
(42 |
%) | |||||||||||
BENDEKA/TREANDA |
496 |
642 |
656 |
(23 |
%) | |||||||||||
ProAir* |
274 |
397 |
501 |
(31 |
%) | |||||||||||
QVAR |
250 |
182 |
313 |
38 |
% | |||||||||||
AJOVY |
93 |
3 |
— |
N/A |
||||||||||||
AUSTEDO |
412 |
204 |
24 |
102 |
% | |||||||||||
Anda |
1,492 |
1,347 |
1,153 |
11 |
% | |||||||||||
Other |
546 |
708 |
1,175 |
(23 |
%) | |||||||||||
Total |
$ | 8,542 |
$ | 9,297 |
$ | 12,141 |
||||||||||
* | Does not include revenues from the ProAir authorized generic, which are included under generic products. |
Product Name |
Brand Name |
Launch Date |
Total Annual U.S. Branded Sales at Time of Launch (U.S. $ in millions (IQVIA)) (1) |
|||||||||
Vardenafil hydrochloride tablets, 2.5 mg, 5 mg, 10 mg & 20 mg |
Levitra ® |
January |
$ | 88 |
||||||||
Albuterol sulfate HFA inhalation aerosol with dose counter, 90 mcg (2) |
ProAir ® |
January |
$ | 1,497 |
||||||||
Vigabatrin tablets, USP, 500 mg |
Sabril ® |
February |
$ | 183 |
||||||||
ALYQ TM (tadalafil tablets), USP, 20 mg |
Adcirca ® |
February |
$ | 475 |
||||||||
Ketoconazole cream, 2% (3) |
Nizoral ® |
February |
$ | 92 |
||||||||
Clindamycin phosphate and benzoyl peroxide gel, 1.2%/2.5% |
Acanya ® |
February |
$ | 21 |
||||||||
Minocycline hydrochloride extended-release tablets, USP, 80 mg & 105 mg |
Solodyn ® ER |
February |
$ | 173 |
||||||||
Diclofenac epolamine topical patch, 1.3% |
Flector ® |
March |
$ | 123 |
||||||||
Cyclobenzaprine hydrochloride extended-release capsules, 15 mg & 30 mg (2) |
Amrix ® |
March |
$ | 50 |
||||||||
Deferasirox tablets, 125 mg, 250 mg & 500 mg |
Exjade ® |
March |
$ | 134 |
||||||||
Methylergonovine maleate tablets, USP, .2 mg |
Methergine ® |
March |
$ | 62 |
||||||||
Docosanol cream, 10% |
Abreva ® |
March |
$ | 88 |
||||||||
Fluoxetine tablets, USP 20 mg |
— |
April |
$ | 56 |
||||||||
Testosterone gel, metered 1.62% CIII |
AndroGel ® 1.62% [CIII] |
April |
$ | 755 |
||||||||
Solifenacin succinate tablets, 5 mg & 10 mg |
Vesicare ® |
April |
$ | 946 |
||||||||
Ambrisentan tablets, 5 mg & 10 mg |
Letairis ® |
May |
$ | 254 |
Product Name |
Brand Name |
Launch Date |
Total Annual U.S. Branded Sales at Time of Launch (U.S. $ in millions (IQVIA)) (1) |
|||||||||
Erlotinib tablets, 100 mg & 150 mg |
Tarceva ® |
May |
$ | 188 |
||||||||
Mesalamine delayed-release capsules, 400 mg |
Delzicol ® |
May |
$ | 130 |
||||||||
Ranolazine extended-release tablets, 500 mg & 1000 mg |
Ranexa ® |
May |
$ | 950 |
||||||||
Aspirin and extended-release dipyridamole capsules, 25 mg/200 mg (3) |
Aggrenox ® |
June |
$ | 168 |
||||||||
Desmopressin acetate injection, USP, 4 mcg/mL (3) |
DDAVP ® |
June |
$ | 58 |
||||||||
Albendazole tablets, USP, 200 mg |
Albenza ® |
June |
$ | 85 |
||||||||
Bosentan tablets, 62.5 mg & 125 mg |
Tracleer ® |
June |
$ | 84 |
||||||||
Doxylamine succinate and pyridoxine hydrochloride delayed-release tablets, 10 mg/10 mg |
Diclegis ® |
June |
$ | 151 |
||||||||
Penicillamine capsules, USP, 250 mg |
Cuprimine ® |
June |
$ | 130 |
||||||||
1% Sodium hyaluronate injection |
(4) |
June |
— |
|||||||||
Oseltamivir phosphate for oral suspension, 6 mg/mL |
Tamiflu ® |
July |
$ | 281 |
||||||||
Icatibant injection, 30 mg/3 mL |
Firazyr ® |
July |
$ | 304 |
||||||||
Pregabalin capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg & 300 mg |
Lyrica ® |
July |
$ | 5,456 |
||||||||
Ramelteon tablets, 8 mg |
Rozerem ® |
July |
$ | 91 |
||||||||
Bisoprolol fumarate and hydrochlorothiazide tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg & 10 mg/6.25 mg (2) |
Ziac ® |
August |
$ | 42 |
||||||||
Doxycycline hyclate delayed-release tablets, USP, 50 mg & 200 mg |
Doryx ® |
August |
$ | 20 |
||||||||
Mycophenolic acid delayed-release tablets, USP, 180 mg & 360 mg |
Myfortic ® DR |
August |
$ | 180 |
||||||||
Epinephrine injection, USP (auto-injector), 0.15 mg/0.3 mL |
EpiPen Jr ® |
August |
$ | 201 |
||||||||
Minocycline hydrochloride extended-release tablets, USP, 55 mg |
Solodyn ® ER |
August |
$ | 44 |
||||||||
Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) |
(5) |
August |
— |
|||||||||
Triamcinolone acetonide injectable suspension, USP, 40 mg/mL (40 mg), 40 mg/mL (200 mg) & 40 mg/mL (400 mg) |
Kenalog ® -40 |
August |
$ | 135 |
||||||||
Acyclovir cream, 5% (6) |
Zovirax ® |
August |
$ | 97 |
||||||||
Fosaprepitant for injection, 150 mg/Vial |
(5) |
September |
— |
|||||||||
Treprostinil injection, 1 mg/mL (20 mg), 2.5 mg/mL (50 mg), 5 mg/mL (100 mg) & 10 mg/mL (200 mg) |
Remodulin ® |
September |
$ |
3 |
||||||||
Ivermectin cream, 1% |
Soolantra ® |
October |
$ |
206 |
||||||||
TRUXIMA, 100 mg/10 mL & 500 mg/50 mL |
Rituxan ® (7) |
November |
$ | 4,378 |
||||||||
Deferasirox tablets, 90 mg & 360 mg |
Jadenu ® |
November |
$ | 390 |
(1) | The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or re-launch. |
(2) | Authorized generic of a Teva specialty product. |
(3) | Products were re-launched. |
(4) | Approved via 515(d)(1)(B)(ii) regulatory pathway for medical devices; not equivalent to a brand product. |
(5) | Approved via 505(b)(2) regulatory pathway; not equivalent to a brand product. |
(6) | Authorized generic. |
(7) | Biosimilar. |
Generic Name |
Brand Name |
Total U.S. Annual Branded Market (U.S. $ in millions (IQVIA))* |
||||||
Dapagliflozin tablets, 5 mg |
Farxiga ® |
$ | 1,688 |
|||||
Deferasirox Oral Tablets 180 mg |
Jadenu ® |
$ | 55 |
|||||
Efinaconazole Topical Solution |
Jublia ® |
$ | 231 |
|||||
Enzalutamide capsules, 40 mg |
Xtandi ® |
$ | 999 |
|||||
Everolimus tablets, 2.5 mg, 5 mg, 7.5 mg & 10 mg |
Afinitor ® |
$ | 770 |
|||||
Icatibant injection, 30 mg/3 mL |
Firazyr ® |
$ | 318 |
|||||
Ivermectin lotion, 0.5% |
Sklice ® |
$ | 81 |
|||||
Sildenafil, 10 mg/mL |
Revatio ® |
$ | 189 |
|||||
Sorafenib tablets, 200 mg |
Nexavar ® |
$ | 55 |
* | For the twelve months ended in the calendar quarter immediately prior to the receipt of tentative approval. |
Year ended December 31, |
||||||||||||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||||||||||
(U.S. $ in millions / % of Segment Revenues) |
||||||||||||||||||||||||
Revenues |
$ | 4,795 |
100 |
% | $ | 5,186 |
100 |
% | $ | 5,466 |
100 |
% | ||||||||||||
Gross profit |
2,704 |
56.4 |
% | 2,884 |
55.6 |
% | 2,887 |
52.8 |
% | |||||||||||||||
R&D expenses |
262 |
5.5 |
% | 283 |
5.5 |
% | 390 |
7.1 |
% | |||||||||||||||
S&M expenses |
890 |
18.6 |
% | 1,003 |
19.3 |
% | 1,130 |
20.7 |
% | |||||||||||||||
G&A expenses |
239 |
5.0 |
% | 325 |
6.3 |
% | 354 |
6.5 |
% | |||||||||||||||
Other (income) expense |
(5 |
) | § |
— |
§ |
(16 |
) | § |
||||||||||||||||
Segment profit* |
$ | 1,318 |
27.5 |
% | $ | 1,273 |
24.5 |
% | $ | 1,029 |
18.8 |
% | ||||||||||||
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
Year ended December 31, |
Percentage Change 2018-2019 |
|||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Generic products |
$ | 3,470 |
$ | 3,593 |
$ | 3,471 |
(3 |
%) | ||||||||
COPAXONE |
432 |
535 |
595 |
(19 |
%) | |||||||||||
Respiratory products |
354 |
402 |
368 |
(12 |
%) | |||||||||||
Other |
539 |
656 |
1,033 |
(18 |
%) | |||||||||||
Total |
$ | 4,795 |
$ | 5,186 |
$ | 5,466 |
(8 |
%) | ||||||||
2019 |
2018 |
2017 |
||||||||||||||||||||||
(U.S. $ in millions / % of Segment Revenues) |
||||||||||||||||||||||||
Revenues |
$ | 2,246 |
100 |
% | $ | 2,422 |
100 |
% | $ | 2,863 |
100 |
% | ||||||||||||
Gross profit |
1,167 |
51.9 |
% | 1,254 |
51.8 |
% | 1,433 |
50.1 |
% | |||||||||||||||
R&D expenses |
88 |
3.9 |
% | 96 |
4.0 |
% | 154 |
5.4 |
% | |||||||||||||||
S&M expenses |
481 |
21.4 |
% | 518 |
21.4 |
% | 672 |
23.5 |
% | |||||||||||||||
G&A expenses |
138 |
6.1 |
% | 153 |
6.3 |
% | 189 |
6.6 |
% | |||||||||||||||
Other (income) expense |
(3 |
) | § |
(11 |
) | § |
(8 |
) | § |
|||||||||||||||
Segment profit* |
$ | 464 |
20.6 |
% | $ | 498 |
20.6 |
% | $ | 426 |
14.9 |
% | ||||||||||||
* | Segment profit does not include amortization and certain other items. |
§ | Represents an amount less than 0.5%. |
Year ended December 31, |
Percentage Change 2018-2019 |
|||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Generic products |
$ | 1,893 |
$ | 2,022 |
$ | 2,370 |
(6 |
%) | ||||||||
COPAXONE |
63 |
72 |
91 |
(13 |
%) | |||||||||||
Distribution |
20 |
19 |
17 |
6 |
% | |||||||||||
Other |
271 |
309 |
385 |
(12 |
%) | |||||||||||
Total |
$ | 2,246 |
$ | 2,422 |
$ | 2,863 |
(7 |
%) | ||||||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
North America profit |
$ | 2,252 |
$ | 2,837 |
$ | 4,624 |
||||||
Europe profit |
1,318 |
1,273 |
1,029 |
|||||||||
International Markets profit |
464 |
498 |
426 |
|||||||||
Total reportable segments profit |
4,034 |
4,608 |
6,079 |
|||||||||
Profit (loss) of other activities |
108 |
115 |
(6 |
) | ||||||||
Total segments profit |
4,142 |
4,723 |
6,073 |
|||||||||
Amounts not allocated to segments: |
||||||||||||
Amortization |
1,113 |
1,166 |
1,444 |
|||||||||
Other asset impairments, restructuring and other items |
423 |
987 |
1,836 |
|||||||||
Goodwill impairment |
— |
3,027 |
17,100 |
|||||||||
Intangible asset impairments |
1,639 |
1,991 |
3,238 |
|||||||||
Gain on divestitures, net of divestitures related costs |
(50 |
) | (66 |
) | (1,083 |
) | ||||||
Inventory Step-up |
— |
— |
67 |
|||||||||
Other R&D expenses |
(15 |
) | 83 |
221 |
||||||||
Costs related to regulatory actions taken in facilities |
45 |
14 |
47 |
|||||||||
Legal settlements and loss contingencies |
1,178 |
(1,208 |
) | 500 |
||||||||
Other unallocated amounts |
252 |
366 |
187 |
|||||||||
Consolidated operating income (loss) |
(443 |
) | (1,637 |
) | (17,484 |
) | ||||||
Financial expenses, net |
822 |
959 |
895 |
|||||||||
Consolidated income (loss) before income taxes |
$ | (1,265 |
) | $ | (2,596 |
) | $ | (18,379 |
) | |||
• | $300 million of our $2.0 billion 1.7% senior notes due in July 2019 |
• | € 90 million of our € 1.75 billion 0.38% senior notes due in July 2020 |
• | our management and Board of Directors use the non-GAAP measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management; |
• | our annual budgets are prepared on a non-GAAP basis; and |
• | senior management’s annual compensation is derived, in part, using these non-GAAP measures. While qualitative factors and judgment also affect annual bonuses, the principal quantitative element in the determination of such bonuses is performance targets tied to the work plan, which is based on the non-GAAP presentation set forth below. |
• | amortization of purchased intangible assets; |
• | legal settlements 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, inventory step-up and in-process R&D acquired in development arrangements; |
• | expenses related to our equity compensation; |
• | significant one-time financing costs and devaluation losses; |
• | deconsolidation charges; |
• | material tax and other awards or settlement amounts, both paid and 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, such as inventory write-offs or related consulting costs, or other unusual events; and |
• | corresponding tax effects of the foregoing items. |
Year Ended December 31, 2019 (U.S. $ and shares in millions, except per share amounts) |
||||||||||||||||||||||||||||||||||||||||||||||||||||
GAAP |
Excluded for non GAAP measurement |
Non GAAP |
||||||||||||||||||||||||||||||||||||||||||||||||||
Amortization of purchased intangible assets |
Legal settlements and loss contingencies |
Impairment of long- lived assets |
Other R&D expenses |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Gain on sale of business |
Other non GAAP items |
Other items |
||||||||||||||||||||||||||||||||||||||||||
COGS |
9,351 |
973 |
45 |
26 |
121 |
8,185 |
||||||||||||||||||||||||||||||||||||||||||||||
R&D |
1,010 |
(15 |
) | 20 |
1 |
1,004 |
||||||||||||||||||||||||||||||||||||||||||||||
S&M |
2,614 |
139 |
35 |
1 |
2,438 |
|||||||||||||||||||||||||||||||||||||||||||||||
G&A |
1,192 |
42 |
5 |
1,145 |
||||||||||||||||||||||||||||||||||||||||||||||||
Other income |
(76 |
) | (50 |
) | (27 |
) | ||||||||||||||||||||||||||||||||||||||||||||||
Legal settlements and loss contingencies |
1,178 |
1,178 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||
Other asset impairments, restructuring and other items |
423 |
139 |
199 |
59 |
26 |
— |
||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets impairment |
1,639 |
1,639 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||
Financial expenses |
822 |
(3 |
) | 824 |
||||||||||||||||||||||||||||||||||||||||||||||||
Corresponding tax effect |
(278 |
) | (875 |
) | 597 |
|||||||||||||||||||||||||||||||||||||||||||||||
Share in losses of associated companies – net |
13 |
— |
13 |
|||||||||||||||||||||||||||||||||||||||||||||||||
Net income attributable to non-controlling interests |
(2 |
) | (82 |
) | 80 |
|||||||||||||||||||||||||||||||||||||||||||||||
Total reconciled items |
1,113 |
1,178 |
1,778 |
(15 |
) | 199 |
45 |
123 |
59 |
(50 |
) | 155 |
(959 |
) | ||||||||||||||||||||||||||||||||||||||
EPS—Basic |
(0.91 |
) | 3.32 |
2.41 |
||||||||||||||||||||||||||||||||||||||||||||||||
EPS—Diluted |
(0.91 |
) | 3.32 |
2.40 |
Year ended December 31, 2018 (U.S. $ and shares in millions, except per share amounts) |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GAAP |
Excluded for non GAAP measurement |
Non GAAP |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Amortization of purchased intangible assets |
Goodwill impairment |
Legal settlements and loss contingencies |
Impairment of long- lived assets |
Other R&D expenses |
Acquisition integration and related expenses |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Gain on sale of business |
Other non GAAP items |
Other items |
||||||||||||||||||||||||||||||||||||||||||||||||
COGS* |
9,975 |
1,004 |
14 |
28 |
204 |
8,725 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
R&D |
1,213 |
83 |
26 |
2 |
1,102 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
S&M |
2,916 |
162 |
43 |
(7 |
) | 2,718 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
G&A |
1,298 |
55 |
15 |
1,228 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other income |
(291 |
) | (66 |
) | (225 |
) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Legal settlements and loss contingencies |
(1,208 |
) | (1,208 |
) | — |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other asset impairments, restructuring and other items |
987 |
500 |
13 |
488 |
57 |
(71 |
) | — |
||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets impairment |
1,991 |
1,991 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill impairment |
3,027 |
3,027 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Financial expenses |
959 |
66 |
893 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Corresponding tax effect |
(195 |
) | (714 |
) | 519 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share in losses of associated companies – net |
71 |
103 |
(32 |
) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net income attributable to non-controlling interests |
(322 |
) | (431 |
) | 109 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total reconciled items |
1,166 |
3,027 |
(1,208 |
) | 2,491 |
83 |
13 |
488 |
14 |
152 |
57 |
(66 |
) | 143 |
(976 |
) | ||||||||||||||||||||||||||||||||||||||||||||
EPS—Basic |
(2.35 |
) | 5.27 |
2.92 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EPS—Diluted |
(2.35 |
) | 5.27 |
2.92 |
* | The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b to our consolidated financial statements for additional information. |
Year ended December 31, 2017 U.S. $ and shares in millions (except per share amounts) |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GAAP |
Excluded for non GAAP measurement |
Non GAAP |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Amortization of purchased intangible assets |
Goodwill impairment |
Legal settlements and loss contingencies |
Impairment of long- lived assets |
Other R&D expenses |
Inventory step-up |
Acquisition, integration and related expenses |
Restructuring costs |
Costs related to regulatory actions taken in facilities |
Equity compensation |
Contingent consideration |
Other non GAAP items |
Other items |
||||||||||||||||||||||||||||||||||||||||||||||||
COGS* |
11,237 |
1,235 |
67 |
47 |
23 |
47 |
9,818 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||
R&D |
1,778 |
221 |
22 |
20 |
1,515 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
S&M |
3,395 |
209 |
38 |
(1 |
) | 3,149 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
G&A |
1,451 |
46 |
(8 |
) | 1,413 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other income |
(1,199 |
) | (1,083 |
) | (116 |
) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
Legal settlements and loss contingencies |
500 |
500 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other asset impairments, restructuring and other items |
1,836 |
544 |
105 |
535 |
154 |
498 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible assets impairment |
3,238 |
3,238 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill impairment |
17,100 |
17,100 |
— |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Financial expenses |
895 |
(13 |
) | 908 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Corresponding tax effect |
(1,933 |
) | (2,721 |
) | 788 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share in losses of associated companies – net |
3 |
47 |
(44 |
) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Net income attributable to non-controlling interests |
(184 |
) | (270 |
) | 86 |
|||||||||||||||||||||||||||||||||||||||||||||||||||||||
Total reconciled items |
1,444 |
17,100 |
500 |
3,782 |
221 |
67 |
105 |
535 |
47 |
129 |
154 |
(527 |
) | (2,957 |
) | |||||||||||||||||||||||||||||||||||||||||||||
EPS—Basic |
(16.26 |
) | 20.27 |
4.01 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EPS—Diluted |
(16.26 |
) | 20.27 |
4.01 |
* | The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b to our consolidated financial statements for additional information. |
• | Success of our specialty products AJOVY, AUSTEDO and our biosimiliar products; |
• | execution of our global operations optimization plan, which may affect our business and operations, and the risk of incurring additional restructuring expenses; |
• | ability to successfully execute key generic launches in a timely manner; |
• | our high debt levels and non-investment grade credit rating will have a negative effect on our ability to borrow additional funds and may increase the cost of any such borrowing; |
• | a decrease in sales of COPAXONE following the launches of generic versions to the product, and the possibility of additional generic competition in the future; |
• | a decrease in sales of other specialty products due to potential loss of exclusivity or generic competition; |
• | 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; and |
• | continued impact of currency fluctuations on revenues and net income, as well as on various balance sheet line items. |
Payments Due by Period |
||||||||||||||||||||
Total |
Less than 1 year |
1-3 years |
3-5 years |
More than 5 years |
||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||
Long-term debt obligations, including expected interest* |
$ | 34,043 |
$ | 2,737 |
$ | 6,310 |
$ | 8,723 |
$ | 16,274 |
||||||||||
Purchase obligations (including purchase orders) |
1,876 |
1,624 |
248 |
4 |
— |
|||||||||||||||
Total |
$ | 35,919 |
$ | 4,361 |
$ | 6,558 |
$ | 8,727 |
$ | 16,274 |
||||||||||
* | Long-term debt obligations mainly include senior notes and convertible senior debentures as disclosed in note 9 to our consolidated financial statements. |
• | Revenue Recognition and SR&A |
• | Income Taxes |
• | Contingencies |
• | Inventories |
• | Goodwill |
• | Identifiable Intangible Assets |
• | Restructuring Costs |
• | 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. |
Net exposure as of December 31, 2019 |
||||
Liability/Asset |
(U.S. $ in millions) |
|||
GBP/EUR |
610 |
|||
USD/EUR |
375 |
|||
USD/CHF |
360 |
|||
USD/JPY |
313 |
|||
BGN/EUR |
251 |
|||
PLN/EUR |
243 |
|||
CAD/EUR |
97 |
|||
EUR/HRK |
96 |
|||
USD/MXN |
75 |
|||
INR/USD |
72 |
|||
EUR/RUB |
85 |
|||
USD/ILS |
70 |
|||
GBP/USD |
63 |
Currency (sold) |
Cross Currency (bought) |
Net Notional Value |
Fair Value |
2019 Weighted Average Cross Currency Prices or Strike Prices |
||||||||||||||||||||
2019 |
2018 |
2019 |
2018 |
|||||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||
Forward: |
||||||||||||||||||||||||
EUR |
USD |
503 |
147 |
(6 |
) | 2 |
1.12 |
|||||||||||||||||
EUR |
GBP |
445 |
416 |
12 |
(3 |
) | 0.88 |
|||||||||||||||||
CHF |
USD |
384 |
274 |
(5 |
) | (1 |
) | 0.98 |
||||||||||||||||
JPY |
USD |
302 |
283 |
2 |
(5 |
) | 107.71 |
|||||||||||||||||
EUR |
PLN |
216 |
115 |
4 |
1 |
4.33 |
||||||||||||||||||
USD |
RUB |
205 |
* |
(5 |
) | * |
64.78 |
|||||||||||||||||
USD |
INR |
192 |
70 |
— |
2 |
72.69 |
||||||||||||||||||
NIS |
USD |
131 |
66 |
(1 |
) | — |
3.48 |
|||||||||||||||||
PLN |
USD |
105 |
* |
(2 |
) | * |
3.85 |
|||||||||||||||||
CAD |
USD |
101 |
* |
— |
* |
1.31 |
||||||||||||||||||
EUR |
CAD |
96 |
140 |
— |
(4 |
) | 1.47 |
|||||||||||||||||
RUB |
EUR |
92 |
* |
(2 |
) | — |
71.51 |
|||||||||||||||||
MXN |
USD |
68 |
* |
(2 |
) | — |
19.49 |
|||||||||||||||||
USD |
GBP |
* |
60 |
* |
— |
* |
||||||||||||||||||
CHF |
EUR |
* |
53 |
* |
(1 |
) | * |
|||||||||||||||||
Options: |
||||||||||||||||||||||||
EUR |
USD |
381 |
* |
(2 |
) | * |
1.10 |
|||||||||||||||||
JPY |
USD |
139 |
77 |
— |
— |
109.72 |
||||||||||||||||||
EUR |
GBP |
131 |
* |
— |
* |
0.84 |
||||||||||||||||||
CHF |
USD |
85 |
99 |
(1 |
) | — |
0.99 |
|||||||||||||||||
GBP |
USD |
63 |
* |
(1 |
) | * |
1.26 |
* | Represents Net Notional Value of less than $50 million. |
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Cross currency swap—cash flow hedge |
$ | — |
$ | 588 |
||||
Interest rate swap—fair value hedge |
$ | — |
$ | 500 |
Currency |
Total Amount |
Interest Rate Ranges |
2020 |
2021 |
2022 |
2023 |
2024 |
2025 & thereafter |
||||||||||||||||||||||||||||
(U.S. dollars in millions) |
||||||||||||||||||||||||||||||||||||
Fixed Rate: |
||||||||||||||||||||||||||||||||||||
USD |
16,404 |
1.70 |
% | 7.13 |
% | 700 |
2,092 |
856 |
2,995 |
1,250 |
8,512 |
|||||||||||||||||||||||||
Euro |
9,368 |
0.38 |
% | 6.00 |
% | 1,131 |
587 |
784 |
1,451 |
1,673 |
3,743 |
|||||||||||||||||||||||||
CHF |
723 |
0.50 |
% | 1.00 |
% | — |
— |
361 |
— |
— |
362 |
|||||||||||||||||||||||||
USD convertible debentures* |
514 |
0.25 |
% | 0.25 |
% | 514 |
— |
— |
— |
— |
— |
|||||||||||||||||||||||||
Floating Rate: |
||||||||||||||||||||||||||||||||||||
Others |
1 |
1.00 |
% | 2.00 |
% | — |
— |
— |
— |
1 |
||||||||||||||||||||||||||
Total: |
27,010 |
$ | 2,345 |
$ | 2,679 |
$ | 2,001 |
$ | 4,446 |
$ | 2,923 |
$ | 12,618 |
|||||||||||||||||||||||
Less debt issuance costs |
(103 |
) | ||||||||||||||||||||||||||||||||||
Total: |
$ | 26,908 |
||||||||||||||||||||||||||||||||||
* | Classified under short-term debt. |
Page |
||||
97 |
||||
Consolidated Financial Statements: |
||||
101 |
||||
Statements of income (loss) |
102 |
|||
103 |
||||
104 |
||||
105 |
||||
107 |
/s/ Kesselman & Kesselman |
Kesselman & Kesselman |
Certified Public Accountants (Isr.) |
A member of PricewaterhouseCoopers International Limited |
Tel-Aviv, Israel |
February 21, 2020 |
December 31, |
December 31, |
|||||||
2019 |
2018 |
|||||||
|
|
|
|
|
|
| ||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | |
$ | |
||||
Accounts receivables |
|
|
||||||
Inventories |
|
|
||||||
Prepaid expenses |
|
|
||||||
Other current assets |
|
|
||||||
Assets held for sale |
|
|
||||||
Total current assets |
|
|
||||||
Deferred income taxes |
|
|
||||||
Other non-current assets |
|
|
||||||
Property, plant and equipment, net |
|
|
||||||
Operating lease right-of-use assets |
|
|
|
|
|
|
— |
|
Identifiable intangible assets, net |
|
|
||||||
Goodwill |
|
|
||||||
Total assets |
$ | |
$ | |
||||
LIABILITIES AND EQUITY |
||||||||
Current liabilities: |
||||||||
Short-term debt |
$ |
|
$ |
|
||||
Sales reserves and allowances |
|
|
||||||
Accounts payables |
|
|
||||||
Employee-related obligations |
|
|
||||||
Accrued expenses |
|
|
||||||
Other current liabilities |
|
|
||||||
Total current liabilities |
|
|
||||||
Long-term liabilities: |
||||||||
Deferred income taxes |
|
|
||||||
Other taxes and long-term liabilities |
|
|
||||||
Senior notes and loans |
|
|
||||||
Operating lease liabilities |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
|
|
|
Total long-term liabilities |
|
|
||||||
Commitments and contingencies |
||||||||
Total liabilities |
|
|
||||||
Equity: |
||||||||
Teva shareholders’ equity: |
||||||||
Ordinary shares of NIS 9 and December 31, 2018 : authorized shares and |
|
|
||||||
Additional paid-in capital |
|
|
||||||
Accumulated deficit |
( |
) | ( |
) | ||||
Accumulated other comprehensive loss |
( |
) | ( |
) | ||||
Treasury shares as of December 31, 201 9 and December 31, 2018 : |
( |
) | ( |
) | ||||
|
|
|||||||
Non-controlling interests |
|
|
||||||
Total equity |
|
|
||||||
Total liabilities and equity |
$ | |
$ | |
||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Net revenues |
$ | |
$ | |
$ | |
||||||
Cost of sales |
|
|
|
|||||||||
Gross profit |
|
|
|
|||||||||
Research and development expenses |
|
|
|
|||||||||
Selling and marketing expenses |
|
|
|
|||||||||
General and administrative expenses |
|
|
|
|||||||||
Intangible assets impairments |
|
|
|
|||||||||
Goodwill impairment |
— |
|
|
|||||||||
Other asset impairments, restructuring and other items |
|
|
|
|||||||||
Legal settlements and loss contingencies |
|
( |
) | |
||||||||
Other income |
( |
) | ( |
) | ( |
) | ||||||
Operating (loss) income |
( |
) | ( |
) | ( |
) | ||||||
Financial expenses—net |
|
|
|
|||||||||
Income (loss) before income taxes |
( |
) | ( |
) | ( |
) | ||||||
Income taxes (benefit) |
( |
) | ( |
) | ( |
) | ||||||
Share in (profits) losses of associated companies—net |
|
|
|
|||||||||
Net income (loss) |
( |
) | ( |
) | ( |
) | ||||||
Net loss attributable to non-controlling interests |
( |
) | ( |
) | ( |
) | ||||||
Net income (loss) attributable to Teva |
( |
) | ( |
) | ( |
) | ||||||
Accrued dividends on preferred shares |
— |
|
|
|||||||||
Net income (loss) attributable to ordinary shareholders |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Earnings (loss) per share attributable to ordinary shareholders: |
||||||||||||
Basic |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Diluted |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Weighted average number of shares (in millions): |
||||||||||||
Basic |
|
|
|
|||||||||
Diluted |
|
|
|
|||||||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Net income (loss) |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Other comprehensive income (loss), net of tax: |
||||||||||||
Currency translation adjustment* |
|
( |
) | |
||||||||
Unrealized gain (loss) on derivative financial instruments, net |
|
|
( |
) | ||||||||
Unrealized gain (loss) on available-for-sale securities, net |
( |
) | — |
|
||||||||
Unrealized gain (loss) on defined benefit plans, net |
( |
) | |
( |
) | |||||||
Total other comprehensive income (loss) |
|
( |
) | |
||||||||
Total comprehensive loss |
( |
) | ( |
) | ( |
) | ||||||
Comprehensive income (loss) attributable to non-controlling interests |
|
( |
) | ( |
) | |||||||
Comprehensive loss attributable to Teva |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
* |
In 2017 includes amount that was released from accumulated other comprehensive loss as part of the deconsolidation of the Venezuelan subsidiaries and is included in Venezuela deconsolidation charge under other asset impairment, restructuring and other items. |
|
Teva shareholders’ equity |
|
|
|||||||||||||||||||||||||||||||||||||
|
Ordinary shares |
|
|
|
|
|
|
|
|
|||||||||||||||||||||||||||||||
|
Number of shares (in millions) |
Stated value |
MCPS** |
Additional paid-in capital |
Retained earnings (accumulated deficit) |
Accumulated other compre- hensive income (loss) |
Treasury shares |
Total Teva share-holders’ equity |
Non- controlling interests |
Total equity |
||||||||||||||||||||||||||||||
(U.S. dollars in millions) |
||||||||||||||||||||||||||||||||||||||||
Balance at January 1, 2017 |
|
|
|
|
|
( |
) | ( |
) | |
|
|
||||||||||||||||||||||||||||
Changes during 2017: |
||||||||||||||||||||||||||||||||||||||||
Comprehensive income (loss) |
( |
) | |
( |
) | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
Exercise of options by employees and vested RSUs |
|
* |
( |
) | |
* |
* |
|||||||||||||||||||||||||||||||||
Stock-based compensation expense |
|
|
|
|||||||||||||||||||||||||||||||||||||
Dividends to ordinary shareholders |
( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||||||
Dividends to preferred shareholders |
|
( |
) | ( |
) | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
Transactions with non-controlling interests |
— |
( |
) | ( |
) | |||||||||||||||||||||||||||||||||||
Other |
( |
) | |
( |
) | ( |
) | ( |
) | |||||||||||||||||||||||||||||||
Balance at December 31, 2017 |
|
|
|
|
( |
) | ( |
) | ( |
) | |
|
|
|||||||||||||||||||||||||||
Changes during 2018: |
||||||||||||||||||||||||||||||||||||||||
Cumulative effect of new accounting standard**** |
( |
) | |
— |
||||||||||||||||||||||||||||||||||||
Comprehensive income (loss) |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||||||||||||||||||
Issuance of Treasury Shares |
* |
( |
) | |
|
|
||||||||||||||||||||||||||||||||||
Stock-based compensation expense |
|
|
|
|||||||||||||||||||||||||||||||||||||
Issuance of shares*** |
|
|
( |
) | |
( |
) | ( |
) | |||||||||||||||||||||||||||||||
Dividends to preferred shareholders |
|
( |
) | — |
— |
|||||||||||||||||||||||||||||||||||
Transactions with non-controlling interests |
|
|
( |
) | ( |
) | ||||||||||||||||||||||||||||||||||
Balance at December 31, 2018 |
|
|
— |
|
( |
) | ( |
) | ( |
) | |
|
|
|||||||||||||||||||||||||||
Changes during 2019: |
||||||||||||||||||||||||||||||||||||||||
Comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
( |
) | |
Issuance of Shares |
|
* |
|
|
|
|
|
|
|
* |
||||||||||||||||||||||||||||||
Issuance of Treasury Shares |
|
* |
|
( |
) | |
|
|
|
|
|
|||||||||||||||||||||||||||||
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||
Transactions with non-controlling interests |
|
|
|
|
|
|
|
|
( |
) | ( |
) | ||||||||||||||||||||||||||||
Other |
|
|
|
( |
) | |
|
|
( |
) | |
( |
) | |||||||||||||||||||||||||||
Balance at December 31, 2019 |
|
$ | |
— |
$ | |
$ | ( |
) | $ | ( |
) | $ | ( |
) | $ | |
$ | |
$ | |
|||||||||||||||||||
* | Represents an amount less than |
** |
Mandatory convertible preferred shares. |
*** |
Mainly MCPS conversion. |
**** |
Following the adoption of ASU 2016-01, the Company recorded a $ |
|
Year ended December 31, |
| ||||||||||
|
2019 |
|
2018 |
|
|
2017 |
| |||||
Operating activities: |
||||||||||||
Net loss |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Adjustments to reconcile net loss to net cash provided by operations: |
||||||||||||
Impairment of long-lived assets |
|
|
|
|||||||||
Depreciation and amortization |
|
|
|
|||||||||
Net change in operating assets and liabilities |
( |
) | ( |
) | ( |
) | ||||||
Deferred income taxes—net and uncertain tax positions |
( |
) | ( |
) | ( |
) | ||||||
Stock-based compensation |
|
|
|
|||||||||
Other items |
|
( |
) | |
||||||||
Research and development in process |
— |
|
|
|||||||||
Net loss from sale of long-lived assets and investments |
( |
) | ( |
) | ( |
) | ||||||
Venezuela deconsolidation loss |
— |
— |
|
|||||||||
Venezuela impairment of net monetary assets |
— |
— |
|
|||||||||
Net cash provided by operating activities |
|
|
|
|||||||||
Investing activities: |
||||||||||||
Beneficial interest collected in exchange for securitized trade receivables |
|
|
|
|||||||||
Proceeds from sales of long-lived assets and investments |
|
|
|
|||||||||
Purchases of property, plant and equipment |
( |
) | ( |
) | ( |
) | ||||||
Purchases of investments and other assets |
( |
) | ( |
) | ( |
) | ||||||
Other investing activities |
|
|
( |
) | ||||||||
Acquisitions of subsidiaries, net of cash acquired |
— |
— |
|
|||||||||
Net cash provided by investing activities |
|
|
|
|||||||||
|
|
|
|
|
|
|
|
|
| |||
Financing activities: |
||||||||||||
Repayment of senior notes and loans and other long-term liabilities |
( |
) | ( |
) | ( |
) | ||||||
Proceeds from senior notes and loans, net of issuance costs |
|
|
|
|||||||||
Net change in short-term debt |
( |
) | ( |
) | ( |
) | ||||||
Other financing activities |
( |
) | ( |
) | ( |
) | ||||||
Dividends paid on ordinary shares* |
— |
( |
) | ( |
) | |||||||
Dividends paid on preferred shares* |
( |
) | ( |
) |
( |
) | ||||||
Dividends paid to non-controlling interests |
— |
— |
( |
) | ||||||||
Net cash used in financing activities |
( |
) | ( |
) | ( |
) | ||||||
Translation adjustment on cash and cash equivalents |
|
( |
) | |
||||||||
Net change in cash and cash equivalents |
|
|
( |
) | ||||||||
Balance of cash and cash equivalents at beginning of year |
|
|
|
|||||||||
Balance of cash and cash equivalents at end of year |
$ | |
$ | |
$ | |
||||||
* |
In 2019 and 2018, the amounts consist of tax withholding payments made on shares and dividends. |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Supplemental cash flow information: |
||||||||||||
Non-cash financing and investing activities: |
||||||||||||
Beneficial interest obtained in exchange for securitized trade receivables |
$ |
|
$ |
|
$ |
|
||||||
Conversion of mandatory convertible preferred shares into ordinary shares |
— |
$ |
|
— |
||||||||
Cash paid during the year for: |
||||||||||||
Interest |
$ |
|
$ |
|
$ |
|
||||||
Income taxes, net of refunds |
$ |
|
$ |
|
$ |
|
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Other current assets |
$ |
( |
) |
$ |
( |
) |
$ |
|
||||
Trade payables, accrued expenses, employee-related obligations and other current liabilities |
|
( |
) |
( |
) | |||||||
Trade receivables net of sales reserves and allowances |
( |
) |
|
|
||||||||
Inventories |
|
|
|
|||||||||
Inventory step-up |
— |
— |
|
|||||||||
$ |
( |
) |
$ |
( |
) |
$ |
( |
) | ||||
a. |
General: |
b. |
Revision of Previously Reported Consolidated Financial Statements |
Net revenues |
Cost of sales |
|||||||||||||||||||||||
As reported |
Adjustment |
As revised |
As reported |
Adjustment |
As revised |
|||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||
2017 |
( |
) |
( |
) |
||||||||||||||||||||
2018 |
( |
) |
( |
) |
c. |
New accounting pronouncements |
d . |
Acquisitions: |
e. |
Collaborative arrangements: |
f. |
Equity investments: |
g. |
Fair value measurement: |
h. |
Investment in debt securities: |
i. |
Cash and cash equivalents: |
j. |
Accounts receivables: |
k |
Concentration of credit risks: |
l . |
Inventories: |
m. |
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. |
n. |
Contingencies: |
o. |
Treasury shares: |
p . |
Stock-based compensation: |
q. |
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. |
r . |
Uncertain tax positions: |
s. |
Derivatives and hedging: |
t . |
Revenue recognition: |
u . |
Research and development: |
v . |
Shipping and handling costs: |
w . |
Advertising costs: |
x . |
Restructuring: |
y. |
Segment reporting: |
(a) |
North America segment, which includes the United States and Canada. |
(b) |
Europe segment, which includes the European Union 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. |
z . |
Earnings per share: |
aa . |
Securitization |
bb . |
Divestitures: |
cc. |
Debt instruments |
dd. |
Leases |
a. |
Business acquisitions: |
b. |
Assets and Liabilities Held For Sale: |
December 31, 2019 |
December 31, 2018 |
|||||||
(U.S. $ in millions) |
||||||||
Property, plant and equipment, net |
|
|
||||||
Goodwill |
— |
|
||||||
Adjustments of assets held for sale to fair value |
( |
) |
( |
) | ||||
Total assets of the disposal group classified as held for sale in the consolidated balance sheets |
$ | |
$ | |
||||
c. |
Other significant agreements: |
Year ended December 31, 201 9 |
||||||||||||||||||||
North America |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S. |
||||||||||||||||||||
Sale of goods |
||||||||||||||||||||
Licensing arrangements |
||||||||||||||||||||
Distribution |
— |
|||||||||||||||||||
Other |
( |
) | ||||||||||||||||||
$ | $ | $ | $ | $ | ||||||||||||||||
Year ended December 31, 201 8 |
||||||||||||||||||||
North America |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S. |
||||||||||||||||||||
Sale of goods |
||||||||||||||||||||
Licensing arrangements |
||||||||||||||||||||
Distribution |
— |
|||||||||||||||||||
Other |
||||||||||||||||||||
$ |
$ |
$ |
$ |
$ |
||||||||||||||||
Year ended December 31, 201 7 |
||||||||||||||||||||
North America |
Europe |
International Markets |
Other activities |
Total |
||||||||||||||||
(U.S. |
||||||||||||||||||||
Sale of goods |
||||||||||||||||||||
Licensing arrangements |
||||||||||||||||||||
Distribution |
— |
|||||||||||||||||||
Other |
||||||||||||||||||||
$ |
$ |
$ |
$ |
$ |
§ |
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, 2018 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Provisions related to sales made in current year period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
|
|
Provisions related to sales made in prior periods |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
— |
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
$ |
( |
) |
Credits and payments |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
$ |
( |
) |
Translation differences |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
$ |
( |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2018 |
$ | |
$ |
|
$ | |
$ | |
$ | |
$ | |
$ | |
$ | |
||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Provisions related to sales made in current year period |
|
|
|
|
|
|
|
$ | |
|||||||||||||||||||||||
Provisions related to sales made in prior periods |
— |
( |
) | ( |
) | ( |
) |
|
( |
) | ( |
) | $ | ( |
) | |||||||||||||||||
Credits and payments |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ( |
) | $ | ( |
) | |||||||||||||||
Translation differences |
— |
( |
) |
( |
) | |
|
|
|
$ | |
|||||||||||||||||||||
Balance at December 31, 201 9 |
$ | |
$ |
|
$ | |
$ | |
$ | |
$ | |
$ | |
$ | |
||||||||||||||||
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Finished products |
$ | |
$ | |
||||
Raw and packaging materials |
|
|
||||||
Products in process |
|
|
||||||
Materials in transit and payments on account |
|
|
||||||
$ | |
$ | |
|||||
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Machinery and equipment |
$ | |
$ | |
||||
Buildings |
|
|
||||||
Computer equipment and other assets |
|
|
||||||
Assets under construction and payments on account |
|
|
||||||
Land |
|
|
||||||
|
|
|||||||
Less—accumulated depreciation |
( |
) | ( |
) | ||||
$ | |
$ | |
|||||
|
Gross carrying amount net of impairment |
Accumulated amortization |
Net carrying amount |
|||||||||||||||||||||
|
December 31, |
|||||||||||||||||||||||
|
2019 |
2018 |
2019 |
2018 |
2019 |
2018 |
||||||||||||||||||
|
(U.S. $ in millions) |
|||||||||||||||||||||||
Product rights |
$ | |
$ | |
$ | |
$ | |
$ | |
$ | |
||||||||||||
Trade names |
|
|
|
|
|
|
||||||||||||||||||
In-process research and development (IPR&D) |
|
|
— |
— |
|
|
||||||||||||||||||
Total |
$ | |
$ | |
$ | |
$ | |
$ | |
$ | |
||||||||||||
1. |
Identifiable product rights of $ mainly related to: (i) $million due to updated market assumptions regarding price and volume of $certain products acquired from Actavis Generics and primarily marketed in the United States, (ii)million related to a decrease in future expected sales in Japan as a result of generic competition, and (iii) $ the discontinuation of certain products from Actavis Generics ’ portfolio in several international markets. |
2. | IPR&D assets of $ million related to various generic pipeline products acquired from Actavis Generics , due to development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date or discount rate) in the United States, (ii) $ 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) $ related to a change in assumptions concerning the future European market share of a number of pipeline products acquired from Actavis Generics. |
North America |
Europe |
International Market |
Other |
Total |
||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||
Balance as of January 1, 201 8 (1) |
|
|
|
|
|
|||||||||||||||
Changes during the year: |
||||||||||||||||||||
Goodwill impairment (2) |
— |
— |
( |
) |
( |
) |
( |
) | ||||||||||||
Goodwill disposal (3) |
— |
( |
) |
( |
) |
— |
( |
) | ||||||||||||
Goodwill reclassified as assets to held for sale |
— |
( |
) |
— |
( |
) |
( |
) | ||||||||||||
Translation differences and Other |
( |
) |
( |
) |
( |
) |
|
( |
) | |||||||||||
Balance as of December 31, 201 8 (1) |
$ |
|
$ |
|
$ |
|
$ |
|
$ |
|
||||||||||
Changes during the year: |
||||||||||||||||||||
Goodwill disposal |
( |
) |
( |
) | — |
— |
( |
) | ||||||||||||
Translation differences and Other |
|
( |
) | |
— |
( |
) | |||||||||||||
Balance as of December 31, 201 9 (1) |
$ | |
$ | |
$ | |
$ | |
$ | |
||||||||||
(1) | Accumulated goodwill impairment as of December 31, 2019, December 31, 2018 and January 1, 2018 was approximately $b |
(2) | Goodwill impairment mainly attributable to the International Markets segment , Mexico and Medis. |
( 3 ) |
Mainly due to the divestment of the women’s health business, the sale of Actavis Brazil and other activities. |
• |
In the second quarter of 2019, management noted a difference with regard to sales projections of AJOVY and AUSTEDO in the International Markets reporting unit. Management continues to believe that the majority of analysts do not focus on this market in preparing their financial models and, as a result, have not attributed value to the launch potential in this reporting unit. Accordingly, management’s projections exceed those it believes are being used by analysts, particularly in International Markets. However, if management were to conform to analyst expectations, the International Markets reporting unit’s fair value would approximate its book value. Future impairment charges, if any, reflecting conditions at that time may be materially different. |
• |
In the second quarter of 2019, management also noted a difference with regard to sales projections of AUSTEDO in the North America reporting unit, resulting in higher fair value as analyzed by management compared to Teva’s market capitalization. Management continues to believe that it has more accurate information based on its knowledge of the market and its growth and therefore no adjustment was incorporated to the fair value. |
• |
Management continues to believe market concerns regarding the volatility and uncertainty of certain litigation risks, namely from the opioid and price fixing litigations, are impacting its market capitalization. Management believes that these concerns led to an acute reaction, which resulted in a decline in Teva’s share price in the second quarter of 2019, and will continue to impact the Company’s stock price into 2020. However, developments in these cases are expected to clarify the outlook with regards to the opioid litigation, assuming the proposed settlement framework is finalized in 2020. Based upon Teva’s current estimates of fair value, even if management was to adjust the fair value of the North America reporting unit for this uncertainty, the estimated fair value would still exceed its carrying amount. |
|
Year ended December 31, 2019 |
| ||
|
(U.S. $ in millions) |
| ||
Operating lease cost: |
||||
Fixed payments and variable payments that depend on an index or rate |
$ |
|
||
Variable lease payments not included in the lease liability |
|
|||
Short-term lease cost |
|
|||
Total operating lease cost |
$ | |
||
|
Year ended December 31, 2019 |
| ||
(U.S. $ in millions) |
||||
Cash paid for amounts included in the measurement of lease liabilities: |
||||
Operating cash flows from operating leases |
$ |
|
||
|
|
|
| |
Right-of-use assets obtained in exchange for lease obligations(non-cash): |
||||
Operating leases |
$ |
|
December 31, 2019 |
||||
(U.S. $ in millions) |
||||
Operating leases: |
||||
Operating lease ROU assets |
$ |
|
||
Other current liabilities |
|
|||
Operating lease liabilities |
|
|||
Total operating lease liabilities |
$ |
|
||
December 31, |
||||
2019 |
||||
Weighted average remaining lease term |
||||
Operating leases |
years |
|||
Weighted average discount rate |
||||
Operating leases |
|
% |
December 31, |
||||
2019 |
||||
(U.S. $ in millions) |
||||
2020 |
$ |
|
||
2021 |
|
|||
2022 |
|
|||
2023 |
|
|||
2024 and thereafter |
|
|||
Total operating lease payments |
$ | |
||
Less: imputed interest |
|
|||
Present value of lease liabilities |
$ | |
December 31, |
||||
2018 |
||||
(U.S. $ in millions) |
||||
According to ASC 840: |
|
|
|
|
2019 |
$ |
|
||
2020 |
|
|||
2021 |
|
|||
2022 |
|
|||
2023 |
|
|||
2024 and thereafter |
|
|||
Total lease payments |
$ |
|
a. |
Short-term debt: |
December 31, |
||||||||||||||||
Weighted average interest rate as of December 31, 201 9 |
Maturity |
2019 |
2018 |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Bank and financial institutions |
— |
— |
— |
|
||||||||||||
Convertible debentures |
% |
|
|
|
||||||||||||
Current maturities of long-term liabilities |
|
|
||||||||||||||
Total short term debt |
$ | |
$ | |
||||||||||||
Weighted average interest 201 9 |
Maturity |
December 31, 2019 |
December 31, 2018 |
|||||||||||||
% |
(U.S. $ in millions) |
|||||||||||||||
Senior notes EUR |
|
% | |
$ | |
$ | |
|||||||||
Senior notes EUR |
|
% | |
|
|
|||||||||||
Senior notes EUR |
|
% | |
|
|
|||||||||||
Senior notes EUR |
|
% | |
|
|
|||||||||||
Senior notes EUR |
|
% | |
|
|
|||||||||||
Senior notes EUR |
|
% | |
|
|
|||||||||||
Senior notes EUR |
|
% | |
|
|
|||||||||||
Senior notes EUR |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
— |
|
Senior notes USD |
|
|
|
% |
|
|
|
|
|
|
|
|
|
|
— |
|
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
— |
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes USD |
|
% | |
|
|
|||||||||||
Senior notes CHF |
|
% | |
|
|
|||||||||||
Senior notes CHF |
|
% | |
|
|
|||||||||||
Fair value hedge accounting adjustments |
— |
( |
) | |||||||||||||
Total senior notes |
|
|
||||||||||||||
Other long-term debt |
|
% | |
|
|
|||||||||||
Less current maturities |
( |
) | ( |
) | ||||||||||||
Derivative instruments |
|
|
||||||||||||||
Less debt issuance costs |
( |
) | ( |
) | ||||||||||||
Total senior notes and loans |
$ | |
$ | |
(1) | During the first six months of 2019, Teva repurchased and canceled approximately $ |
(2) | In December 2019, Teva consummated an early redemption of |
(3) | In November 2019, Teva consummated a cash tender offer for its $ |
(4) | In November 2019, Teva Pharmaceutical Finance Netherlands II B.V, a Teva finance subsidiary, issued senior notes in an aggregate principal amount of bearing |
(5) | In November 2019, Teva Pharmaceutical Finance Netherlands III B.V, a Teva finance subsidiary, issued senior notes in an aggregate principal amount of $ bearing |
December 31, 2019 |
||||
(U.S. $ in millions) |
||||
2021 |
$ |
|||
2022 |
||||
2023 |
||||
2024 |
||||
2025 and thereafter |
||||
$ |
||||
a. |
Foreign exchange risk management: |
b. |
Interest risk management: |
c. |
Derivative instrument disclosure: |
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Cross-currency swap—cash flow hedge |
$ | — |
$ | |||||
Interest rate swap—fair value hedge |
— |
|||||||
Cross-currency swap—net investment hedge |
d. |
Derivative instrument outstanding: |
Fair value |
||||||||||||||||
Designated as hedging instruments |
Not designated as hedging instruments |
|||||||||||||||
December 31, 2019 |
December 31, 2018 |
December 31, 2019 |
December 31, 2018 |
|||||||||||||
Reported under |
(U.S. $ in millions) |
|||||||||||||||
Asset derivatives: |
||||||||||||||||
Other current assets: |
||||||||||||||||
Option and forward contracts |
$ | — |
$ | — |
$ | |
$ | |||||||||
Other non-current assets: |
||||||||||||||||
Cross-currency swaps—cash flow hedge |
— |
|||||||||||||||
Liability derivatives: |
||||||||||||||||
Other current liabilities: |
||||||||||||||||
Cross-currency swaps—net investment hedge |
( |
) | — |
|||||||||||||
Option and forward contracts |
— |
— |
( |
) | ( |
) | ||||||||||
Other taxes and long-term liabilities: |
||||||||||||||||
Cross-currency swaps—net investment hedge |
— |
( |
) | — |
— |
|||||||||||
Senior notes and loans: |
||||||||||||||||
Interest rate swaps—fair value hedge |
— |
( |
) | — |
— |
Financial expenses, net |
Other comprehensive income |
|||||||||||||||||||||||
Year ended December 31, |
Year ended December 31, |
|||||||||||||||||||||||
2019 |
2018** |
2017** |
2019 |
2018** |
2017** |
|||||||||||||||||||
Reported under |
(U.S. $ in millions) |
|||||||||||||||||||||||
Line items in which effects of hedges are recorded |
$ | $ | $ | $ | $ | ( |
) | $ | ||||||||||||||||
Cross-currency swaps—cash flow hedge (1) |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||
Cross-currency swaps—net investment hedge (2) |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||||
Interest rate swaps—fair value hedge (3) |
* |
( |
) | — |
— |
— |
* |
Represents an amount less than $0.5 million. |
** |
Comparative figures are based on prior hedge accounting standard. |
Financial expenses, net |
Net revenues |
|||||||||||||||||||||||
Year ended December 31, |
Year ended December 31, |
|||||||||||||||||||||||
2019 |
2018 |
2017 |
2019 |
2018 |
2017 |
|||||||||||||||||||
Reported under |
(U.S. $ in millions) |
|||||||||||||||||||||||
Line items in which effects of hedges are recorded |
$ | $ | $ | $ | $ | $ | ||||||||||||||||||
Option and forward contracts (4) |
( |
) | ( |
) | — |
— |
— |
|||||||||||||||||
Option and forward contracts Economic hedge (5) |
— |
— |
— |
( |
) | — |
(1) | With respect to cross-currency swap agreements, Teva recognized gains which mainly reflect the differences between the fixed interest rate and the floating interest rate. In the fourth quarter of 2019, Teva terminated cross-currency swap agreements against its outstanding |
(2) | In each of the first and second quarters of 2017, Teva entered into a cross currency swap agreement with a notional amount of $ float-for-float interest rates paid in euros and received in U.S. dollar . No amounts were reclassified from accumulated other comprehensive income into income related to the sale of a subsidiary. |
(3) | In the fourth quarter of 2016, Teva entered into an interest rate swap agreement designated as fair value hedge relating to its cash proceeds of $fair value hedge instruments, which are recorded under senior notes and loans, are amortized under financial expenses-net over the life of the debt as additional interest expense. |
(4) | 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. |
(5) | Teva entered into option and forward contracts designed to limit the exposure of foreign exchange fluctuations on revenues and expenses recorded in euro, the British pound, the Russian ruble and some other currencies during the quarter for which such instruments are purchased. These derivative instruments do not meet the criteria for hedge accounting, however, they are accounted for as economic hedge. These derivative instruments are recognized on the Balance Sheet at their fair value, with changes in the fair value recognized under 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. |
Matured forward starting interest rate swaps and treasury lock agreements: |
f. |
Securitization: |
As of and for the year ended December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Sold receivables at the beginning of the year |
$ | $ | ||||||
Proceeds from sale of receivables |
||||||||
Cash collections (remitted to the owner of the receivables) |
( |
) | ( |
) | ||||
Effect of currency exchange rate changes |
( |
) | ||||||
Sold receivables at the end of the year |
$ |
$ | ||||||
a. |
Commitments: |
b. |
Contingencies: |
a. |
Income (loss) before income taxes: |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Parent Company and its Israeli subsidiaries |
$ | $ | $ | |||||||||
Non-Israeli subsidiaries |
( |
) | ( |
) | ( |
) | ||||||
$ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
b. |
Income taxes: |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
In Israel |
$ | $ | $ | |||||||||
Outside Israel |
( |
) | ( |
) | ( |
) | ||||||
$ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
Current |
$ | $ | $ | |||||||||
Deferred |
( |
) | ( |
) | ( |
) | ||||||
$ | ( |
) | $ | ( |
) | $ | ( |
) | ||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Income ( L oss) before income taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Statutory tax rate in Israel |
% | % | % | |||||||||
Theoretical provision for income taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Increase (decrease) in effective tax rate due to: |
||||||||||||
The Parent Company and its Israeli subsidiaries - Mainly tax benefits arising from reduced tax rates under benefit programs |
( |
) | ( |
) | ( |
) | ||||||
Non-Israeli subsidiaries, including impairments (*) |
( |
) | ||||||||||
U.S. Tax Cuts and Jobs Act effect |
( |
) | ||||||||||
Increase (decrease) in other uncertain tax positions—net |
( |
) | ||||||||||
Effective consolidated income taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
* |
In 2019, i ncome before income taxes includes intangible impairments in non-Israeli subsidiaries with a corresponding tax effect. In 2017 and 2018, i ncome before income taxes includes goodwill impairments in non-Israeli subsidiaries that did |
c. |
Deferred income taxes: |
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Long-term deferred tax assets (liabilities)—net: |
||||||||
Inventory related |
$ | $ | ||||||
Sales reserves and allowances |
||||||||
Provision for legal settlements |
||||||||
Intangible assets (*) |
( |
) | ( |
) | ||||
Carryforward losses and deductions and credits (**) |
||||||||
Property, plant and equipment |
( |
) | ( |
) | ||||
Deferred interest |
||||||||
Provisions for employee related obligations |
||||||||
Other |
||||||||
( |
) | |||||||
Valuation allowance—in respect of carryforward losses and deductions that may not be utilized (**) |
( |
) | ( |
) | ||||
$ | ( |
) | $ | ( |
) | |||
* | The decrease in deferred tax liability is mainly due to impairment and amortization. |
** | The amounts are shown after reduction for unrecognized tax benefits of $ |
Th ese amounts represent the tax effect of gross carryforward losses and deductions with the following expirations: - —$2029—$ |
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Long-term assets—deferred income taxes |
||||||||
Long-term liabilities—deferred income taxes |
( |
) | ( |
) | ||||
$ | ( |
) | $ | ( |
) | |||
d. |
Uncertain tax positions: |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Balance at the beginning of the year |
$ | $ | $ | |||||||||
Increase related to prior year tax positions, net |
||||||||||||
Increase related to current year tax positions |
||||||||||||
Decrease related to settlements with tax authorities and lapse of applicable statutes of limitations |
( |
) | ( |
) | ( |
) | ||||||
Liabilities assumed in acquisitions |
— |
— |
||||||||||
Other |
— |
— |
||||||||||
Balance at the end of the year |
$ | $ | $ | |||||||||
e. |
Tax assessments: |
f. |
Basis of taxation: |
a. | Investment of at least |
b. | One of the following: |
a. | At least |
b. | A venture capital investment approximately equivalent to at least $ |
c. | Growth in sales or workforce by an average of |
a. |
Ordinary shares and ADSs |
b. |
Mandatory convertible preferred shares |
c. |
Stock-based compensation plans: |
Year ended December 31, |
||||||||||||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||||||||||
Number (in thousands) |
Weighted average exercise price |
Number (in thousands) |
Weighted average exercise price |
Number (in thousands) |
Weighted average exercise price |
|||||||||||||||||||
Balance outstanding at begin n ing of year |
$ |
$ | $ | |||||||||||||||||||||
Changes during the year: |
||||||||||||||||||||||||
Granted |
— |
— |
||||||||||||||||||||||
Exercised |
( |
) | ( |
) | ( |
) | ||||||||||||||||||
Forfeited |
( |
) | ( |
) | ( |
) | ||||||||||||||||||
Expired |
— |
— |
( |
) | ( |
) | ||||||||||||||||||
Balance outstanding at end of year |
||||||||||||||||||||||||
Balance exercisable at end of year |
||||||||||||||||||||||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Weighted average fair value |
— |
$ |
$ |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
Dividend yield |
— |
% |
% | |||||||||
Expected volatility |
— |
% |
% | |||||||||
Risk-free interest rate |
— |
% |
% |
(1) Number of ordinary shares issuable upon exercise of outstanding options |
||||||||||||||||
|
Balance at end of period (in thousands) |
Weighted average exercise price |
Weighted average remaining life |
Aggregate intrinsic value (in millions) |
||||||||||||
Number of shares |
$ |
Years |
$ |
|||||||||||||
Lower than $ |
|
|
|
|
||||||||||||
$ |
|
|
|
— |
||||||||||||
$ |
|
|
|
— |
||||||||||||
$ |
|
|
|
— |
||||||||||||
$ |
|
|
|
— |
||||||||||||
$ |
|
|
|
— |
||||||||||||
Total |
|
|
|
— |
||||||||||||
(2) Number of ordinary shares issuable upon exercise of vested options |
||||||||||||||||
|
Balance at end of period (in thousands) |
Weighted average exercise price |
Weighted average remaining life |
Aggregate intrinsic value (in millions) |
||||||||||||
Number of shares |
$ |
Years |
$ |
|||||||||||||
Lower than $ |
|
|
|
— |
||||||||||||
$ - $ |
|
|
|
— |
||||||||||||
$ - $ |
|
|
|
— |
||||||||||||
$ - $ |
|
|
|
— |
||||||||||||
$ - $ |
|
|
|
— |
||||||||||||
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
|
— |
||||||||||||
Year ended December 31, |
||||||||||||||||||||||||
2019 |
2018 |
2017 |
||||||||||||||||||||||
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 |
|
$ | |
|
$ | |
|
$ | |
|||||||||||||||
Granted |
|
|
|
|
|
|
||||||||||||||||||
Vested |
( |
) | |
( |
) | |
( |
) | |
|||||||||||||||
Forfeited |
( |
) | |
( |
) | |
( |
) | |
|||||||||||||||
Balance outstanding at end of year |
|
|
|
|
|
|
||||||||||||||||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Employee stock options |
$ | |
$ | |
$ | |
||||||
RSUs and PSUs |
|
|
|
|||||||||
Total stock-based compensation expense |
|
|
|
|||||||||
Tax effect on stock-based compensation expense |
|
|
|
|||||||||
Net effect |
$ | |
$ | |
$ | |
||||||
d. |
Dividends: |
e. |
Accumulated other comprehensive loss: |
Net Unrealized Gains/(Losses) |
Benefit Plans |
|||||||||||||||||||
Foreign currency translation adjustments |
Available- for- sale securities |
Derivative financial instruments |
Actuarial gains/(losses) and prior service (costs)/credits |
Total |
||||||||||||||||
Balance, January 1, 201 7 |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Other comprehensive income/(loss) before reclassifications |
|
|
( |
) | ( |
) | |
|||||||||||||
Amounts reclassified to the statements of income |
|
( |
) | |
( |
) | |
|||||||||||||
Net other comprehensive income/(loss) before tax |
|
( |
) | ( |
) | ( |
) | |
||||||||||||
Corresponding income tax |
|
|
— |
( |
) | |
||||||||||||||
Net other comprehensive income/(loss) after tax* |
|
|
( |
) | ( |
) | |
|||||||||||||
Balance, December 31, 2017 |
( |
) | ( |
) | ( |
) | ( |
) | ( |
) | ||||||||||
Cumulative effect of new accounting standard ** |
— |
|
— |
— |
|
|||||||||||||||
Other comprehensive income/(loss) before reclassifications |
( |
) | ( |
) | |
|
( |
) | ||||||||||||
Amounts reclassified to the statements of income |
|
|
|
|
||||||||||||||||
Net other comprehensive income/(loss) before tax |
( |
) | — |
|
|
( |
) | |||||||||||||
Corresponding income tax |
— |
|
— |
( |
) | ( |
) | |||||||||||||
Net other comprehensive income/(loss) after tax* |
( |
) | — |
|
|
( |
) | |||||||||||||
Balance, December 31, 2018 |
( |
) | |
( |
) | ( |
) | ( |
) | |||||||||||
Other comprehensive income/(loss) before reclassifications |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
( |
) |
|
|
|
|
Amounts reclassified to the statements of income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
|
|
Net other comprehensive income/(loss) before tax |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
( |
) |
|
|
|
|
Corresponding income tax |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
|
|
|
|
|
|
Net other comprehensive income/(loss) after tax* |
|
|
|
|
|
|
( |
) |
|
|
|
|
|
|
( |
) |
|
|
|
|
Balance, December 31, 2019 |
|
|
( |
) |
|
|
— |
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
* | Amounts do not include foreign currency translation adjustments attributable to non-controlling interests of $9 , $gain in 2018 and $7 . |
** | Following the adoption of ASU 2016-01, the Company recorded a $ |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Impairment of long-lived tangible assets |
$ | |
$ | |
$ | |
||||||
Contingent consideration (see note 2 0 ) |
|
|
|
|||||||||
Acquisition, integration and related costs |
— |
|
|
|||||||||
Restructuring |
|
|
|
|||||||||
Venezuela deconsolidation charge (see note 1) |
— |
— |
|
|||||||||
Other |
|
( |
) | |
||||||||
Total |
$ | |
$ | |
$ | |
||||||
(1) |
Including impairments related to exit and disposal activities |
Year ended December 31, |
||||||||||||
201 9 |
201 8 |
201 7 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Restructuring |
||||||||||||
|
$ | |
$ | |
$ | |
||||||
|
|
|
|
|||||||||
Total |
$ | |
$ | |
$ | |
||||||
Employee termination costs |
Other |
Total |
||||||||||
(U.S. $ in millions) |
||||||||||||
Balance as of January 1, 201 8 |
$ | ( |
) |
$ | ( |
) | $ | ( |
) | |||
Provision |
( |
) | ( |
) | ( |
) | ||||||
Utilization and other* |
|
|
|
|||||||||
Balance as of December 31, 201 8 |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
Provision |
( |
) | ( |
) | ( |
) | ||||||
Utilization and other* |
|
|
|
|||||||||
Balance as of December 31, 201 9 |
$ | ( |
) | $ | ( |
) |
$ | ( |
) | |||
* |
Includes adjustments for foreign currency translation. |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Gain on divestitures, net of divestitures related costs (1) |
$ | |
|
|
||||||||
Section 8 and similar payments (2) |
|
|
|
|||||||||
Gain ( on sale of assets loss) |
( |
) | |
|
||||||||
Other, net |
|
|
|
|||||||||
Total other income |
$ | |
$ | |
$ | |
||||||
(1) | Mainly related to the divestment of several activities in the International Markets segment. |
(2) | Section 8 of the Patented Medicines (Notice of Compliance) Regulation relates to recoveries of lost revenue related to patent infringement proceedings in Canada. |
Year ended December, 31 |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Venezuela devaluation (1) |
$ | |
$ | |
$ | |
||||||
Interest expenses and other bank charges |
|
|
|
|||||||||
Income from investments |
( |
) | ( |
) | ( |
) | ||||||
Foreign exchange (gains) losses — net |
( |
) | |
|
||||||||
Other, net (2) |
( |
) | |
( |
) | |||||||
Total finance expense—net |
$ | |
$ | |
$ | |
||||||
(1) |
For further information regarding the Venezuela devaluation, refer to note 1a. |
(2) | In 2018 , |
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions, except share data) |
||||||||||||
Net income (loss) used for the computation of diluted loss per share |
$ |
( |
) | $ |
( |
) | $ | ( |
) | |||
Weighted average number of shares used in the computation of basic loss per share |
|
|
|
|||||||||
Add: |
||||||||||||
Weighted average number of shares used in the computation of diluted loss per share |
|
|
|
|||||||||
(a) | North America segment, which includes the United States and Canada. |
(b) | Europe segment, which includes the European Union and certain other European countries. |
(c) | International Markets segment, which includes all countries other than those in the North America and Europe segments. |
a. |
Segment information: |
Year ended December 31, |
||||||||||||
2019 |
||||||||||||
North |
Europe |
International * |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | |
$ |
|
$ | |
||||||
Gross profit |
|
|
|
|||||||||
R&D expenses |
|
|
|
|||||||||
S&M expenses |
|
|
|
|||||||||
G&A expenses |
|
|
|
|||||||||
Other income |
( |
) | ( |
) | ( |
) | ||||||
Segment profit |
$ | |
$ | |
$ | |
||||||
Year ended December 31, |
||||||||||||
2018 |
||||||||||||
North America |
Europe |
International Markets * |
||||||||||
(U.S. $ in millions) |
||||||||||||
Revenues |
$ | |
$ | |
$ | |
||||||
Gross profit |
|
|
|
|||||||||
R&D expenses |
|
|
|
|||||||||
S&M expenses |
|
|
|
|||||||||
G&A expenses |
|
|
|
|||||||||
Other income |
( |
) | — |
( |
) | |||||||
Segment profit |
$ | |
$ | |
$ | |
||||||
|
Year ended December 31, |
|||||||||||
|
2017 |
|||||||||||
|
North America |
Europe |
International Markets* |
|||||||||
|
(U.S. $ in millions) |
|||||||||||
Revenues |
$ | |
|
$ | |
|
$ | |
||||
Gross profit |
|
|
|
|||||||||
R&D expenses |
|
|
|
|||||||||
S&M expenses |
|
|
|
|||||||||
G&A expenses |
|
|
|
|||||||||
Other income |
( |
) | ( |
) | ( |
) | ||||||
Segment profit |
$ | |
$ | |
$ | |
* |
The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b. |
|
Year ended |
|||||||||||
|
December 31, |
|||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. |
||||||||||||
North America profit |
$ | |
$ | |
$ | |
||||||
Europe profit |
|
|
|
|||||||||
International Markets profit |
|
|
|
|||||||||
Total reportable segments profit |
|
|
|
|||||||||
Profit (loss) of other activities |
|
|
( |
) | ||||||||
Total segments profit |
|
|
|
|||||||||
Amounts not allocated to segments: |
||||||||||||
Amortization |
|
|
|
|||||||||
Other asset impairments, restructuring and other items |
|
|
|
|||||||||
Goodwill impairment |
— |
|
|
|||||||||
Intangible asset impairments |
|
|
|
|||||||||
Gain on divestitures, net of divestitures related costs |
( |
) | ( |
) | ( |
) | ||||||
Inve nto —r y St ep up |
|
|
— | |
|
|
— |
|
|
|
|
|
Other R&D expenses |
( |
) | |
|
||||||||
Costs related to regulatory actions taken in facilities |
|
|
|
|||||||||
Legal settlements and loss contingencies |
|
( |
) | |
||||||||
Other unallocated amounts |
|
|
|
|||||||||
Consolidated operating income (loss) |
( |
) | ( |
) | ( |
) | ||||||
Financial expenses, net |
|
|
|
|||||||||
Consolidated income (loss) before income taxes |
$ | ( |
) | $ | ( |
) | $ | ( |
) | |||
b. |
Segment revenues by major products and activities: |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Generic products |
$ | $ | $ | |||||||||
COPAXONE |
||||||||||||
BENDEKA/TREANDA |
||||||||||||
ProAir* |
||||||||||||
QVAR |
||||||||||||
AJOVY |
— |
|||||||||||
AUSTEDO |
||||||||||||
Anda |
||||||||||||
Other |
||||||||||||
Total |
$ | $ | $ | |||||||||
* | Does not include revenues from the ProAir authorized generic, which are included under generic products. |
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Generic products |
$ |
$ |
$ |
|||||||||
COPAXONE |
||||||||||||
Respiratory products |
||||||||||||
Other |
||||||||||||
Total |
$ |
$ |
$ |
5,466 |
||||||||
Year ended December 31, |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
(U.S. $ in millions) |
||||||||||||
Generic products |
$ |
$ |
$ |
|||||||||
COPAXONE |
||||||||||||
Distributio n |
||||||||||||
Other |
||||||||||||
Total |
$ |
$ |
$ |
|||||||||
* |
The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1b. |
c. |
Supplemental data — major customers: |
Percentage of Third Party Net Sales |
||||||||||||
2019 |
2018 |
2017 |
||||||||||
McKesson Corporation |
% |
% |
% | |||||||||
AmerisourceBergen Corporation |
% |
% |
% |
d. |
Property, plant and equipment—by geographical location were as follows: |
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Israel |
$ |
$ |
||||||
United States |
||||||||
Croatia |
||||||||
Germany |
||||||||
Czech republic |
||||||||
Hungary |
||||||||
Japan |
||||||||
Other |
||||||||
Total property, plant and equipment |
$ |
$ |
||||||
December 31, 2019 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money markets |
$ | $ | — |
$ | — |
$ | ||||||||||
Cash, deposits and other |
— |
— |
||||||||||||||
Investment in securities: |
||||||||||||||||
Equity securities |
— |
— |
||||||||||||||
Other, mainly debt securities |
— |
|||||||||||||||
Derivatives: |
||||||||||||||||
Asset derivatives — options and forward contracts |
— |
— |
||||||||||||||
Liabilities derivatives — options and forward contracts |
— |
( |
) | — |
( |
) | ||||||||||
Liabilities derivatives — interest rate and cross-currency swaps |
— |
( |
) | — |
( |
) | ||||||||||
Contingent consideration* |
— |
— |
( |
) | ( |
) | ||||||||||
Total |
$ | $ | ( |
) | $ | ( |
) | $ | ||||||||
December 31, 2018 |
||||||||||||||||
Level 1 |
Level 2 |
Level 3 |
Total |
|||||||||||||
(U.S. $ in millions) |
||||||||||||||||
Cash and cash equivalents: |
||||||||||||||||
Money markets |
$ | $ | — |
$ | — |
$ | ||||||||||
Cash, deposits and other |
— |
— |
||||||||||||||
Investment in securities: |
||||||||||||||||
Equity securities |
— |
— |
||||||||||||||
Other, mainly debt securities |
— |
|||||||||||||||
Derivatives: |
||||||||||||||||
Asset derivatives — options and forward contracts |
— |
— |
||||||||||||||
Asset derivatives — cross-currency swaps |
— |
— |
||||||||||||||
Liability derivatives — options and forward contracts |
— |
( |
) | — |
( |
) | ||||||||||
Liabilities derivatives — interest rate and cross-currency swaps |
— |
( |
) | — |
( |
) | ||||||||||
Contingent consideration* |
— |
— |
( |
) | ( |
) | ||||||||||
Total |
$ | $ | — |
|
$ | ( |
) | $ | ||||||||
* | Contingent consideration represents liabilities recorded at fair value in connection with acquisitions. |
December 31, 2019 |
December 31, 2018 |
|||||||
(U.S. $ in millions) |
||||||||
Fair value at the beginning of the period |
$ | ( |
) | $ | ( |
) | ||
Investment in debt securities |
( |
) | ||||||
Adjustments to provisions for contingent consideration: |
||||||||
Actavis Generics transaction |
— |
|||||||
Labrys acquisition |
— |
( |
) | |||||
Eagle transaction |
( |
) | ( |
) | ||||
Settlement of contingent consideration: |
||||||||
Labrys acquisition |
— |
|||||||
Eagle transaction |
||||||||
Fair value at the end of the period |
$ | ( |
) | $ | ( |
) | ||
Estimated fair value* |
||||||||
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Senior notes included under long-term liabilities |
$ | $ | ||||||
Senior notes and convertible senior debentures included under short-term liabilities |
||||||||
Fair value at the end of the period |
$ | $ | ||||||
* The fair value was estimated based on quoted market prices. |
a. |
Long-term employee-related obligations consisted of the following: |
December 31, |
||||||||
2019 |
2018 |
|||||||
(U.S. $ in millions) |
||||||||
Accrued severance obligations |
$ | $ | ||||||
Defined benefit plans |
||||||||
Total |
$ | $ | ||||||
b. |
Terms of arrangements: |
2019 |
||||||||||||||||
4th quarter |
3rd quarter |
2nd quarter |
1st quarter |
|||||||||||||
(U.S $ in millions except per share amounts) |
||||||||||||||||
Net revenues * |
||||||||||||||||
Gross profit |
||||||||||||||||
Net income (loss) |
( |
) |
( |
) |
( |
) | ||||||||||
Net income (loss) attributable to Teva |
( |
) |
( |
) |
( |
) | ||||||||||
Net income (loss) attributable to ordinary shareholders |
( |
) |
( |
) |
( |
) | ||||||||||
Earnings per share attributable to ordinary shareholders: |
||||||||||||||||
Basic |
( |
) |
( |
) |
( |
) | ||||||||||
Diluted |
( |
) |
( |
) |
( |
) |
2018 |
||||||||||||||||
4th quarter |
3rd quarter |
2nd quarter |
1st quarter |
|||||||||||||
(U.S $ in millions except per share amounts) |
||||||||||||||||
Net revenues * |
||||||||||||||||
Gross profit |
||||||||||||||||
Net income (loss) |
( |
) |
( |
) |
( |
) |
||||||||||
Net income (loss) attributable to Teva |
( |
) |
( |
) |
( |
) |
||||||||||
Net income (loss) attributable to ordinary shareholders |
( |
) |
( |
) |
( |
) |
||||||||||
Earnings per share attributable to ordinary shareholders: |
||||||||||||||||
Basic |
( |
) |
( |
) |
( |
) |
||||||||||
Diluted |
( |
) |
( |
) |
( |
) |
* |
The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See table below and not e 1b. |
Net revenues |
Cost of sales |
|||||||||||||||||||||||||||
As reported |
Adjustment |
As revised |
As reported |
Adjustment |
As revised |
|||||||||||||||||||||||
(U.S. $ in millions) |
||||||||||||||||||||||||||||
2018 |
Q1 |
( |
) |
( |
) |
|||||||||||||||||||||||
Q2 |
( |
) |
( |
) |
||||||||||||||||||||||||
Q3 |
( |
) |
( |
) |
||||||||||||||||||||||||
Q4 |
( |
) |
( |
) |
||||||||||||||||||||||||
2019 |
Q1 |
( |
) |
( |
) |
|||||||||||||||||||||||
Q2 |
( |
) |
( |
) |
||||||||||||||||||||||||
Q3 |
( |
) |
( |
) |
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, 2019 |
$ |
$ |
( |
) |
$ |
— |
$ |
( |
) |
$ |
||||||||||
Year ended December 31, 2018 |
$ |
$ |
$ |
( |
) |
$ |
( |
) |
$ |
|||||||||||
Year ended December 31, 2017 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||
Allowance in respect of carryforward tax losses and deductions that may not be utilized: |
||||||||||||||||||||
Year ended December 31, 2019 |
$ |
$ |
$ |
— |
$ |
( |
) |
$ |
||||||||||||
Year ended December 31, 2018 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||
Year ended December 31, 2017 |
$ |
$ |
$ |
$ |
( |
) |
$ |
|||||||||||||
(a) | The following financial statements are filed as part of this Annual Report on Form 10-K: |
page |
||||
97 |
||||
Consolidated Financial Statements: |
||||
101 |
||||
Statements of income (loss) |
102 |
|||
103 |
||||
104 |
||||
105 |
||||
107 |
||||
Financial Statement Schedule: |
||||
Report of Independent Registered Public Accounting Firm |
||||
183 |
3.1 |
Memorandum of Association (1)(2) | |||
3.2 |
||||
3.3 |
||||
4.1 |
||||
4.2 |
||||
4.3 |
||||
4.4 |
||||
4.5 |
||||
4.6 |
||||
4.7 |
||||
4.8 |
4.9 |
||||
4.10 |
||||
4.11 |
||||
4.12 |
||||
4.13 |
||||
4.14 |
||||
4.15 |
||||
4.16 |
||||
4.17 |
||||
4.18 |
||||
4.19 |
||||
4.20 |
||||
4.21 |
||||
4.22 |
||||
4.23 |
||||
4.24 |
4.25 |
||||
4.26 |
||||
4.27 |
||||
4.28 |
||||
4.29 |
||||
4.30 |
||||
4.31 |
||||
4.32 |
||||
4.33 |
||||
4.34 |
Other long-term debt instruments: The registrant hereby undertakes to provide the Securities and Exchange Commission with copies upon request. | |||
10.1 |
||||
10.2 |
||||
10.3 |
||||
10.4 |
||||
10.5 |
10.6 |
||||
10.7 |
||||
10.8 |
||||
10.9 |
||||
10.10 |
||||
10.11 |
||||
10.12 |
||||
10.13 |
||||
10.14 |
Teva Pharmaceutical Industries Limited 2015 Long-Term Equity-Based Incentive Plan (46) | |||
10.15 |
||||
10.16 |
||||
10.17 |
||||
10.18 |
||||
10.19 |
||||
10.20 |
||||
10.21 |
||||
10.22 |
||||
10.23 |
||||
10.24 |
||||
10.25 |
||||
10.26 |
10.27 |
||||
10.28 |
||||
10.29 |
||||
10.30 |
||||
10.31 |
||||
10.32 |
||||
21 |
||||
23 |
||||
31.1 |
||||
31.2 |
||||
32 |
||||
101.INS |
Inline XBRL Instance Document (The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document) | |||
101.SCH |
Inline XBRL Taxonomy Extension Schema Document | |||
101.CAL |
Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||
101.DEF |
Inline XBRL Taxonomy Extension Definition Linkbase Document | |||
101.LAB |
Inline XBRL Taxonomy Extension Labels Linkbase Document | |||
101.PRE |
Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||
104 |
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
* | Filed herewith |
1. | English translation or summary from Hebrew original, which is the official version. |
2. | Incorporated by reference to Exhibit 3.1 to Registration Statement on Form F-1(Reg. No. 33-15736). |
3. | Incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed on December 14, 2018. |
4. | Incorporated by reference to Exhibit 3.3 to Current Report on Form 8-K filed on December 14, 2018. |
5. | Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed on December 4, 2018. |
6. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on January 31, 2006. |
7. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on January 31, 2006. |
8. | Incorporated by reference to Exhibit 4.3 to Form 6-K filed on January 31, 2006. |
9. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on May 4, 2010. |
10. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on November 10, 2011. |
11. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on December 18, 2012. |
12. | Incorporated by reference to Exhibit 4.3 to Form 6-K filed on November 10, 2011. |
13. | Incorporated by reference to Exhibit 4.4 to Form 6-K filed on November 10, 2011. |
14. | Incorporated by reference to Exhibit 4.4 to Form 6-K filed on December 18, 2012. |
15. | Incorporated by reference to Exhibit 4.5 to Form 6-K filed on November 10, 2011. |
16. | Incorporated by reference to Exhibit 4.6 to Form 6-K filed on November 10, 2011. |
17. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on April 25, 2012. |
18. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on April 25, 2012. |
19. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on March 31, 2015. |
20. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on March 31, 2015. |
21. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on July 25, 2016. |
22. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on July 21, 2016. |
23. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on July 21, 2016. |
24. | Incorporated by reference to Exhibit 4.1 to Form 6-K filed on July 28, 2016. |
25. | Incorporated by reference to Exhibit 4.2 to Form 6-K filed on July 28, 2016. |
26. | Incorporated by reference to Exhibit 4.3 to Form 6-K filed on July 28, 2016. |
27. | Incorporated by reference to Exhibit 4.5 to Form 6-K filed on July 28, 2016. |
28. | Incorporated by reference to Exhibit 4.6 to Form 6-K filed on July 28, 2016. |
29. | Incorporated by reference to Exhibit 4.1 to Current Report on Form 8-K filed on March 14, 2018. |
30. | Incorporated by reference to Exhibit 4.2 to Current Report on Form 8-K filed on March 14, 2018. |
31. | Incorporated by reference to Exhibit 4.5 to Current Report on Form 8-K filed on March 14, 2018. |
32. | Incorporated by reference to Exhibit 4.6 to Current Report on Form 8-K filed on March 14, 2018. |
33. | Incorporated by reference to Exhibit 4.2 to Current Report on Form 8-K filed on November 25, 2019. |
34. | Incorporated by reference to Exhibit 4.4 to Current Report on Form 8-K filed on November 25, 2019. |
35. | Incorporated by reference to Exhibit 4.6 to Current Report on Form 8-K filed on November 25, 2019. |
36. | Incorporated by reference to Exhibit 4.8 to Current Report on Form 8-K filed on November 25, 2019. |
37. | Incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on April 10, 2019. |
38. | Incorporated by reference to Exhibit 10.20 to Annual Report on Form 10-K filed on February 12, 2018. |
39. | Incorporated by reference to Exhibit 10.27 to Annual Report on Form 10-K filed on February 12, 2018. |
40. | Incorporated by reference to Exhibit 10.29 to Annual Report on Form 10-K filed on February 12, 2018. |
41. | Incorporated by reference to Exhibit 10.30 to Annual Report on Form 10-K filed on February 12, 2018. |
42. | Incorporated by reference to Exhibit 10.31 to Annual Report on Form 10-K filed on February 12, 2018. |
43. | Incorporated by reference to Exhibit 10.32 to Annual Report on Form 10-K filed on February 12, 2018. |
44. | Incorporated by reference to Exhibit 10.26 to Annual Report on Form 10-K filed on February 19, 2019. |
45. | Incorporated by reference to Exhibit 10.1 to Quarterly Report on Form 10-Q filed on November 1, 2018. |
46. | Incorporated by reference to Exhibit A to Proxy Statement filed on June 8, 2017. |
47. | Incorporated by reference to Exhibit 10.49 to Annual Report on Form 10-K filed on February 12, 2018. |
48. | Incorporated by reference to Exhibit 10.50 to Annual Report on Form 10-K filed on February 12, 2018. |
49. | Incorporated by reference to Exhibit 10.51 to Annual Report on Form 10-K filed on February 12, 2018. |
50. | Incorporated by reference to Exhibit 10.52 to Annual Report on Form 10-K filed on February 12, 2018. |
51. | Incorporated by reference to Exhibit 10.53 to Annual Report on Form 10-K filed on February 12, 2018. |
52. | Incorporated by reference to Exhibit 10.54 to Annual Report on Form 10-K filed on February 12, 2018. |
53. | Incorporated by reference to Exhibit 10.56 to Annual Report on Form 10-K filed on February 12, 2018. |
54. | Incorporated by reference to Exhibit 10.57 to Annual Report on Form 10-K filed on February 12, 2018. |
55. | Incorporated by reference to Exhibit 10.58 to Annual Report on Form 10-K filed on February 12, 2018. |
56. | Incorporated by reference to Exhibit 10.60 to Annual Report on Form 10-K filed on February 12, 2018. |
57. | Incorporated by reference to Exhibit 10.61 to Annual Report on Form 10-K filed on February 12, 2018. |
58. | Incorporated by reference to Exhibit 10.63 to Annual Report on Form 10-K filed on February 12, 2018. |
59. | Incorporated by reference to Exhibit 10.64 to Annual Report on Form 10-K filed on February 12, 2018. |
60. | Incorporated by reference to Exhibit 10.65 to Annual Report on Form 10-K filed on February 12, 2018. |
TEVA PHARMACEUTICAL INDUSTRIES LIMITED |
By: |
/s/ Kåre Schultz | |
Name: |
Kåre Schultz | |
Title: |
President and Chief Executive Officer | |
Dated: |
February 21, 2020 |
Name |
Title |
Date | ||||
By: |
/s/ Dr. Sol J. Barer Dr. Sol J. Barer |
Chairman of the Board of Directors |
February 21, 2020 | |||
By: |
/s/ Kåre Schultz Kåre Schultz |
President and Chief Executive Officer and Director |
February 21, 2020 | |||
By: |
/s/ Eli Kalif Eli Kalif |
Executive Vice President, Chief Financial Officer (Principal Financial Officer) |
February 21, 2020 | |||
By: |
/s/ Deborah A. Griffin Deborah A. Griffin |
Senior Vice President, Chief Accounting Officer (Principal Accounting Officer) |
February 21, 2020 | |||
By: |
/s/ Rosemary A. Crane Rosemary A. Crane |
Director |
February 21, 2020 | |||
By: |
/s/ Amir Elstein Amir Elstein |
Director |
February 21, 2020 |
Name |
Title |
Date | ||||
By: |
/s/ Murray A. Goldberg Murray A. Goldberg |
Director |
February 21, 2020 | |||
By: |
/s/ Jean-Michel Halfon Jean-Michel Halfon |
Director |
February 21, 2020 | |||
By: |
/s/ Gerald M. Lieberman Gerald M. Lieberman |
Director |
February 21, 2020 | |||
By: |
/s/ Roberto A. Mignone Roberto A. Mignone |
Director |
February 21, 2020 | |||
By: |
/s/ Dr. Perry D. Nisen Dr. Perry D. Nisen |
Director |
February 21, 2020 | |||
By: |
/s/ Nechemia (Chemi) J. Peres Nechemia (Chemi) J. Peres |
Director |
February 21, 2020 | |||
By: |
/s/ Prof. Ronit Satchi-Fainaro Prof. Ronit Satchi-Fainaro |
Director |
February 21, 2020 |