UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

 

FORM10-Q

 

 

 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31,September 30, 2018

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number001-16174

 

 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

(Exact name of registrant as specified in its charter)

 

 

 

Israel Not Applicable
(State or other jurisdiction of incorporation or organization) (IRS Employer Identification Number)
5 Basel Street, Petach Tikva, ISRAEL 4951033
(Address of principal executive offices) (Zip code)

+972(3) 914-8171

(Registrant’s telephone number, including area code)

 

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of RegulationS-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes  ☒    No  ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, anon-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule12b-2 of the Exchange Act.

 

Large accelerated filer   Accelerated filer 
Non-accelerated filer   (Do not check if a smaller reporting company)  Smaller reporting company 
Emerging growth company    

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule12b-2 of the Act).    Yes  ☐    No  ☒

As of AprilOctober 30, 2018, the registrant had 1,018,226,8031,018,711,443 ordinary shares outstanding.

 

 

 


TEVA PHARMACEUTICAL INDUSTRIES LIMITED

INDEX

 

PART I.

 Page No.

PART I – FINANCIAL INFORMATION

  

Item 1.

 

Financial Statements (unaudited)

Consolidated Balance Sheets

4

Consolidated Statements of Income (loss)

   5 

Consolidated Statements of Comprehensive Income (loss)

6

Consolidated Statements of Cash Flows

7

Notes to Consolidated Financial Statements

8

Item 2.

 

Management’s Discussion and Analysis of Financial Condition and Results of Operations

   5044 

Item 3.

 

Quantitative and Qualitative Disclosures about Market Risk

   7477 

Item 4.

 

Controls and Procedures

   7578 

PART II.

PART II – OTHER INFORMATION

  

Item 1.

 

Legal Proceedings

   7679 

Item 1A1A.

 

Risk Factors

   7679 

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

   7679 

Item 3.

 

Defaults Upon Senior Securities

   7679 

Item 4.

 

Mine Safety Disclosures

   7679 

Item 5.

 

Other Information

   7679 

Item 6.

 

Exhibits

   7779 

SIGNATURES

  78Signatures80 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

INTRODUCTION AND USE OF CERTAIN TERMS

Unless otherwise indicated, all references to the “Company,” “we,” “our” and “Teva” refer to Teva Pharmaceutical Industries Limited and its subsidiaries, and references to “revenues” refer to net revenues. References to “U.S. dollars,” “dollars,” “U.S. $” and “$” are to the lawful currency of the United States of America, and references to “NIS” are to new Israeli shekels. References to “MS” are to multiple sclerosis. Market data, including both sales and share data, is based on information provided by IQVIA (formerly IMS Health Inc.), a provider of market research to the pharmaceutical industry (“IQVIA”), unless otherwise stated. References to “Actavis Generics” are to the generic pharmaceuticals business we purchased from Allergan plc (“Allergan”) on August 2, 2016. References to “P&G” are to The Procter & Gamble Company, and references to “PGT” are to PGT Healthcare, the joint venture we formed with P&G. References to “R&D” are to Research and Development, references to “IPR&D” are toin-process R&D, references to “S&M” are to Selling and Marketing and references to “G&A” are to General and Administrative. Some amounts in this report may not add up due to rounding. All percentages have been calculated using unrounded amounts.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

In addition to historical information, this Quarterly Report on Form10-Q, and the reports and documents incorporated by reference in this Quarterly Report on Form10-Q, may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly

from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to:

 

 

 

our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; 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; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights;

 

our substantially increasedsubstantial indebtedness, and significantly decreased cash on hand, 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: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation; interruptions in our supply chain; disruptions of our or third party information technology systems or breaches of our data security; the failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; 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 in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;

 

compliance, regulatory and litigation matters, including: 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;

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

 

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;

and other factors discussed in Item 1A to our Annual Report on Form10-K for the year ended December 31, 2017.2017, including the sections thereof captioned “Risk Factors” and “Forward Looking Statements,” and in our subsequent quarterly reports on Form10-Q and other filings with the Securities and Exchange Commission, which are available atwww.sec.gov andwww.tevapharm.com. Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

PART I — FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

CONSOLIDATED BALANCE SHEETS

(U.S. dollars in millions)

(Unaudited)

 

   March 31,
2018
  December 31,
2017
 

ASSETS

   

Current assets:

   

Cash and cash equivalents

  $1,418  $963 

Trade receivables

   6,289   7,128 

Inventories

   5,113   4,924 

Prepaid expenses

   1,138   1,100 

Other current assets

   712   701 

Assets held for sale

   17   566 
  

 

 

  

 

 

 

Total current assets

   14,687   15,382 

Deferred income taxes

   463   574 

Othernon-current assets

   832   932 

Property, plant and equipment, net

   7,420   7,673 

Identifiable intangible assets, net

   17,314   17,640 

Goodwill

   28,465   28,414 
  

 

 

  

 

 

 

Total assets

  $69,181  $70,615 
  

 

 

  

 

 

 

LIABILITIES AND EQUITY

   

Current liabilities:

   

Short-term debt

  $1,302  $3,646 

Sales reserves and allowances

   7,410   7,881 

Trade payables

   1,929   2,069 

Employee-related obligations

   607   549 

Accrued expenses

   2,632   3,014 

Other current liabilities

   876   724 

Liabilities held for sale

   —     38 
  

 

 

  

 

 

 

Total current liabilities

   14,756   17,921 

Long-term liabilities:

   

Deferred income taxes

   2,998   3,277 

Other taxes and long-term liabilities

   1,875   1,843 

Senior notes and loans

   29,450   28,829 
  

 

 

  

 

 

 

Total long-term liabilities

   34,323   33,949 
  

 

 

  

 

 

 

Commitments and contingencies, see note 16

   

Total liabilities

   49,079   51,870 
  

 

 

  

 

 

 

Equity:

   

Teva shareholders’ equity:

   

Preferred shares of NIS 0.10 par value per mandatory convertible preferred share; March 31, 2018 and December 31, 2017: authorized 5.0 million shares; issued 3.7 million shares

   3,696   3,631 

Ordinary shares of NIS 0.10 par value per share; March 31, 2018 and December 31, 2017: authorized 2,495 million shares; issued 1,124 million shares

   54   54 

Additionalpaid-in capital

   23,443   23,479 

Retained earnings

   (2,688  (3,808

Accumulated other comprehensive loss

   (1,735  (1,848

Treasury shares as of March 31, 2018 and December 31, 2017 —106 million ordinary shares and 107 million ordinary shares, respectively

   (4,149  (4,149
  

 

 

  

 

 

 
   18,621   17,359 
  

 

 

  

 

 

 

Non-controlling interests

   1,481   1,386 
  

 

 

  

 

 

 

Total equity

   20,102   18,745 
  

 

 

  

 

 

 

Total liabilities and equity

  $69,181  $70,615 
  

 

 

  

 

 

 

The accompanying notes are an integral part of the financial statements.

  September 30,  December 31, 
  2018  2017 

ASSETS

  

Current assets:

  

Cash and cash equivalents

 $1,875  $963 

Trade receivables

  5,665   7,128 

Inventories

  4,866   4,924 

Prepaid expenses

  911   1,100 

Other current assets

  483   701 

Assets held for sale

  81   566 
 

 

 

  

 

 

 

Total current assets

  13,881   15,382 

Deferred income taxes

  427   574 

Othernon-current assets

  722   932 

Property, plant and equipment, net

  7,101   7,673 

Identifiable intangible assets, net

  15,345   17,640 

Goodwill

  27,585   28,414 
 

 

 

  

 

 

 

Total assets

 $65,061  $ 70,615 
 

 

 

  

 

 

 

LIABILITIES AND EQUITY

  

Current liabilities:

  

Short-term debt

 $2,673  $3,646 

Sales reserves and allowances

  6,701   7,881 

Trade payables

  1,626   2,069 

Employee-related obligations

  712   549 

Accrued expenses

  2,232   3,014 

Other current liabilities

  886   724 

Liabilities held for sale

  —     38 
 

 

 

  

 

 

 

Total current liabilities

  14,830   17,921 

Long-term liabilities:

  

Deferred income taxes

  2,478   3,277 

Other taxes and long-term liabilities

  1,803   1,843 

Senior notes and loans

  26,816   28,829 
 

 

 

  

 

 

 

Total long-term liabilities

  31,097   33,949 
 

 

 

  

 

 

 

Commitments and contingencies, see note 16

  

Total liabilities

  45,927   51,870 
 

 

 

  

 

 

 

Equity:

  

Teva shareholders’ equity:

  

Preferred shares of NIS 0.10 par value per mandatory convertible preferred share; September 30, 2018 and December 31, 2017: authorized 5.0 million shares; issued 3.7 million shares

  3,825   3,631 

Ordinary shares of NIS 0.10 par value per share; September 30, 2018 and December 31, 2017: authorized 2,495 million shares; issued 1,125 million shares and 1,124 million shares, respectively

  54   54 

Additionalpaid-in capital

  23,404   23,479 

Accumulated deficit

  (3,072  (3,808

Accumulated other comprehensive loss

  (2,335  (1,848

Treasury shares as of September 30, 2018 and December 31, 2017 — 106 million ordinary shares and 107 million ordinary shares, respectively

  (4,146  (4,149
 

 

 

  

 

 

 
  17,730   17,359 
 

 

 

  

 

 

 

Non-controlling interests

  1,404   1,386 
 

 

 

  

 

 

 

Total equity

  19,134   18,745 
 

 

 

  

 

 

 

Total liabilities and equity

 $  65,061  $70,615 
 

 

 

  

 

 

 

 

The accompanying notes are an integral part of the financial statements.

 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

CONSOLIDATED STATEMENTS OF INCOME (LOSS)

(U.S. dollars in millions, except share and per share data)

(Unaudited)

 

                                                        
  Three months ended Nine months ended 
  Three months ended
March 31,
   September 30, September 30, 
  2018 2017   2018 2017 2018 2017 

Net revenues

  $5,065  $5,650   $4,529  $5,617  $14,295  $16,987 

Cost of sales

   2,717  2,811    2,508   2,967   7,865   8,643 
  

 

  

 

   

 

  

 

  

 

  

 

 

Gross profit

   2,348  2,839    2,021   2,650   6,430   8,344 

Research and development expenses

   317  432    311   531   918   1,432 

Selling and marketing expenses

   771  958    743   843   2,224   2,745 

General and administrative expenses

   329  366    309   372   954   1,101 

Other asset Impairments, restructuring and other items

   707  240 

Other asset impairments, restructuring and other items

   658   550   2,080   1,209 

Goodwill impairment

   180   —      —     —     300   6,100 

Legal settlements and loss contingencies

   (1,278 20    19   (20  (1,239  324 

Other income

   (203 (72   (35  (4  (334  (100
  

 

  

 

   

 

  

 

  

 

  

 

 

Operating income

   1,525  895 

Operating income (loss)

   16   378   1,527   (4,467

Financial expenses, net

   271  207    229   259   736   704 
  

 

  

 

   

 

  

 

  

 

  

 

 

Income before income taxes

   1,254  688 

Income taxes

   46  54 

Share in (profits) losses of associated companies, net

   74  (7

Income (loss) before income taxes

   (213  119   791   (5,171

Tax benefits

   (26  (494  (56  (462

Share in losses of associated companies, net

   10   3   76   10 
  

 

  

 

   

 

  

 

  

 

  

 

 

Net income

   1,134  641 

Net Income (loss) attributable tonon-controlling interests

   14  (4

Net income (loss)

   (197  610   771   (4,719

Net income attributable tonon-controlling interests

   11   15   35   11 
  

 

  

 

   

 

  

 

  

 

  

 

 

Net income attributable to Teva

   1,120  645 

Net income (loss) attributable to Teva

   (208  595   736   (4,730
  

 

  

 

   

 

  

 

  

��

 

  

 

 

Dividends on preferred shares

   65  65    65   65   195   195 
  

 

  

 

   

 

  

 

  

 

  

 

 

Net income attributable to ordinary shareholders

  $1,055  $580 

Net income (loss) attributable to ordinary shareholders

  $(273 $530  $541  $(4,925
  

 

  

 

   

 

  

 

  

 

  

 

 

Earnings per share attributable to ordinary shareholders:

   

Earnings (loss) per share attributable to ordinary shareholders:

     

Basic

  $1.04  $0.57   $(0.27 $0.52  $0.53  $(4.85
  

 

  

 

   

 

  

 

  

 

  

 

 

Diluted

  $1.03  $0.57   $(0.27 $0.52  $0.53  $(4.85
  

 

  

 

   

 

  

 

  

 

  

 

 

Weighted average number of shares (in millions):

        

Basic

   1,017  1,016    1,018   1,017   1,018   1,016 
  

 

  

 

   

 

  

 

  

 

  

 

 

Diluted

   1,020  1,017    1,018   1,017   1,020   1,016 
  

 

  

 

   

 

  

 

  

 

  

 

 

The accompanying notes are an integral part of the financial statements.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(U.S. dollars in millions)

(Unaudited)

 

   Three months ended
March 31,
 
   2018  2017 

Net income

  $1,134  $641 

Other comprehensive income, net of tax:

   

Currency translation adjustment

   239   466 

Unrealized gain (loss) from derivative financial instruments, net

   (44  8 

Unrealized gain fromavailable-for-sale securities, net

   1   54 

Unrealized loss on defined benefit plans

   —     (13
  

 

 

  

 

 

 

Total other comprehensive income

   196   515 
  

 

 

  

 

 

 

Total comprehensive income

   1,330   1,156 

Comprehensive income attributable tonon-controlling interests

   97   66 
  

 

 

  

 

 

 

Comprehensive income attributable to Teva

  $1,233  $1,090 
  

 

 

  

 

 

 
   Three months ended  Nine months ended 
   September 30,  September 30, 
   2018  2017  2018  2017 

Net income (loss)

  $(197 $610  $771  $(4,719

Other comprehensive income (loss), net of tax:

     

Currency translation adjustment

   (105  264   (577  1,136 

Unrealized gain (loss) from derivative financial instruments

   19   (49  75   (118

Unrealized gain (loss) fromavailable-for-sale securities

   1   (17  —     20 

Unrealized gain (loss) on defined benefit plans

   1   1   —     (12
  

 

 

  

 

 

  

 

 

  

 

 

 

Total other comprehensive income (loss)

   (84  199   (502  1,026 
  

 

 

  

 

 

  

 

 

  

 

 

 

Total comprehensive income (loss)

   (281  809   269   (3,693

Comprehensive income (loss) attributable tonon-controlling interests

   (26  11   20   75 
  

 

 

  

 

 

  

 

 

  

 

 

 

Comprehensive income (loss) attributable to Teva

  $    (255)  $    798  $     249  $    (3,768) 
  

 

 

  

 

 

  

 

 

  

 

 

 

The accompanying notes are an integral part of the financial statements.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

CONSOLIDATED STATEMENTS OF CASH FLOWS

(U.S. dollars in millions)

(Unaudited)

 

                            
  Three months ended
March 31,
   Nine months ended
September 30,
 
  2018 2017   2018 2017 

Operating activities:

      

Net income

  $1,134  $641 

Adjustments to reconcile net income to net cash provided by operations:

   

Net income (loss)

  $771  $(4,719

Adjustments to reconcile net income (loss) to net cash provided by operations:

   

Net change in operating assets and liabilities

   (592 (797   (1,521  (1,717

Depreciation and amortization

   1,460   1,584 

Impairment of long-lived assets

   432  11    1,501   564 

Depreciation and amortization

   507  480 

Deferred income taxes, net and uncertain tax positions

   (650  (733

Goodwill impairment

   180   —      300   6,100 

Deferred income taxes – net and uncertain tax positions

   (221 (217

Net gain from sale of long-lived assets and investments

   (106 (39

Stock-based compensation

   122   106 

Impairment of equity investment

   94   —      103   —   

Research and development in process

   54   —      54   175 

Stock-based compensation

   30  40 

Net gain from sale of long-lived assets and investments

   (53  (48

Other items

   (16 17    (8  9 

Venezuela impairment of net monetary assets

   —     45 
  

 

  

 

   

 

  

 

 

Net cash provided by operating activities

   1,496  136    2,079   1,366 
  

 

  

 

   

 

  

 

 

Investing activities:

      

Beneficial interest collected in exchange for securitized trade receivables

   1,372   962 

Proceeds from sales of business, investments and long-lived assets

   824  1,412    880   1,607 

Beneficial interest collected in exchanged for securitized trade receivables

   444  334 

Purchases of property, plant and equipment

   (163 (202   (438  (607

Purchases of investments and other assets

   (56 (6   (56  (194

Other investing activities

   (10 (22   34   (277

Acquisitions of subsidiaries, net of cash acquired

   —     43 
  

 

  

 

   

 

  

 

 

Net cash provided by investing activities

   1,039  1,516    1,792   1,534 
  

 

  

 

   

 

  

 

 

Financing activities:

      

Repayment of long-term loans and other long-term liabilities

   (6,243  —   

Proceeds from long-term loans, net of issuance costs

   4,440   —   

Repayment of senior notes and loans and other long-term liabilities

   (6,989  (1,005

Proceeds from senior notes and loans, net of issuance costs

   4,434   507 

Net change in short-term debt

   (261 (1,350   (262  (1,630

Other financing activities

   (13  (69

Dividends paid on ordinary shares

   (12 (346   (12  (814

Dividends paid on preferred shares

   (10 (65   (10  (195

Other financing activities

   (5 (7

Dividends paid tonon-controlling interests

   —     (38
  

 

  

 

   

 

  

 

 

Net cash used in financing activities

   (2,091 (1,768   (2,852  (3,244
  

 

  

 

   

 

  

 

 

Translation adjustment on cash and cash equivalents

   11  28    (107  36 
  

 

  

 

   

 

  

 

 

Net change in cash and cash equivalents

   455  (88   912   (308

Balance of cash and cash equivalents at beginning of period

   963  988    963   988 
  

 

  

 

   

 

  

 

 

Balance of cash and cash equivalents at end of period

  $1,418  $900   $1,875  $680 
  

 

  

 

   

 

  

 

 

Supplemental cash flow information:

   

Non-cash financing and investing activities:

      

Beneficial interest obtained in exchange for securitized trade receivables

  $551  $285   $1,345  $911 

The accompanying notes are an integral part of the financial statements.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Note 1 – Basis of presentation:

The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of management, the financial statements reflect all recurring adjustments necessary to fairly state the financial position and results of operations of Teva. The information included in this Quarterly Report on Form10-Q should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Form10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission (“SEC”). Amounts as of December 31, 2017 were derived from the audited balance sheet at that date, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included. Certain comparative figures have been reclassified to conform to current presentation. The results of operations for the threenine months ended March 31,September 30, 2018 are not necessarily indicative of results that could be expected for the entire fiscal year.

Note 2 - Significant accounting policies:

Recently adopted accounting pronouncements

On January 1, 2018, Teva adopted the new accounting standard ASC 606, Revenue from Contracts with Customers, and all the related amendments (“new revenue standard”) to all contracts using the modified retrospective method. The cumulative effect of initially applying the new revenue standard was immaterial. See note 9 for further discussion.

In May 2017, the FASB issued guidance on changes to terms and conditions of share-based payment awards. The amendment provides guidance about which changes to terms or conditions of a share-based payment award require an entity to apply modification accounting. The guidance is effective for the fiscal year beginning on January 1, 2018, including interim periods within that year. Teva adopted the provisions of this update in the first quarter of 2018. The impact that this new standard has on Teva’s financial statements after adoption will depend on any future modification of share-based compensation.

In February 2017, the FASB issued guidance onde-recognition of nonfinancial assets. The amendments address the recognition of gains and losses on the transfer (i.e., sale) of nonfinancial assets to counterparties other than customers. The guidance conformsde-recognition on nonfinancial assets with the model for transactions in the new revenue standard. Teva adopted the provisions of this update in the first quarter of 2018 with no material impact on its consolidated financial statements.

In August 2016, the FASB issued guidance on statements of cash flows. The guidance addresses eight specific issues: debt prepayment or debt extinguishment costs; settlement of certain debt instruments; contingent consideration payments made after a business combination; proceeds from the settlement of insurance claims; proceeds from the settlement of corporate-owned life insurance policies; distributions received from equity method investees; beneficial interest in securitization transactions; and separately identifiable cash flows and application of predominance principle. The amendments should be applied retrospectively. Teva adopted the provisions of this update in the first quarter of 2018. This resulted in athe reclassification of $444$962 million and $334 millionof beneficial interest in securitization transactions from operating activities to investing activities infor the first quarter of 2018 and 2017, respectively.nine month period ended September 30, 2017.

In January 2016, the FASB issued guidance which updates certain aspects of recognition, measurement, presentation and disclosure of equity investments. The guidance requires entities to recognize changes in fair value in net income rather than in accumulated other comprehensive income. Teva adopted the provisions of this update in the first quarter of 2018. Following the adoption, the Company recorded a $5 million opening balance reclassification from accumulated other comprehensive loss to retained earnings. See note 10.

Recently issued accounting pronouncements, not yet adopted

In FebruaryAugust 2018, the FASB issued guidance onthat aligns the recognition and measurement of financial assets and financial liabilities.requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtaininternal-use software. The guidance provides updates which address certain aspects of recognition, measurement, presentation and disclosure of financial instruments. The guidance iswill be effective for fiscal years beginning after December 15, 2017; however, public business entities with fiscal years beginning between December 15, 2017, and June 15, 2018 are not required to adopt these amendments until the interim period beginning after June 15, 2018. Teva2019, although early adoption is permitted. The Company is currently evaluating this guidance to determine the potential effect of the guidanceimpact it may have on its consolidated financial statements.

In August 2018, the FASB issued guidance that removes certain disclosure requirements related to the fair value hierarchy, modifies existing disclosure requirements related to measurement uncertainty and adds new disclosure requirements. The new disclosure requirements include disclosing the changes in unrealized gains and losses for the period included in other comprehensive

TEVA PHARMACEUTICAL INDUSTRIES LIMITEDincome for recurring Level 3 fair value measurements held at the end of the reporting period and the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements. Certain disclosures required by this guidance will need to be applied on a retrospective basis and others on a prospective basis. The guidance will be effective for fiscal years beginning after December 15, 2019, although early adoption is permitted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.

NotesIn July 2018, the FASB issued a codification improvement, which does not prescribe any new accounting guidance, but instead provides minor improvements and clarifications to Consolidated Financial Statementsvarious FASB accounting guidance. Certain updates are applicable immediately while others provide for a transition period until the next fiscal year beginning after December 15, 2018. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.

(Unaudited)

In June 2018, the FASB issued guidance which simplifies the accounting fornon-employee share-based payment transactions. The amendments specify that ASC 718 applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards. The guidance will be effective for fiscal years beginning after December 31, 2018, although early adoption is permitted. The Company does not expect that the adoption of this guidance will have a significant impact on its consolidated financial statements.

In February 2018, the FASB issued guidance on the reclassification of certain tax effects from accumulated other comprehensive income. The guidance allows reclassification of stranded tax effects resulting from the Tax Cuts and Jobs Act from accumulated other comprehensive income to retained earnings. This guidance is effective for fiscal years beginning after December 15, 2018, with early adoption permitted. Teva is currently evaluatingThe Company does not expect that the potential effectadoption of thethis guidance will have a significant impact on its consolidated financial statements.

In August 2017, the FASB issued guidance on derivatives and hedging, which expands and refines hedge accounting for bothnon-financial and financial risk components and aligns the recognition and presentation of the effects of the hedging instrument and the hedged item in the financial statements. The guidance will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years (early adoption is permitted for any interim and annual financial statements that have not yet been issued). Teva is currently evaluating the potential effect of the guidance on its consolidated financial statements.

In June 2016, the FASB issued guidance on financial instruments. The guidance replaces the current incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance will be effective for the fiscal year beginning on January 1, 2020, including interim periods within that year. Teva is currently evaluating the potential effect of the guidance on its consolidated financial statements.

In February 2016, the FASB issued guidance on leases. The guidance requires entities to record lease assets and lease liabilities on the balance sheet and disclose key information about leasing arrangements. In September 2017, the FASB issued additional amendments providing clarification and implementation guidance. The guidance will become effective for interim and annual periods beginning on January 1, 2019 (early adoption is permitted) and is required to be adopted at the earliest period presented using a modified retrospective approach.. In January 2018, the FASB issued an update that permits an entity to elect an optional transition practical expedient to not evaluate land easements that existed or expired before the entity’s adoption of the new standard and that were not previously accounted for as leases. In July 2018, the FASB issued both codification improvements, which clarify how to apply certain aspects of the new lease standard and an update. The update provided to either adopt at the earliest period presented using a modified retrospective approach, or to continue applying the guidance under the current lease standard in the comparative periods presented in the consolidated financial statements. Companies that elect this option would record a cumulative-effect adjustment to the opening balance of retained earnings on the date of adoption. The Company expects to apply the guidance using the cumulative-effect approach, thereby applying the new guidance at the effective date, without adjusting the comparative periods and, if necessary, recognizing a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption.

The Company is performing a comprehensive evaluation of the impact of the adoption of this guidance, which includes assessing the Company’s lease portfolio, implementation of a new enterprise-wide lease management system to meet reporting requirements, assessing the impact to business processes and implementation of internal controls over financial reporting and related disclosure requirements. The Company is working closely with the software system developer, as the timely readiness of the lease software system is critical to ensure an efficient and effective adoption of the standard. Although the Company has not finalized its process of evaluating the impact of adoption of the ASU on its consolidated financial statements, the Company expects there will be a material increase to assets and liabilities related to the recognition of newright-of-use assets and lease liabilities on the Company’s consolidated balance sheet for leases currently classified as operating leases.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes The Company does not, however, expect a material impact to Consolidated Financial Statements

(Unaudited)its consolidated statements of income.

NOTE 3 – Certain transactions:

Business acquisitions:

Actavis Generics and Anda acquisitions

On August 2, 2016, Teva consummated its acquisition of Allergan plc’s (“Allergan”) worldwide generic pharmaceuticals business (“Actavis Generics”). At closing, Teva transferred to Allergan consideration of approximately $33.4 billion in cash and approximately 100.3 million Teva shares.

On October 3, 2016, Teva consummated the acquisition of Anda Inc. (“Anda”), the fourth largest distributor of generic pharmaceuticals in the United States, from Allergan, for cash consideration of $500 million. The purchase is a transaction related to the Actavis Generics acquisition and as such the purchase price accounting and related disclosures were treated on a combined basis.

The final cash consideration for the Actavis Generics acquisition was subject to certain net working capital adjustments. Following the terms of the agreement, Teva submitted an adjustment for $1.4 billion with regards to a working capital true up as well as potential recoveries of purchase price related to certain tax items. On January 31, 2018, Teva and Allergan entered into a settlement agreement and mutual releases providing thatfor which Allergan will makemade aone-time payment of $703 million to Teva, which was paid during the first quarter of 2018.Teva. The Agreement also provides that Teva and Allergan will jointly dismiss the working capital dispute arbitration, as well as actual or potential claims under the Master Purchase Agreement, dated July 26, 2015, by and between Teva and Allergan, for breach of any representation, warranty or covenant (other than any breach of a post-closing covenant not known as of the date of the settlement agreement). As the measurement period has ended, this amount has beenwas recorded as a gain under legal settlements and loss contingencies.contingencies in the first quarter of 2018.

Rimsa

On March 3, 2016, Teva completed the acquisition of Representaciones e Investigaciones Médicas, S.A. de C.V. (“Rimsa”), a pharmaceutical manufacturing and distribution company in Mexico, for $2.3 billion, in a cash free, debt free set of transactions. Teva financed the transaction using cash on hand.

Following the closing of the acquisition, Teva identified issues concerning Rimsa’spre-acquisition quality, manufacturing and other practices, at which point Teva began an assessment of the extent and cost of remediation required to return its products to the market. In September 2016, two lawsuits were filed: apre-emptive suit by the Rimsa sellers against Teva and Teva’s lawsuit alleging fraud and breach of contract against the Rimsa sellers. The Rimsa sellers subsequently dismissed their lawsuit and the dismissal was approved by court order on December 20, 2016.

On February 15, 2018, Teva and the Rimsa sellers entered into a settlement agreement and mutual releases on the breach of contract claim providing thatfor which the sellers will makemade aone-time payment to Teva, whichTeva. As the measurement period has ended, this was paid during the first quarter of 2018 and recorded as a gain under legal settlements and loss contingencies.contingencies in the first quarter of 2018. This settlement was approved by the court and Teva’s breach of contract claim was subsequently dismissed.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Assets and Liabilities Held For Sale:

Certain Women’s Health and Other Specialty Products

On September 17, 2017, Teva entered into a definitive agreement under which CVC Capital Partners Fund VI willwould acquire a portfolio of products for $703 million in cash. The portfolio of products, which is marketed and sold outside of the United States, includes the women’s health products OVALEAP®, ZOELY®, SEASONIQUE®, COLPOTROPHINE® and other specialty products such as ACTONEL®.

As of December 31, 2017, the Company accounted for this transaction as assets and liabilities held for sale and determined that the fair value less cost to sell exceeded the carrying value of the business. The Company disposed of $329 million of goodwill associated with the divested business.

On January 31, 2018, Teva completed the sale of the portfolio of products to CVC Capital Partners Fund VI. As a result of these transactions, the Company recognized a net gain on sale of approximately $93 million in the first quarter of 2018 within other income in the consolidated statement of income. The transaction expenses for these divestitures of approximately $2 million were recognized concurrently and included as a reduction to the net gain on sale.

The Company determined that the sale of its global women’s health businessbusinesses did not constitute a strategic shift and that it did not, and will not, have a major effect on its operations and financial results. Accordingly, the operations associated with the transactions are not reported as discontinued operations.

The table below summarizes the major classes of assets and liabilities included as held for sale as of March 31,September 30, 2018 and December 31, 2017:

 

  March 31, 2018   December 31, 2017   September 30, 2018   December 31, 2017 
  (U.S. $ in millions)   (U.S. $ in millions) 

Inventories

   —      39    —      39 

Property, plant and equipment, net

   17    16 

Property, plant and equipment, net (*)

   41    16 

Identifiable intangible assets, net

   —      236    —      236 

Goodwill

   —      275 

Goodwill (*)

   40    275 
  

 

   

 

   

 

   

 

 

Total assets of the disposal group classified as held for sale in the consolidated balance sheets

  $17   $566   $81   $566 
  

 

   

 

   

 

   

 

 

Other taxes and long-term liabilities

   —      38    —      38 
  

 

   

 

   

 

   

 

 

Total liabilities of the disposal group classified as held for sale in the consolidated balance sheets

  $—     $38   $—     $38 
  

 

   

 

   

 

   

 

 

(*)

Mainly comprised of certain facilities in Israel.

Other significant agreements:

The Company has entered into alliances and other arrangements with third parties to acquire rights to products it does not have, to access markets it does not operate in and to otherwise share development costs or business risks. The Company’s most significant agreements of this nature are summarized below.

PGT Healthcare Partnership

In April 2018, Teva signed a separation agreement with the Procter & Gamble Company (“P&G”) to terminate theTeva’s joint venture with P&G, PGT Healthcare partnership that(“PGT”) which the two companies established in 2011 to marketover-the-counter (“OTC”) medicines. Teva will continue to maintain its OTC business on an independent basis.

The separation is planned to becomebecame effective on July 1, 2018, subject to receipt of applicable regulatory approvals.2018. As part of the separation, Teva will transfertransferred to P&G the shares it holdsheld in New Chapter Inc. and ownership rights in an OTC plant located in India to P&G.India. Teva will continue to provide certain services to P&G after the separation for a transition period.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

During the first quarter of 2018, Teva classified the plant in India as an asset held for sale and recorded an impairment of $56$64 million related to the plant in Indiaunder other asset impairments, restructuring and an impairmentother items. In addition, Teva recorded a write-down of $94 million related to theof its investment in New Chapter Inc. which was recorded withinunder share in loss (profits)losses of associated companies.

During September 2018, Teva and P&G completed the final net asset distribution as part of the dissolution and Teva recorded a gain of $50 million to reflect the cash payment received from P&G to settle the dissolution.

Alder BioPharmaceuticals®

On January 8, 2018, Teva signed a global license agreement with Alder BioPharmaceuticals (“Alder”). The agreement validates Teva’s IP and resolves Alder’s opposition to Teva’s European patent with respect to anti-calcitonin gene-related peptide (CGRP) antibodies, including the withdrawal of Alder’s appeal before the European Patent Office. Under the terms of the agreement, Alder will receive anon-exclusive license to Teva’s anti-CGRP antibodies patent portfolio to develop, manufacture and commercialize eptinezumab in the U.S. and worldwide, excluding Japan and Korea. Teva received a $25 million upfront payment during the first quarter of 2018, which was recognized as revenue. The agreement stipulates additional milestone payments to Teva of up to $175 million, as well as future royalties.

AUSTEDO®

On September, 19, 2017, Teva entered into a partnership agreement with Nuvelution Pharma, Inc. (“Nuvelution”) for development of AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States. Nuvelution will fund and manage clinical development, driving all operational aspects of the phase 3 program, and Teva will lead the regulatory process and be responsible for commercialization. Upon and subject to FDA approval of AUSTEDO for the treatment of Tourette syndrome, Teva will pay Nuvelution apre-agreed amount as compensation for their contribution to the partnership.

Otsuka

On May 12, 2017, Teva 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 fremanezumab in Japan and, if approved, to commercialize the product in Japan. Otsuka paid Teva an upfront payment of $50 million in consideration for the transaction. Teva may receive additional milestone payments upon filing with Japanese regulatory authorities, receipt of regulatory approval and achievement of certain revenue targets. Otsuka will also pay Teva royalties on fremanezumab sales in Japan.

AttenukineTM

In December 2016, Teva entered into a license agreement for research, development, manufacture and commercializing of AttenukineTM with a subsidiary of Takeda Pharmaceutical Company Ltd. (“Takeda”). Teva received a $30 million upfront payment. The agreement stipulates additional milestone payments to Teva of up to $280 million, as well as future royalties.

Ninlaro®

In November 2016, Teva entered into an agreement to sell its royalties and other rights in Ninlaro® (ixazomib) to a subsidiary of Takeda, for a $150 million upfront payment to Teva and an additional $150 million payment based on sales during 2017. Teva was entitled to these royalties pursuant to an agreement from 2014 assigning the Ninlaro® patents to an affiliate of Takeda in consideration of milestone payments and sales royalties. In the first six months of 2017, Teva received payments in the amount of $150 million, which were recognized as revenue for the period.

Celltrion

In October 2016, Teva and Celltrion, Inc. (“Celltrion”) entered into a collaborative agreement to commercialize two of Celltrion’s biosimilar products in development for the U.S. and Canadian markets. Teva paid Celltrion $160 million, of which up to $60 million is refundable or creditable under certain circumstances. Teva and Celltrion will share the profit from the commercialization of these products.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Regeneron

In September 2016, Teva and Regeneron Pharmaceuticals, Inc. (“Regeneron”) entered into a collaborative agreement to develop and commercialize Regeneron’s pain medication product, fasinumab. Teva and Regeneron share equally in the global commercial rights to this product, as well as ongoing associated R&D costs of approximately $1 billion. Teva made an upfront payment of $250 million to Regeneron in the third quarter of 2016 as part of the agreement and additional milestoneagreement. Milestone payments of $25 million and $35 million were paid in the second quarter of 2017 and in the first quarter of 2018, respectively.respectively, and a provision of $60 million was recorded in the third quarter of 2018.

NOTE 4 – Inventories:

Inventories, net of reserves, consisted of the following:

 

  March 31,
2018
   December 31,
2017
   September 30,
2018
   December 31,
2017
 
  (U.S. $ in millions)   (U.S. $ in millions) 

Finished products

  $2,772   $2,689   $2,679   $2,689 

Raw and packaging materials

   1,483    1,454    1,395    1,454 

Products in process

   646    597    609    597 

Materials in transit and payments on account

   212    184    183    184 
  

 

   

 

   

 

   

 

 
  $5,113   $4,924   $4,866   $4,924 
  

 

   

 

   

 

   

 

 

NOTE 5 - Property, plant and equipment, net:equipment:

Property, plant and equipment, net, consisted of the following:

 

  March 31,   December 31, 
  2018   2017   September 30,
2018
   December 31,
2017
 
  (U.S. $ in millions)   (U.S. $ in millions) 

Machinery and equipment

  $5,759   $5,809   $5,783   $5,809 

Buildings

   3,307    3,329    3,179    3,329 

Computer equipment and other assets

   2,055    2,016    2,115    2,016 

Payments on account

   615    634    538    634 

Land(1)

   358    390    361    390 
  

 

   

 

   

 

   

 

 
   12,094    12,178    11,976    12,178 

Less—accumulated depreciation

   4,674    4,505    4,875    4,505 
  

 

   

 

   

 

   

 

 
  $7,420   $7,673   $7,101   $7,673 
  

 

   

 

   

 

   

 

 

 

(1)

Land includes long-term leasehold rights in various locations, with useful lives between 30 and 99 years.

NOTE 6 - Identifiable intangible assets:

Identifiable intangible assets consisted of the following:

 

   Gross carrying amount net
of impairment
   Accumulated amortization   Net carrying amount 
   March 31,   December 31,   March 31,   December 31,   March 31,   December 31, 
   2018   2017   2018   2017   2018   2017 
   (U.S. $ in millions) 

Product rights

  $21,395   $21,011   $8,728   $8,276   $12,667   $12,735 

Trade names

   618    617    64    55    554    562 

Research and development in process

   4,093    4,343    —      —      4,093    4,343 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $26,106   $25,971   $8,792   $8,331   $17,314   $17,640 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

   Gross carrying amount net of
impairment
   Accumulated amortization   Net carrying amount 
   September 30,   December 31,   September 30,   December 31,   September 30,   December 31, 
   2018   2017   2018   2017   2018   2017 
   (U.S. $ in millions) 

Product rights

  $21,094   $21,011   $9,132   $8,276   $11,962   $12,735 

Trade names

   610    617    82    55    528    562 

Research and development in process

   2,855    4,343    —      —      2,855    4,343 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Total

  $24,559   $25,971   $9,214   $8,331   $15,345   $17,640 
  

 

 

   

 

 

   

 

 

   

 

 

   

 

 

   

 

 

 

Product rights and trade names are assets presented at amortized cost. These assets represent a portfolio of pharmaceutical products from various categories with a weighted average amortization life of approximately 11 years. Amortization of intangible assets was $310$297 million and $357 million for the three months ended March 31,September 30, 2018 and 2017, respectively and $909 million and $1,088 million for the nine months ended September 30, 2018 and 2017, respectively. Amortization is recorded in earnings, as relevant, under cost of sales andor S&M expenses, depending on the nature of the asset.

The fair value of acquired identifiable intangible assets is generally determined using an income approach. This method starts with a forecast of all expected future net cash flows associated with the asset and then adjusts the forecast to present value by applying an appropriate discount rate that reflects the risk factors associated with the cash flow streams.

Whenever impairment indicators are identified for definite life intangible assets, Teva reconsiders the asset’s estimated life, calculates the undiscounted value of the asset’s or asset group’s cash flows and then calculates, if required, the discounted value of cash flow by applying an appropriate discount rate that reflectsto the risk factors associated with theundiscounted cash flow streams andstreams. Teva then compares such value against the asset’s or asset group’s carrying amount. If the carrying amount is greater, Teva records an impairment loss for the excess of bookcarrying value over fair value based on the discounted cash flows.

The more significant estimates and assumptions inherent in the estimate of the fair value of identifiable intangible assets include all assumptions associated with forecasting product profitability, including sales and cost to sell projections, R&D expenditure for ongoing support of product rights or continued development of IPR&D, estimated useful lives and IPR&D expected launch dates. Additionally, for IPR&D assets the risk of failure has been factored into the fair value measure.

Impairment of identifiable intangible assets was $206of $519 million inand $355 million for the three months ended March 31,September 30, 2018 and is2017, respectively and $1,246 million and $409 million for the nine months ended September 30, 2018 and 2017, respectively. Impairments of identifiable intangible assets are recorded in earnings under other asset impairments, restructuring and other items. See note 14.

Additional reductions to RIPR&D intangibles relate to reclassification to product rights following regulatory approvals of generic products and impairments of assets due to development status, changes in projected launch date or changes in commercial projections related to products under development.

In the first quarternine months of 2018, $103Teva reclassified approximately $553 million was reclassifiedrelating to certain products from IPR&D to product rights following regulatory approval, mainly $444 million in connection with mesalamine following regulatory approval for this product.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

AJOVY (fremanezumab) and $103 million in connection with mesalamine.

NOTE 7 - Goodwill:

The changes in the carrying amount of goodwill for the period ended March 31,September 30, 2018 were as follows:

 

  Generics  Specialty  Other  Total  North
America
  Europe  Growth
Market
  Other  Total 
  (U.S. $ in millions)  (U.S. $ in millions)    

Balance as of December 31, 2017(3)

 $18,864  $8,464  $1,086  $28,414  $—    $—    $—    $—    $—   

Relative fair value allocation

  (18,864  (8,464  (1,086  (28,414  11,144   9,001   5,404   2,865   28,414 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance as of January 1, 2018

  —     —     —     —     11,144   9,001   5,404   2,865   28,414 

Changes during the period:

         

Goodwill impairment(1)

        (180   (180

Goodwill disposal(2)

       (54    (54

Translation differences

      (13  269   28   1   285 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance as of March 31, 2018(3)

 $—    $—    $—    $—    $11,131  $9,216  $5,252  $2,866  $28,465 
 

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
   Generics  Specialty  Other  Total  North
America
  Europe  International
Market
  Other  Total 
   (U.S. $ in millions)  (U.S. $ in millions)    

Balance as of December 31,
2017 (1)

  $18,864  $8,464  $1,086  $28,414  $—    $—    $—    $—    $—   

Relative fair value allocation

   (18,864  (8,464  (1,086  (28,414  11,144   9,001   5,404   2,865   28,414 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance as of January
1, 2018

   —     —     —     —     11,144   9,001   5,404   2,865   28,414 

Goodwill impairment(3)

   —     —     —     —     —     —        (300  —     (300

Goodwill disposal(2)

   —     —     —     —     —     (65  (14  —     (79

Goodwill reclassified as assets to held for
sale

   —     —     —     —     —     —     —     (40  (40

Translation differences

   —     —     —     —     (21  (338  (50  (1  (410
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance as of September
30, 2018 (1)

  $—    $—    $—    $—    $ 11,123  $ 8,598  $ 5,040  $ 2,824  $ 27,585 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

 

(1)Due to the

Accumulated goodwill impairment related to Rimsa.as of September 30, 2018 and December 31, 2017 was approximately $18.3 billion and $18.0 billion, respectively.

(2)

Due to the divestment of the women’s health business.business, the sale of Actavis Brazil and other activity.

(3)Accumulated

Due to the goodwill impairment as of March 31, 2018 and December 31, 2017 was approximately $18.2 billion and $18.0 billion, respectively.related to the Rimsa and/or Mexico reporting unit.

In November 2017, Teva announced a new organizational structure and leadership changes to enable strategic alignment across its portfolios, regions and functions. Teva now operates its business through three segments: North America, Europe and GrowthInternational Markets. The purpose of the new structure is to enable stronger alignment and integration between operations, commercial regions, R&D and Teva’s global marketing and portfolio function, in order to optimize its product lifecycle across the therapeutic areas. Teva’sTeva began reporting its financial results forunder this structure in the first quarter of 2018 are being reported under this new structure for the first time.2018.

In addition to these three segments, Teva has other activities, primarily the sale of active pharmaceutical ingredientingredients (“API”) manufacturing businessto third parties and certain contract manufacturing services. See note 17.

Following the announcement of its new organizational structure and leadership changes in November 2017, Teva conducted an analysis of its business segments, which led to changes in Teva’s identified reporting units, operating and reporting segments. As a result, on January 1, 2018, Teva reallocated its goodwill to the adjusted reporting units using a relative fair value allocation. In conjunction with the goodwill reallocation, Teva performed a goodwill impairment test for the balances in its adjusted reporting units, utilizing the same annual operating plan (“AOP”) and long range plan model that were used in its 2017 annual impairment test; Thethe Company concluded that the fair value of each reporting unit was in excess of its carrying value.

During the first quarter of 2018, Teva identified an increase in certain components of the weighted average cost of capital (“WACC”), such as an increase in the risk free interest and the unlevered beta. The Company addressed these changes in rates as an indication for impairment and performed an additional impairment test as of March 31, 2018.

Based on its revised analysis, Teva recorded a goodwill impairment of $180 million related to its Rimsa reporting unit in the first quarter of 2018. The remaining goodwill allocated to this reporting unit iswas $706 million as of March 31, 2018. This impairment was driven by the change in fair value, including the discount rate updated for the WACC change noted above, and the change in allocated net assets to the reporting unit. See note 3.

In the second quarter of 2018, the Company completed its long-range planning (“LRP”) process. The LRP is part of Teva’s internal financial planning and budgeting processes and is discussed and reviewed by Teva’s management and its board of directors. Certain events and changes in circumstances, reflected in the LRP, indicated that it was more likely than not that the carrying value of certain reporting units exceeded their fair value:

Historically, Rimsa had been carved out as a separate reporting unit due to the significant operational challenges. Teva wanted to ensure that any impairment related to Rimsa would be recorded, by separating it from the International Markets reporting unit. During the second quarter of 2018, Rimsa and Teva Mexico substantially completed the integration process and as a result Teva decided to utilize the combined Mexico reporting unit for goodwill impairment testing, as opposed to “Rimsa only” in prior periods.

Following the integration, and although the remediation plan is progressing in connection with Rimsa legacy products, Teva estimates that the recovery time will be longer than initially planned, specifically in connection with the time to regain lost market share. As a result, the Company recorded an additional goodwill impairment charge of $120 million related to its Mexico reporting unit in the second quarter of 2018.

Additionally, the Company identified further developments with respect to legislation proposed by the Russian Ministry of Health. The draft legislation includes, among other items, amendments in the mechanism of regulating prices for vital and essential medicines. The suggested amendments triggered a public discussion between authorities and pharmaceutical companies, which ended in the second quarter of 2018, followed by an internal discussion by the relevant authorities. The estimated impact of developments and uncertainties with respect to the final legislation in Russia were reflected in the LRP and triggered an impairment test for the International Markets reporting unit and related intangible assets, significantly decreasing the difference between the estimated fair value and estimated carrying value of the reporting unit, from 6% to 2%; however no impairment was recorded.

After assessing the totality of relevant events and circumstances, Teva determined that, as of the second quarter of 2018, it is not more likely than not that the fair value of its remaining reporting units is less than their carrying amount.

In light of the integration and the progress toward operational remediation in Rimsa as discussed above, Teva concluded that commencing July 1, 2018, it would no longer view Mexico separately from the International Markets reporting unit and accordingly will no longer perform impairment testing on Mexico as a separate reporting unit.

During the third quarter of 2018, Teva identified an increase in the risk free interest rate, which caused an increase in WACC. In addition, certain currencies in countries included in Teva’s International Markets reporting unit experienced significant devaluations. Teva addressed these events as an indication for impairment and performed an additional impairment test for the International Markets and Europe reporting units as of September 30, 2018. Teva assumed that the currency devaluations would cause price increases of its imported goods to those countries which would not be completely offset by corresponding price adjustments to the selling price of Teva’s goods. These changes decreased the difference between the estimated fair value and estimated carrying value of the International Markets reporting unit from 2% to 1% and of the Europe reporting unit from 6% to 4%, however, no impairment charge was recorded for either reporting unit.

In the third quarter of 2018, the fair value exceeded the estimated carrying value by 36% and 43% for North America and Other reporting units, respectively.

Based on current macro-economic developments and capital markets anticipation, a possibleassumptions and holding all other assumptions constant, an increase in the risk free interest rate of 0.5% maywould result in an increase to Teva’s WACC by approximately the same amount and consequently in a change in fair value of the International Markets reporting unit of $653 million, resulting in an additional impairment of $70 million and $100 million with respect to Rimsa and$605 million. In addition, the Growth Marketssame change in the Europe reporting units, respectively.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

For Teva’s remaining reporting units, the percentage difference between estimatedunit would result in a change in fair value and estimated carrying valueof $871 million, resulting in the first quarteran impairment of 2018 was 6%, 10%, 21% and 49% for Teva’s Growth Markets, Europe, North America and other reporting units, respectively.$243 million.

Teva determines the fair value of its reporting units using a weighting of fair values derived from the income approach. The income approach is a forward-looking approach for estimating fair value and utilizes the 2018 remaining year forecast, projections for growth off that base with an associated price erosion, as well as terminal growth rate. Within the income approach, the method that was used is the discounted cash flow method. Teva started with a forecast of all the expected net cash flows associated with the reporting unit, which includes the application of a terminal value, and then applied a discount rate to arrive at a net present value amount. Cash flow projections are based on Teva’s estimates of revenue growth rates and operating margins, taking into consideration industry and market conditions. The discount rate used is based on the WACC, adjusted for the relevant risk associated with country-specific characteristics. If any of these expectations were to vary materially from Teva’s assumptions, Teva could face impairment of goodwill allocated to these reporting units in the future.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

NOTE 8 – Earnings (Loss) per share:

Basic earnings and loss per share are computed by dividing net results attributable to Teva’s ordinary shareholders by the weighted average number of ordinary shares outstanding (including fully vested restricted share units (“RSUs”)) during the period, net of treasury shares.

In computing the diluted loss per share for the three months ended September 30, 2018, no account was taken of the potential dilution by the assumed exercise of employee stock options andnon-vested RSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share. Diluted earnings per share for the three months ended March 31, 2018 andSeptember 30, 2017 basic earnings per share was adjusted to take into account the potential dilution that could occur upon the exercise of options andnon-vested RSUs granted under employee stock compensation plans, using the treasury stock method.

Additionally, no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to 6466 million (including shares that may be issued due to unpaid dividends to date) for the three months ended March 31,September 30, 2018 and 59 million for the three months ended March 31,September 30, 2017, as well as for the convertible senior debentures for the respective periods, since both had an anti-dilutive effect on earnings (loss) per share.

TEVA PHARMACEUTICAL INDUSTRIES LIMITEDDiluted earnings per share for the nine months ended September 30, 2018 take into account the potential dilution that could occur upon the exercise of options andnon-vested RSUs granted under employee stock compensation plans, using the treasury stock method. In computing loss per share for the nine months ended September 30, 2017, no account was taken of the potential dilution by the assumed exercise of employee stock options andnon-vested RSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.

NotesAdditionally, no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to Consolidated Financial Statements

(Unaudited)

68 million (including shares that may be issued due to unpaid dividends to date) for the nine months ended September 30, 2018 and 59 million for the nine months ended September 30, 2017, as well as for the convertible senior debentures for the respective periods, since both had an anti-dilutive effect on earnings (loss) per share.

NOTE 9 – Revenue from contracts with customers:

On January 1, 2018, Teva adopted the new accountingrevenue standard ASC 606, Revenue from Contracts with Customers, and all the related amendments (“new revenue standard”) to all contracts using the modified retrospective method. The cumulative effect of initially applying the new revenue standard was immaterial.

Revenue recognition prior to the adoption of the new revenue standard

Please refer to note 1 to the consolidated financial statements and critical accounting policies included in ourTeva’s Annual Report on Form10-K for the year ended December 31, 2017 for a summary of ourthe significant accounting policiespolicies.

Revenue recognition following the adoption of the new revenue standard

A contract with a customer exists only when: the parties to the contract have approved it and are committed to perform their respective obligations, the Company can identify each party’s rights regarding the distinct goods or services to be transferred (“performance obligations”), the Company can determine the transaction price for the goods or services to be transferred, the contract has commercial substance and it is probable that the Company will collect the consideration to which it will be entitled in exchange for the goods or services that will be transferred to the customer.

Revenues are recorded in the amount of consideration to which the Company expects to be entitled in exchange for performance obligations upon transfer of control to the customer, excluding amounts collected on behalf of other third parties and sales taxes.

The amount of consideration to which Teva expects to be entitled varies as a result of rebates, chargebacks, returns and other sales reserve and allowances (“SR&A”) the Company offers its customers and their customers, as well as the occurrence or nonoccurrence of future events, including milestone events. A minimum amount of variable consideration is recorded concurrently with the satisfaction of performance obligations to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Estimates of variable consideration are based on historical experience and the specific terms in the individual agreements (which the Company believes approximates expected value). Rebates and chargebacks are the largest components of SR&A. For further description of SR&A components and how they are estimated, see “Variable consideration”Consideration” below.

Shipping and handling costs after control over a product has transferred to a customer are accounted for as a fulfillment cost and are recorded under S&M expenses.

Teva does not adjust the promised amount of consideration for the effects of a significant financing component since the Company expects, at contract inception, that the period between the time of transfer of the promised goods or services to the customer and the time the customer pays for these goods or services to be generally one year or less.less, based on the practical expedient. The Company’s credit terms to customers are in average between thirty and ninety days.

The Company generally recognizes the incremental costs of obtaining contracts as an expense since the amortization period of the assets that the Company otherwise would have recognized is one year or less. The costs are recorded under S&M expenses. Similarly, Teva does not disclose the value of unsatisfied performance obligations for contracts with original expected duration of one year or less.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Disaggregation of revenue

The following table disaggregates Teva’s revenues by major revenue streams. For additional information on disaggregation of revenues see note 17.

 

  March 31, 2018   Three months ended September 30, 2018 
  North America   Europe   Growth Markets   Other activities   Total   North America   Europe   International
Markets
   Other activities   Total 
  (U.S. dollars in millions)   (U.S. $ in millions) 

Sale of goods

   2,168    1,429    519    177    4,293    1,902    1,210    525    166    3,803 

Licensing arrangements

   32    10    20    2    64    29    1    —      2    32 

Distribution

   331    3    153    —      487    333    1    149    —      483 

Other

   —      —      58    163    221    1    —      52    158    211 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $2,531   $1,442   $750   $342   $5,065   $2,265   $1,212   $726   $326   $4,529 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  March 31, 2017   Three months ended September 30, 2017 
  North America   Europe   Growth Markets   Other activities   Total   North America   Europe   International
Markets
   Other activities   Total 
  (U.S. dollars in millions)   (U.S. $ in millions) 

Sale of goods

   2,824    1,287    529    196    4,836    2,724    1,321    672    168    4,885 

Licensing arrangements

   121    1    1    1    124    25    —      1    1    27 

Distribution

   295    53    125    —      473    294    59    146    —      499 

Other

   —      —      63    154    217    —      —      63    143    206 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  $3,240   $1,341   $718   $351   $5,650   $3,043   $1,380   $882   $312   $5,617 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  Nine months ended September 30, 2018 
  North America   Europe   International
Markets
   Other activities   Total 
  (U.S. $ in millions) 

Sale of goods

   5,983    3,956    1,617    526    12,082 

Licensing arrangements

   91    19    21    6    137 

Distribution

   984    7    456    —      1,447 

Other

   1    —      171    457    629 
  

 

   

 

   

 

   

 

   

 

 
  $7,059   $3,982   $2,265   $989   $14,295 
  

 

   

 

   

 

   

 

   

 

 
  Nine months ended September 30, 2017 
  North America   Europe   International
Markets
   Other activities   Total 
  (U.S. $ in millions) 

Sale of goods

   8,338    3,848    1,862    567    14,615 

Licensing arrangements

   249    2    36    4    291 

Distribution

   864    166    406    —      1,436 

Other

   1    —      181    463    645 
  

 

   

 

   

 

   

 

   

 

 
  $9,452   $4,016   $2,485   $1,034   $16,987 
  

 

   

 

   

 

   

 

   

 

 

Nature of revenue streams

Revenue from sales of goods, including sales to distributors is recognized when the customer obtains control of the product. This generally occurs when products are shipped once the Company has a present right to payment and legal title, and risk and rewards of ownership are obtained by the customer.

Licensing arrangements performance obligations generally include intellectual property (“IP”) rights, certain R&D and contract manufacturing services. The Company accounts for IP rights and services separately if they are distinct – i.e. if they are separately

identifiable from other items in the arrangement and if the customer can benefit from them on their own or with other resources that are readily available to the customer. The consideration is allocated between IP rights and services based on their relative stand-alone selling prices.

Revenue for distinct IP rights is accounted for based on the nature of the promise to grant the license. In determining whether the Company’s promise is to provide a right to access its IP or a right to use its IP, the Company considers the nature of the IP to which the customer will have rights. IP is either functional IP which has significant standalone functionality or symbolic IP which does not have significant standalone functionality. Revenue from functional IP is recognized at the point in time when control of the distinct license is transferred to the customer, when the Company has a present right to payment and risks and rewards of ownership are transferred to the customer. Revenue from symbolic IP is recognized over the access period to the Company’s IP.

Revenue from sales based milestones and royalties promised in exchange for a license of IP is recognized only when, or as, the later of subsequent sale or the performance obligation to which some or all of the sales-based royalty has been allocated, has beenis satisfied. Revenues from licensing arrangements included royalty income of $21$31 million and $105$27 million for the three months ended March 31,September 30, 2018 and 2017, respectively. Revenues from licensing arrangements included royalty income of $82 million and $239 million for the nine months ended September 30, 2018 and 2017, respectively. The amountamounts recognized in 2017 includesinclude royalty income resulting from the Ninlaro® transaction.

Distribution revenues are derived from sales of third-party products for which the Company acts as distributor, mostly in the United States via Anda and in Israel. The Company is the principal in these arrangements and therefore records revenue on a gross basis as it controls the promised goods before transferring these goods to the customer. Revenue is recognized when the customer obtains control of the products. This generally occurs when products are shipped once the Company has a present right to payment and legal title, and risk and rewards of ownership are obtained by the customer.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Other revenues are primarily comprised of contract manufacturing services, sales of medical devices, and other miscellaneous items. The Company is generally the principal in these arrangements and therefore records revenue on a gross basis as it controls the promised goods before transferring these goods to the customer. Revenue is recognized when the customer obtains control of the products. This generally occurs when products are shipped once the Company has a present right to payment and legal title and risk and rewards of ownership are obtained by the customer.

Contract assets and liabilities

Contract assets are mainly comprised of trade receivables net of allowance for doubtful debts, which includes amounts billed and currently due from customers.

Contract liabilities are mainly comprised of deferred revenues which were immaterial as of March 31,September 30, 2018 and December 31, 2017, respectively.

Variable consideration

Variable consideration mainly includes SR&A, comprised of rebates (including Medicaid and other governmental program discounts), chargebacks, returns and other promotional (including shelf stock adjustments) items. Provisions for prompt payment discounts are netted against trade receivables.

The Company recognizes these provisions at the time of sale and adjusts them if the actual amounts differ from the estimated provisions. The following briefly describes the nature of each deduction and how provisions are estimated:

Rebates

Rebates are primarily related to volume incentives and are offered to key customers to promote loyalty. These rebate programs provide that, upon the attainment ofpre-established volumes or the attainment of revenue milestones for a specified period, the customer receives a rebate. Since rebates are contractually agreed upon, they are estimated based on the specific terms in each agreement based on historical trends and expected sales. Externally obtained inventory levels are evaluated in relation to estimates made for rebates payable to indirect customers.

Medicaid and Other Governmental Rebates

Pharmaceutical manufacturers whose products are covered by the Medicaid program are required to provide a rebate to each state as a percentage of their average manufacturer’s price for the products dispensed. Many states have also implemented supplemental rebate programs that obligate manufacturers to pay rebates in excess of those required under federal law. The Company estimates these rebates based on historical trends of rebates paid, as well as on changes in wholesaler inventory levels and increases or decreases in sales.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Chargebacks

The Company has arrangements with various third parties, such as managed care organizations and drug store chains, establishing prices for certain of Teva’s products. While these arrangements are made between the Company and the customers, the customers independently select a wholesaler from which they purchase the products. Alternatively, certain wholesalers may enter into

agreements with the customers, with Teva’s concurrence, which establish the pricing for certain products which the wholesalers provide. Under either arrangement, Teva will issue a credit (referred to as a “chargeback”) to the wholesaler for the difference between the invoice price to the wholesaler and the customer’s contract price. Provisions for chargebacks involve estimates of contract prices of over 2,000 products and multiple contracts with multiple wholesalers. The provision for chargebacks varies in relation to changes in product mix, pricing and the level of inventory at the wholesalers and therefore will not necessarily fluctuate in proportion to an increase or decrease in sales. Provisions for estimating chargebacks are calculated using historical chargeback experience and/or expected chargeback levels for new products and anticipated pricing changes. Teva considers current and expected price competition when evaluating the provision for chargebacks. Chargeback provisions are compared to externally obtained distribution channel reports for reasonableness. The Company regularly monitors the provision for chargebacks and makes adjustments when the Company believes that actual chargebacks may differ from estimated provisions.

Other Promotional Arrangements

Other promotional or incentive arrangements are periodically offered to customers, specifically related to the launch of products or other targeted promotions. Provisions are made in the period for which the Company can estimate the incentive earned by the customer, in accordance with the contractual terms. The Company regularly monitors the provision for other promotional arrangements and makes adjustments when Teva believes that the actual provision may differ from the estimated provisions.

Shelf Stock Adjustments

The custom in the pharmaceutical industry is generally to grant customers a shelf stock adjustment based on the customers’ existing inventory contemporaneously with decreases in the market price of the related product. The most significant of these relate to products for which an exclusive or semi-exclusive period exists. Provisions for price reductions depend on future events, including price competition, new competitive launches and the level of customer inventories at the time of the price decline. Teva regularly monitors the competitive factors that influence the pricing of its products and customer inventory levels and adjust these estimates where appropriate.

Returns

Returns primarily relate to customer returns of expired products which, the customer has the right to return up to one year following the expiration date. Such returned products are destroyed and credits and/or refunds are issued to the customer for the value of the returns. Accordingly, no returned assets are recoded in connection with those products. The returns provision is estimated by applying a historical return rate to the amounts of revenue estimated to be subject to returns. Revenue subject to returns is estimated based on the lag time from time of sale to date of return. The estimated lag time is developed by analyzing historical experience. Additionally, The Company considers specific factors, such as levels of inventory in the distribution channel, product dating and expiration, size and maturity of launch, entrance of new competitors, changes in formularies or packaging and any changes to customer terms, for determining the overall expected levels of returns.

Prompt Pay Discounts

Prompt pay discounts are offered to most customers to encourage timely payment. Discounts are estimated at the time of invoice based on historical discounts in relation to sales. Prompt pay discounts are almost always utilized by customers. As a result, the actual discounts do not vary significantly from the estimated amount.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

SR&A to U.S. customers comprised approximately 86%84% of the Company’s total SR&A as of March 31,September 30, 2018, with the remaining balance primarily in Canada and Germany. The changes in SR&A for third-party sales for the period ended March 31,September 30, 2018 were as follows:

 

  Sales Reserves and Allowances    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  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. dollars in millions)  (U.S.$ in millions) 

Balance at December 31, 2017

  $196  $3,077  $1,908  $1,849  $780  $267  $7,881  $8,077  $196  $3,077  $1,908  $1,849  $780  $267  $7,881  $8,077 

Provisions related to sales made in current year period

   136  1,865  357  2,711  70  103  5,106  5,242  380  4,956  931  7,738  232  309  14,166  14,546 

Provisions related to sales made in prior periods

   2  (19 3  (1 21  (8 (4 (2 7  (39 17  3  21  (19 (17 (10

Credits and payments

   (157 (2,051 (349 (2,927 (119 (139 (5,585 (5,742 (412 (5,082 (1,288 (8,203 (364 (354 (15,291 (15,703

Translation differences

   1  9  2  1  1  (1 12  13   —    (20 (4 (3 (4 (7 (38 (38
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

Balance at March 31, 2018

  $178  2,881  $1,921  $1,633  $753  $222  $7,410  $7,588 

Balance at September 30, 2018

 $171  2,892  $1,564  $1,384  $665  $196  $6,701  $6,872 
  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

  

 

 

NOTE 10 – Accumulated other comprehensive loss:

The components of, and changes within, accumulated other comprehensive losses attributable to Teva are presented in the table below:

 

  Net Unrealized Gains/(Losses) Benefit Plans     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   Foreign
currency
translation
adjustments
 Available-for-
sale securities
   Derivative
financial
instruments
 Actuarial
gains/(losses)
and prior
service
(costs)/credits
 Total 

Balance as of December 31, 2017*

  $(1,316 $1   $(442 $(91 $(1,848
  

 

  

 

   

 

  

 

  

 

   (U.S.$ in millions) 

Balance as of December 31, 2017 *

  $(1,316 $1   $(442 $(91 $(1,848

Other comprehensive income (loss) before reclassifications

   156  1    (51  —    106    (562  —      54   —    (508

Amounts reclassified to the statements of income

   —     —      7   —    7    —       21  2  23 
  

 

  

 

   

 

  

 

  

 

   

 

  

 

   

 

  

 

  

 

 

Net other comprehensive income (loss) before tax

   156  1    (44  —    113    (562  —      75  2  (485

Corresponding income tax

   —     —      —    (2 (2
  

 

  

 

   

 

  

 

  

 

   

 

  

 

   

 

  

 

  

 

 

Net other comprehensive income (loss) after tax**

   156  1    (44  —    113 

Net other comprehensive income (loss) after tax **

   (562  —      75   —    (487
  

 

  

 

   

 

  

 

  

 

   

 

  

 

   

 

  

 

  

 

 

Balance as of March 31, 2018

  $(1,160 $2   $(486 $(91 $(1,735

Balance as of September 30, 2018

  $(1,878 $1   $(367 $(91 $(2,335
  

 

  

 

   

 

  

 

  

 

   

 

  

 

   

 

  

 

  

 

 

 

*

Following the adoption of ASU2016-01, the Company recorded a $5 million opening balance reclassification from accumulated other comprehensive income to retained earnings.

**

Amounts do not include a $15 million gain from foreign currency translation adjustments attributable tonon-controlling interests of a $83 million gain.interests.    

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

   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, December 31, 2016

  $(2,769 $(7 $(302 $(81 $(3,159
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Other comprehensive income/(loss) before reclassifications

   448   90   2   (9  531 

Amounts reclassified to the statements of income

   (52  (35  6   1   (80
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net other comprehensive income/(loss) before tax

   396   55   8   (8  451 

Corresponding income tax

   —     (1  —     (5  (6
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net other comprehensive income/(loss) after tax*

   396   54   8   (13  445 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance, March 31, 2017

  $(2,373 $47  $(294 $(94 $(2,714
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
   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 
   (U.S.$ in millions) 

Balance, December 31, 2016

  $(2,769 $(7 $(302 $(81 $(3,159

Other comprehensive income (loss) before reclassifications

   1,124   56   (138  (9  1,033 

Amounts reclassified to the statements of income

   (52  (41  20   2   (71
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net other comprehensive income (loss) before tax

   1,072   15   (118  (7  962 

Corresponding income tax

   —     5   —     (5  —   
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Net other comprehensive income (loss) after tax *

   1,072   20   (118  (12  962 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Balance, September 30, 2017

  $(1,697 $13  $(420 $(93 $(2,197
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

 

*

Amounts do not include a $64 million gain from foreign currency translation adjustments attributable tonon-controlling interests of a $70 million gain.interests.    

NOTE 11 – Debt obligations:

Short-term debt:

 

  Weighted average interest
rate as of March 31, 2018
 Maturity   March 31,
2018
   December 31,
2017
   Weighted average interest rate as of
September 30, 2018
 Maturity September 30,
2018
   December 31,
2017
 
       (U.S. $ in millions)       (U.S. $ in millions) 

Term loan JPY 28.3 billion(5)

  JPY LIBOR+0.25% 2018   $—     $251    JPY LIBOR+0.25%  2018  $—     $251 

Convertible debentures

  0.25% 2026   514    514    0.25%  2026 514    514 

Other

  11.68% 2018    2    1    9.37%  2018  1    1 

Current maturities of long-term liabilities

Current maturities of long-term liabilities

 

   786    2,880     2,158    2,880 
  

 

   

 

     

 

   

 

 

Total short term debt

Total short term debt

 

  $1,302   $3,646     $2,673   $3,646 
  

 

   

 

     

 

   

 

 

 

*

Net-share settlement feature exercisable at any time.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Senior notes and loans:

 

Long-term debt includes the following:

   Weighted average interest
rate as of September 30, 2018
  Maturity   September 30,
2018
  December 31,
2017
 
   %      (U.S. $ in millions) 

Senior notes EUR 1,660 million(8)

   0.38%   2020   $1,924  $2,095 

Senior notes EUR 1,500 million

   1.13%   2024    1,731   1,788 

Senior notes EUR 1,300 million

   1.25%   2023    1,501   1,550 

Senior notes EUR 1,000 million(3)

   2.88%   2019    —     1,199 

Senior notes EUR 900 million(1)

   4.50%   2025    1,045   —   

Senior notes EUR 750 million

   1.63%   2028    863   891 

Senior notes EUR 700 million(1)

   3.25%   2022    812   —   

Senior notes EUR 700 million

   1.88%   2027    810   837 

Senior notes USD 3,500 million

   3.15%   2026    3,493   3,492 

Senior notes USD 3,000 million

   2.20%   2021    2,997   2,996 

Senior notes USD 3,000 million

   2.80%   2023    2,993   2,992 

Senior notes USD 1,700 million(8)

   1.70%   2019    1,700   2,000 

Senior notes USD 2,000 million

   4.10%   2046    1,984   1,984 

Senior notes USD 1,500 million(3)

   1.40%   2018    —     1,500 

Senior notes USD 1,250 million(2)

   6.00%   2024    1,250   —   

Senior notes USD 1,250 million(2)

   6.75%   2028    1,250   —   

Senior notes USD 844 million

   2.95%   2022    862   864 

Senior notes USD 789 million

   6.15%   2036    782   781 

Senior notes USD 700 million

   2.25%   2020    700   700 

Senior notes USD 613 million

   3.65%   2021    622   624 

Senior notes USD 588 million

   3.65%   2021    587   587 

Senior notes CHF 450 million

   1.50%   2018    458   461 

Senior notes CHF 350 million

   0.50%   2022    357   360 

Senior notes CHF 350 million

   1.00%   2025    357   360 

Senior notes CHF 300 million(9)

   0.13%   2018    —     308 

Fair value hedge accounting adjustments

      (24  (2
     

 

 

  

 

 

 

Total senior notes

      29,054   28,367 

Term loan USD 2.5 billion(4)

   LIBOR +1.1375%   2018    —     285 

Term loan USD 2.5 billion(4)

   LIBOR +1.50%   2017-2020    —     2,000 

Term loan JPY 58.5 billion(5)

   JPY LIBOR +0.55%   2022    —     519 

Term loan JPY 35 billion(6)

   1.42%   2019    —     311 

Term loan JPY 35 billion(6)

   JPY LIBOR +0.3%   2018    —     311 
     

 

 

  

 

 

 

Total loans

      —     3,426 

Debentures USD 15 million(7)

   7.20%   2018    —     15 

Other

   7.78%   2026    6   5 
     

 

 

  

 

 

 

Total debentures and others

      6   20 
     

 

 

  

 

 

 

Less current maturities

      (2,158  (2,880

Derivative instruments

      24   2 

Less debt issuance costs

      (110  (106
     

 

 

  

 

 

 

Total senior notes and loans

     $26,816  $28,829 
     

 

 

  

 

 

 

 

   Weighted average interest
rate as of March 31, 2018
 Maturity  March 31, 2018   December 31,
2017
 
       
   %    (U.S. $ in millions) 

Senior notes EUR 1,750 million

  0.38% 2020  $2,152   $2,095 

Senior notes EUR 1,500 million

  1.13% 2024   1,837    1,788 

Senior notes EUR 1,300 million

  1.25% 2023   1,593    1,550 

Senior notes EUR 1,000 million(3)

  2.88% 2019   —      1,199 

Senior notes EUR 900 million(1)

  4.50% 2025   1,109    —   

Senior notes EUR 750 million

  1.63% 2028   915    891 

Senior notes EUR 700 million(1)

  3.25% 2022   863    —   

Senior notes EUR 700 million

  1.88% 2027   859    837 

Senior notes USD 3,500 million

  3.15% 2026   3,492    3,492 

Senior notes USD 3,000 million

  2.20% 2021   2,997    2,996 

Senior notes USD 3,000 million

  2.80% 2023   2,992    2,992 

Senior notes USD 2,000 million

  1.70% 2019   2,000    2,000 

Senior notes USD 2,000 million

  4.10% 2046   1,984    1,984 

Senior notes USD 1,500 million(3)

  1.40% 2018   —      1,500 

Senior notes USD 1250 million(2)

  6.00% 2024   1,250    —   

Senior notes USD 1250 million(2)

  6.75% 2028   1,250    —   

Senior notes USD 844 million

  2.95% 2022   863    864 

Senior notes USD 789 million

  6.15% 2036   781    781 

Senior notes USD 700 million

  2.25% 2020   700    700 

Senior notes USD 613 million

  3.65% 2021   623    624 

Senior notes USD 588 million

  3.65% 2021   587    587 

Senior notes CHF 450 million

  1.50% 2018   472    461 

Senior notes CHF 350 million

  0.50% 2022   367    360 

Senior notes CHF 350 million

  1.00% 2025   368    360 

Senior notes CHF 300 million

  0.13% 2018   314    308 

Fair value hedge accounting adjustments

   (16   (2
     

 

 

   

 

 

 

Total senior notes

   30,352    28,367 

Term loan USD 2.5 billion(4)

  LIBOR +1.1375% 2018   —      285 

Term loan USD 2.5 billion(4)

  LIBOR +1.50% 2017-2020   —      2,000 

Term loan JPY 58.5 billion(5)

  JPY LIBOR +0.55% 2022   —      519 

Term loan JPY 35 billion(6)

  1.42% 2019   —      311 

Term loan JPY 35 billion(6)

  JPY LIBOR +0.3% 2018   —      311 
     

 

 

   

 

 

 

Total loans

   —      3,426 

Debentures USD 15 million(7)

  7.20% 2018   —      15 

Other

  7.31% 2026   5    5 
  

 

 

   

 

 

 

Total debentures and others

   5    20 
     

 

 

   

 

 

 

Less current maturities

   (786   (2,880

Derivative instruments

   16    2 

Less debt issuance costs

   (137   (106
  

 

 

   

 

 

 

Total long-term debt

  $29,450   $28,829 
  

 

 

   

 

 

 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Debt development

 

(1)

In March 2018, Teva Pharmaceutical Finance Netherlands II B.V., a Teva finance subsidiary, issued senior notes in an aggregate principal amount of €1.6 billion.

 

(2)

In March 2018, Teva Pharmaceutical Finance Netherlands III B.V., a Teva finance subsidiary, issued senior notes in an aggregate principal amount of $2.5 billion.

 

(3)

In March 2018, Teva redeemed in full its $1.5 billion 1.4% senior notes due in July 2018 and its €1.0 billion 2.88% senior notes due in April 2019.

 

(4)

During the first quarter of 2018, Teva prepaid approximately $2.3 billion principal amount of the remaining term loan facilities.

(5)

During the first quarter of 2018, Teva prepaid in full JPY 86.8 billion principal amount of the outstanding term loan facilities of which JPY 28.3 billion were in short-term debt as of December 31, 2017.

 

(6)

During the first quarter of 2018, Teva prepaid in full JPY 70 billion of its 1.42% and JPY LIBOR+0.3% outstanding term loans.

 

(7)

During the first quarter of 2018, Teva prepaid in full $15 million of its outstanding debentures.

(8)

In September 2018, Teva consummated a cash tender offer for certain of its outstanding senior notes. As a result of the offer, Teva redeemed $300 million aggregate principal amount of its 1.7% senior notes and €90 million principal amount of its 0.38% senior notes.

(9)

In July 2018, Teva repaid at maturity CHF 300 million of its 0.13% senior notes.

Long term debt was issued by several indirect wholly-owned subsidiaries of the Company and is fully and unconditionally guaranteed by the Company as to payment of all principal, interest, discount and additional amounts (as defined), if any.

Long term debt as of March 31,September 30, 2018 is effectively denominated (taking into consideration cross currency swap agreements) in the following currencies: U.S. dollar 64%63%, euro 34% and Swiss franc 2%3%.

Teva’s principal sources of short-term liquidity are its existing cash investments, liquid securities and available credit facilities, primarily its $3 billion syndicated revolving credit facility (“RCF”), which was not utilized as of March 31,September 30, 2018, as well as internally generated funds. In connection with the requirements of the RCF, the Company entered into negative pledge agreements with certain banks and institutional investors. Under the agreements, the Company and its subsidiaries have undertaken not to register floating charges on assets in favor of any third parties without the prior consent of the banks, to maintain certain financial ratios, including the requirement to maintain compliance with a net debt to EBITDA ratio, which becomes more restrictive over time, and to fulfill other restrictions, as stipulated by the agreements. As of March 31,September 30, 2018, the Company did not have any outstanding debt under the RCF, which is ourits only debt subject to the net debt to EBITDA covenantcovenant. Assuming utilization of the RCF, and under specified circumstances, includingnon-compliance with such covenants and the unavailability of any waiver, amendment or other modification thereto and the expiration of any applicable grace period thereto, substantially all of the Company’s debt could be negatively impacted bynon-compliance with such covenants. The Company has sufficient resources to meet its financial obligations in the ordinary course of business for at least twelve months from the date of the release of this Quarterly Report.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

quarterly report.

NOTE 12 – Fair value measurement:

Teva’s financial instruments consist mainly of cash and cash equivalents, investment in securities, current andnon-current receivables, short-term debt, current andnon-current payables, contingent consideration, senior notes and loans, convertible senior debentures and derivatives.

The fair value of the financial instruments included in working capital andnon-current receivables and payables approximates their carrying value. The fair value of term loans and bank facilities mostly approximates their carrying value, since they bear interest at rates close to the prevailing market rates.

Financial instruments measured at fair value

The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.

The accounting standard establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described below:

Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.

Level 2: Observable inputs that are based on inputs not quoted on active markets, but corroborated by market data.

Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs.

In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs, to the extent possible, and considers counterparty credit risk in its assessment of fair value.

There were no transfers between Level 1, Level 2 and Level 3 during the first quarternine months of 2018.

Financial items carried at fair value as of March 31,September 30, 2018 and December 31, 2017 are classified in the tables below in one of the three categories described above:

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

  March 31, 2018   September 30, 2018 
  Level 1   Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 
  (U.S. $ in millions)   (U.S. $ in millions) 

Cash and cash equivalents:

                

Money markets

  $6   $—     $—     $6   $302   $—     $—     $302 

Cash, deposits and other

   1,412    —      —      1,412    1,573    —      —      1,573 

Investment in securities:

                

Equity securities

   58    —      —      58    53    —      —      53 

Other, mainly debt securities

   13    —      19    32    2    —      18    20 

Derivatives:

                

Asset derivatives - options and forward contracts

   —      15    —      15 

Asset derivatives - cross currency swaps

   —      4    —      4 

Liabilities derivatives - options and forward contracts

   —      (18   —      (18

Liabilities derivatives - interest rate and cross-currency swaps

   —      (141   —      (141

Asset derivatives—options and forward contracts

   —      23    —      23 

Asset derivatives—cross currency swaps

   —      42    —      42 

Liabilities derivatives—options and forward contracts

   —      (14   —      (14

Liabilities derivatives—interest rate and cross-currency swaps

   —      (82   —      (82

Contingent consideration*

   —      —      (708   (708   —      —      (717   (717
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $1,489   $(140  $(689  $660   $1,930   $(31  $(699  $1,200 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 
  December 31, 2017   December 31, 2017 
  Level 1 �� Level 2   Level 3   Total   Level 1   Level 2   Level 3   Total 
  (U.S. $ in millions)   (U.S. $ in millions) 

Cash and cash equivalents:

                

Money markets

  $5   $—     $—     $5   $5   $—     $—     $5 

Cash, deposits and other

   958    —      —      958    958    —      —      958 

Investment in securities:

                

Equity securities

   65    —      —      65    65    —      —      65 

Structured investment vehicles

   —      —      —      —   

Other, mainly debt securities

   14    —      18    32    14    —      18    32 

Derivatives:

                

Asset derivatives - options and forward contracts

   —      17    —      17 

Asset derivatives - cross-currency swaps

   —      25    —      25 

Liability derivatives - options and forward contracts

   —      (15   —      (15

Liabilities derivatives - interest rate and cross-currency swaps

   —      (98   —      (98

Asset derivatives—options and forward contracts

   —      17    —      17 

Asset derivatives—cross-currency swaps

   —      25    —      25 

Liability derivatives—options and forward contracts

   —      (15   —      (15

Liabilities derivatives—interest rate and cross-currency swaps

   —      (98   —      (98

Contingent consideration*

   —      —      (735   (735   —      —      (735   (735
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $1,042   $(71  $(717  $254   $1,042   $(71  $(717  $254 
  

 

   

 

   

 

   

 

   

 

   

 

   

 

   

 

 

 

*

Contingent consideration represents liabilities recorded at fair value in connection with acquisitions.

Teva determined the fair value of the liability for the contingent consideration based on a probability-weighted discounted cash flow analysis. This fair value measurement is based on significant unobservable inputs in the market and thus represents a Level 3 measurement within the fair value hierarchy. The fair value of the contingent consideration is based on several factors, such as: the cash flows projected from the success of unapproved product candidates; the probability of success of product candidates, including risks associated with uncertainty regarding achievement and payment of milestone events; the time and resources needed to complete the development and approval of product candidates; the life of the potential commercialized products and associated risks of obtaining regulatory approvals in the U.S. and Europe, and the risk adjusted discount rate for fair value measurement.

The contingent consideration is evaluated quarterly, or more frequently, if circumstances dictate. Changes in the fair value of contingent consideration are recorded in earnings.

Significant changes in unobservable inputs, mainly the probability of success and cash flows projected, could result in material changes to the contingent consideration liability.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

The following table summarizes the activity for those financial assets and liabilities where fair value measurements are estimated utilizing Level 3 inputs:

 

  Three months ended
March 31, 2018
 
    Nine months ended
September 30, 2018
 
  (U.S. $ in millions)   (U.S. $ in millions) 

Fair value at the beginning of the period

  $(717  $(717

Revaluation of debt securities

   1 

Adjustments to provisions for contingent consideration:

    

Actavis Generics transaction

   (6   (21

Labrys transaction

   (1   (17

Eagle transaction

   (1   (46

Settlement of contingent consideration:

    

Eagle transaction

   35    102 
  

 

   

 

 

Fair value at the end of the period

  $(689  $(699
  

 

   

 

 

Financial instruments not measured at fair value

Financial instruments measured on a basis other than fair value mostly consist of senior notes and convertible senior debentures and are presented in the table below in terms of fair value:

 

  Estimated fair value* 
  Estimated fair value*   September 30,   December 31, 
  March 31,
2018
   December 31,
2017
   2018   2017 
  (U.S. $ in millions)   (U.S. $ in millions) 

Senior notes included under senior notes and loans

  $26,365   $23,459   $24,775   $23,459 

Senior notes and convertible debentures included under short-term debt

   1,242    2,713 

Senior notes and convertible senior debentures included under short-term debt

   2,614    2,713 
  

 

   

 

   

 

   

 

 

Total

  $27,607   $26,172   $27,389   $26,172 
  

 

   

 

   

 

   

 

 

 

*

The fair value was estimated based on quoted market prices, where available.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

NOTE 13 – Derivative instruments and hedging activities:

The following table summarizes the notional amounts for hedged items, when transactions are designated as hedge accounting:

 

   March 31,
2018
   December 31,
2017
 
   (U.S. $ in millions) 

Cross-currency swap – cash flow hedge

  $588   $588 

Cross-currency swap – net investment hedge

   1,000    1,000 

Interest rate swap – fair value hedge

   500    500 
   September 30,
2018
   December 31,
2017
 
   (U.S. $ in millions) 

Cross-currency swap—cash flow hedge

  $588   $588 

Cross-currency swap—net investment hedge

   1,000    1,000 

Interest rate swap—fair value hedge

   500    500 

The following table summarizes the classification and fair values of derivative instruments:

 

  Fair value   Fair value 
  Designated as hedging
instruments
   Not designated as hedging
instruments
   Designated as hedging
instruments
 Not designated as hedging
instruments
 
  March 31,
2018
   December 31,
2017
   March 31,
2018
   December 31,
2017
   September 30,
2018
 December 31,
2017
 September 30,
2018
 December 31,
2017
 

Reported under

  (U.S. $ in millions)   (U.S. $ in millions) 

Asset derivatives:

             

Other current assets:

             

Option and forward contracts

  $—     $—     $15   $17   $—    $—    $23  $17 

Othernon-current assets:

             

Cross-currency swaps – cash flow hedge

   4    25    —      —   

Cross-currency swaps—cash flow hedge

   42  25   —     —   

Liability derivatives:

             

Other current liabilities:

             

Option and forward contracts

   —      —      (18   (15   —     —    (14 (15

Other taxes and long-term liabilities:

             

Cross-currency swaps – net investment hedge

   (125   (96   —      —   

Cross-currency swaps—net investment hedge

   (58 (96  —     —   

Senior notes and loans:

             

Interest rate swaps – fair value hedge

   (16   (2   —      —   

Interest rate swaps—fair value hedge

   (24 (2  —     —   

Derivatives on foreign exchange contracts mainly hedge Teva’s balance sheet items from currency exposure but are not designated as hedging instruments for accounting purposes. With respect to such derivatives, gains of $11 million and losses of $19$72 million were recognized under financial expenses, net for the nine months ended September 30, 2018 and 2017, respectively, and gains of $6 million and $47losses of $14 million were recognized under financial expenses, net for the three months ended March 31,September 30, 2018 and 2017, respectively. Such losses and gains offset the revaluation of the balance sheet items which is also recorded under financial expenses, net.

During the second quarter of 2018, the Company entered into option contracts and designed these transactions to limit the exposure of foreign exchange fluctuations on the euro denominated revenues with respect to 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. During the third quarter of 2018, the impact of such derivative instruments was immaterial.

With respect to the interest rate and cross-currency swap agreements, gains of $1 million and $4 million were recognized under financial expenses, net for the nine months ended September 30, 2018 and 2017, respectively, and gains of $0.5 million and $1 million were recognized under financial expenses, net for the three months ended March 31,September 30, 2018 and 2017, respectively. Such gains mainly reflect the differences between the fixed interest rate and the floating interest rate.

Commencing in the third quarter of 2015, Teva entered into forward starting interest rate swap and treasury lock agreements designated as cash flow hedges of the U.S. dollar debt issuance in July 2016, with respect to $3.75 billion and $1.5 billion notional amounts, respectively. These agreements hedged the variability in anticipated future interest payments due to possible changes in the benchmark interest rate between the date the agreements were entered into and the actual date of the U.S. dollar debt issuance in July 2016 (in connection with the closing of the Actavis Generics acquisition).

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Certain of the forward starting interest rate swaps and treasury lock agreements matured during the first half of 2016. In July 2016, Teva terminated the remaining forward starting interest rate swaps and treasury lock agreements. The termination of these transactions resulted in a loss position of $493 million, of which $242 million were settled on October 7, 2016 and the remaining amount was settled in January 2017. The change in fair value of these instruments recorded as part of other comprehensive income will beis amortized under financial expenses, net over the life of the debt. Such losses mainly reflect the changes in the benchmark interest rate between the date the agreements were entered into and the actual date of the U.S. debt issuance in July 2016.

With respect to the forward starting interest rate swaps and treasury lock agreements, losses of $21 million and $20 million were recognized under financial expenses, net for the nine months ended September 30, 2018 and 2017, respectively, and losses of $7 million were recognized under financial expenses, net for each of the three months ended March 31,September 30, 2018 and 2017.

In the third quarter of 2016, Teva terminated interest rate swap agreements designated as fair value hedge relating to certain senior notes. Settlement of these transactions resulted in a gain position of $41 million. The fair value hedge accounting adjustments of these instruments recorded under senior notes and loans will be amortized under financial expenses, net over the life of the debt. With respect to these terminated interest rate swap agreements, gains of $5 million were recognized under financial expenses, net for both the nine months ended September 30, 2018 and 2017, and gains of $2 million were recognized under financial expenses, net for both the three months ended March 31,September 30, 2018 and 2017.

In the fourth quarter of 2016, Teva entered into an interest rate swap agreement designated as fair value hedge relating to its 2.8% senior notes due 2023 with respect to $500 million notional amount of outstanding debt.

In each of the first and second quarters of 2017, Teva entered into a cross currency swap agreement maturing in 2020 with a notional amount of $500 million. These cross currency swaps were designated as a net investment hedge of Teva’s euro denominated net assets, in order to reduce the risk of adverse exchange rate fluctuations. The effective portion of the hedge will be determined by looking into changes in spot exchange rate. The change in fair value of the cross currency swap attributable to changes other than those due to fluctuations in the spot exchange rates are excluded from the assessment of hedge effectiveness and are reported directly in the statement of income.

With respect to these cross currency swap agreements, gains of $7$22 million and $8 million were recognized under financial expenses, net for the nine months ended September 30, 2018 and 2017, respectively, and gains of $6 million and $4 million were recognized under financial expenses, net for the three months ended March 31, 2018. The amount recorded in the statement of income in the first quarter ofSeptember 30, 2018 and 2017, was not material.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

respectively.

NOTE 14 – Other asset impairments, restructuring and other items:

Other impairments, restructuring and other items consisted of the following:

 

  Three months ended
March 31,
   Three months ended
September 30,
   Nine months ended
September 30,
 
  2018   2017   2018   2017   2018   2017 
  (U.S. $ in millions)   (U.S. $ in millions) 

Restructuring expenses

  $247   $130   $88   $72   $442   $300 

Integration expenses

   —      23 

Integration and acquisition expenses

   4    31    9    87 

Contingent consideration

   8    21    29    18    84    179 

Impairments of long-lived assets

   432    11    521    408    1,501    564 

Other

   20    55    16    21    44    79 
  

 

   

 

   

 

   

 

   

 

   

 

 

Total

  $707   $240   $658   $550   $2,080   $1,209 
  

 

   

 

   

 

   

 

   

 

   

 

 

In determining the estimated fair value of long-lived assets, Teva utilized a discounted cash flow model. The key assumptions within the model related to forecasting future revenue and operating income, an appropriate WACC and an appropriate terminal value based on the nature of the long-lived asset. The Company’s updated forecasts of net cash flows for the impaired assets reflect, among others, the following: (i) for IPR&D assets, the impact of changes to the development programs, the projected development and regulatory timeframes and the risks associated with these assets; and (ii) for product rights, pricing and volume projections, as well as patent life and any significant changes to the competitive environment.

As a result of Teva’s plant rationalization acceleration, following the two year restructuring plan that was announced in December, 2017, to the extent the Company will change its plans on any given asset and/or the assumptions underlying such plan, there could be additional impairments in the future.

Impairments

 

Impairments of long-lived intangible assets in the third quarter of 2018 were $519 million, mainly consisting of:

a)

IPR&D assets of $306 million, mainly related to revaluation of generic products acquired from Actavis Generics due to development progress and changes in other key valuation indications (e.g., market size, legal landscape, launch date or discount rate).

b)

Identifiable product rights of $185 million, mainly due to updated market assumptions regarding price and volume of products acquired from Actavis Generics currently marketed in the United States and supply constraints.

Impairments of property, plant and equipment of $2 million.

Impairments of long-lived intangible assets in the first quarternine months of 2018 were $206$1,246 million, mainly consisting of:

 

Identifiable IPR&D of $117 million mainly related to revaluation of generic products acquired from Actavis Generics due to development progress and changes in other key valuation indications (market size, legal landscape, launch date or discount rate).
a)

IPR&D assets of $867 million, mainly related to revaluation of generic products acquired from Actavis Generics due to development progress and changes in other key valuation indications (e.g., market size, legal landscape, launch date or discount rate).

b)

Identifiable product rights of $328 million due to updated market assumptions regarding price and volume of products acquired from Actavis Generics currently marketed in the United States and supply constraints.

 

Identifiable product rights of $76 million due to revaluation of Actavis Generics product rights in the United States.

Impairments of property, plant and equipment in the first quarternine months of 2018 were $226$255 million, mainly consisting of:

 

$147 million related to restructuring costs, including:
a)

$155 million related to the restructuring plan, including:

 

$113 million related to site closures in Israel; and

 

$3442 million related to the consolidation of headquarters and distribution sites consolidation in the United States;States.

 

Other impairment costs, mainly $56 million related to a plant located India, in connection with the P&G separation agreement.
b)

Other impairment costs, mainly $64 million related to a plant located in India in connection with the P&G separation agreement. See note 3.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Restructuring

In the first quarter ofthree months ended September 30, 2018, Teva recorded $247$88 million of restructuring expenses, compared to $130$72 million in the three months ended September 30, 2017.

In the first nine months of 2018, Teva recorded $442 million of restructuring expenses, compared to $300 million in the first quarternine months of 2017. The expenses in the first quarternine months of 2018 were primarily related to headcount reductions across all functions.

Since Teva’sthe announcement of its restructuring plan, the CompanyTeva reduced its global headcount by approximately 6,2009,100 full-time-equivalent employees.

During the three months ended September 30, 2018, Teva also recorded a $226$2 million impairment of property, plant and equipment related to restructuring costs.

During the first nine months of 2018 Teva recorded a $155 million impairment of property, plant and equipment related to restructuring costs as detailed in “— Impairments” above.

The following table providestables provide the components of costs associated with Teva’s restructuring plan, including other costs related to exitassociated with Teva’s restructuring plan and disposal activities:recorded under different items:

 

  Three months ended March 31,   

Three months ended September 30,

 
  2018   2017   

2018

   

2017

 
  (U.S. $ in millions)   

(U.S. $ in millions)

 

Restructuring

        

Employee termination

  $228   $95   

$

62

 

  

$

54

 

Other

   19    35   

 

26

 

  

 

18

 

  

 

   

 

   

 

   

 

 

Total

  $247   $130   

$

88

 

  

$

72

 

  

 

   

 

   

 

   

 

 
  

Three months ended September 30,

 
  

2018

   

2017

 
  

(U.S. $ in millions)

 

Other

    

Cost of sales

  

$

8

 

  

$

3

 

Selling and marketing expenses

  

 

—  

 

  

 

3

 

Other items

  

 

16

 

  

 

—  

 

  

Nine months ended September 30,

 
  

2018

   

2017

 
  

(U.S. $ in millions)

 

Restructuring

    

Employee termination

  

$

380

 

  

$

228

 

Other

  

 

62

 

  

 

72

 

  

 

   

 

 

Total

  

$

442

 

  

$

300

 

  

 

   

 

 
  

Nine months ended September 30,

 
  

2018

   

2017

 
  

(U.S. $ in millions)

 

Other

    

Cost of sales

  

$

23

 

  

$

5

 

Selling and marketing expenses

  

 

—  

 

  

 

3

 

Other items

  

 

54

 

  

 

—  

 

The following table provides the components of and changes in the Company’s restructuring accruals:

 

  Employee termination
costs
   Other   Total   Employee
termination costs
   Other   Total 
  (U.S. $ in millions )   (U.S. $ in millions) 

Balance as of January 1, 2018

  $(294  $(17  $(311  

$

(294

  

$

(17

  

$

(311

Provision

   (228   (19   (247  

 

(380

  

 

(62

  

 

(442

Utilization and other*

   129    7    136   

 

418

 

  

 

51

 

  

 

469

 

  

 

   

 

   

 

   

 

   

 

   

 

 

Balance as of March 31, 2018

  $(393  $(29  $(422

Balance as of September 30, 2018

  

$

(256

  

$

(28

  

$

(284

  

 

   

 

   

 

   

 

   

 

   

 

 

*

Includes adjustments for foreign currency translation.

In July 2018, the FDA completed an inspection of Teva’s manufacturing plant in Davie, Florida in the United States and issued a FormFDA-483 to the site. In October 2018, the FDA notified Teva that the inspection of the site is classified as “official action indicated” (OAI). Teva is working diligently to investigate the FDA’s observations in a manner consistent with Current Good Manufacturing Practices (CGMPs) and to address those observations as quickly and as thoroughly as possible. The impact of such investigation and remediation on the financial statements in the third quarter of 2018 was immaterial. However, if Teva is unable to remediate the findings in a timely manner, Teva may face additional consequences, including potential delays in FDA approval for future products from the site, other financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges and other costs of remediation.

In July 2018, Teva announced the voluntary recall of valsartan and certain combination valsartan medicines in various countries due to the detection of trace amounts of an unexpected impurity in the API provided by a third party supplier, Zhejiang Huahai

Pharmaceutical (“Zhejiang”), used in the production of such medicines. On September 28, 2018, the FDA issued an import ban on all APIs and other drug products made by Zhejiang in its Chuannan site into the United States. On the same date, the EU authorities issued to Zhejiang a statement ofnon-compliance for the manufacture of valsartan (and its intermediates) for EU medicines produced in the Chuannan site, thus prohibiting marketing authorization holders in the EU from using such valsartan materials in the production of finished products. On October 15, 2018, the EU authorities announced that Zhejiang was under increased supervision with respect to other APIs produced by Zhejiang. Many regulatory agencies around the world continue to review information relating to valsartan medicines and the sartan products as a group. The impact of this recall on the Company’s financial statements in the first nine months of 2018 was $46 million, primarily related to recall and inventory reserves. Depending on the scope of regulatory actions, duration of the API outage and severity of the impurity, Teva may face additional loss of revenues and profits, customer penalties, impairments and/or other litigation costs.

NOTE 15 – Legal settlements and loss contingencies:

LegalIn the third quarter of 2018, the Company recorded expenses of $19 million for legal settlements and loss contingencies, for the three months ended March 31, 2018 resulted in income of $1.3 billion compared to expensesincome of $20 million forin the threethird quarter of 2017.

In the first nine months ended March 31,of 2018, Teva recorded income of $1,239 million in connection with legal settlements, compared to an expense of $324 million in the first nine months of 2017. The income in the first quarternine months of 2018 consisted primarily of the working capital adjustment with Allergan, the Rimsa settlement and a reversal of the reserve recorded in the second quarter of 2017 with respect to the carvedilol patent litigation, following the reversal of the verdict granting the award to GSK. litigation.

As of March 31,September 30, 2018 and December 31, 2017 an accrued amountTeva’s provision for legal settlements and loss contingencies of $872recorded under accrued expenses was $663 million and $1.2 billion, respectively, was recorded in accrued expenses.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

$1,232 million, respectively.

NOTE 16 – Commitments and Contingencies:

General

From time to time, Teva and/or its subsidiaries are subject to claims for damages and/or equitable relief arising in the ordinary course of business. In addition, as described below, in large part as a result of the nature of its business, Teva is frequently subject to litigation. Teva generally believes that it has meritorious defenses to the actions brought against it and vigorously pursues the defense or settlement of each such action. Except as described below, Teva does not currently have a reasonable basis to estimate the loss, or range of loss, that is reasonably possible with respect to matters disclosed in this note.

Teva records a provision in its financial statements to the extent that it concludes that a contingent liability is probable and the amount thereof is estimable. Based upon the status of the cases described below, management’s assessments of the likelihood of damages, and the advice of counsel, no provisions have been made regarding the matters disclosed in this note, except as noted below. Litigation outcomes and contingencies are unpredictable, and excessive verdicts can occur. Accordingly, management’s assessments involve complex judgments about future events and often rely heavily on estimates and assumptions. Teva continuously reviews the matters described below and may, from time to time, remove previously disclosed matters that the Company has determined no longer meet the materiality threshold for disclosure.

If one or more of such proceedings described below were to result in final judgments against Teva, such judgments could be material to its results of operations and cash flows in a given period. In addition, Teva incurs significant legal fees and related expenses in the course of defending its positions even if the facts and circumstances of a particular litigation do not give rise to a provision in the financial statements.

In connection with third-party agreements, Teva may under certain circumstances be required to indemnify, and may be indemnified by, in unspecified amounts, the parties to such agreements against third-party claims. Among other things, Teva’s agreements with third parties may require Teva to indemnify them, or require them to indemnify Teva, for the costs and damages incurred in connection with product liability claims, in specified or unspecified amounts.

Except as otherwise noted, all of the litigation matters disclosed below involve claims arising in the United States. Except as otherwise noted, all third party sales figures given below are based on IQVIA (formerly IMS Health Inc.) data.

Intellectual Property Litigation

From time to time, Teva seeks to develop generic versions of patent-protected pharmaceuticals for sale prior to patent expiration in various markets. In the United States, to obtain approval for most generics prior to the expiration of the originator’s patents, Teva must challenge the patents under the procedures set forth in the Hatch-Waxman Act of 1984, as amended. To the extent that Teva seeks to utilize such patent challenge procedures, Teva is and expects to be involved in patent litigation regarding the validity,

enforceability or infringement of the originator’s patents. Teva may also be involved in patent litigation involving the extent to which its product or manufacturing process techniques may infringe other originator or third-party patents.

Additionally, depending upon a complex analysis of a variety of legal and commercial factors, Teva may, in certain circumstances, elect to market a generic version even though litigation is still pending. To the extent Teva elects to proceed in this manner, it could face substantial liability for patent infringement if the final court decision is adverse to Teva, which could be material to its results of operations and cash flows in a given period.

The general rule for damages in patent infringement cases in the United States is that the patentee should be compensated by no less than a reasonable royalty, and it may also be able in certain circumstances to be compensated for its lost profits. The amount of a reasonable royalty award would generally be calculated based on the sales of Teva’s product. The amount of lost profits would generally be based on the lost sales of the patentee’s product. In addition, the patentee may seek consequential damages as well as enhanced damages of up to three times the profits lost by the patent holder for willful infringement, although courts have typically awarded much lower multiples.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Teva is also involved in litigation regarding patents in other countries where it does business, particularly in Europe, where Teva has in recent years increased the number of launches of its generic versions of branded pharmaceuticals prior to the expiration of the innovator’s patents. The laws concerning generic pharmaceuticals and patents differ from country to country. Damages for patent infringement in Europe may include lost profits or a reasonable royalty, but enhanced damages for willful infringement are generally not available.

In July 2014, GlaxoSmithKline (“GSK”) sued Teva in Delaware federal court for infringement of a patent expiring in June 2015 directed to using carvedilol in a specified manner to decrease the risk of mortality in patients with congestive heart failure. Teva and eight other generic producers began selling their carvedilol tablets (the generic version of GSK’s Coreg®) in September 2007. Teva vigorously disputed GSK’s claims on the merits and also disputed the amount and nature of GSK’s alleged damages. A jury trial was held and the jury returned a verdict in GSK’s favor finding Teva liable for induced infringement, including willful infringement, and assessing damages of $235.5 million, not includingpre- or post-judgment interest. Teva filed post-trial motions for judgment as a matter of law asking the court to overturn the jury verdict on inducement, invalidity, and the award of lost profits damages, and GSK filed post-trial motions asking the court to increase the damages amount in light of the willful infringement finding and to set the interest rate(s) to be applied to the total damages amount. On March 28, 2018, the District Courtdistrict court issued an opinion overturning the jury verdict and instead found no induced infringement by Teva, thereby finding that Teva did not owe any damages. The District Courtdistrict court denied Teva’s motion seeking to overturn the jury verdict with respect to invalidity and denied GSK’s motion seeking to increase the damages award. On May 25, 2018, GSK canappealed the decision, and Teva filed an appeal this decision.of certain adverse rulings. If the appeal of the District Court’sdistrict court’s decision is decided against Teva, the case would be remanded to the District Courtdistrict court for it to consider Teva’s other legal and equitable defenses that have not yet been considered by the District Court.district court. The provision that was included in the financial statements for this matter has been reversed as the exposure is no longer considered probable.

In 2014, Teva Canada succeeded in its challenge of the bortezomib (the generic equivalent of Velcade®) product and mannitol ester patents under the Patented Medicines (Notice Of Compliance) Regulations (“PM(NOC)”). Teva commenced sales in the first quarter of 2015. At the time of Teva’s launch, annual sales of Velcade were approximately 94 million Canadian dollars. Teva commenced an action under Section 8 of PM(NOC) to recover damages for being kept off of the market during the PM(NOC) proceedings. Janssen and Millennium filed a counterclaim for infringement of the same two patents as well as a patent covering a process to prepare bortezomib. The product patent expired in October 2015; the other patents expire in January 2022 and March 2025. On December 20, 2017, Teva entered into an agreement with Janssen and MilleniumMillennium which limits the damages payable by either party depending on the outcome of the infringement/impeachment action. As a result, the most Janssen and MilleniumMillennium could recover is 200 million Canadian dollars (approximately $159 million) plus post-judgment interest. The trial, which is limited to the issue of patent validity and infringement, began on January 29, 2018 and concluded on March 8, 2018. TheOn June 27, 2018, the court has not yet issued any decision.its opinion in Teva’s favor and ruled that Janssen and Millennium are to pay Teva 5 million Canadian dollars in Section 8 damages. On September 28, 2018, Janssen and Millennium filed an appeal of this decision with respect to two of the patents subject to the original proceedings. If the decision is overturned on appeal, Teva could owe the capped damages set forth above. In addition to the potential damages that could be awarded, if Janssen and MilleniumMillennium are ultimately were successful in their allegations of patent infringement,this claim, Teva could be enjoined from furtherordered to cease sales of its bortezomib product.

On July 8, 2011, Helsinn sued Teva over its filing of an ANDA to market a generic version of palonosetron IV solution (the generic equivalent of Aloxi®), and in November 2015, the District Court of New Jersey ruled against Teva. Teva appealed this decision, and in May 2017, the Federal Circuit Court of Appeals reversed the district court’s ruling and found the asserted patents invalid. In January 2018, full appellate review of that decision was denied. Helsinn filed an appeal with the US Supreme Court, which was granted on June 25, 2018. Oral argument has been scheduled for December 4, 2018. If the Supreme Court reverses the appellate decision, the case may be remanded to the district court. Separately, in October 2014, Helsinn filed an additional claim on later-acquired patents, but that litigation was stayed pending the outcome of the original case. Following the appellate court’s decision in

Teva’s favor in the original case, Helsinn reopened the stayed case on the later-acquired patent and filed a motion for a preliminary injunction based on that later-acquired patent. On January 30, 2018, the District Court of New Jersey denied Helsinn’s request for a preliminary injunction. Teva launched its generic palonosetron IV solution after obtaining final regulatory approval on March 23, 2018. If Teva ultimately loses either one of the cases discussed above, Teva may be ordered, by the court, to cease sales of its generic product and/or pay damages to Helsinn. Aloxi® annual sales as of November 2017 were $459 million in the U.S.

Product Liability Litigation

Teva’s business inherently exposes it to potential product liability claims. Teva maintains a program of insurance, which may include commercial insurance, self-insurance (including direct risk retention), or a combination of both approaches, in amounts and on terms that it believes are reasonable and prudent in light of its business and related risks. However, Teva sells, and will continue to sell, pharmaceuticals that are not covered by its product liability insurance; in addition, it may be subject to claims for which insurance coverage is denied as well as claims that exceed its policy limits. Product liability coverage for pharmaceutical companies is becoming more expensive and increasingly difficult to obtain. As a result, Teva may not be able to obtain the type and amount of commercial insurance it desires, or any commercial insurance on reasonable terms, in all of its markets.

Competition Matters

As part of its generic pharmaceuticals business, Teva has challenged a number of patents covering branded pharmaceuticals, some of which are among the most widely-prescribed and well-known drugs on the market. Many of Teva’s patent challenges have resulted in litigation relating to Teva’s attempts to market generic versions of such pharmaceuticals under the federal Hatch-Waxman Act. Some of this litigation has been resolved through settlement agreements in which Teva obtained a license to market a generic version of the drug, often years before the patents expire.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Teva and its subsidiaries have increasingly been named as defendants in cases that allege antitrust violations arising from such settlement agreements. The plaintiffs in these cases, which are usually direct and indirect purchasers of pharmaceutical products, and often assert claims on behalf of classes of all direct and indirect purchasers, typically allege that (1) Teva received something of value from the innovator in exchange for an agreement to delay generic entry, and (2) significant savings could have been realized if there had been no settlement agreement and generic competition had commenced earlier. These class action cases seek various forms of injunctive and monetary relief, including damages based on the difference between the brand price and what the generic price allegedly would have been and disgorgement of profits, which are automatically trebled under the relevant statutes, plus attorneys’ fees and costs. The alleged damages generally depend on the size of the branded market and the length of the alleged delay, and can be substantial – potentially measured in multiples of the annual brand sales – particularly where the alleged delays are lengthy or branded drugs with annual sales in the billions of dollars are involved.

Teva believes that its settlement agreements are lawful and serve to increase competition, and has defended them vigorously. In Teva’s experience to date, these cases have typically settled for a fraction of the high end of the damages sought, although there can be no assurance that such outcomes will continue.

In June 2013, the United States Supreme Court held, in Federal Trade Commission v. Actavis, Inc. (the “AndroGel case”), that a rule of reason test should be applied in analyzing whether such settlements potentially violate the federal antitrust laws. The Supreme Court held that a trial court must analyze each agreement in its entirety in order to determine whether it violates the antitrust laws.

This new test has resulted in increased scrutiny of Teva’s patent settlements, additional action by the FTC and state and local authorities, and an increased risk of liability in Teva’s currently pending antitrust litigations.

In April 2006, certain subsidiaries of Teva were named in a class action lawsuit filed in the U.S. District Court for the Eastern District of Pennsylvania. The case alleges that the settlement agreements entered into between Cephalon, Inc., now a Teva subsidiary (“Cephalon”), and various generic pharmaceutical companies in late 2005 and early 2006 to resolve patent litigation involving certain finished modafinil products (marketed as PROVIGIL®) were unlawful because they had the effect of excluding generic competition. The case also alleges that Cephalon improperly asserted its PROVIGIL patent against the generic pharmaceutical companies. The first lawsuit was brought by King Drug Company of Florence, Inc. on behalf of itself and as a proposed class action on behalf of any other person or entity that purchased PROVIGIL directly from Cephalon (the “Direct Purchaser Class”).Cephalon. Similar allegations were made in other complaints, including those filed on behalf of a proposed class of end payers of PROVIGIL, (the “End Payer Class”), by certain individual end payers, by certain retail chain pharmacies and by Apotex, Inc. (collectively, these cases are referred to as the “Philadelphia Modafinil Action”). Separately, Apotex challenged Cephalon’s PROVIGIL patent, and in October 2011, the Courtcourt found the patent to be invalid and unenforceable based on inequitable conduct. This decision was affirmed on appeal in April 2013. Teva has either settled or reached agreements in principle to settle with all of the plaintiffs in the Philadelphia Modafinil Action. However, one of the end payers, United Healthcare Services, took the position that it is not bound by the settlement that was agreed to on its behalf and brought a separate action in Minnesota federal court, which has beenwas transferred to the U.S. District Court for the Eastern District of Pennsylvania, where Teva has alsohad filed suit to enforce the settlement. A bench trial was held in the suit to enforce the settlement commenced on April 23, 2018, and concludedthe court issued its opinion on April 27,September 19, 2018, ruling in Teva’s favor

and holding that United Healthcare is bound by the settlement. On October 16, 2018, United Healthcare moved the court to amend its final judgment and to clarify that the final judgment does not address how settlement proceeds should be allocated among United Healthcare and the other end payers. That motion was denied on October 30, 2018. The court ordered post-trial briefing to be submitted within 45 days and has not yet issued any decision.

Additionally, Cephalon and Teva have reached a settlement with 48 state attorneys general, which was approved by the court on November 7, 2016. Certain other claimants, including the State of California, have given notices of potential claims related to these settlement agreements. Teva has produced documents and information in response to discovery requests issued by the California Attorney General’s office as part of its ongoing investigation of generic competition to PROVIGIL.

In May 2015, Cephalon entered into a consent decree with the FTC under which the FTC dismissed its claims against Cephalon in the FTC Modafinil Action in exchange for payment of $1.2 billion (lessset-offs for prior settlements) by Cephalon and Teva into a settlement fund. Under the consent decree, Teva also agreed to certain injunctive relief with respect to the types of settlement agreements Teva may enter into to resolve patent litigation in the United States for a period of ten years. The settlement fund does not cover any judgments or settlements outside the United States.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

Following an investigation initiated by the European Commission in April 2011 regarding a modafinil patent settlement in Europe, the Commission issued a Statement of Objections in July 2017 against both Cephalon and Teva alleging that the 2005 settlement agreement between the parties had the object and effect of hindering the entry of generic modafinil. Teva submitted its defense in writing and an oral hearing was held. No final decision regarding infringement has yet been taken by Thethe Commission. The sales of modafinil in the European Economic Area during the last full year of the alleged infringement amounted to EUR 46.5 million.

In January 2009, the FTC and the State of California filed a complaint for injunctive relief in California federal court alleging that a September 2006 patent lawsuit settlement between Watson Pharmaceuticals, Inc. (“Watson”), now a Teva subsidiary, and Solvay Pharmaceuticals, Inc. (“Solvay”) relating to AndroGel® 1% (testosterone gel) violated the antitrust laws. Additional lawsuits alleging similar claims were later filed by private plaintiffs (including plaintiffs purporting to represent classes of similarly situated claimants as well as direct purchaser plaintiffs filing separately), and the various actions were consolidated in a multidistrict litigation in Georgia federal court. The defendants filed various summary judgment motions on September 29, 2017, which the district court granted in part, and thedenied in part, on June 13, 2018. The direct-purchaser plaintiffs moved for class certification on February 9, 2018 and that motion was denied on July 16, 2018. Both setsThe direct-purchaser plaintiffs have not sought to immediately appeal the denial of motions remain pending.such class certification. As a result, the three direct purchasers that had sought class certification can proceed as individual plaintiffs, but any other member of the proposed direct purchaser class will need to file a separate, individual lawsuit if it wishes to participate in the litigation. The court has ordered a bench trial on the FTC’s claims to start on February 25, 2019, with a jury trial on the private plaintiffs’ claims to be scheduled thereafter. Annual sales of AndroGel® 1% at the time of the settlement were approximately $350 million, and annual sales of the AndroGel franchise (AndroGel® 1% and AndroGel® 1.62%) were approximately $140 million and $1.05 billion, respectively, at the time Actavis launched its generic version of AndroGel® 1% in November 2015.

In December 2011, three groups of plaintiffs sued Wyeth and Teva for alleged violations of the antitrust laws in connection with their settlement of patent litigation involving extended release venlafaxine (generic Effexor® XR) entered into in November 2005. The cases were filed by a purported class of direct purchasers, by a purported class of indirect purchasers and by certain chain pharmacies in the United States District Court for the District of New Jersey. The plaintiffs claim that the settlement agreement between Wyeth and Teva unlawfully delayed generic entry. In October 2014, the court granted Teva’s motion to dismiss in the direct purchaser cases, after which the parties agreed that the court’s reasoning applied equally to the indirect purchaser cases. Plaintiffs appealed, and on August 21, 2017, the Third Circuit reversed the district court’s decision and remanded for further proceedings. On November 20, 2017, Teva and Wyeth filed a petition for a writ of certiorari in the United States Supreme Court. That petition was denied on February 20, 2018, and litigation has resumed before the district court. Annual sales of Effexor® XR were approximately $2.6 billion at the time of settlement and at the time generic versions were launched in July 2010.

In February 2012, two purported classes of direct-purchaser plaintiffs sued GSK and Teva in New Jersey federal court for alleged violations of the antitrust laws in connection with their settlement of patent litigation involving lamotrigine (generic Lamictal®) entered into in February 2005. The plaintiffs claim that the settlement agreement unlawfully delayed generic entry and seek unspecified damages. In December 2012, the court dismissed the case. In January 2014, the court denied the direct purchaser plaintiffs’ motion for reconsideration and affirmed its original dismissal. Incase, but in June 2015, the Third Circuit reversed and remanded for further proceedings. On February 19, 2016, Teva and GSK filed a petition for a writ of certiorari in the United States Supreme Court, which was denied on November 7, 2016. In the meantime, litigation has resumed before the district court.court, and direct-purchaser plaintiffs moved for class certification in June 2018. That motion has been fully briefed and remains pending. Annual sales of Lamictal® were approximately $950 million at the time of the settlement, and approximately $2.3 billion at the time generic competition commenced in July 2008.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

In April 2013, purported classes of direct purchasers of, and end payers for, Niaspan® (extended release niacin) sued Teva and Abbott for violating the antitrust laws by entering into a settlement agreement in April 2005 to resolve patent litigation over the product. A multidistrict litigation has been established in the U.S. District Court for the Eastern District of Pennsylvania. Throughout

2015 and in January 2016, several individual direct purchaseropt-out plaintiffs filed complaints with allegations nearly identical to those of the direct purchaser class. In October 2016, the District Attorney for Orange County, California, filed a similar complaint, which has since been amended, in California state court, alleging violations of state law. Further proceedings in the California action have been stayed pending resolution of Defendants’ petition for writ of mandate or prohibition filed with the Court of Appeal, Fourth Appellate District, which seeks an order vacating the Superior Court’s denial of Defendants’ motionDefendants moved to strike allthe District Attorney’s claims for restitution and civil penalties to the extent they are not limited to alleged activity occurring in Orange County. The Superior Court denied that motion, but defendants appealed, and on May 31, 2018, the Court of Appeal, Fourth Appellate District, reversed and instructed the Superior Court to grant defendants’ motion. The District Attorney petitioned the California Supreme Court to review the Court of Appeal’s decision. The petition was granted on August 22, 2018, and the District Attorney filed its opening brief before the California Supreme Court on September 21, 2018. Annual sales of Niaspan® were approximately $416 million at the time of the settlement and approximately $1.1 billion at the time generic competition commenced in September 2013.

In November 2013, a putative class action was filed in Pennsylvania federal court against Actavis, Inc. and certain of its affiliates, alleging that Watson’s 2012 patent lawsuit settlement with Endo Pharmaceuticals Inc. relating to Lidoderm® (lidocaine transdermal patches) violated the antitrust laws. Additional lawsuits containing similar allegations followed on behalf of other classes of putative direct purchaser andend-payer plaintiffs, as well as retailers acting in their individual capacities, and those cases were consolidated as a multidistrict litigation in federal court in California. On February 21, 2017, the court granted both the indirect purchaser plaintiffs’ and the direct purchaser plaintiffs’ motions for class certification. WeTeva reached an agreement to settle the multidistrict litigation with the various plaintiff groups in the first quarter of 2018. A provision for these settlements has been included in the financial statements, and on March 20,in September 2018, the district court gave final approval for the settlements with the direct purchaser andend-payorend-payer plaintiffs moved the court to preliminarily approve their respective settlements.plaintiffs. The FTC has also filed suit to challenge the Lidoderm® settlement, initially bringing antitrust claims against Watson, Endo, and Allergan in Pennsylvania federal court in March 2016, and then2016. The FTC later voluntarily dismissingdismissed those claims andre-filing refiled them along(along with a stipulated order for permanent injunction to settle its claims against EndoEndo) in the same California federal court in which the private multidistrict litigation referenced above was pending. On February 3, 2017, the State of California filed aits own complaint against Allergan and Watson, and that complaint was also assigned to the California federal court presiding over the multidistrict litigation. After the FTC dismissed its claims in Pennsylvania, but before itre-filed them in California, Watson and Allergan filed suit against the FTC in the same Pennsylvania federal court where the agency had initially brought its lawsuit, seeking a declaratory judgment that the FTC’s claims are not authorized by statute, or, in the alternative, that the FTC does not have statutory authority to pursue a disgorgement remedy. That declaratory judgment action remains pending, and thedisgorgement. The federal court in California has stayed both the FTC’s claims and the State of California’s claims against Allergan and Watson, pending the outcome of the declaratory judgment action in Pennsylvania. On October 29, 2018, the Pennsylvania court dismissed that declaratory judgment action for lack of jurisdiction. Annual sales of Lidoderm® at the time of the settlement were approximately $1.2 billion, and were approximately $1.4 billion at the time Actavis launched its generic version in September 2013.

Since November 2013, numerous lawsuits have been filed in various federal courts by purported classes of end payers for, and direct purchasers of, Aggrenox® (dipyridamole/aspirin tablets) against Boehringer Ingelheim (“BI”), the innovator, and several Teva subsidiaries. The lawsuits allege, among other things, that the settlement agreement between BI and Barr entered into in August 2008 violated the antitrust laws. A multidistrict litigation has been established in the U.S. District Court for the District of Connecticut. Teva and BI’s motion to dismiss was denied in March 2015. On April 11, 2017, the Orange County District Attorney filed a complaint for violations of California’s Unfair Competition Law based on the Aggrenox® patent litigation settlement. Teva has settled with the putative classes of direct purchasers and end payers, as well as with theopt-out direct purchaser plaintiffs, and with two of theopt-out end payer plaintiffs, Humana and Blue Cross/Blue Shield of Louisiana. A provision has been included in the financial statements for this matter. The district court overruled certain objections to the end payer settlement, including objections made by the Orange County District Attorney, and approved such settlement. The District Attorney subsequently appealed the court’s approval to the Second Circuit.Opt-outs from the end payer class have also appealed certain aspects of the court’s approval order to the Second Circuit. Those appeals remain pending. Annual sales of Aggrenox® were approximately $340 million at the time of the settlement and approximately $455 million at the time generic competition began in July 2015. Teva has settled with the putative class of direct purchasers and theopt-out direct purchaser plaintiffs. Additionally, on January 8, 2018, Teva reached an agreement to settle with the end payer class plaintiffs, and subsequently settled with two of theopt-out end payer plaintiffs, Humana and Blue Cross/Blue Shield of Louisiana. The settlement with the end payer class was preliminarily approved by the court on March 6, 2018. A provision has been included in the financial statements for this matter.

Since January 2014, numerous lawsuits have been filed in the U.S. District Court for the Southern District of New York by purported classes of end payers for and direct purchasers of Actos® and Acto plus Met® (pioglitazone and pioglitazone plus metformin) against Takeda, the innovator, and several generic manufacturers, including Teva, Actavis and Watson.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

The lawsuits allege, among other things, that the settlement agreements between Takeda and the generic manufacturers (including Takeda’s December 2010 settlement agreement with Teva) violated the antitrust laws. The Court dismissed the end payer lawsuits against all defendants in September 2015. In October 2015, the end payers appealed that ruling, and on March 22, 2016, a stipulation was filed dismissing Teva and the other generic defendants from the appeal. On February 8, 2017, the Court of Appeals for the Second Circuit affirmed the dismissal in part and vacated and remanded the dismissal in part with respect to the claims against Takeda. The direct purchasers’ case had been stayed pending resolution of the appeal in the end payer matter, and the direct purchasers amended their complaint for a second time after the Court of Appeals for the Second Circuit’s decision. Defendants had moved to dismiss the direct purchasers’ original complaint and supplementalcomplaint. Supplemental briefing on that motion based on the new allegations in the amended complaint was completed on June 29, 2017. The court has not yet issued its decision.2017 and oral argument was held on October 23, 2018. At the time of the settlement, annual sales of Actos® were approximately $3.7 billion and annual sales of ACTO plus Met® were approximately $500 million. At the time generic

competition commenced in August 2012, annual sales of Actos® were approximately $2.8 billion and annual sales of ACTO plus Met® were approximately $430 million.

In June 2014, two groups of end payers sued AstraZeneca and Teva, as well as Ranbaxy and Dr. Reddy’s, in the Philadelphia Court of Common Pleas for violating the antitrust laws by entering into settlement agreements to resolve the esomeprazole (generic Nexium®) patent litigation (the “Philadelphia Esomeprazole Actions”). These end payers had opted out of a class action that was filed in the Massachusetts federal court in September 2012 and resulted in a jury verdict in December 2014 in favor of AstraZeneca and Ranbaxy (the “Massachusetts Action”). Prior to the jury verdict, Teva settled with all plaintiffs in the Massachusetts Action for $24 million. The allegations in the Philadelphia Esomeprazole Actions are nearly identical to those in the Massachusetts Action. The Philadelphia Esomeprazole Actions were stayed pending resolution of the Massachusetts Action, which was on appeal to the Court of Appeals for the First Circuit with respect to the claims against thenon-settling defendants, AstraZeneca and Ranbaxy. On November 21, 2016, the First Circuit affirmed the district court’s judgment in favor of AstraZeneca and Ranbaxy, and the plaintiffs’ petitions for rehearing and rehearing en banc were denied on January 10, 2017.

In September 2014, the FTC sued AbbVie Inc. and certain of its affiliates (“AbbVie”) andas well as Teva in the U.S. District Court for the Eastern District of Pennsylvania alleging that they violated the antitrust laws when they entered into a settlement agreement to resolve the AndroGel® patent litigation and a supply agreement under which AbbVie wouldagreed to supply Teva with an authorized generic product forversion of TriCor® to Teva.. The FTC alleges that Teva agreed to delay the entry of its generic testosterone gel product in exchange for entering into the TriCor supply agreement. In May 2015, the court granted Teva’s motion to dismissdismissed the FTC’s claim concerning the settlement and supply agreements, and thus dismissed Teva from the case entirely. The FTC proceeded with a separate claim against AbbVie alone and in June 2018, following a bench trial, the court held that AbbVie had violated the antitrust laws by filing sham patent infringement lawsuits against both Teva and Perrigo in the underlying AndroGel patent litigation. The court ordered AbbVie to pay $448 million in disgorgement but declined to award injunctive relief. The FTC has since filed a notice of appeal as to, Teva. The FTC’s motions for reconsideration and for entryamong other things, the district court’s May 2015 dismissal of partial final judgment to permit an immediate appeal were denied, so the FTC cannot appeal the dismissal until its claims against AbbVie are resolved. The Court granted the FTC’s summary judgment motion that AbbVie’s patent infringement lawsuitclaim against Teva, in the AndroGel patent litigation was objectively baseless. A bench trial for the FTC’s case against AbbVie began in February 2018 and concluded in April 2018. The court has not yet issued its decision.referenced above.

Since May 2015, two lawsuits have been filed in the U.S. District Court for the Southern District of New York by a purported class of direct purchasers of, and a purported class of end payers for, Namenda IR® (memantine hydrochloride) against Forest Laboratories, LLC (“Forest”) and Actavis PLC,, the innovator, and several generic manufacturers, including Teva. Teva is only a defendant in the end payer case, andin which defendants moved to dismiss the claims made by the end payers. The lawsuits allege, among other things, that the settlement agreements between Forest and the generic manufacturers (including Forest’s November 2009 settlement agreement with Teva) violated the antitrust laws. On September 13, 2016, the court denied defendants’ motions to dismiss, but stayed the cases with respect to the claims brought under state law, which are the only claims asserted against Teva. The court lifted the stay on September 10, 2018 and has referred the parties to mediation. Annual sales of Namenda IR® at the time of the settlement were approximately $1.1 billion, and are currently approximately $1.4 billion.

On March 8, 2016 and April 11, 2016, certain Actavis subsidiaries in the United Kingdom, including Auden Mckenzie Holdings Limited, received notices from the U.K. Competition and Markets Authority (“CMA”) that it had launched formal investigations under Section 25 of the Competition Act of 1998 (“Competition Act”) into suspected breaches of competition law in connection with the supply of 10mg and 20mg hydrocortisone tablets. On December 16, 2016, the CMA issued a statement of objections (a provisional finding of infringement of the Competition Act) in respect of certain allegations against Actavis UK and Allergan, which was later reissued to include certain Auden Mckenzie entities.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

A response was submitted and an oral hearing was held. On December 18, 2017, the CMA issued a Statement of Draft Penalty Calculation. A response was submitted and an oral hearing was held. No final decision regarding infringement of competition law has yet been issued by the CMA. On March 3, 2017, the CMA issued a second statement of objection in respect of certain additional allegations (relating to the same products and covering part of the same time period as for the first statement of objections) against Actavis UK, Allergan, and a number of other companies, which was later reissued to include certain Auden Mckenzie entities. A response was submitted and an oral hearing was held. On January 9, 2017, Teva completed the sale of Actavis UK to Accord Healthcare Limited, pursuant to which Teva will indemnify Accord Healthcare for potential fines imposed by the CMA and/or damages awarded by a court onagainst Actavis UK as a result of the investigations in respect of conduct prior to the closing date of the sale. In the event of any such fines or damages, Teva expects to assert claims, including claims for breach of warranty, against the sellers of Auden Mckenzie. The terms of the purchase agreement may preclude a full recovery by Teva. A liability for this matter has been recorded in purchase accounting related to the acquisition of Actavis Generics. Further to ourthe Master Purchase Agreement with Allergan whereby Teva agreed to indemnify Allergan for liabilities related to acquired assets, Teva agreed with Allergan to settle and release Teva’s indemnity claim and Allergan’s potential losses arising from the CMA in connection with this matter, pursuant to the agreement the parties entered into on January 31, 2018. See note 3.

In November 2016, three putative indirect purchaser class actions were filed in federal courts in Wisconsin, Massachusetts and Florida against Shire U.S., Inc. and Shire LLC (collectively, “Shire”) and Actavis, alleging that Shire’s 2013 patent litigation settlement with Actavis related to the ADHD drug Intuniv® (guanfacine) violated various state consumer protection and antitrust laws. On December 30, 2016 and January 11, 2017, two additional similar actions were filed, also in Massachusetts federal court, against Shire and Actavis or Teva (as successor to Actavis) by putative classes of direct purchaser plaintiffs. All five cases are now in Massachusetts federal court and on March 10, 2017, both the indirect purchaser plaintiffs and the direct purchaser plaintiffs filed

consolidated amended complaints. Annual sales of Intuniv® were approximately $335 million at the time of the settlement, and approximately $327 million at the time generic competition began in 2014.

Government Investigations and Litigation Relating to Pricing and Marketing

Teva is involved in government investigations and litigation arising from the marketing and promotion of its pharmaceutical products in the United States. Many of these investigations originate through what are known asqui tam complaints, in which the government reviews a complaint filed under seal by a whistleblower (a “relator”) that alleges violations of the federal False Claims Act. The government considers whether to investigate the allegations and will, in many cases, issue subpoenas requesting documents and other information, including conducting witness interviews. The government must decide whether to intervene and pursue theclaimsthe claims as the plaintiff. Once a decision is made by the government, the complaint is unsealed. If the government decides not to intervene, then the relator may decide to pursue the lawsuit on his own without the active participation of the government.

A number of state attorneys general have filed various actions against Teva and/or certain of its subsidiaries, including certain Actavis subsidiaries, relating to reimbursements or drug price reporting under Medicaid or other programs. Such price reporting is alleged to have caused governmentsstates and others to pay inflated reimbursements for covered drugs. Teva and its subsidiaries have reached settlements in most of these cases,cases. On October 4, 2018, Teva settled longstanding litigation filed by the State of Illinois against subsidiaries of Teva and remain partiesWatson for a total settlement amount of $135 million, to activebe paid over time through January 2020. Teva accepted the settlement while denying any liability with respect to the claims made by the state. Pending the final settlement payment, the Illinois litigation is stayed. In August 2013, judgment was entered in Illinois.a separate case brought by the State of Mississippi against Watson, pursuant to which Watson was ordered to pay compensatory damages amounting to $12.4 million. In March of 2014, the Mississippi court amended the judgment to also include punitive damages in the amount of $17.9 million. The judgment was affirmed in all respects by the Mississippi Supreme Court in January of 2018 and has since been satisfied in full. The Actavis subsidiaries remain parties to active litigation in Illinois and Utah.Utah where previously dismissed claims against Watson are now on appeal. A provision for thethese cases has been included in the financial statements. Trial in the Illinois case against Teva concluded in the fourth quarter of 2013, and post-trial briefing was submitted. On June 28, 2017, after several years, the court issued a Memorandum Order After Trial finding liability against Teva, but reserved its decision on damages. Teva denies any liability and sought reconsideration of the order, which was denied. A hearing on damages is scheduled for August 8, 2018. The State of Illinois is seeking approximately $90 million in compensatory damages. Any such damages ultimately awarded by the court are subject to automatic trebling. In addition, the state is seeking statutory penalties ranging from $362 million to approximately $1.2 billion. Teva will continue to argue that any damages and penalties should be significantly less than the amount sought by the state. In August 2013, in the Mississippi case against Watson, the court ruled in favor of the state, awarding $12.4 million in compensatory damages and civil penalties. In March 2014, the court awarded the state an additional $17.9 million in punitive damages. A provision for these amounts has been included in the financial statements. Watson appealed both the original and the punitive damage awards. On January 11, 2018, the Mississippi Supreme Court affirmed the judgment in favor of the State of Mississippi and against Watson in all respects.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

On February 9, 2018, the judgment was fully satisfied and on February 16, 2018, the trial court discharged the appeal bond fully concluding this matter. In Utah, claims against Watson that were dismissed in their entirety by the trial court are now on appeal.

Severalqui tam complaints have been unsealed in recent years as a result of government decisions not to participate in the cases. The following is a summary of certain government investigations,qui tam actions and related matters.

In January 2014, Teva received a civil investigative demand from the U.S. Attorney for the Southern District of New York seeking documents and information from January 1, 2006 related to sales, marketing and promotion of COPAXONE and AZILECT, focusing on educational and speaker programs. The demand states that the government is investigating possible civil violations of the federal False Claims Act. In March 2015, the docket in this matter and a False Claims Act civilqui tam complaint concerning this matter were unsealed by the court, which revealed that the U.S. Attorney had notified the court in November 2014 that it had declined to intervene in and proceed with the lawsuit. Thequi tam relators, however, are moving forward with the lawsuit. In June 2015, Teva filed motions to dismiss the complaint. In February 2016, the court stayed its decision on the relators’ claims based on state and local laws, denied Teva’s motions to dismiss the False Claims Act claims, and instructed the relators to amend their complaint with additional information. In March 2016, the relators filed an amended complaint, which Teva answered in April 2016. The parties are currently engagedcompleted discovery. In August 2018, Teva filed a motion for summary judgment on all claims, which is now pending before the court. No trial date has been set.

In January 2014, aqui tam complaint was filed in discovery.Rhode Island federal court alleging that Teva and several other defendants, including manufacturers of MS drugs and pharmacy benefit managers, violated the False Claims Act. Thequi tam action was unsealed on April 4, 2018 after the government declined to intervene. The relator alleges that Teva and the other defendants induced fraudulent overpayments for illegitimate “Bona Fide Service Fees” in excess of fair market value to inflate prices for the Medicare Part D program. Teva expects to move to dismiss the complaint in November 2018.

In May 2017, aqui tam action was filed against a number of Teva subsidiaries. Thequi tam action was unsealed on June 13, 2018 after the government declined to intervene. The relator in the case alleges that Teva violated the False Claims Act by devising and engaging in promotional schemes that violate the Anti-Kickback Statute (“AKS”), resulting in false certifications of compliance with the AKS. Specifically, the relator alleges that Teva paid in-kind remuneration to physicians through reimbursement support and nursing services in order to increase the number of Copaxone prescriptions. An amended complaint was filed on October 15, 2018. Teva will move to dismiss in November 2018.

Beginning in May 2014, various complaints have beenwere filed with respect to opioid sales and distribution against various Teva affiliates, along with several other pharmaceutical companies, by a number of cities, counties, states and agencies across the country. There are actions currently pending against Teva and its affiliates that have been brought by various states, subdivisions and state agencies in both Statestate and Federal Courts.federal courts. Most of the Federalfederal cases have been consolidated into a multidistrict litigation in the Northern District of Ohio.Ohio (“MDL Proceeding”). In addition to the complaints filed by states, state agencies and political subdivisions, private class actionover 1,500 total lawsuits have been filed in Arkansas, Massachusetts, Ohio and Pennsylvania. Several counties in various states, both in state and federal courts. Most of the State of Delawarefederal class action cases, as well as

state cases that have commenced an action against Anda, Inc. (and other distributor and manufacturer defendants) alleging that Anda, Inc. failed to develop and implement systems sufficient to identify suspicious orders of opioid products and preventbeen removed, have been consolidated into the diversion of such products to individuals who used them for other than legitimate medical purposes. The complaints,MDL Proceeding. Complaints asserting claims under similar provisions of different state law, generally contend that the defendants allegedly engaged in improper marketing and distribution of opioids, including ACTIQ® and FENTORAFENTORA. The complaints also assert claims related to Teva’s generic opioid products. In addition, several dozen complaints filed by cities, counties and the State of Delaware have named Anda, Inc. (and other distributors and manufacturers) alleging that Anda failed to develop and implement systems sufficient to identify suspicious orders of opioid products and prevent the abuse and diversion of such products to individuals who used them for other than legitimate medical purposes. Plaintiffs seek a variety of remedies, including restitution, civil penalties, disgorgement of profits, treble damages, attorneys’ fees and injunctive relief. None of the complaints specifiesspecify the exact amount of damages at issue. Teva and its affiliates that are defendants in the various lawsuits deny all allegations asserted in these complaints and have filed or will be filingfile motions to dismiss where possible. On April 11,August 13, 2018, the judge in the multidistrict litigationMDL Proceeding issued a revised case management order setting the first trial for MarchSeptember 2019. The court has also commenced motion to dismiss briefing on certain issues in bellwether cases and the first set of briefing was completed in July 2018. On October 5, 2018, the court issued a Report & Recommendation on the first motion to dismiss filed in the bellwether cases, in which it denied defendants’ motions to dismiss except for the common law public nuisance claim, which was dismissed. Motions to dismiss in eight additional similar cases remain pending. In addition, discovery has commenced in the MDL Proceeding for three cases based in Ohio and fact discovery is ongoing. Other cases remain pending in various state courts, including Oklahoma, where a trial is scheduled to begin in May 2019. In some jurisdictions, such as Connecticut, Illinois, New York, Pennsylvania and Texas, certain state court cases have been transferred to a single court within their respective state court systems for coordinated pretrial proceedings. Several state courts have allowed discovery to begin. On April 27, 2018, Teva received subpoena requests from the DOJ seeking documents relating to the manufacture, marketing and sale of opioids. Teva intends to complyis complying with this subpoena. In addition, a number of State Attorneys General,state attorneys general, including a coordinated multistate effort, have initiated investigations into sales and marketing practices of Teva and its affiliates with respect to opioids. Other states are conducting their own investigations outside of the multistate group. Teva is cooperating with these ongoing investigations which are ongoing, and cannot predict the outcome at this time the outcome.time.

On June 21, 2016, Teva USA received a subpoena from the Antitrust Division of the DOJ seeking documents and other information relating to the marketing and pricing of certain of Teva USA’sUSA generic products and communications with competitors about such products. Actavis received a similar subpoena in June 2015. Teva and Actavis are cooperating fully with the DOJ subpoena requests. On July 12, 2016, Teva USA received a subpoena from the Connecticut Attorney General seeking documents and other information relating to potential state antitrust law violations. In 2015, Actavis has also received a similar subpoena from the Connecticut Attorney General. Teva and Actavis are cooperating fully with these subpoenas.

On December 15, 2016, a civil action was brought by the attorneys general of twenty states against Teva USA and several other companies asserting claims under federal antitrust law (specifically, section 1 of the Sherman Act) alleging price fixing of generic products in the United States. An amended complaint was filed on March 1, 2017 adding twenty additional states to the named plaintiffs and adding supplemental state law claims.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

The states seek a finding that the defendants’ actions violated federal antitrust law, and state antitrust and consumer protection laws, as well as injunctive relief, disgorgement, damages on behalf of various state and governmental entities and consumers, civil penalties and costs. On August 3, 2017, the Judicial Panel on Multidistrict Litigation (“JPML”) transferred this action to the generic drug multidistrict litigation pending in federal court in Pennsylvania, which is discussed in greater detail below. On July 17, 2017, a new complaint was filed in the District Court of Connecticut on behalf of four additional states – Arkansas, Missouri, New Mexico and West Virginia, as well as the District of Columbia. These plaintiffs were not previously party to the State Attorney General action that commenced in December 2016. This complaint, which the JPML has also transferred to the generic drug multidistrict litigation discussed below, makes the same factual allegations and claims that are at issue in the earlier State Attorneys General complaint. On October 31, 2017 the attorneys general of 45 states plus Puerto Rico and the District of Columbia filed a motion for leave to file an amended complaint in this action. The proposed amended complaint names Actavis and Teva as a defendant as well as Teva,defendants, and adds new allegations and claims to those appearing in the prior complaints. Defendants have opposed the motion. On June 5, 2018, the District Court for the Eastern District of Pennsylvania granted the attorneys general’s motion to amend.

Beginning on March 2, 2016, numerous complaints have been filed in the United States on behalf of putative classes of direct and indirect purchasers of several generic drug products, as well as several individual direct purchaseropt-out plaintiffs. These complaints, which allege that the defendants engaged in conspiracies to fix, increase, maintain and/or stabilize the prices of thecertain generic drug products, named,and/or allocate market share of generic products, have been brought against various manufacturer defendants, including among others, Teva USA, Actavis Holdco U.S., Inc., Actavis Elizabeth and Pliva, Inc.Actavis. The plaintiffs generally seek injunctive relief and damages under federal antitrust law, and damages under various state laws. On April 6, 2017, the Judicial Panel on Multidistrict Litigation (JPML)JPML entered an order transferring such cases brought by classes of direct or indirect purchasers and alleging claims of generic price-fixing for coordination or consolidation with the multidistrict litigation currently pending in the Eastern District of Pennsylvania; thePennsylvania. The panel subsequently transferred further cases to that court and the plaintiffs filed consolidated amended complaints on August 15, 2017. Defendants moved to dismiss certain of those consolidated amended complaints on October 6, 2017. InOn October 16, 2018, the pending motions to dismiss were denied. Pursuant to orders dated February and April 2018, the court overseeing the multidistrict litigation lifted the stay of discovery on a limited basis to allow for document discovery andnon-merits based depositions. Teva deniesand Actavis deny having engaged in any conduct that would give rise to liability with respect to the above-mentioned subpoenas and civil suits.

In May 2018, Teva received a civil investigative demand from the DOJ Civil Division, pursuant to the federal False Claims Act, seeking documents and information produced since January 1, 2009 relevant to the Civil Division’s investigation concerning allegations that generic pharmaceutical manufacturers, including Teva, engaged in market allocation and price-fixing agreements, paid illegal remuneration, and caused false claims to be submitted in violation of the False Claims Act. Teva is cooperating fully with this subpoena.

On March 21, 2017, Teva received a subpoena from the U.S. Attorney’s office in Boston, Massachusetts requesting documents related to Teva’s donations to patient assistance programs. Teva is cooperating fully in responding to the subpoena.

For several years,In December 2016, Teva had conducted a voluntary worldwide investigation into business practices that may have implicationsresolved certain claims under the U.S. Foreign Corrupt Practices Act (“FCPA”), following the receipt, beginning in 2012, of subpoenas and informal document requests from with the SEC and the DOJ, with respect to compliance with the FCPAas more fully described in certain countries. In December 2016, Teva reached a resolution with the SEC and DOJ to fully resolve these FCPA matters.Teva’s 2017 Annual Report. The resolution, which relates to conduct in Russia, Mexico and Ukraine from 2007 to 2013, provides for penalties of approximately $519 million (reserved in the financial statements in the third quarter of 2016), which includessettlement included a fine, disgorgement and prejudgment interest; a three-year deferred prosecution agreement (“DPA”) for Teva; a guilty plea by Teva’s Russian subsidiary to criminal charges of violations of the anti-bribery provisions of the FCPA; consent to entry of a final judgment against Teva settlingresolving civil claims of violations of the anti-bribery, internal controls and books and records provisions of the FCPA; and the retention of an independent compliance monitor for a period of three years. The SEC civil consentIf, during the term of the DPA (approximately three years, unless extended), the DOJ determines that Teva has committed a felony under federal law, provided deliberately false or misleading information or otherwise breached the DPA, Teva could be subject to prosecution and DOJadditional fines or penalties, including the deferred prosecution agreement have each obtained court approval.charges.

Following the above resolution with the SEC and DOJ, Teva has had requests for documents and information from various Russian government entities. In December 2016, Teva was informed by Israeli authorities that they had initiated an investigation into the conduct that was the subject of the FCPA investigation and which resulted in the above-mentioned resolution with the SEC and DOJ. Onaddition, on January 14, 2018, Teva and the Government of Israel entered into an arrangement for the Contingent Cessation of Proceedings pursuant to the Israeli Securities Law with the Government of Israel that endsended the investigation of the Israeli government into suchthe conduct againstthat was subject to the CompanyFCPA investigation, and provides forprovided a payment of 75 million New Israeli Shekels (approximatelyapproximately $22 million).

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

million.

Shareholder Litigation

On November 6, 2016 and December 27, 2016, two putative securities class actions were filed in the U.S. District Court for the Central District of California against Teva and certain of its current and former officers.officers and directors. After those two lawsuits were consolidated and transferred to the U.S. District Court for the District of Connecticut, the court appointed the Ontario Teachers’ Pension Plan Board as lead plaintiff.plaintiff (the “Ontario Teachers Securities Litigation”). The lead plaintiff then filed a consolidated amended complaint. On December 1, 2017, Teva and the current and former officer and director defendants subsequently filed motions to dismiss the consolidated amended complaint, with prejudice. On April 3, 2018, the court granted the motions to dismiss without prejudice. Lead plaintiff filed a second amended complaint on June 22, 2018, purportedly on behalf of purchasers of Teva’s securities between February 6, 2014 and August 3, 2017. The consolidatedsecond complaint seeks unspecified damages, legal fees, interest, and costs, and it asserts that Teva and certain of its current and former officers and directors violated the federal securities laws and Israeli securities laws in connection with Teva’s alleged failure to disclose Teva’s participation in an alleged anticompetitive scheme to fix prices and allocate marketspricing strategies for genericvarious drugs in its generic drug portfolio and by making allegedly false or misleading statements in certain offering materials issued during the United States. On December 1, 2017,class period. The second complaint seeks unspecified damages, legal fees, interest, and costs. Teva and the current and former officer and director defendants filed motions to dismiss the consolidated amendedsecond complaint with prejudice. On April 3, 2017, the Court grantedon September 14, 2018. Lead plaintiff’s opposition to the motions to dismiss without prejudice. A second amended complaint is expected with renewed dismissal briefing.due on November 9, 2018.

On July 17, 2017, a lawsuit was filed in the U.S. District Court for the Southern District of Ohio derivatively on behalf of the Teva Employee Stock Purchase Plan, and alternatively as a putative class action lawsuit on behalf of individuals who purchased Teva stock through that plan. That lawsuit seeks unspecified damages, legal fees, interest and costs. The complaint alleges that Teva failed to maintain adequate financial controls based on the facts underpinning Teva’s FCPA deferred prosecution agreement,DPA and also based on allegations substantially similar to those in the putative class action securities lawsuit pending in U.S. District Court for the District of Connecticut, discussed above.Ontario Teachers Securities Litigation. On November 29, 2017, the Courtcourt granted Teva’s motion to transfer the litigation to the U.S. District Court for the District of Connecticut where the putative class action securities lawsuitOntario Teachers Securities Litigation is pending. On December 29, 2017,February 12, 2018, the parties jointly moved to staydistrict court stayed the case pending resolution of the motions to dismiss filed in the consolidated putative securities class action described above.

On August 3, 2017, a securities lawsuit was filed in the U.S. District Court for the District of Connecticut by OZ ELS Master Fund, Ltd., OZ Special Funding, L.P, OZ Enhanced Master Fund, Ltd., Gordel Capital Limited, OZ Global Equity Opportunities Master Fund, Ltd., OZ Master Fund, Ltd., and OZ Global Special Investments Master Fund L.P.related entities. The complaint asserts that Teva and certain of its current and former officers violated the federal securities laws in connection with Teva’s alleged failure to disclose Teva’s participation in an alleged anticompetitive scheme to fix prices and allocate markets for generic drugs in the United States. On August 30, 2017, the court entered an order deferring all deadlines pending the resolution of the motions to dismiss filed in the consolidated putative securities class actionOntario Teachers Securities Litigation described above.

On August 21 and 30, 2017, each of Elliot Grodko and Barry Baker filed a putative securities class action securities lawsuit was filed by Elliot Grodko in the U.S. District Court for the Eastern District of Pennsylvania purportedly on behalf of purchasers of Teva’s securities between November 15, 2016 and August 2, 2017 seeking unspecified damages, legal fees, interest, and costs. The complaint allegedcomplaints allege that Teva and certain of its current and former officers violated the federal securities laws and Israeli securities laws by making false and misleading statements in connection with Teva’s acquisition and integration of Actavis Generics. On November 1, 2017, the court consolidated the Baker and Grodko cases. On April 10, 2018, the Courtcourt granted Teva’s motion to transfer thisthe consolidated action to the District of Connecticut where the Ontario Teachers securities litigationSecurities Litigation is currently pending.

On

Between August 30, 2017, aand October 2018, four complaints were filed against Teva and current and former officer and director defendants seeking unspecified compensatory and rescissory damages, legal fees, costs and expenses. The allegations in these complaints are substantially similar to the allegations in the Ontario Teachers Securities Litigation, but have been brought on behalf of plaintiffs that have “opted out” of the putative securities class action wasin the Ontario Teachers Securities Litigation. The plaintiffs in these“opt-out” cases are Fir Tree Value Master Fund, L.P. and FT SOF V Holdings, LLC; The Phoenix Insurance Company Ltd., The Phoenix Pension Ltd., Excellence Gemel & Hishtalmut Ltd., Excellence Kesem ETNS and Excellence Mutual Fund; Nordea Investment Management AB; and the State of Alaska Department of Revenue, Treasury Division and the Alaska Permanent Fund Corporation, and they filed by Barry Bakertheir complaints in the Court of Common Pleas of Montgomery County, Pennsylvania on August 3, 2018, the U.S. District Court for the Eastern District of Pennsylvania on behalfAugust 3, 2018 and the U.S. District Court for the District of purchasers of Teva’s securities between November 15, 2016Connecticut on October 10 and October 16, 2018, respectively. In the two cases filed in August 2, 2017 seeking unspecified damages, legal fees, interest, and costs. The complaint alleges that2018, Teva and certain officers violated the federal securities laws by making falsecurrent and misleading statements in connection with Teva’s acquisitionformer officer and integration of Actavis Generics. On November 1, 2017, the Court consolidated the Baker case with the Grodko case, discussed above. On April 10, 2018, the Court granted Teva’s motiondirector defendants filed motions to transfer this actionthe cases to the U.S. District Court for the District of Connecticut, where the Ontario Teachers Securities Litigation is pending. In the two cases filed in October 2018, the parties jointly moved to stay the case pending resolution of the motions to dismiss filed in the consolidated putative securities litigation is currently pending.class action described above.

Motions to approve derivative actions against certain past and present directors and officers have been filed in Israel with respect to alleged negligence and recklessness with respect to the acquisition of the Rimsa business and the acquisition of Actavis Generics. Motions for document disclosure prior to initiating derivativesderivative actions were filed with respect to dividend distribution, executive compensation and executive compensation.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

several patent settlement agreements. Motions to approve securities class actions against Teva and certain of its current and former directors and officers were filed in Israel withbased on allegations regarding properof improper disclosure of the above-mentioned pricing investigation, as well as lack of disclosure of negative developments in the generic sector, andincluding price erosion of the prices ofwith respect to Teva’s products as were presented in the second quarter financial reporting of Teva.products. Other motions were filed in Israel to approve a derivative action, discovery and a class action related to alleged claims regarding Teva’s above-mentioned FCPA resolution with the SEC and DOJ.

Environmental Matters

Teva or its subsidiaries are party to a number of environmental proceedings, or have received claims, including under the federal Superfund law or other federal, provincial or state and local laws, imposing liability for alleged noncompliance, or for the investigation and remediation of releases of hazardous substances and for natural resource damages. Many of these proceedings and claims seek to require the generators of hazardous wastes disposed of at a third party-owned site, or the party responsible for a release of hazardous substances that impacted a site, to investigate and cleanupclean the site or to pay or reimburse others for such activities, including for oversight by governmental authorities and any related damages to natural resources. Teva or its subsidiaries have received claims, or been made a party to these proceedings, along with others, as an alleged generator of wastes that were disposed of or treated at third-party waste disposal sites, or as a result of an alleged release from one of Teva’s facilities or former facilities.

Although liability among the responsible parties, under certain circumstances, may be joint and several, these proceedings are frequently resolved so that the allocation of cleanupclean-up and other costs among the parties reflects the relative contributions of the parties to the site conditions and takes into account other pertinent factors. Teva’s potential liability varies greatly at each of the sites; for some sites the costs of the investigation, cleanupclean-up and natural resource damages have not yet been determined, and for others Teva’s allocable share of liability has not been determined. At other sites, Teva has taken an active role in identifying those costs, to the extent they are identifiable and estimable, which do not include reductions for potential recoveries of cleanupclean-up costs from insurers, indemnitors, former site owners or operators or other potentially responsible parties. In addition, enforcement proceedings relating to alleged violations of federal, state, commonwealth or local requirements at some of Teva’s facilities may result in the imposition of significant penalties (in amounts not expected to materially adversely affect Teva’s results of operations) and the recovery of certain costs and natural resource damages, and may require that corrective actions and enhanced compliance measures be implemented.

Other Matters

On February 1, 2018, former shareholders of Ception Therapeutics, Inc., a company that was acquired by and merged into Cephalon in 2010, prior to Cephalon’s acquisition by Teva, filed breach of contract and other related claims against the Company, Teva USA and Cephalon in the Delaware Court of Chancery. Among other things, the plaintiffs allege that Cephalon breached the terms of the 2010 Ception-Cephalon merger agreement by failing to exercise commercially reasonable efforts to develop and commercialize CINQAIR® (reslizumab) for the treatment of eosinophilic esophagitis (EE). The plaintiffs claim damages of at least $200 million, an amount they allege is equivalent to the milestones payable to the former shareholders of Ception in the event Cephalon were to obtain regulatory approval for EE in the United States ($150 million) and Europe ($50 million). All defendants have moved to dismiss the plaintiffs’ complaint and filed briefs in support of theirthose motions on April 10, 2018.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

remain pending.

NOTE 17 – Segments:

In November 2017, Teva announced a new organizational structure and leadership changes to enable strategic alignment across its portfolios, regions and functions. Teva now operates its business through three segments: North America, Europe and GrowthInternational Markets. The purpose of the new structure is to enable stronger alignment and integration between operations, commercial regions,

R&D and Teva’s global marketing and portfolio function, in order to optimize its product lifecycle across the therapeutic areas. Teva’sThe Company began reporting its financial results forunder this structure in the first quarter of 2018 are being reported under this new structure for the first time.2018.

In addition to these three segments, Teva has other activities, primarily the sale of API manufacturing businessto third parties and certain contract manufacturing services.

All the above changes were reflected through retroactive revision of prior period segment information.

Since 2013 and until December 31, 2017, Teva had two reportable segments: generic and specialty medicines. The generic medicines segment included Teva’s OTC and API businesses. Teva’s other activities included distribution activities, sales of medical devices and certain contract manufacturing operation (“CMO”) services.

Teva now operates its business and reports its financial results in three segments:

a) North America segment, which includes the United States and Canada.

(a)

North America segment, which includes the United States and Canada.

b) Europe segment, which includes the European Union and certain other European countries.

(b)

Europe segment, which includes the European Union and certain other European countries.

c) Growth

(c)

International Markets segment, which includes all countries other than those in the North America and Europe segments.

Teva’s Chief Executive Officer (“CEO”), who is the chief operating decision maker (“CODM”), reviews financial information prepared on a consolidated basis, accompanied by disaggregated information about revenues and contributed profit by the three identified reportable segments, namely North America, Europe and GrowthInternational Markets, to make decisions about resources to be allocated to the segments and assess their performance.

Segment profit is comprised of gross profit for the segment less R&D expenses, S&M expenses, G&A expenses and other income related to the segment. Segment profit does not include amortization and certain other items.

Teva manages its assets on a company basis, not by segments, as many of its assets are shared or commingled. Teva’s CODM does not regularly review asset information by reportable segment and, therefore, Teva does not report asset information by reportable segment.

Teva’s CEO may review its strategy and organizational structure. Any changes in strategy may lead to a reevaluation of the Company’s segments and goodwill allocation to reporting units, as well as fair value attributable to its reporting units. See note 7.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

a. Segment information:

 

   North America  Europe   Growth Markets 
   Three months ended
March 31,
  Three months ended
March 31,
   Three months ended
March 31,
 
   2018  2017  2018   2017   2018  2017 
   (U.S. $ in millions)  (U.S. $ in millions)   (U.S. $ in millions) 

Revenues

  $2,531  $3,240  $1,442   $1,341   $750  $718 

Gross profit

   1,432   2,080   797    734    313   292 

R&D expenses

   188   267   73    106    24   47 

S&M expenses

   305   441   255    279    134   158 

G&A expenses

   126   139   91    79    41   48 

Other income

   (102  (73  1    2    (8  (1
  

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

Segment profit

  $915  $1,306  $377   $268   $122  $40 
  

 

 

  

 

 

  

 

 

   

 

 

   

 

 

  

 

 

 

   Three months ended
March 31,
 
   2018   2017 
   (U.S.$ in millions) 

North America profit

  $915   $1,306 

Europe profit

   377    268 

Growth Markets profit

   122    40 
  

 

 

   

 

 

 

Total segment profit

   1,414    1,614 

Profit of other activities

   21    7 
  

 

 

   

 

 

 
   1,435    1,621 

Amounts not allocated to segments:

    

Amortization

   310    320 

Other asset impairments, restructuring and other items

   707    240 

Goodwill impairment

   180    —   

Gain on divestitures, net of divestitures related costs

   (93   —   

Inventorystep-up

   —      64 

Other R&D expenses

   22    —   

Costs related to regulatory actions taken in facilities

   1    34 

Legal settlements and loss contingencies

   (1,278   20 

Other unallocated amounts

   61    48 
  

 

 

   

 

 

 

Consolidated operating income

   1,525    895 
  

 

 

   

 

 

 

Financial expenses, net

   271    207 
  

 

 

   

 

 

 

Consolidated income before income taxes

  $1,254   $688 
  

 

 

   

 

 

 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
   North America  Europe  International Markets 
   Three months ended September 30, 
   2018  2017  2018  2017  2018  2017 
   (U.S. $ in millions) 

Revenues

  $2,265  $3,043  $1,212  $1,380  $726  $882 

Gross profit

   1,232   1,833   683   721   301   351 

R&D expenses

   158   230   62   101   21   35 

S&M expenses

   301   325   249   289   120   158 

G&A expenses

   128   149   74   90   37   51 

Other income (loss)

   (4  (1  1   —     —     (3
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Segment profit

  $649  $1,130  $297  $241  $123  $110 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 
   North America  Europe  International Markets 
   Nine months ended September 30, 
   2018  2017  2018  2017  2018  2017 
   (U.S. $ in millions) 

Revenues

  $7,059  $9,452  $3,982  $4,016  $2,265  $2,485 

Gross profit

   3,867   5,971   2,211   2,147   942   1,043 

R&D expenses

   528   777   208   312   70   129 

S&M expenses

   902   1,158   741   864   384   503 

G&A expenses

   357   432   243   258   115   144 

Other income

   (206  (82  (1  (15  (11  (4
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Segment profit

  $2,286  $3,686  $1,020  $728  $384  $271 
  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

 

Notes to Consolidated Financial Statements

(Unaudited)

   Three months ended
September 30,
   Nine months ended
September 30,
 
   2018   2017   2018   2017 
   (U.S. $ in millions)   (U.S. $ in millions) 

North America profit

  $649   $1,130   $2,286   $3,686 

Europe profit

   297    241    1,020    728 

International Markets profit

   123    110    384    271 
  

 

 

   

 

 

   

 

 

   

 

 

 

Total segment profit

   1,069    1,481    3,690    4,685 

Profit (loss) of other activities

   35    (11   87    3 
  

 

 

   

 

 

   

 

 

   

 

 

 
   1,104    1,470    3,777    4,688 

Amounts not allocated to segments:

        

Amortization

   297    357    909    1,088 

Other asset impairments, restructuring and other items

   658    550    2,080    1,209 

Goodwill impairment

   —      —      300    6,100 

Gain on divestitures, net of divestitures related costs

   (31   —      (114   —   

Inventorystep-up

   —      —      —      67 

Other R&D expenses

   60    150    82    176 

Costs related to regulatory actions taken in facilities

   1    (1   6    48 

Legal settlements and loss contingencies

   19    (20   (1,239   324 

Other unallocated amounts

   84    56    226    143 
  

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated operating income (loss)

   16    378    1,527    (4,467
  

 

 

   

 

 

   

 

 

   

 

 

 

Financial expenses, net

   229    259    736    704 
  

 

 

   

 

 

   

 

 

   

 

 

 

Consolidated income (loss) before income taxes

  $(213  $119   $791   $(5,171
  

 

 

   

 

 

   

 

 

   

 

 

 

b. Segment revenues by major products and activities:

The following tables present revenues by major products and activities for the nine and three months ended March 31,September 30, 2018 and 2017:

 

  Three months ended   Nine months ended 
  Three months ended
March 31,
   September 30,   September 30, 
  2018   2017   2018   2017   2018   2017 
  (U.S.$ in millions)   (U.S. $ in millions)   (U.S. $ in millions) 

North America segment

            

Generic products

  $1,088   $1,415   $922   $1,233   $2,957   $3,979 

COPAXONE

   476    797    463    819    1,403    2,475 

BENDEKA / TREANDA

   181    156    161    179    502    498 

ProAir

   130    121    107    155    352    399 

QVAR

   107    84    36    83    173    265 

AUSTEDO

   30    —      62    6    136    8 

Distribution

   331    295    333    294    984    864 
  Three months ended
March 31,
   Three months ended   Nine months ended 
  2018   2017   September 30,   September 30, 
  (U.S.$ in millions)   2018   2017   2018   2017 
  (U.S. $ in millions)   (U.S. $ in millions) 

Europe segment

            

Generic products

  $997   $850   $845   $871   $2,749   $2,543 

COPAXONE

   153    152    124    150    417    440 

Respiratory products

   113    84    93    90    312    258 
  Three months ended
March 31,
 
  2018   2017 
  (U.S.$ in millions) 

Growth Markets segment

 

Generic products

  $488   $486 

COPAXONE

   16    21 

Distribution

   153    125 

   Three months ended   Nine months ended 
   September 30,   September 30, 
   2018   2017   2018   2017 
   (U.S. $ in millions)   (U.S. $ in millions) 

International Markets segment

        

Generic products

  $498   $629   $1,523   $1,720 

COPAXONE

   14    18    52    65 

Distribution

   149    146    456    406 

A significant portion of Teva’s revenues, and a higher proportion of the profits, come from the manufacture and sale of patent-protected pharmaceuticals. Many of Teva’s specialty medicines are covered by several patents that expire at different times. Nevertheless, once patent protection has expired, or has been lost prior to the expiration date as a result of a legal challenge, Teva no longer has patent exclusivity on these products, and subject to regulatory approval, generic pharmaceutical manufacturers are able to produce and market similar (or purportedly similar) products and sell them for a lower price. The commencement of generic competition, even in the form ofnon-equivalent products, can result in a substantial decrease in revenues for a particular specialty medicine in a very short time. Any such expiration or loss of IP rights could therefore significantly adversely affect Teva’s results of operations and financial condition.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

NOTE 18—18 – Other income:

 

  Three months ended March 31,   Three months ended September 30,   Nine months ended September 30, 
  2018   2017   2018   2017   2018   2017 
  (U.S. $ in millions)   (U.S. $ in millions)   (U.S. $ in millions) 

Gain on divestitures, net of divestitures related costs(1)

  $93    —     $31    —     $114    —   

Section 8 and similar payments(2)

   99    75    1    —      195    83 

Gain on sale of assets

   8    —      1    —      9    —   

Other, net

   3    (3   2    4    16    17 
  

 

   

 

   

 

   

 

   

 

   

 

 

Total other income

  $203   $72   $35   $4   $334   $100 
  

 

   

 

   

 

   

 

   

 

   

 

 

 

(1)Gain

Mainly related to the divestment of the women’s health business and the PGT dissolution in 2018. See note 3.

(2)

Section 8 of the Patented Medicines (Notice of Compliance) RegulationsRegulation relates to recoveries of lost revenue related to patent infringement proceedings in Canada.

TEVA PHARMACEUTICAL INDUSTRIES LIMITED

Notes to Consolidated Financial Statements

(Unaudited)

NOTE 19 – Income Taxes:

In the firstthird quarter of 2018, income taxes were $46Teva recognized a tax benefit of $26 million, or 4%12%, onpre-tax loss of $213 million. In the third quarter of 2017, Teva recognized a tax benefit of $494 million, onpre-tax income of $1.3 billion. $119 million. Teva’s tax rate for the third quarter of 2018 was mainly affected by the mix of products sold in different geographies. Teva’s tax rate for the third quarter of 2017 was mainly affected by aone-time tax benefit associated with the utilization of Actavis Generics historical capital losses.

In the first quarternine months of 2018, Teva recognized a tax benefit of $56 million onpre-tax income of $791 million. In the first nine months of 2017, income taxes were $54$462 million or 8%, onpre-tax incomeloss of $688$5,171 million. OurTeva’s tax rate for the first quarternine months of 2018 was mainly affected byone-time legal settlements and divestments that had awith low corresponding tax effect.effect, as well as the mix of products sold in different geographies.

The Company recognized the income tax effects of the Tax Cuts and Jobs Act (“TCJA”) in its audited consolidated financial statements included in the Company’s Annual Report on Form10-K for the year ended December 31, 2017, in accordance with Staff Accounting Bulletin No. 118, which provides SEC staff guidance for the application of ASC Topic 740, Income Taxes, in the reporting period in which the TCJA was enacted into law. The guidance also provides for a measurement period of up to one year from the enactment date for the Company to complete the accounting for the U.S. tax law changes. As such, theThe Company’s financial results for the year ended December 31, 2017 reflectedincluded a $112 million provisional estimate for itsone-time deemed repatriation taxes liability. In the third quarter of 2018, the Company recorded an additional provision of $40 million, due to an increase in repatriation taxes as a result of theon-going analysis of the earnings of relevantnon-US subsidiaries, partially offset by a decrease for U.S. foreign tax liability. No subsequent adjustments have been madecredits, pursuant to guidance issued by the U.S. Department of Treasury and revisions to the Company’s estimates since the assessment date. The amounts recorded as of December 31, 2017, which continue to represent aremain provisional estimate of the impact of the TCJA. The estimated impact of the TCJA is based on certain assumptions and the Company’s current interpretation, and may changerequire further adjustments as the Company receives additional clarification and implementationnew guidance and as the interpretation of the TCJA evolves over time.becomes available.

The statutory Israeli corporate tax rate is 23% in 2018. OurTeva’s tax rate differs from the Israeli statutory tax rate, mainly due to the mixgeneration of profits generated in various jurisdictions wherein which tax rates are different than the Israeli tax rate, tax benefits in Israel and other countries, as well as infrequent or nonrecurring items.

ITEM 2.

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

Business Overview

We are a global pharmaceutical company, committed to increasing access to high-quality healthcare to patients around the world. We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Our key strengths include our world-leading generics expertise and portfolio, focused specialty portfolio and global infrastructure and scale.

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

In November 2017, we announced a new organizational structure and leadership changes to enable strategic alignment across our portfolios, regions and functions. We now operate our business through three segments: North America, Europe and GrowthInternational Markets. The purpose of the new structure is to enable stronger alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, in order to optimize our product lifecycle across therapeutic areas. OurWe began reporting our financial results forunder this structure in the first quarter of 2018 are being reported under this new structure for the first time.2018.

In addition to these three segments, we have other activities, primarily ourthe sale of active pharmaceutical ingredientingredients (“API”) manufacturing businessto third parties and certain contract manufacturing services.

The data presented in this report for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018.

Highlights

Significant highlights of the firstthird quarter of 2018 included:

 

On September 14, 2018, the FDA approved AJOVYTM (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. We launched the product immediately upon approval.

Revenues in the firstthird quarter of 2018 were $5.1 billion,$4,529 million, a decrease of 10%19%, or 15%18% in local currency terms, compared to the firstthird quarter of 2017.

 

  

Our North America segment generated revenues of $2.5 billion$2,265 million and profit of $915$649 million in the firstthird quarter of 2018. Revenues decreased by 22%,26% compared to the third quarter of 2017, mainly due to adverse market dynamicsa decline in therevenues of COPAXONE®, as well as a decline in revenues in our U.S. generics market,business, a decreasedecline in COPAXONErevenues of ProAir® revenues due to generic competitionand QVAR® and the loss of revenues from the sale of our women’s health business, partially offset by higher revenues from AUSTEDO®and our North America distribution business. Profit decreased by 30%43% mainly due to lower revenues, partially offset by cost reductions and efficiency measures as part of the restructuring plan.

 

Our Europe segment generated revenues of $1.4 billion$1,212 million and profit of $377 million.$297 million in the third quarter of 2018. Revenues increased by 8% but decreased by 6%12%, or 11% in local currency terms, compared to the third quarter of 2017, mainly due to the loss of revenues from the closure of our distribution business in Hungary, and the sale of our women’s health business and a decline in COPAXONE revenues due to the entry of competing glatiramer acetate products, partially offset by new generic product launches. Profit increased by 41%. The increase was23% mainly due to higher revenues as well as cost reductions and efficiency measures as part of the restructuring plan.

 

Our GrowthInternational Markets segment generated revenues of $750$726 million and profit of $122 million.$123 million in the third quarter of 2018. Revenues increaseddecreased by 4%18%, flator 12% in local currency terms.terms compared to the third quarter of 2017, mainly due to lower sales in Japan and Russia, the effect of the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business. Profit increased by $82 million,12%, mainly due to higher revenues as well as cost reductions and efficiency measures as part of the restructuring plan.

 

Other asset impairments, restructuring and other items were $707 million, compared to $240$658 million in the firstthird quarter of 2017,2018, mainly due tocomprised of a $432$521 million impairment of long-lived assets and $247$88 million of restructuring expenses.

We recorded a goodwill impairment of $180 million, driven by the change in fair value, including the discount rate and the change in allocated net assets, to the Rimsa reporting unit.

We recorded income of $1.3 billion under legal settlements and loss contingencies. The income consisted primarily of the working capital adjustment with Allergan, the Rimsa settlement and a reversal of the reserve recorded with respect to the carvedilol patent litigation verdict reversal.

Operating income was $1.5 billion in the first quarter of 2018, compared to $895 million in the first quarter of 2017, mainly due to income in connection with legal settlements, partially offset by other Other asset impairments, restructuring and other items a goodwill impairment and lowerwere $550 million in the third quarter of 2017.

Operating income was $16 million in the third quarter of 2018, compared to $378 million in the third quarter of 2017. The decrease in operating income was mainly due to lower gross profit and higher impairment charges recorded in our North America segment.the third quarter of 2018.

Exchange rate movements between the firstthird quarter of 2018 and the firstthird quarter of 2017 positivelynegatively impacted overall revenues by $240$80 million and operating income by $37$34 million.

 

Our

As of September 30, 2018, our debt decreased by $1.7 billion,was $29,489 million compared to $30,237 million as of June 30, 2018, mainly due to $6.5 billiona debt tender offer completed in September 2018 and repayment of prepayments of certain term loans and senior notes partially offset by our March 2018 issuance of $4.4 billion of senior notes as well as foreign exchange fluctuations.in July 2018.

 

Cash flow generated from operating activities was $1.5 billion$421 million in the firstthird quarter of 2018, compared to $0.1 billion$795 million in the firstthird quarter of 2017, mainly due to proceeds fromlower net income and higher payments related to restructuring liabilities during the working capital adjustment with Allergan and the legal settlement with Rimsa.third quarter of 2018.

Transactions

On January 31,July 1, 2018, we completed the sale of a portfolio of products to CVC Capital Partners Fund VI for $703 million in cash. The portfolio of products, which is marketed and sold outside of the United States, includes the women’s health products OVALEAP®, ZOELY®, SEASONIQUE®, COLPOTROPHINE® and other specialty products such as ACTONEL®.

In April 2018, we signed a separation agreementour PGT Healthcare partnership with P&G to terminate the PGT Healthcare partnership that the two companies established in 2011 to market OTC medicines. We will continue to maintain our OTC business on an independent basis. The separation is planned to become effective July 1, 2018, subject to receipt of applicable regulatory approvals.was dissolved. As part of the separation, we will transfertransferred to P&G the shares we holdheld in New Chapter Inc. and ownership rights in an OTC plant located in India to P&G. India.

We will continue to maintain our OTC business on an independent basis and to provide certain services to P&G after the separation for a transition period.

Results of Operations

Comparison of Three Months Ended March 31,September 30, 2018 to Three Months Ended March 31,September 30, 2017

The following table sets forth, for the periods indicated, certain financial data derived from our U.S. GAAP financial statements.statements:

 

   Percentage of Net Revenues   Percentage
Change
2018 - 2017
 
   Three Months Ended
March 31,
   
   2018   2017   
   %   %   % 

Net revenues

   100.0    100.0    (10

Gross profit

   46.4    50.2    (17

Research and development expenses

   6.3    7.6    (27

Selling and marketing expenses

   15.2    17.0    (20

General and administrative expenses

   6.5    6.5    (10

Other asset impairments, restructuring and other items

   14.0    4.2    195 

Goodwill impairment

   3.6    —      § 

Legal settlements and loss contingencies

   (25.2   0.4    —   

Other income

   (4.0   (1.3   182 

Operating income

   30.0    15.8    70 

Financial expenses, net

   5.4    3.7    31 

Income before income taxes

   24.6    12.1    82 

Income taxes (benefit)

   0.9    1.0    (15

Share in (profits) losses of associated companies, net

   1.4    (0.1   —   

Net income attributable tonon-controlling interests

   0.3    (0.1   —   

Net income attributable to Teva

   22.0    11.3    74 

Dividends on preferred shares

   1.3    1.2    § 

Net income attributable to ordinary shareholders

   20.7    10.1    82 

§Represents an amount less than 0.5%.
   Percentage of Net Revenues    
   Three Months Ended
September 30,
  Percentage
Change
 
   2018  2017  2018 -2017 
   %  %  % 

Net revenues

   100.0   100.0   (19

Gross profit

   44.6   47.2   (24

Research and development expenses

   6.9   9.5   (41

Selling and marketing expenses

   16.4   15.0   (12

General and administrative expenses

   6.8   6.6   (17

Other asset impairments, restructuring and other items

   14.5   9.8   20 

Legal settlements and loss contingencies

   0.4   (0.4  —   

Other income

   (0.8  (0.1  775 

Operating income

   0.4   6.7   (96

Financial expenses, net

   5.1   4.6   (12

Income (loss) before income taxes

   (4.7  2.1   —   

Tax benefit

   (0.6  (8.8  (95

Share in losses of associated companies, net

   0.2   0.1   —   

Net income attributable tonon-controlling interests

   0.2   0.3   —   

Net income (loss) attributable to Teva

   (4.6  10.6   —   

Dividends on preferred shares

   1.4   1.2  

Net income (loss) attributable to ordinary shareholders

   (6.0  9.4   —   

Segment Information

North America Segment

The following table presents revenues, expenses and profit for our North America segment for the three months ended March 31,September 30, 2018 and 2017:

 

  Three months ended March 31,   Three months ended September 30, 
                        2018                                              2017                      2018 2017 
  (U.S.$ in millions / % of Segment Revenues)   (U.S. $ in millions /% of Segment Revenues) 

Revenues

  $2,531    100 $3,240    100  $2,265    100 $3,043    100

Gross profit

   1,432    57 2,080    64   1,232    54.4 1,833    60.2

R&D expenses

   188    8 267    8   158    7.0 230    7.6

S&M expenses

   305    12 441    14   301    13.3 325    10.7

G&A expenses

   126    5 139    4   128    5.7 149    4.9

Other income

   (102   (4%)  (73   (2%)    (4   §  (1   § 
  

 

   

 

 

 

   

 

  

 

   

 

  

 

   

 

 

Segment profit*

  $915    36 $1,306    40

Segment profit*

  $649    28.7 $1,130    37.1
  

 

   

 

 

 

   

 

  

 

   

 

  

 

   

 

 

 

*

Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “Teva“—Teva Consolidated Results—Operating Income” below.below for additional information.

§

Represents an amount less than 0.5%.

North America Revenues

Our North America segment includes the United States and Canada. Revenues from our North America segment in the firstthird quarter of 2018 were $2.5 billion,$2,265 million, a decrease of $709$778 million, or 22%26%, compared to the firstthird quarter of 2017, mainly due to adverse market dynamics in the U.S. generics market, a decline in revenues of COPAXONE, a decline in revenues due to generic competitionin our U.S. generics business, a decline in revenues of ProAir and QVAR and the loss of revenues from the sale of our women’s health business, partially offset by higher revenues from AUSTEDO BENDEKA and TREANDA, QVAR and our distribution business.

Revenues in the United States, our largest market, were $2.4 billion in the first quarter of 2018, a decrease of $719 million, or 23%, compared to the first quarter of 2017.

Revenues by Major Products and Activities

The following table presents revenues for our North America segment by major products and activities for the three months ended March 31,September 30, 2018 and 2017:

 

   Three months ended
March 31,
   Percentage
Change
 
   2018   2017   2017-2018 
   (U.S.$ in millions)     

Generic products

  $1,088   $1,415    (23%) 

COPAXONE

   476    797    (40%) 

BENDEKA / TREANDA

   181    156    16

ProAir

   130    121    7

QVAR

   107    84    27

AUSTEDO

   30    —      N/A 

Distribution

   331    295    12

   Three months ended
September 30,
   

Percentage

Change

 
   2018   2017   2017 -2018 
   (U.S. $ in millions)     

Generic products

  $922   $1,233    (25%) 

COPAXONE

   463    819    (43%) 

BENDEKA / TREANDA

   161    179    (10%) 

ProAir

   107    155    (31%) 

QVAR

   36    83    (57%) 

AUSTEDO

   62    6    870

Distribution

   333    294    13

Generic products revenues in our North America segment in the firstthird quarter of 2018 decreased by 23%25% to $1.1 billion,$922 million, compared to the firstthird quarter of 2017, mainly due to lower volumesprice erosion in our U.S. generics business, additional competition to methylphenidate extended-release tablets (Concerta® authorized generic) and continued price erosion.portfolio optimization, primarily as part of the restructuring plan.

Among the most significant generic products we sold in North America in the firstthird quarter of 2018 were methylphenidate extended-release tablets (Concerta® authorized generic), sildenafil citrate tablets (the generic equivalent of Viagra®), daptomycin injection (the generic equivalent of Cubicin®), amphetamine salttadalafil tablets (the generic equivalent of Adderall IRCialis®) and estradiol vaginal cream (the generic equivalent of Estracemethylphenidate extended-release tablets (Concerta®) authorized generic).

In the firstthird quarter of 2018, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 584547 million total prescriptions, representing 15%14.1% of total U.S. generic prescriptions according to IQVIA data.

COPAXONE® revenues in our North America segment in the firstthird quarter of 2018 decreased by 40%43% to $476$463 million, compared to the firstthird quarter of 2017, mainly due to generic competition in the United States.

COPAXONE revenues in the United States were $462$446 million in the firstthird quarter of 2018.

Revenues of COPAXONE in our North America segment were 74%77% of global COPAXONE revenues in the firstthird quarter of 2018, compared to 82%83% in the firstthird quarter of 2017.

COPAXONE global sales accounted for approximately 13% of our global revenues in the firstthird quarter of 2018 and a significantly higher percentage of our profits and cash flow from operations during this period.

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. 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 fiveOn October 12, 2018, the U.S. Orange Book patents that expire in 2030. These patents have been challenged in proceedingsCourt of Appeals for the Federal Circuit (“CAFC”) handed down its ruling in the United States. We are appealing certain adverseconsolidated appeal of decisions from the U.S. District Court and Patent Trial and Appeal Board, decisionsrelating to defend these patents in the United States. At least one competitor has fully launched its generic version ofcovering COPAXONE 40 mg/mL. This launch, priorml. The CAFC found all claims at issue to final resolution of the pending patent litigation, should be considered an “at-risk” launch, which means that if the pending litigation is resolved ininvalid, and we are currently evaluating our favor, the company selling this generic product could face significant damages claims and other potential remedies.options for further appeals. COPAXONE 40 mg/mL is also protected by one European patent expiring in 2030. This patent is being challenged in Italy and Norway and has been opposed at the European Patent Office. The U.K. High Court found this patent invalid and our application for permission to appeal this decision was rejected.

The market for MS treatments continues to develop, particularly with the recent approvals of generic versions of COPAXONE discussed above, as well as additional generic versions expected to be approved in the future. The increasing number of oralOral treatments for MS, such as Tecfidera®, Gilenya® and Aubagio®, continuescontinue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies.

BENDEKAand TREANDA combined revenues in our North America segment in the firstthird quarter of 2018 increaseddecreased by 16%10% to $181$161 million, compared to the firstthird quarter of 2017, mainly due to lower volumes, partially offset by higher volumes resulting from supply stabilization.pricing. Our partner, Eagle Pharmaceuticals, Inc. prevailed in its suit in the U.S. district court 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 by the appellate court, drug applications referencing BENDEKA will not be approved by the FDA until the orphan drug exclusivity expires in December 2022.

ProAir revenues in our North America segment in the firstthird quarter of 2018 increaseddecreased by 7%31% to $130$107 million, compared to the firstthird quarter of 2017, mainly due to higher volumes.lower net pricing. ProAir is the second-largest short-acting beta-agonist in the market, with an exit market share of 46.1%45.2% in terms of total number of prescriptions during the firstthird quarter of 2018, compared to 47.7%46.2% in the firstthird quarter of 2017. In June 2014, we settled a patent challenge to ProAir HFA with Perrigo Pharmaceuticals (“Perrigo”) permitting Perrigo to launch its generic product in limited quantities once it receives FDA approval and without quantity limitations after June 2018. In November 2017, we settled another patent challenge to ProAir HFA with Lupin Pharmaceuticals, Inc.

QVARrevenues in our North America segment in the firstthird quarter of 2018 increaseddecreased by 27%57% to $107$36 million, compared to the firstthird quarter of 2017. We launched QVAR® RediHaler in the first quarter of 2018. The increasedecrease in sales in the firstthird quarter of 2018 was mainly due to slightly higherlower volumes during this quarter following wholesaler stocking for all QVAR family productsin the first quarter of 2018 in connection with the launch.launch of QVAR® RediHaler™. QVAR maintained its second-place position in the inhaled corticosteroids category in the United States, with an exit market share of 29.4%21.7% in terms of total number of prescriptions during the firstthird quarter of 2018, compared to 38.1%37.9% in the firstthird quarter of 2017.

AUSTEDOrevenues in our North America segment in the firstthird quarter of 2018 were $30$62 million. 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.

Distribution revenues in our North America segment, which are generated by Anda, increased by 12%13% to $331$333 million in the firstthird quarter of 2018, compared to the firstthird quarter of 2017, mainly due to the severe cold, cough and influenza season in the first quarter of 2018, which increased demand for certain medicines.higher volumes. Our Anda business distributes generic, specialty and OTC pharmaceutical products from various third party manufacturers to independent retail pharmacies, pharmacy retail chains, hospitals and physician offices in the United States. Anda is able to compete in the secondary distribution market by maintaining high inventory levels for a broad offering of products, next day delivery throughout the United States and competitive pricing.

Product Launches and Pipeline

In the firstthird quarter of 2018, we launched the generic versionsversion of the following branded products in North America (listed by month of launch):America:

 

Product Name

  

Brand Name

  

Launch
Date

  Total Annual U.S.
Branded Sales at Time
of Launch
(U.S.$ in millions (IQVIA))*
 

Estradiol Vaginal Cream, USP, 0.01%

  Estrace®  January  $304 

Methylphenidate Hydrochloride Extended-Release Capsules (LA), CII 20 mg, 30 mg & 40 mg

  Ritalin LA® ER  January  $97 

Busulfan Injection 6 mg/mL, 60 mg

  Busulfex®  January  $86 

Trientine Hydrochloride Capsules, USP 250 mg

  Syprine®  February  $147 

Hydrocortisone Butyrate Cream USP, 0.1% (Lipophilic)

  Locoid Lipocream®  February  $6 

Minocycline Hydrochloride Extended-Release Tablets, USP 65 mg & 115 mg

  Solodyn® ER  February  $148 

Lansoprazole Delayed-Release Orally Disintegrating Tablets 15 mg & 30 mg

  Prevacid® SoluTab DR ODT  March  $184 

Tiagabine Hydrochloride Tablets 12 mg & 16 mg **

  Gabitril®  March  $9 

Palonosetron Hydrochloride Injection 0.05 mg/mL, 0.25 mg

  Aloxi®  March  $452 

Mesalamine Delayed-Release Tablets, USP 1.2 g

  Lialda® DR  March  $1,128 

Product Name

  Brand
Name
  Launch
Date
   Total Annual U.S.
Branded Sales at Time
of Launch
(U.S. $ in millions
(IQVIA))*
 

Budesonide Extended-Release Tablets, 9 mg

   Uceris® ER   July   $199 

Romidepsin for Injection, 10 mg/vial

   Istodax®   August   $52 

Cisatracurium Besylate Injection, USP 2 mg/mL, 10 mg, 10 mg/mL, 200 mg & 2 mg/mL, 20 mg

   Nimbex®   September   $49 

Tadalafil Tablets, USP 2.5 mg, 5 mg, 10 mg & 20 mg

   Cialis®   September   $1,926 

 

*

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

**Authorized generic version of a Teva specialty product.

Our generic products pipeline in the United States includes, as of March 31,September 30, 2018, 325310 product applications awaiting FDA approval, including 8693 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended December 31, 2017June 30, 2018 exceeding $111$120 billion, according to IQVIA. Approximately 70% of pending applications include a paragraph IV patent challenge and we believe we are first to file with respect to 110107 of these products, or 129130 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first to file opportunities represent over $63$68 billion in U.S. brand sales for the twelve months ended December 31, 2017,June 30, 2018, according to IQVIA.

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

In the firstthird quarter of 2018, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications. A “tentative approval” indicates that the FDA has substantially completed its review of an application and final approval is expected once the relevant patent expires, a court decision is reached, a30-month regulatory stay lapses or a180-day exclusivity period awarded to another manufacturer either expires or is forfeited.

Generic Name

  Brand Name Total U.S. Annual Branded
Market (U.S. $ in millions (IQVIA))*
 

Eltrombopag tablets, 12.5 mg, 25 mg & 75 mg

  Promacta® $200 

Esomeprazole magnesium delayed-release capsules, 20 mg

  Nexium® DR $85 

Ingenol mebutate gel, 0.05%

  Picato® $17 

Nicotine polacrilex mini mint lozenges, 2 mg & 4 mg

  Nicorette® $68 

Perampanel tablets, 2 mg, 4 mg, 6 mg, 8 mg & 10 mg

  Fycompa® $68 

Rotigotine transdermal system, 1 mg/24 hr, 2 mg/24 hr, 3 mg/24 hr, 4 mg/24 hr, 6 mg/24 hr & 8 mg/24 hr

  Neupro® $143 

Ticagrelor tablets, 60 mg & 90 mg

  Brilinta® $712 

Generic Name

Brand NameTotal U.S. Annual Branded
Market (U.S. $
in millions (IQVIA))*

Nicotine Polacrilex Mini Lozenges, 2 mg & 4 mg (Ice Mint)

Nicorette®—  

Azelaic Acid Foam, 15%

Finacea®$  58

Saxagliptin Tablets, 2.5mg & 5mg

Onglyza®$383

Mesalamine Extended-Release Capsules USP, 375 mg

Apriso®$282

Oxcarbazepine Extended-Release Tablets, 150 mg, 300 mg & 600 mg

Oxtellar®XR $123

Ingenol Mebutate Gel, 0.015%

Picato®$  61

Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/3.75%

Onexton®$125

Axitinib Tablets, 1 mg & 5 mg

Inlyta®$120

Mesalamine Delayed-Release Capsules, 400mg

Delzicol®$140

 

*

For the twelve months ended in the calendar quarter immediately prior to the receipt of tentative approval.

In the firstthird quarter of 2018, our pipeline in North America consisted of the following products:

 

Therapeutic Area

Product

  

Potential
Indication(s)

Route of

Administration

  Route of
Administration

Development Phase


(date entered phase 3)

Comments

neurologyNeurology and neuropsychiatryNeuropsychiatry  
AUSTEDO
(deutetrabenazine)
  Tourette syndrome  Oral  3 (December 2017)
LaquinimodRelapsing remitting multiple sclerosisOralDiscontinued
  Progressive forms of multiple sclerosisOralDiscontinued
Laquinimod  Huntington disease  Oral  2
Pridopidine  Huntington diseaseOralDiscontinued dueBased on the negative outcome of the phase 2 clinical trial, we will not continue the clinical development of laquinimod. We terminated the development and license agreement and returned the development and commercialization rights to pipeline prioritizationActive Biotech in September 2018.
TV-46000 (risperidone
LAI)
  Schizophrenia  LAI  3 (April 2018)

Product

Potential Indication(s)

Route of

Administration

Development Phase
(date entered phase 3)

Comments

Migraine and Pain  Fremanezumab
AJOVY (fremanezumab) (anti
CGRP)
  Chronic and episodic migraine  Subcutaneous  SubmittedApproved by FDA
and launched
(September 2018);
Response package
submitted for
Marketing
Authorization
Application
(“MAA”) to the
European
Medicines Agency
(“EMA”)
(September 2018)

On September 14, 2018, the FDA (October 2017)(1)approved AJOVY (fremanezumab-vfrm) injection for the preventive treatment of migraine in adults. We launched the product immediately upon approval.

We filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly’s planned marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents. Eli Lilly has also submitted inter partes review petitions to the Patent Trial and Appeal Board, challenging the validity of the nine patents asserted against them in the litigation.

  Cluster

Episodic

cluster headache

  Subcutaneous  3 (November 2016)
  
  Post traumatic headache  Subcutaneous  2
  
Fasinumab(2)  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).
  Chronic lower back pain  Subcutaneous  2
  TV-45070

Product

  Neuropathic pain

Potential Indication(s)

  Topical

Route of

Administration

  Partnership with Xenon terminated by mutual agreementDevelopment Phase
(date entered phase 3)

Comments

Respiratory  
CINQAIR/
CINQAERO
  

Severe asthma with

eosinophilia

  Subcutaneous  3 (August 2015)
 In January 2018, we announced that the phase 3 study did not meet its primary endpoint. We are reviewing the full data to determine next steps.
ProAire-RespiClick e-RespiClick™  Bronchospasm and exercise induced bronchitis  Oral
inhalation
  Submitted to FDA (September
(September 2017)

Resubmitted to
FDA (August
2018)

Following feedback from the FDA, changes on application were implemented resulting in are-submission of the supplemental new drug application to the FDA on August 30, 2018.
Oncology  
CT-P10(3)  (biosimilar candidate to Rituxan® US)    Submitted to FDA
(2017)

Resubmitted to
FDA (2018)

Developed under a collaboration agreement with Celltrion, Inc. (“Celltrion”). The FDA acknowledged the resubmission of the marketing
CT-P6CT-P06(3)  (biosimilar candidate to Herceptin® US)    Submitted to FDA
(2017)

Resubmitted to
FDA (2018)

(1)We do not expectapprovals forCT-P10 andCT-P06. The review period is approximately six months. On October 10, 2018, the FDA Oncologic Drugs Advisory Committee unanimously recommended to receiveapproveCT-P10. The FDA approvalwill take the committee’s recommendation into consideration before taking action on ourthe Biologics License Applications (“BLA”)Application (BLA) for fremanezumab on themid-June PDUFA date. proposed Rituxan biosimilar. We are engaged in a constructive dialogue with the FDA in close collaboration with our partner Celltrion, Inc. (“Celltrion”). We expecthave reached an FDApre-approval inspection to take place in the coming months and to receive FDA approval and launch before the end of 2018.
(2)Developed in collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”). Regeneron recently reported that an independent Data Monitoring Committee monitoring the ongoing safety and efficacy of the fasinumab clinical trials recommended that the higher dose-regimens be discontinued based on the risk benefit assessment, and that the program may continue with the lower dose-regimens of fasinumab. We understand that Regeneron is modifying the trials accordingly.
(3)Developed under collaboration agreement with Celltrion. DuringGenentech to settle the first quarter of 2018, Celltrion received complete response letters from the FDA regarding the BLAs for these biosimilar products. Celltrion is workingpatent litigation on resolving all issues and resubmitting the BLAs.CT-P10, which includes a licensed entry date.

North America Gross Profit

Gross profit from our North America segment in the firstthird quarter of 2018 was $1.4 billion,$1,232 million, a decrease of 31%33% compared to $2.1 billion$1,833 million in the firstthird quarter of 2017. The decrease was mainly due to lower revenues from COPAXONE and generic products.

Gross profit margin for our North America segment in the third quarter of 2018 decreased to 54.4% from 60.2% in the third quarter of 2017. The decrease was mainly due to lower COPAXONE and generic products revenues.

Gross profit margin for our North America segment in the first quarter of 2018 decreased to 56.6% from 64.2% in the first quarter of 2017. This decrease was mainly due to lower COPAXONE revenues (4.0 points) and continued price erosion of generic products (3.0(6.2 points).

North America R&D Expenses

R&D expenses relating to our North America segment in the firstthird quarter of 2018 were $188$158 million, a decrease of 30%31% compared to $267$230 million in the firstthird quarter of 2017.

For a description of our R&D expenses in the firstthird quarter of 2018, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

North America S&M Expenses

S&M expenses relating to our North America segment in the firstthird quarter of 2018 were $305$301 million, a decrease of 31%7% compared to $441$325 million in the firstthird quarter of 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

North America G&A Expenses

G&A expenses relating to our North America segment in the firstthird quarter of 2018 were $126$128 million, a decrease of 9%14% compared to $139$149 million in the firstthird quarter of 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

North America Other Income

Other income from our North America segment in the firstthird quarter of 2018 was $102$4 million, an increase of 40% compared to $73$1 million in the firstthird quarter of 2017. The increase was mainly due to higher Section 8 recoveries from multiple cases in Canada. Section 8 of the Patented Medicines (Notice of Compliance) Regulations relates to recoveries of lost revenue related to patent infringement proceedings.

North America Profit

Profit from our North America segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “Teva“—Teva Consolidated Results—Operating Income” below.

Profit from our North America segment in the firstthird quarter of 2018 was $915$649 million, a decrease of 30%43% compared to $1.3 billion$1,130 million in the firstthird quarter of 2017. The decrease was mainly due to lower revenues due to generic competition forfrom COPAXONE and continued price erosion in the U.S. generics market,generic products, partially offset by cost reductions and efficiency measures as part of the restructuring plan and higher other income.plan.

Europe Segment

The following table presents revenues, expenses and profit for our Europe segment for the three months ended March 31,September 30, 2018 and 2017:

 

  Three months ended March 31,   Three months ended September 30, 
  2018 2017   2018 2017 
  (U.S.$ in millions / % of Segment Revenues)   (U.S. $ in millions /% of Segment Revenues) 

Revenues

  $1,442        100 $1,341        100  $1,212    100.0 $1,380    100

Gross profit

   797    55 734    55   683    56.4 721    52.2

R&D expenses

   73    5 106    8   62    5.1 101    7.3

S&M expenses

   255    18 279    21   249    20.5 289    20.9

G&A expenses

   91    6 79    6   74    6.1 90    6.5

Other expenses

   1   §  2   §    1    §       § 
  

 

   

 

 

 

   

 

  

 

   

 

  

 

   

 

 

Segment profit*

  $377    26 268    20  $297    24.5 241    17.5
  

 

   

 

 

 

   

 

  

 

   

 

  

 

   

 

 

 

*

Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “Teva“—Teva Consolidated Results—Operating Income” below.below for additional information.

§

Represents an amount less than 0.5%.

Europe Revenues

Our Europe segment includes the European Union and certain other European countries. Revenues from our Europe segment in the firstthird quarter of 2018 were $1.4 billion, an increase$1,212 million, a decrease of 8%12% or $101$168 million, compared to the firstthird quarter of 2017. In local currency terms, revenues decreased by 6%11%, mainly due to the loss of revenues from the closure of our distribution business in Hungary, and the sale of our women’s health business and a decline in COPAXONE revenues due to the entry of competing glatiramer acetate products, partially offset by new generic product launches.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the three months ended March 31,September 30, 2018 and 2017:

  Three months ended   Percentage 
  March 31,   Change   Three months ended
September 30,
   

Percentage

Change

 
  2018   2017   2017-2018   2018   2017   2017-2018 
  (U.S.$ in millions)       (U.S. $ in millions)     

Generic products

  $997   $850    17  $845   $871    (3%) 

COPAXONE

   153    152    1   124    150    (17%) 

Respiratory products

   113    84    35   93    90    3

Generic products revenues in our Europe segment in the firstthird quarter of 2018, including OTC products, increaseddecreased by 17%3% to $997$845 million, compared to the firstthird quarter of 2017. In local currency terms, revenues increaseddecreased by 2%1%, mainly due to new product launchesthe loss of revenues from the termination of the PGT joint venture and volume growth in OTC,generic price reductions, partially offset by price reductions.new generic product launches.

COPAXONE revenues in our Europe segment in the firstthird quarter of 2018 increaseddecreased by 1%17% to $153$124 million, compared to the firstthird quarter of 2017. In local currency terms, revenues decreased by 13%16%, mainly due to price reductions resulting from the entry of generic competition.competing glatiramer acetate products.

Revenues of COPAXONE in our Europe segment were 24%21% of global COPAXONE revenues in the firstthird quarter of 2018, compared to 16%15% in the firstthird quarter of 2017.

For further information onabout COPAXONE, see “—North America Revenues—Revenues by Major Product” above.

Respiratory products revenues in our Europe segment in the firstthird quarter of 2018 increased by 35%3% to $113$93 million, compared to the firstthird quarter of 2017. In local currency terms, revenues increased by 18%4%, mainly due to the launch of BRALTUS® in 2017.

Product Launches and Pipeline

As of March 31,September 30, 2018, our generic products pipeline in Europe included 234576 generic approvals in Europe relating to 4681 compounds in 95172 formulations, and approximately 1,5031,280 marketing authorization applications pending approval in 37 European countries, relating to 183180 compounds in 364346 formulations, including one applicationtwo applications pending with the EMA for one strength in 30 countries.

For information regarding our specialty pipeline and launches in the firstthird quarter of 2018, see “—North America Segment—ProductSegment —Product Launches and Pipeline.”

Europe Gross Profit

Gross profit from our Europe segment in the firstthird quarter of 2018 was $797$683 million, an increasea decrease of 9%5% compared to $734$721 million in the firstthird quarter of 2017. The increasedecrease was mainly due to the positive impact of currency fluctuations, partially offset by the loss of revenues from the sale of our women’s health business.business and a decline in COPAXONE revenues.

Gross profit margin for our Europe segment in the firstthird quarter of 2018 increased to 55.3%56.4%, from 54.7%52.2% in the firstthird quarter of 2017. ThisThe increase was mainly due to lower cost of goods (3.4 points) and the closure of our distribution business in Hungary (1.6(2.6 points), partially offset by other production costs (1.0a decline in COPAXONE revenues (0.7 points) and the sale of our women’s health business (0.8 points).

Europe R&D Expenses

R&D expenses relating to our Europe segment in the firstthird quarter of 2018 were $73$62 million, a decrease of 31%39% compared to $106$101 million in the firstthird quarter of 2017.

For a description of our R&D expenses in the firstthird quarter of 2018, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

Europe S&M Expenses

S&M expenses relating to our Europe segment in the firstthird quarter of 2018 were $255$249 million, a decrease of 9%14% compared to $279$289 million in the firstthird quarter of 2017. The decrease was mainly due to cost reductions as part of the restructuring plan, partially offset by currency fluctuations.plan.

Europe G&A Expenses

G&A expenses relating to our Europe segment in the firstthird quarter of 2018 were $91$74 million, an increasea decrease of 15%18% compared to $79$90 million in the firstthird quarter of 2017. The increasedecrease was mainly due to currency fluctuations, partially offset by cost reductions as part of the restructuring plan.

Europe Profit

The profitProfit of our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “—Teva Consolidated Results—Operating Income” below.

Profit from our Europe segment in the firstthird quarter of 2018 was $377$297 million, an increase of 41%23% compared to $268$241 million in the firstthird quarter of 2017. The increase was mainly due to higher revenues as well as cost reductions and efficiency measures as part of the restructuring plan.

GrowthInternational Markets Segment

The following table presents revenues, expenses and profit for our GrowthInternational Markets segment for the three months ended March 31,September 30, 2018 and 2017:

 

  Three months ended March 31,   Three months ended September 30, 
                    2018                                      2017                  2018 2017 
  (U.S.$ in millions / % of Segment Revenues)   (U.S. $ in millions /
% of Segment Revenues)
 

Revenues

  $750    100 $718    100  $726    100.0 $882    100

Gross profit

   313    42 292    41   301    41.5 351    39.8

R&D expenses

   24    4 47    7   21    2.9 35    4.0

S&M expenses

   134    18 158    22   120    16.5 158    17.9

G&A expenses

   41    5 48    7   37    5.1 51    5.8

Other income

   (8   (1%)  (1  §    —      §  (3   § 
  

 

   

 

 

 

   

 

  

 

   

 

  

 

   

 

 

Segment profit*

  $122    16 $40    6  $123    16.9 $110    12.5
  

 

   

 

 

 

   

 

  

 

   

 

  

 

   

 

 

 

*

Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “—Teva Consolidated Results—Operating Income” below.below for additional information.

§

Represents an amount less than 0.5%.

GrowthInternational Markets Revenues

Our GrowthInternational Markets segment includes all countries other than those in our North America and Europe segments. Our key growthinternational markets are Japan, RussiaIsrael and Israel.Russia. The countries in this category range from highly regulated, pure generic markets, such as Israel, to hybrid markets, such as Japan, to branded generics oriented markets, such as Russia and certain Commonwealth of Independent States (CIS), Latin American and Asia Pacific markets.

Revenues from our GrowthInternational Markets segment in the firstthird quarter of 2018 were $750$726 million, an increasea decrease of $32$156 million, or 4%18%, compared to the firstthird quarter of 2017. In local currency terms, revenues were flatdecreased 12% compared to the firstthird quarter of 2017, mainly due to higherlower sales in Israel, Japan and Russia, partially offset by the effect of the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business.

Revenues by Major Products and Activities

The following table presents revenues for our GrowthInternational Markets segment by major products and activities for the three months ended March 31,September 30, 2018 and 2017:

 

   Three months ended   Percentage 
   March 31,   Change 
   2018   2017   2017-2018 
   (U.S.$ in millions)     

Generic products

  $488   $486   § 

COPAXONE

   16    21    (24%) 

Distribution

   153    125    22

§Represents an amount less than 0.5%.

   Three months ended
September 30,
   

Percentage

Change

 
   2018   2017   2017-2018 
   (U.S. $ in millions)     

Generic products

  $498   $629    (21%) 

COPAXONE

   14    18    (24%) 

Distribution

   149    146    2

Generic products revenues in our GrowthInternational Markets segment in the firstthird quarter of 2018, which include OTC products, were flatdecreased by 21% to $498 million compared to the firstthird quarter of 2017. In local currency terms, revenues decreased by 3%15%, mainly due to lower sales in Japan resulting from regulatory pricing reductions and generic competition tooff-patented products, lower sales in Russia, loss of revenues from the termination of the PGT joint venture and the effect of the deconsolidation of our subsidiaries in Venezuela.

COPAXONE revenues in our GrowthInternational Markets segment in the firstthird quarter of 2018 decreased by 24% to $16$14 million, compared to the firstthird quarter of 2017. In local currency terms, revenues decreased by 20%2%.

For further information about COPAXONE, see “—North America Revenues—Revenues by Major Product” above.

Distribution revenues in our GrowthInternational Markets segment in the firstthird quarter of 2018 increased by 22%2% to $153$149 million, compared to the firstthird quarter of 2017. In local currency terms, revenues increased by 13%4%.

GrowthInternational Markets Gross Profit

Gross profit from our GrowthInternational Markets segment in the firstthird quarter of 2018 was $313$301 million, an increasea decrease of 7%14% compared to $292$351 million in the firstthird quarter of 2017.

Gross profit margin for our International Markets segment in the third quarter of 2018 increased to 41.5%, from 39.8% in the third quarter of 2017. The increase was mainly due to higher revenues in Japan, including a milestone payment from Takeda following approval of AZILECT®, and higher revenues in Israel, partially offset by the deconsolidation of our subsidiaries in Venezuela and the loss of revenues from the sale of our women’s health business.

Gross profit margin for our Growth Markets segment in the first quarter of 2018 increased to 41.7%, from 40.7% in the first quarter of 2017. This increase was mainly due to higher gross profit resulting from changes in Japan (3.5product mix in certain countries, mainly Israel, Russia and Mexico, as well as lower cost of goods (6.4 points), partially offset by the Venezuela deconsolidation of our subsidiaries in Venezuela (1.3(3.2 points) and currency fluctuationslower revenues in Argentina (0.8Japan (1.5 points).

GrowthInternational Markets R&D Expenses

R&D expenses relating to our GrowthInternational Markets segment in the firstthird quarter of 2018 were $24$21 million, a decrease of 49%40% compared to $47$35 million in the firstthird quarter of 2017.

For a description of our R&D expenses in the firstthird quarter of 2018, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.

GrowthInternational Markets S&M Expenses

S&M expenses relating to our GrowthInternational Markets segment in the firstthird quarter of 2018 were $134$120 million, a decrease of 15%24% compared to $158 million in the firstthird quarter of 2017. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.

GrowthInternational Markets G&A Expenses

G&A expenses relating to our GrowthInternational Markets segment in the firstthird quarter of 2018 were $41$37 million, a decrease of 15%27% compared to $48$51 million in the firstthird quarter of 2017. The decrease was mainly due to cost reductions as part of the restructuring plan.

GrowthInternational Markets Profit

The profitProfit of our GrowthInternational Markets segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “—Teva Consolidated Results—Operating Income” below.

Profit from our GrowthInternational Markets segment in the firstthird quarter of 2018 was $122$123 million, compared to $40$110 million in the firstthird quarter of 2017. The increase was mainly due to higher revenues, as well as cost reductions and efficiency measures as part of the restructuring plan.

During the fourth quarter of 2017, we deconsolidated our subsidiaries in Venezuela from our financial results after concluding that we did not meet the accounting criteria for control over our wholly-owned subsidiaries in Venezuela and that we no longer had significant influence over such subsidiaries. Consequently, results of operations of our subsidiaries in Venezuela are not included in our financial results for the firstthird quarter of 2018. We recorded $21$38 million in revenues and $3$24 million in operating income in the firstthird quarter of 2017 with respect to our subsidiaries in Venezuela. We exclude these changes in revenues and operating profit in Venezuela from any discussion of local currency results.

Other Activities

We have other sources of revenues, primarily ourthe sale of API manufacturing businessto third parties and certain contract manufacturing services. Our other activities are not included in our North America, Europe or GrowthInternational Markets segments described above.

Our revenues from other activities in the firstthird quarter of 2018 decreasedincreased by 2.6%4% to $342 million.$326 million compared to the third quarter of 2017. In local currency terms, revenues decreasedincreased by 8%, mainly due to lower API sales to third parties.7%.

API sales to third parties in the firstthird quarter of 2018 decreased by 9%were $171 million, flat compared to $179 million.the third quarter of 2017. In local currency terms, revenues decreasedincreased by 10%, mainly due to the timing of certain shipments in the first quarter of 2018.1%.

Teva Consolidated Results

Revenues

Revenues in the firstthird quarter of 2018 were $5.1 billion,$4,529 million, a decrease of 10%19%, or 15%18% in local currency terms, compared to the firstthird quarter of 2017, mainly due to adverse market dynamics in the U.S. generics market, generic competition to COPAXONE, price erosion in our U.S. generics business and loss of revenues following ourthe divestment of certain products and discontinuation of certain activities. See “—North America Revenues,” “—Europe Revenues,” “—GrowthInternational Markets Revenues” and “—Other Activities” above.

Exchange rate movements during the firstthird quarter of 2018 in comparison with the first quarter of 2017 positivelynegatively impacted revenues by $240 million.$80 million, compared to the third quarter of 2017.

Gross Profit

Gross profit in the firstthird quarter of 2018 was $2.3 billion,$2,021 million, a decrease of 17%24% compared to the firstthird quarter of 2017. The lower gross profitdecrease was mainly a result of the factors discussed above under “—North America Gross Profit,” “—Europe Gross Profit” and “—GrowthInternational Markets Gross Profit” as well as lower remediation expenses and higher accelerated depreciation and inventorystep-up in the first quarter of 2017, which did not recur in the first quarter of 2018.Profit.”

Gross profit as a percentage of revenues was 46.4%44.6% in the firstthird quarter of 2018, compared to 50.2%47.2% in the firstthird quarter of 2017.

The decrease in gross profit as a percentage of revenues was mainly due to lower profitability in North America (5.1resulting from a decline in COPAXONE revenues due to generic competition and price erosion in our U.S. generics business (4.3 points), the sale of our women’s health business (0.9(1.0 points) and higher accelerated depreciation (0.4(0.3 points), partially offset by inventorystep-uplower amortization expenses (1.3(1.4 points), higher profitability in Europe (0.9(1.1 points) and remediation expenses (0.7International Markets (0.6 points).

Research and Development (R&D) Expenses

Net R&D expenses in the firstthird quarter of 2018 were $317$311 million, a decrease of 27%41% compared to the firstthird quarter of 2017.

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

Our R&D activities for specialty products in each of our segments include costs of discovery research, preclinical development, early- and late-clinical development and drug formulation, clinical trials and product registration costs. These expenditures are reported net of contributions received from collaboration partners. Our spending takes place throughout the development process, including (i) early-stage projects in both discovery and preclinical phases; (ii) middle-stage projects in clinical programs up to phase 3; (iii) late-stage projects in phase 3 programs, including where a new drug application is currently pending approval; (iv) life cycle management and post-approval studies for marketed products; and (v) indirect expenses that support our overall specialty R&D efforts but are not allocated by product or to specific R&D projects, such as the costs of internal administration, infrastructure and personnel.

In the firstthird quarter of 2018, our R&D expenses were primarily related to generic products in our North America segment, as well as specialty product candidates in the pain, respiratory, migraine, headache and headacherespiratory therapeutic areas, with additional activities in selected other areas.

Our lower R&D expenses in the firstthird quarter of 2018 compared to the firstthird quarter of 2017 primarily resulted from pipeline optimization and project terminations, phase 3 studies that have ended and related headcount reductions, partially offset by higher costs duea provision related to an increase in phasethe Regeneron collaboration. See note 3 clinical activity (primarily fasinumab, in collaboration with Regeneron).to our consolidated financial statements.

R&D expenses as a percentage of revenues were 6.3%6.9% in the firstthird quarter of 2018, compared to 7.6%9.5% in the firstthird quarter of 2017.

Selling and Marketing (S&M) Expenses

S&M expenses in the firstthird quarter of 2018 were $771$743 million, a decrease of 20%12% compared to the firstthird quarter of 2017. Our S&M expenses were primarily the result of the factors discussed above under “—North America Segment— S&M Expenses,” “—Europe Segment— S&M Expenses” and “—GrowthInternational Markets Segment— S&M Expenses.”

S&M expenses as a percentage of revenues were 15%16.4% in the firstthird quarter of 2018, compared to 17%15% in the firstthird quarter of 2017.

General and Administrative (G&A) Expenses

G&A expenses in the firstthird quarter of 2018 were $329$309 million, a decrease of 10%17% compared to the firstthird quarter of 2017. Our G&A expenses were primarily the result of the factors discussed above under “—North America Segment— G&A Expenses,” “—Europe Segment— G&A Expenses” and “—GrowthInternational Markets Segment— G&A Expenses,” as well as cost reductions in certain corporate functions as part of the restructuring plan.

G&A expenses as a percentage of revenues were 6.5%6.8% in the firstthird quarter of 2018, flat compared to 6.6% in the firstthird quarter of 2017.

Other Asset Impairments, Restructuring and Other Items

We recorded expenses of $707$658 million for other asset impairments, restructuring and other items in the firstthird quarter of 2018, compared to expenses of $240$550 million in the third quarter of 2017. See note 14 to our consolidated financial statements.

In July 2018, the FDA completed an inspection of our manufacturing plant in Davie, Florida in the United States and issued a FormFDA-483 to the site. In October 2018, the FDA notified us that the inspection of the site is classified as “official action indicated” (OAI). We are working diligently to investigate the FDA’s observations in a manner consistent with Current Good Manufacturing Practices (CGMPs) and to address those observations as quickly and as thoroughly as possible. The impact of such investigation and remediation on the financial statements in the third quarter of 2018 was immaterial. However, if we are unable to remediate the findings in a timely manner, we may face additional consequences, including delays in FDA approval for future products from the site, other financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges and other costs of remediation.

In July 2018, 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 impurity in the API provided by a third party supplier, Zhejiang Huahai Pharmaceutical (“Zhejiang”), used in the production of such medicines. On September 28, 2018, the FDA issued an import ban on all APIs and other drug products made by Zhejiang in its Chuannan site into the U.S. On the same date, the EU authorities issued to Zhejiang a statement ofnon-compliance for the manufacture of valsartan (and its intermediates) for EU medicines in the Chuannan site, thus prohibiting marketing authorization holders in the EU from using such valsartan materials in the production of finished products. On October 15, 2018, the EU authorities announced that Zhejiang was under increased supervision with respect to other APIs produced by Zhejiang. Many regulatory agencies around the world continue to review information relating to valsartan medicines and the sartan products as a group. The impact of this recall on the financial statements in the first nine months of 2018 was $46 million, primarily related to recall and inventory reserves. Depending on the scope of regulatory actions, duration of the API outage and severity of the impurity, we may face additional loss of revenues and profits, customer penalties, impairments and/or other litigation costs.

Restructuring

In the third quarter of 2018, we recorded $88 million of restructuring expenses, compared to $72 million in the third quarter of 2017. The expenses in the first quarter of 2018 consisted of:

Impairments

Impairments of long-lived intangible assets in the first quarter of 2018 were $206 million, mainly consisting of:

a)Identifiable IPR&D of $117 million mainly related to revaluation of generic products acquired from Actavis Generics due to development progress and changes in other key valuation indications (market size, legal landscape, launch date or discount rate).

b)Identifiable product rights of $76 million due to revaluation of Actavis Generics product rights in the United States.

Impairments of property, plant and equipment in the first quarter of 2018 were $226 million, mainly consisting of:

$147 million related to restructuring costs, including:

$113 million related to site closures in Israel; and

$34 million related to headquarters and distribution sites consolidation in the United States;

Other impairment costs, mainly $56 million related to a plant located in India in connection with the P&G separation agreement. See note 3 to our consolidated financial statements.

Restructuring

In the first quarter of 2018, we recorded $247 million of restructuring expenses, compared to $130 million in the first quarter of 2017. The expenses in the firstthird quarter of 2018 were primarily related to headcount reductions across all functions.functions, as part of the restructuring plan announced in 2017.

Thetwo-year restructuring plan announced in 2017 is intended to reduce our total cost base by $3 billion by the end of 2019.

Since announcing our restructuring plan,the announcement, we reduced our global headcount by approximately 6,2009,100 full-time-equivalent employees.

Goodwill ImpairmentLegal Settlements and Loss Contingencies

In the firstthird quarter of 2018, we recorded a goodwill impairmentan expense of $180 million. This impairment was driven by the change$19 million in fair value, including the discount ratelegal settlements and the change in allocated net assets to the Rimsa reporting unit. See note 7 to our consolidated financial statements.

Legal Settlements and Loss Contingencies

In the first quarter of 2018, we recorded income of $1.3 billion,loss contingencies compared to an expenseincome of $20 million in the firstthird quarter of 2017. The income in the first quarter of 2018 consisted primarily of the working capital adjustment with Allergan, the Rimsa settlement and a reversal of the reserve recorded in the second quarter of 2017 with respect to the carvedilol patent litigation, following the reversal of the verdict granting the award to GSK (see note 16 to our consolidated financial statements).

Other Income

Other income in the firstthird quarter of 2018 was $203$35 million, compared to $72$4 million in the firstthird quarter of 2017. Other income was primarily the result of the factors discussed above under “—North America Segment— Other Income,”final net asset distribution as well as a $93 million net gain related topart of the divestment of our women’s health business.PGT dissolution.

Other income as a percentage of revenues was 4.0%0.8% in the firstthird quarter of 2018, compared to 1.3%0.1% in the firstthird quarter of 2017.

Operating Income

Operating income was $1.5 billion$16 million in the firstthird quarter of 2018, compared to $895$378 million in the firstthird quarter of 2017.

The increasedecrease in operating income was mainly due to income from legal settlementslower gross profit and loss contingencies, higher operating incomeimpairment charges recorded in our Europe and Growth Markets segments and net gain from the sale of our women’s health business during the firstthird quarter of 2018, partially offset by higher other asset impairments, restructuring and other items, a goodwill impairment and lower operating income in our North America segment.2018.

The following table presents a reconciliation of our segment profits to our consolidated operating income and to consolidated income (loss) before income taxes for the three months ended March 31,September 30, 2018 and 2017:

  Three months ended
March 31,
   Three months ended
September 30,
 
  2018   2017   2018   2017 
  (U.S.$ in millions)   (U.S. $ in millions) 

North America profit

  $915   $1,306   $649   $1,130 

Europe profit

   377    268    297    241 

Growth Markets profit

   122    40 

International Markets profit

   123    110 
  

 

   

 

   

 

   

 

 

Total segment profit

   1,414    1,614    1,069    1,481 

Profit of other activities

   21    7 
  

 

   

 

 

Profit (loss) of other activities

   35    (11
   1,435    1,621   

 

   

 

 
   1,104    1,470 

Amounts not allocated to segments:

        

Amortization

   310    320    297    357 

Other asset impairments, restructuring and other items

   707    240    658    550 

Goodwill impairment

   180    —      —      —   

Gain on divestitures, net of divestitures related costs

   (93   —      (31   —   

Inventorystep-up

   —      64    —      —   

Other R&D expenses

   22    —      60    150 

Costs related to regulatory actions taken in facilities

   1    34    1    (1

Legal settlements and loss contingencies

   (1,278   20    19    (20

Other unallocated amounts

   61    48    84    56 
  

 

   

 

   

 

   

 

 

Consolidated operating income

   1,525    895 

Consolidated operating income (loss)

   16    378 
  

 

   

 

   

 

   

 

 

Financial expenses - net

   271    207 

Financial expenses, net

   229    259 
  

 

   

 

   

 

   

 

 

Consolidated income before income taxes

  $1,254   $688 

Consolidated income (loss) before income taxes

  $(213)   $119 
  

 

   

 

   

 

   

 

 

The increasedecrease in operating margin was 14.26.4 points, mainly due to legal settlements and loss contingencies (25.6 points), higher profitsa decline in our Europe (2.7gross profit (1.8 points) and Growth Markets (1.7 points) segments andhigher impairment charges recorded in the salethird quarter of our women’s health business (1.8 points), partially offset by higher other asset impairments, restructuring and other items (9.7 points), goodwill impairment (3.6 points) and lower profit in our North America segment (5.12018 (4.7 points).

During the fourth quarter of 2017, we deconsolidated our subsidiaries in Venezuela from our financial results. Consequently, results of operations of our subsidiaries in Venezuela are not included in our financial results for the firstthird quarter of 2018.

Financial Expenses, Net

Financial expenses were $271$229 million in the firstthird quarter of 2018, compared to $207$259 million in the firstthird quarter of 2017. The increase was mainly due to $60 million of early redemption charges and accelerated amortization of issuance costs related to

Financial expenses in the repayment of senior notes and term loans, partially offset by a $29 million gain derived from net foreign exchange losses and financial derivatives during the firstthird quarter of 2018 compared to a $36 million gain fromwere mainly comprised of interest expenses of $240 million. Financial expenses in the sale of Mylan shares during the firstthird quarter of 2017.2017 were mainly comprised of interest expenses of $219 million and an approximately $30 million impairment of our net monetary assets in Venezuela.

Tax Rate

In the firstthird quarter of 2018, income taxes were $46we recognized a tax benefit of $26 million, or 4%12%, onpre-tax loss of $213 million. In the third quarter of 2017, we recognized a tax benefit of $494 million, onpre-tax income of $1.3 billion. In the first quarter of 2017, income taxes were $54 million, or 8%, onpre-tax income of $688$119 million. Our tax rate for the firstthird quarter of 2018 was mainly affected byone-time legal settlements and divestments that had a low corresponding tax effect. the mix of products sold in different geographies.

The statutory Israeli corporate tax rate is 23% in 2018. Our tax rate differs from the Israeli statutory tax rate mainly due to the mixgeneration of profits generated in various jurisdictions wherein which tax rates are different than the Israeli tax rate, tax benefits in Israel and other countries, as well as infrequent or nonrecurring items.

In future years, our effective tax rate is expected to increase following the enactment of the Tax Cuts and Jobs Act in the United States.

Share in (Profits) Losses of Associated Companies, Net

Share in losses of associated companies, net in the firstthird quarter of 2018 was $74$10 million, compared to share in profits of $7$3 million in the firstthird quarter of 2017. The loss in the first quarter of 2018 is mainly due to a $94 million impairment related to the investment in New Chapter Inc. in connection with the P&G separation agreement.

Net Income (Loss)

Net incomeloss attributable to Teva was $1.1 billion$208 million in the firstthird quarter of 2018, compared to $645net income of $595 million in the firstthird quarter of 2017. The increase was mainly due to the factors previously discussed in “—Operating Income” above, partially offset by factors previously discussed in “—Financial Expenses, Net” and “—Share in (Profits) Losses of Associated Companies, Net.”

Net incomeloss attributable to ordinary shareholders was $1.1 billion$273 million in the firstthird quarter of 2018, compared to $580net income of $530 million in the firstthird quarter of 2017. The difference from net income attributable to Teva is due to the aforementioned factors.

Diluted Shares Outstanding and Earnings Per(Loss) per Share

The weighted average diluted shares outstanding used for the fully diluted share calculation for the three months ended March 31,September 30, 2018 and 2017 were 1,0201,018 million and 1,017 million shares, respectively.

Diluted earningsIn computing loss per share for the three months ended March 31,September 30, 2018, and 2017 take intono account was taken of the potential dilution that could occur uponby the assumed exercise of employee stock options andnon-vested RSUs granted under employee stock compensation plans using the treasury stock method.and convertible senior debentures, since they had an anti-dilutive effect on loss per share.

Additionally, no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to 6466 million shares (including shares that may be issued due to unpaid dividends to date) for the three months ended March 31,September 30, 2018 and 59 million shares for the three months ended March 31,September 30, 2017, as well as for the convertible senior debentures for the respective periods, since both had an anti-dilutive effect on earningsloss per share.

Diluted earningsloss per share were $1.03was $0.27 in the firstthird quarter of 2018, compared to $0.57earnings per share of $0.52 in the firstthird quarter of 2017.

Share Count for Market Capitalization

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

As of March 31,September 30, 2018 and 2017, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,0951,111 million and 1,0821,083 million, respectively.

Impact of Currency Fluctuations on Results of Operations

In the firstthird quarter of 2018, approximately 51% of our revenues came from sales outside of the United States. Because our results are reported in U.S. dollars, we are subject to significant foreign currency risks and, accordingly, changes in the exchange rate between the U.S. dollar and the local currencies in the markets in which we operate (primarily the euro, British pound, Japanese yen, new Israeli shekel, British pound, Canadian dollar,Polish zloty, Argentinean peso, Turkish lira and Russian ruble, and Polish zloty)ruble) impact our results. During the firstthird quarter of 2018, the following main currencies relevant to our operations decreased in value against the U.S. dollar (each on an annual average compared to annual average basis): Argentinean peso by 45%, Turkish lira by 37%, Russian ruble by 10%, Hungarian forint by 6%, Canadian dollar by 4%, Israeli shekel by 2%, Polish zloty by 2%, Swiss franc by 2%, euro by 1%, Japanese yen by 0.5% and British pound by 0.4%.

As a result, exchange rate movements during the third quarter of 2018 negatively impacted overall revenues by $80 million and our operating income by $34 million, in comparison with the third quarter of 2017.

Commencing in the third quarter of 2018, the cumulative inflation in Argentina exceeded 100% or more over a3-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.

Comparison of Nine Months Ended September 30, 2018 to Nine Months Ended September 30, 2017

The factors used to explain quarterly changes on a year-over-year basis are also generally relevant to a comparison of the results for the nine months ended September 30, 2018 and 2017. Additional factors affecting the nine months comparison are described below.

The following table sets forth, for the periods indicated, certain financial data derived from our U.S. GAAP financial statements:

   Percentage of Net Revenues
Nine months ended
September 30,
   Percentage
Change
2018-2017
 
   2018   2017 
   %   %   % 

Net revenues

   100.0    100.0    (16

Gross profit

   45.0    49.1    (23

Research and development expenses

   6.4    8.4    (36

Selling and marketing expenses

   15.6    16.2    (19

General and administrative expenses

   6.7    6.5    (13

Other asset impairments, restructuring and other items

   14.6    7.1    72 

Goodwill impairment

   2.1    36    (95

Legal settlements and loss contingencies

   (8.7   1.9    —   

Other income

   (2.3   (0.6   234 

Operating income (loss)

   10.7    (26.2   —   

Financial expenses, net

   5.1    4.1    5 

Income (loss) before income taxes

   5.5    (30.3   —   

Tax benefit

   (0.4   (2.7   (88

Share in losses of associated companies, net

   0.5    0.1    660 

Net income (loss) attributable tonon-controlling interests

   (0.2   0.1    —   

Net income (loss) attributable to Teva

   5.1    (27.8   —   

Dividends on preferred shares

   1.4    1.1    —   

Net income (loss) attributable to ordinary shareholders

   3.8    (29.0   —   

Segment Information

North America Segment

The following table presents revenues, expenses and profit for our North America segment for the nine months ended September 30, 2018 and 2017:

   Nine months ended September 30, 
   2018  2017 
   (U.S. $ in millions /% of Segment Revenues) 

Revenues

  $7,059   100 $9,452   100.0

Gross profit

   3,867   54.8  5,971   63.2

R&D expenses

   528   7.4  777   8.2

S&M expenses

   902   12.8  1,158   12.3

G&A expenses

   357   5.1  432   4.6

Other income

   (206  (2.9%)   (82  (0.9%) 
  

 

 

  

 

 

  

 

 

  

 

 

 

Segment profit*

  $2,286   32.4 $3,686   39.0
  

 

 

  

 

 

  

 

 

  

 

 

 

*

Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “—Teva Consolidated Results—Operating Income” below for additional information.

North America Revenues

Our North America segment includes the United States and Canada. Revenues from our North America segment in the first nine months of 2018 were $7,059 million, a decrease of $2,393 million, or 25%, compared to the first nine months of 2017.

Revenues by Major Products and Activities

The following table presents revenues for our North America segment by major products and activities for the nine months ended September 30, 2018 and 2017:

   Nine months ended     
   September 30,   

Percentage

Change

 
   2018   2017   2017-2018 
   (U.S. $ in millions)     

Generic products

  $2,957   $3,979    (26%) 

COPAXONE

   1,403    2,475    (43%) 

BENDEKA / TREANDA

   502    498    1

ProAir

   352    399    (12%) 

QVAR

   173    265    (35%) 

AUSTEDO

   136    8    1708

Distribution

   984    864    14

North America Gross Profit

Gross profit from our North America segment in the first nine months of 2018 was $3,867 million, a decrease of 35% compared to $5,971 million in the first nine months of 2017.

Gross profit margin for our North America segment in the first nine months of 2018 decreased to 54.8% from 63.2% in the first nine months of 2017.

North America R&D Expenses

R&D expenses relating to our North America segment in the first nine months of 2018 were $528 million, a decrease of 32% compared to $777 million in the first nine months of 2017.

North America S&M Expenses

S&M expenses relating to our North America segment in the first nine months of 2018 were $902 million, a decrease of 22% compared to $1,158 million in the first nine months of 2017.

North America G&A Expenses

G&A expenses relating to our North America segment in the first nine months of 2018 were $357 million, a decrease of 17% compared to $432 million in the first nine months of 2017.

North America Other Income

Other income from our North America segment in the first nine months of 2018 was $206 million, compared to $82 million in the first nine months of 2017.

North America Profit

Profit from our North America segment in the first nine months of 2018 was $2,286 million, a decrease of 38% compared to $3,686 million in the first nine months of 2017.

Europe Segment

The following table presents revenues, expenses and profit for our Europe segment for the nine months ended September 30, 2018 and 2017:

   Nine months ended
September 30,
 
   2018  2017 
   (U.S. $ in millions / % of Segment Revenues) 

Revenues

  $3,982    100 $4,016    100

Gross profit

   2,211    55.5  2,147    53.5

R&D expenses

   208    5.2  312    7.7

S&M expenses

   741    18.6  864    21.4

G&A expenses

   243    6.1  258    6.4

Other income

   (1   §   (15   § 
  

 

 

   

 

 

  

 

 

   

 

 

 

Segment profit*

  $1,020    25.6 $728    18.1
  

 

 

   

 

 

  

 

 

   

 

 

 

*

Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “—Teva Consolidated Results—Operating Income” below for additional information.

§

Represents an amount less than 0.5%.

Europe Revenues

Our Europe segment includes the European Union and certain other European countries. Revenues from our Europe segment in the first nine months of 2018 were $3,982 million, a decrease of 1% or $34 million, compared to the first nine months of 2017. In local currency terms, revenues decreased by 7% compared to the first nine months of 2017.

Revenues by Major Products and Activities

The following table presents revenues for our Europe segment by major products and activities for the nine months ended September 30, 2018 and 2017:

   Nine months ended     
   September 30,   

Percentage

Change

 
   2018   2017   2017-2018 
   (U.S. $ in millions)     

Generic products

  $2,749   $2,543    8

COPAXONE

   417    440    (5%) 

Respiratory products

   312    258    21

Europe Gross Profit

Gross profit from our Europe segment in the first nine months of 2018 was $2,211 million, an increase of 3% compared to $2,147 million in the first nine months of 2017.

Gross profit margin for our Europe segment in the first nine months of 2018 increased to 55.5% from 53.5% in the first nine months of 2017.

Europe R&D Expenses

R&D expenses relating to our Europe segment in the first nine months of 2018 were $208 million, a decrease of 33% compared to $312 million in the first nine months of 2017.

Europe S&M Expenses

S&M expenses relating to our Europe segment in the first nine months of 2018 were $741 million, a decrease of 14% compared to $864 million in the first nine months of 2017.

Europe G&A Expenses

G&A expenses relating to our Europe segment in the first nine months of 2018 were $243 million, a decrease of 6% compared to $258 million in the first nine months of 2017.

Europe Profit

Profit from our Europe segment in the first nine months of 2018 was $1,020 million, an increase of 40% compared to $728 million in the first nine months of 2017.

International Markets Segment

The following table presents revenues, expenses and profit for our International Markets segment for the nine months ended September 30, 2018 and 2017:

   Nine months ended September 30, 
   2018  2017 
   (U.S. $ in millions / % of Segment Revenues) 

Revenues

  $2,265    100 $2,485    100

Gross profit

   942    41.6  1,043    42.0

R&D expenses

   70    3.0  129    5.2

S&M expenses

   384    16.9  503    20.2

G&A expenses

   115    5.0  144    5.8

Other income

   (11   §   (4   § 
  

 

 

   

 

 

  

 

 

   

 

 

 

Segment profit*

  $384    17.0 $271    10.9
  

 

 

   

 

 

  

 

 

   

 

 

 

*

Segment profit does not include amortization and certain other items. The data presented for prior periods have been conformed to reflect the changes to our segment reporting commencing in the first quarter of 2018. See note 17 to our consolidated financial statements and “—Teva Consolidated Results—Operating Income” below for additional information.

§

Represents an amount less than 0.5%.

International Markets Revenues

Our International Markets segment includes all countries other than those in our North America and Europe segments. Revenues from our International Markets segment in the first nine months of 2018 were $2,265 million, a decrease of $220 million, or 9%, compared to the first nine months of 2017. In local currency terms, revenues decreased by 7% compared to the first nine months of 2017.

Revenues by Major Products and Activities

The following table presents revenues for our International Markets segment by major products and activities for the nine months ended September 30, 2018 and 2017:

   Nine months ended     
   September 30,   

Percentage

Change

 
   2018   2017   2017-2018 
   (U.S. $ in millions)     

Generic products

  $1,523   $1,720    (11%) 

COPAXONE

   52    65    (20%) 

Distribution

   456    406    12

International Markets Gross Profit

Gross profit from our International Markets segment in the first nine months of 2018 was $942 million, a decrease of 10% compared to $1,043 million in the first nine months of 2017.

Gross profit margin for our International Markets segment in the first nine months of 2018 decreased to 41.6%, from 42.0% in the first nine months of 2017.

International Markets R&D Expenses

R&D expenses relating to our International Markets segment in the first nine months of 2018 were $70 million, a decrease of 46% compared to $129 million in the first nine months of 2017.

International Markets S&M Expenses

S&M expenses relating to our International Markets segment in the first nine months of 2018 were $384 million, a decrease of 24% compared to $503 million in the first nine months of 2017.

International Markets G&A Expenses

G&A expenses relating to our International Markets segment in the first nine months of 2018 were $115 million, a decrease of 20% compared to $144 million in the first nine months of 2017.

International Markets Profit

Profit from our International Markets segment in the first nine months of 2018 was $384 million, compared to $271 million in the first nine months of 2017.

During the fourth quarter of 2017, we deconsolidated our subsidiaries in Venezuela from our financial results after concluding that we did not meet the accounting criteria for control over our wholly-owned subsidiaries in Venezuela and that we no longer had significant influence over such subsidiaries. Consequently, results of operations of our subsidiaries in Venezuela are not included in our financial results for the first nine months of 2018. We recorded $83 million in revenues and $28 million in operating income in the first nine months of 2017 with respect to our subsidiaries in Venezuela. We exclude these changes in revenues and operating profit in Venezuela from any discussion of local currency results.

Other Activities

Our revenues from other activities in the first nine months of 2018 decreased by 4% to $989 million. In local currency terms, revenues decreased by 6%.

API sales to third parties in the first nine months of 2018 decreased by 6% to $537 million. In local currency terms, revenues decreased by 7%.

Teva Consolidated Results

Revenues

Revenues in the first nine months of 2018 were $14,295 million, a decrease of 16%, or 17% in local currency terms, compared to the first nine months of 2017.

Exchange rate movements during the first nine months of 2018 compared to the first nine months of 2017 positively impacted revenues by $253 million.

Gross Profit

Gross profit in the first nine months of 2018 was $6,430 million, a decrease of $1,914 million, compared to the first nine months of 2017.

Gross profit as a percentage of revenues was 45.0% in the first nine months of 2018, compared to 49.1% in the first nine months of 2017.

Research and Development (R&D) Expenses

Net R&D expenses in the first nine months of 2018 were $918 million, a decrease of 36% compared to the first nine months of 2017.

R&D expenses as a percentage of revenues were 6.4% in the first nine months of 2018, compared to 8.4% in the first nine months of 2017.

Selling and Marketing (S&M) Expenses

S&M expenses in the first nine months of 2018 were $2,224 million, a decrease of 19% compared to the first nine months of 2017.

S&M expenses as a percentage of revenues were 15.6% in the first nine months of 2018, compared to 16.2% in the first nine months of 2017.

General and Administrative (G&A) Expenses

G&A expenses in the first nine months of 2018 were $954 million, a decrease of 13% compared to the first nine months of 2017.

G&A expenses as a percentage of revenues were 6.7% in the first nine months of 2018, compared to 6.5% in the first nine months of 2017.

Other Asset Impairments, Restructuring and Other Items

We recorded expenses of $2,080 million for other asset impairments, restructuring and other items in the first nine months of 2018, compared to expenses of $1,209 million in the first nine months of 2017. See note 14 to our consolidated financial statements.

Goodwill Impairment

In the first nine months of 2018, we recorded goodwill impairments of $300 million compared to a $6.1 billion goodwill impairment charge recorded in the first nine months of 2017. See note 7 to our consolidated financial statements.

Legal Settlements and Loss Contingencies

In the first nine months of 2018, we recorded income of $1,239 million, compared to an expense of $324 million in the first nine months of 2017. The income in the first nine months of 2018 consisted primarily of the working capital adjustment settlement with Allergan, the Rimsa settlement and reversal of the reserve recorded in the second quarter of 2017 with respect to the carvedilol patent litigation, following reversal of the verdict in GSK’s favor (see note 15 to our consolidated financial statements).

Other Income

Other income in the first nine months of 2018 was $334 million, compared to $100 million in the first nine months of 2017.

Other income as a percentage of revenues was 2.3% in the first nine months of 2018, compared to 0.6% in the first nine months of 2017.

Operating Income (Loss)

Operating income was $1,527 million in the first nine months of 2018, compared to a loss of $4,467 million in the first nine months of 2017.

The following table presents a reconciliation of our segment profits to our consolidated operating income (loss) and to consolidated income (loss) before income taxes for the nine months ended September 30, 2018 and 2017:

   Nine months ended 
   September 30, 
   2018   2017 
   (U.S. $ in millions) 

North America profit

  $2,286   $3,686 

Europe profit

   1,020    728 

International Markets profit

   384    271 
  

 

 

   

 

 

 

Total segment profit

   3,690    4,685 

Profit of other activities

   87    3 
  

 

 

   

 

 

 
   3,777    4,688 

Amounts not allocated to segments:

    

Amortization

   909    1,088 

Other asset impairments, restructuring and other items

   2,080    1,209 

Goodwill impairment

   300    6,100 

Gain on divestitures, net of divestitures related costs

   (114   —   

Inventorystep-up

   —      67 

Other R&D expenses

   82    176 

Costs related to regulatory actions taken in facilities

   6    48 

Legal settlements and loss contingencies

   (1,239   324 

Other unallocated amounts

   226    143 
  

 

 

   

 

 

 

Consolidated operating income (loss)

   1,527    (4,467
  

 

 

   

 

 

 

Financial expenses, net

   736    704 
  

 

 

   

 

 

 

Consolidated income (loss) before income taxes

  $791   $(5,171
  

 

 

   

 

 

 

Financial Expenses, Net

Financial expenses were $736 million in the first nine months of 2018, compared to $704 million in the first nine months of 2017.

Financial expenses in the first nine months of 2018 were mainly comprised of interest expenses of $689 million and $60 million of early redemption charges and accelerated amortization related to the repayment of senior notes and term loans in the first quarter of 2018. Financial expenses in the first nine months of 2017 were mainly comprised of interest expenses of $654 million and $61 million loss from net foreign exchange fluctuations and financial derivatives.

Tax Rate

In the first nine months of 2018, we recognized a tax benefit of $56 million, onpre-tax income of $791 million. In the first nine months of 2017, we recognized a tax benefit of $462 million, onpre-tax loss of $5,171 million. Our tax rate for the first nine months of 2018 was mainly affected byone-time legal settlements and divestments with a low corresponding tax effect as well as the mix of products sold in different geographies.

Share in Losses of Associated Companies, Net

Share in losses of associated companies, net in the first nine months of 2018 was $76 million, compared to share in losses of $10 million in the first nine months of 2017.

Net Income (Loss)

Net income attributable to Teva was $736 million in the first nine months of 2018, compared to net loss of $4,730 million in the first nine months of 2017.

Net income attributable to ordinary shareholders was $541 million in the first nine months of 2018, compared to net loss of $4,925 million in the first nine months of 2017.

Diluted Shares Outstanding and Earnings (Loss) per Share

The weighted average diluted shares outstanding used for the fully diluted share calculation for the nine months ended September 30, 2018 and 2017 were 1,020 million and 1,016 million shares, respectively.

Diluted earnings per share for the nine months ended September 30, 2018, take into account the potential dilution that could occur upon the exercise of options andnon-vested RSUs granted under employee stock compensation plans, using the treasury stock method. In computing loss per share for the nine months ended September 30, 2017, no account was taken of the potential dilution by the assumed exercise of employee stock options andnon-vested RSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.

Additionally, no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to 68 million shares (including shares that may be issued due to unpaid dividends to date) for the nine months ended September 30, 2018 and 59 million shares for the nine months ended September 30, 2017, as well as for the convertible senior debentures for the respective periods, since both had an anti-dilutive effect on earnings (loss) per share.

Diluted earnings per share were $0.53 in the first nine months of 2018, compared to a loss per share of $4.85 in the first nine months of 2017.

Impact of Currency Fluctuations on Results of Operations

In the first nine months of 2018, approximately 52% of our revenues came from sales outside of the United States. Because our results are reported in U.S. dollars, we are subject to significant foreign currency risks and, accordingly, changes in the exchange rate between the U.S. dollar and local currencies in the markets in which we operate (primarily the euro, British pound, Japanese yen, Polish zloty, Argentinean peso, Turkish lira and Russian ruble) impact our results. During the first nine months of 2018, the following main currencies relevant to our operations decreased in value against the U.S. dollar: Argentinean peso by 35%, Turkish lira by 22% and Russian ruble by 5% (compared on a nine-monthly average basis). During the first quarternine months of 2018, the following main currencies relevant to our operations increased in value against the U.S. dollar: Polish zloty by 8%, euro by 15%7%, British pound by 12%6%, Hungarian forint by 4%, new Israeli shekel by 8%, Polish zloty by 19%,2% and Japanese yen by 5%, Canadian dollar by 5%, Hungarian forint by 15%, Chilean peso by 9%, Swiss franc by 6% and Russian ruble by 3%2% (all compared on a nine-monthly average basis).

As a result, exchange rate movements during the first quarternine months of 2018 in comparison with the first quarter of 2017, positively impacted overall revenues by $240$253 million and increased our operating income by $37 million.$17 million, in comparison to the first nine months of 2017.

Liquidity and Capital Resources

Total balance sheet assets were $69.2 billion$65,061 million as of March 31,September 30, 2018, compared to $70.6 billion$67,030 million as of December 31, 2017.

Trade receivables as of March 31, 2018, net of sales reserves and allowances (“SR&A”), were negative $1.1 billion, compared to negative $0.8 billion as of December 31, 2017, mainly due to the decrease in sales in the first quarter of 2018, compared with the fourth quarter of 2017.

As of March 31, 2018, we do not present any material assets held for sale following the completion of the sale of our woman’s health business. As of December 31, 2017, we presented net assets held for sale in the amount of $0.6 billion.

Accrued expenses as of March 31, 2018 were $2.6 billion, compared to $3.0 billion as of December 31, 2017. The decrease was mainly due to $0.4 billion in connection with legal settlements.June 30, 2018.

Our working capital balance, which includes trade receivables net of SR&A, inventories, prepaid expenses and other current assets, trade payables, employee-related obligations, accrued expenses and other current liabilities, was negative $0.2 billion$232 million as of March 31,September 30, 2018, compared to negative $0.4 billion$121 million as of December 31, 2017.June 30, 2018.

Investment in property, plant and equipment in the firstthird quarter of 2018 was approximately $0.2 billion, flat$139 million, compared to $136 million in the fourthsecond quarter of 2017.2018. Depreciation was $0.2 billion$171 million in each of the firstthird quarter and second quarter of 2018, flat compared to the fourth quarter of 2017.2018.

Cash and cash equivalents and short-term and long-term investments as of March 31,September 30, 2018 were $1.5 billion,$1,948 million, compared to $1.1 billion$1,942 million as of December 31, 2017,June 30, 2018, mainly due to proceeds from the issuanceutilization of senior notes in March 2018, proceeds from the sale of our women’s health business, proceeds from the working capital adjustment with Allergan and the legal settlement with Rimsa, as well as other freetotal cash flow generated during the quarter, offset byfor debt prepayments as discussed below.repayment.

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

Our principal sources of short-term liquidity are our existing cash investments, liquid securities and available credit facilities, primarily our $3 billion syndicated revolving line of credit, which was not utilized as of March 31,September 30, 2018, as well as internally generated funds, which we believe are sufficient to meet ouron-going operating needs.

financial obligations in the ordinary course of business for at least twelve months.

2018 Debt Balance and Movements

As of March 31,September 30, 2018, our debt was $30.8 billion,$29,489 million, compared to $32.5 billion$30,237 million as of December 31, 2017.June 30, 2018. The decrease was mainly due to $6.5 billion ofthe $405 million debt prepayments, partially offset by our Marchtender offer completed in September 2018 issuance of an aggregate principal amount of $4.4 billion of senior notes, as well as exchange rate fluctuations.repayment at maturity of our CHF 300 million 0.13% senior note.

In January 2018, we prepaid in full $15 million of our U.S. dollar debentures.

During the first quarter of 2018, we prepaid in full $2.3 billion of our3-year and5-year U.S. dollar term loans, as well as JPY 156.8 billion of our term loans.

In March 2018, we completed debt issuances for an aggregate principal amount of $4.4 billion, consisting of senior notes with aggregate principal amounts of $2.5 billion and €1.6EUR 1.6 billion with maturities ranging from four to ten years. The effective average interest rate of the notes issued is 5.3% per annum. See note 11 to our consolidated financial statements.

In March 2018, we redeemed in full our $1.5 billion 1.4% senior notes due in July 2018 and our Euro 1.0 billion 2.875% senior notes due in April 2019.

In July 2018, we repaid at maturity our CHF 300 million 0.13% senior notes.

In September 2018, we completed a debt tender offer which resulted in a decrease of $405 million, comprised of:

$300 million of our $2.0 billion 1.7% senior notes due in July 2019

EUR 90 million of our EUR 1.75 billion 0.38% senior notes due in July 2020

In October 2018, we repaid at maturity our CHF 450 million 1.5% senior notes.

Our debt as of March 31,September 30, 2018 was effectively denominated in the following currencies: 63%65% in U.S. dollars, 32%31% in euros and 5%4% in Swiss francs.

The portion of total debt classified as short-term as of March 31,September 30, 2018 was 4%9%, compared to 11%4% as of December 31, 2017, mainlyJune 30, 2018, due to the activities described above.a net increase in current maturities.

Our financial leverage was 60%61% as of March 31,September 30, 2018, compared to 63%the same as of December 31, 2017.June 30, 2018.

Our average debt maturity was approximately 7.36.9 years as of March 31,September 30, 2018, compared to 6.47.0 years as of December 31, 2017.June 30, 2018.

Total Equity

Total equity was $20.1 billion$19,134 million as of March 31,September 30, 2018, compared to $18.7 billion$19,368 million as of December 31, 2017.June 30, 2018. The increasedecrease was mainly due to $1.1 billiona net loss of net income during$197 million for the quarterthree months ended September 30, 2018 and $239 million positivea negative impact of exchange rate fluctuations.$105 million due to currency devaluations against the U.S. dollar, partially offset by an increase of $44 million in stock based compensation expenses and $19 million in unrealized gain associated with hedging activities.

Exchange rate fluctuations affected our balance sheet, as approximately 61%53% of our net assets in the firstthird quarter of 2018 (including bothnon-monetary and monetary assets) were in currencies other than the U.S. dollar. When compared to December 31, 2017,June 30, 2018, changes in currency rates had a positivenegative impact of $330$105 million on our equity as of March 31,September 30, 2018, mainly due to the changechanges in value against the U.S. dollar of: the euroJapanese yen by (3%)1%, the MexicanIndian rupee by 14%, the Turkish lira by 60%, the Russian ruble by 14% and the Argentinean peso by (8%), the Japanese Yen by (6%), the British pound by (4%), the Polish zloty by (2%) and the Bulgarian lev by (3%)122%. All comparisons are on aquarter-end toquarter-end basis.

Cash Flow

Cash flow generated from operating activities during the firstthird quarter of 2018 was $1.5 billion,$421 million, compared to $0.1 billion$795 million in the firstthird quarter of 2017. The increasedecrease was mainly due to proceeds from the working capital adjustment with Allerganlower net income and the legal settlement with Rimsa, compared tohigher payments made to the SEC and DOJ related to restructuring liabilities during the FCPA settlement in the firstthird quarter of 2017.2018.

Cash flow generated from operating activities in the firstthird quarter of 2018, net of cash used for capital investments and beneficial interest collected in exchange for securitized trade receivables, was $1.9 billion,$704 million, compared to $0.3 billion$920 million in the firstthird quarter of 2017.

The increase was mainly due to the increasedecrease in cash flow generated from operating activities as well as lower net of cash used for capital investments and higher beneficial interest collected in exchange for securitized trade receivables.receivables is lower compared to the decrease in cash flow generated from operating activities, mainly due to lower capital expenditures.

Dividends

In December 2017, we announced an immediate suspension of dividends on our ordinary shares and ADSs and that dividends on our mandatory convertible preferred shares will be evaluated on a quarterly basis per current practice.

We have suspended cash dividends on our mandatory convertible preferred shares in the firstthird quarter of 2018 due to our accumulated deficit.

Commitments

In addition to financing obligations under short-term debt and long-term senior notes and loans, debentures and convertible debentures, our major contractual obligations and commercial commitments include leases, royalty payments, contingent payments pursuant to acquisition agreements and participation in joint ventures associated with R&D activities.

In September 2016, we entered into an agreement to develop and commercialize Regeneron’s pain medication product, fasinumab. We paid Regeneron $250 million upfront and will share equally with Regeneron in the global commercial benefits of this product, as well as ongoing associated R&D costs of approximately $1.0 billion. Milestone payments of $25 million and $35 million were paid in the second quarter of 2017 and the first quarter of 2018, respectively, and a provision of $60 million was recorded in the third quarter of 2018.

In October 2016, we entered into an exclusive partnership with Celltrion to commercialize two of Celltrion’s biosimilar products in development for the U.S. and Canadian markets. We paid Celltrion $160 million, of which up to $60 million is refundable or creditable under certain circumstances. We will share the profit from the commercialization of these products with Celltrion.

In September 2017, we entered into a partnership agreement with Nuvelution for development of AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States. Nuvelution will fund and manage clinical development, driving all operational aspects of the phase 3 program, and we will lead the regulatory process and be responsible for commercialization. Upon and subject to FDA approval of AUSTEDO for Tourette syndrome, we will pay Nuvelution apre-agreed return.

Dividends on our mandatory convertible preferred shares (aggregate liquidation preference of approximately $3.7 billion) are payable on a cumulative basis when, as and if declared by our Board of Directors at an annual rate of 7% on the liquidation preference of $1,000 per mandatory convertible preferred share. Declared dividends are paid in cash on March 15, June 15, September 15 and December 15 of each year to and including December 15, 2018. We have suspended cash dividend payments on our mandatory convertible preferred shares.

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

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

Our principal sources of short-term liquidity are our existing cash investments, liquid securities and available credit facilities, primarily our $3 billion syndicated revolving credit facility (“RCF”), which was not utilized as of March 31,September 30, 2018, as well as internally generated funds.

Pursuant to the requirements of the RCF, we have entered into negative pledge agreements with certain banks and institutional investors. Under the agreements, we and certain subsidiaries have undertaken not to register floating charges on assets in favor of any third parties without the prior consent of the banks, to maintain certain financial ratios, including the requirement to maintain compliance with a net debt to EBITDA ratio, which becomes more restrictive over time, and to fulfill other restrictions, as stipulated by the agreements. As of March 31,September 30, 2018, we did not have any outstanding debt under the RCF, which is our only debt subject to the net debt to EBITDA covenant. Assuming utilization of the RCF and under specified circumstances, includingnon-compliance with such covenants and the unavailability of any waiver, amendment or other modification thereto and the expiration of any applicable grace period thereto, substantially all of our other debt could be negatively impacted bynon-compliance with such covenants. We have sufficient resources to meet our financial obligations in the ordinary course of business for at least twelve months from the date of the release of this Quarterly Report.

2018 Aggregated Contractual Obligations

There have not been any material changes in our assessment of material contractual obligations and commitments as set forth in our Quarterly Report on Form10-Q for the period ended March 31, 2018 and in Item 7 of our Annual Report on Form10-K for the year ended December 31, 2017, other than as set forth below. These changes are the result of the significant debt movements during the firstthird quarter of 2018, as described under “—2018 Debt Balance and Movements” above.

In the firstthird quarter of 2018, we repaidcompleted a debt tender offer which resulted in a total amountdecrease of approximately $6.5 billion and raised new debt in a total amount of approximately $4.4 billion.$405 million to our debt. As of March 31,September 30, 2018, the totalour debt on the balance sheet is approximately $30.8 billion.was $29,489 million. See note 11 to our consolidated financial statements.

SupplementalNon-GAAP Income Data

We utilize certainnon-GAAP financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize thenon-GAAP measures:

our management and Board of Directors use thenon-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 anon-GAAP basis; and

senior management’s annual compensation is derived, in part, using thesenon-GAAP measures. While qualitative factors and judgment also affect annual bonuses, the principal quantitative elementdata presented in the determination of such bonuses is performance targets tied to the work plan, and thus is based on thenon-GAAP presentation set forth below.

Non-GAAP financial measures have no standardized meaning and accordingly have limitations in their usefulness to investors. We provide suchnon-GAAP data because management believes that such data provide useful information to investors. However, investors are cautioned that, unlike financial measures prepared in accordance with U.S. GAAP,non-GAAP measures may not be comparable with the calculation of similar measures for other companies. Thesenon-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using thesenon-GAAP financial measures as performance measures are that they provide a view of our results of operations without including all events during a period and may not provide a comparable view of our performance to other companies in the pharmaceutical industry.

Investors should considernon-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with U.S. GAAP.

In arriving at ournon-GAAP presentation, we exclude items that either have anon-recurring impact on the income statement or which, in the judgment of our management, are items that, either as a result of their nature or size, could, were they not singled out, potentially cause investors to extrapolate future performance from an improper base. In addition, we also exclude equity compensation expenses to facilitate a better understanding of our financial results, since we believe that this exclusion is important for understanding the trends in our financial results and that these expenses do not affect our business operations. While not all inclusive, examples of these items include:

amortization of purchased intangible assets;

legal settlements and/or loss contingencies, due to the difficulty in predicting their timing and size;

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, inventorystep-up andin-process R&D acquired in development arrangements;

expenses related to our equity compensation;

significantone-time financing costs and devaluation losses;

deconsolidation charges;

material tax and other awards or settlements, both amounts paid and received;

other exceptional items that we believe are sufficiently large that their exclusion is important to understanding 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

tax effects of the foregoing items.

The following tables present supplementalnon-GAAP data, in U.S. dollars, which we believe facilitates an understanding of the factors affecting our business. In these tables, we exclude the following amounts:

   Three Months Ended
March 31,
 
   2018   2017 
   (U.S. $ in millions) 

Gain on divestitures, net of divestitures related costs

   (93   —   

Amortization of purchased intangible assets

   310    320 

Restructuring expenses

   247    130 

Inventorystep-up

   —      64 

Capital loss from currency translation

   —      52 

Equity compensation expenses

   30    36 

Costs related to regulatory actions taken in facilities

   1    34 

Acquisition, integration and related expenses

   2    23 

Other R&D expenses

   22    —   

Contingent consideration

   8    21 

Legal settlements and loss contingencies

   (1,278   20 

Goodwill impairment

   180    —   

Impairment of long-lived assets

   432    11 

Othernon-GAAP items

   49    15 

Financial expense (income)

   68    (28

Minority interest

   (8   (13

Impairments of equity investments

   94    —   

Tax effect

   (165   (186

The data so presented — after these exclusions —below are the results used by management and our board of directors to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management. For example, each year we prepare a detailed work plan for the next fiscal year. This work plan is used to manage the business and isto measure the plan against which management’s performance is measured.of management. All such plans are prepared on a basis comparable to the presentation below, in that none of the plans takewithout taking into account those elements that are factored out inexcluded from ournon-GAAP presentations.financial measures. In addition, at quarterly meetings of the Board at whichwhen management providespresents financial updates to the Board,board of directors at its quarterly meetings, presentations are made comparing the current fiscal quarterly results against: (i) the comparable quarter of the prior year, (ii) the immediately preceding fiscal quarter and (iii) the work plan. Such presentations are based uponon thenon-GAAP approachfinancial measures reflected in the tables below. Moreover, while there are always qualitative factors and elements of judgment involved in the granting of annual cash bonuses, the principal quantitative element in the determination of such bonuses is performance targets tied to theour work plan, and thus, tied towhich are based on the samenon-GAAP presentation as isfinancial measures set forth below.

The data presented below arenon-GAAP financial measures and should not be considered replacements for GAAP results. We provide suchnon-GAAP data because management believes that it provides useful information to investors. However, investors are cautioned thatnon-GAAP financial measures may not be comparable with the calculation of similar measures for other companies, unlike financial measures prepared in accordance with GAAP. Thesenon-GAAP financial measures are presented solely to permit investors to better understand how management assesses our performance. The limitations of using thesenon-GAAP financial measures as performance measures are that they provide a view of our results of operations without including all events during a period, such as the effects of mergers and acquisitions, related restructuring and other charges, and may not provide a comparable view of our performance to other companies in the pharmaceutical industry.

In arriving atdetermining ournon-GAAP presentation,financial measures, we have excluded items in the past, factored out items, and would expect in the future to continue to factor outexclude items in the future, that either have anon-recurring impact on the income statement or which, in the judgment of our management, are items that, either as a result of their nature or size, could, were they not singled out, potentially cause investors to extrapolate future performance from an improper base. While not all inclusive, examples of these items include: legal settlements

acquisition or divestment related items, including changes in contingent consideration, integration costs, banker and reserves, purchase accounting expense adjustmentsother professional fees, inventorystep-up andin-process R&D acquired in development arrangements;

amortization of purchased intangible assets;

restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to acquisitions, including adjustments for write-offsthe rationalization of IPRour plants, or to certain other strategic activities such as the realignment of R&D amortization of intangible assetsfocus or other similar activities;

significantone-time financing costs and inventory“step-ups” following acquisitions; changes in the fair value of contingent consideration related to business combination; restructuring devaluation losses;

expenses related to efforts to rationalize and integrate operations on a global basis; material tax and otherour equity compensation;

awards or settlements—both in terms of amounts paid or amounts received; impairmentscosts related to intangible and other assets such as intellectual property, product rights or goodwill; the income tax effects of the foregoing types of items when they occur; and costs related tosignificant regulatory actions taken at our facilities (such as uncapitalized production costs, consulting expenses or write-offs of inventory related to remediation). Included;

legal settlements and/or loss contingencies, due to the difficulty in restructuring expenses are severance, shut down costs, contract termination costspredicting their timing and amounts;

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

deconsolidation charges;

material tax and other costsawards or settlements, both amounts paid and received;

other exceptional items that we believe are sufficiently large that their exclusion is important to understanding trends in our financial results.

These data arenon-GAAP financial measures and should not be considered replacements for GAAP results. We provide suchnon-GAAP data because management believes that such data provide useful information to investors. However, investors are cautioned that, unlike financial measures prepared in accordance with GAAP,non-GAAP measures may not be comparable with the calculation of similar measures for other companies. Thesenon-GAAP financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using thesenon-GAAP financial measures as performance measures are that they provide a view of our results, of operations without including all events during a period, such as theimpacts due to changes in accounting, or other unusual events; and

tax effects of acquisition, merger-related, restructuring and other charges, and may not provide a comparable view of our performance to other companies in the pharmaceutical industry.foregoing items.

Investors should considernon-GAAP financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with U.S. GAAP.

The following table presents the GAAP measures, relatednon-GAAP adjustments and the correspondingnon-GAAP amounts for the applicable periods:

 

     Three Months Ended March 31, 2018  Three Months Ended March 31, 2017 
     U.S. dollars and shares in millions (except per share amounts) 
     GAAP  Non-GAAP
Adjustments
  Dividends
on
Preferred
Shares
  Non-GAAP  % of Net
Revenues
  GAAP  Non-GAAP
Adjustments
  Dividends
on
Preferred
Shares
  Non-GAAP  % of Net
Revenues
 
  Gross profit (1)  2,348   303    2,651   52  2,839   377    3,216   57
  Operating income (loss) (1)(2)  1,525   (90   1,435   28  895   726    1,621   29
  Net income attributable to ordinary shareholders (1)(2)(3)(4)  1,055   (101   954   19  580   499    1,079   19
  Earnings per share attributable to ordinary shareholders - diluted  1.03   (0.09   0.94    0.57   0.49    1.06  

(1)

  Amortization of purchased intangible assets   264       267    
  Inventorystep-up   —         64    
  Costs related to regulatory actions taken in facilities   1       34    
  Equity compensation expenses  ��6       5    
  Other COGS related adjustments   32       7    
    

 

 

      

 

 

    
  Gross profit adjustments   303       377    

(2)

  

Gain on divestitures, net of divestitures related costs

   (93      —      
  Goodwill impairment   180       —      
  Restructuring expenses   247       130    
  Amortization of purchased intangible assets   46       53    
  Capital loss on currency translation   —         52    
  Equity compensation expenses   24       31    
  Acquisition, Integration and related expenses   2       23    
  Other R&D expenses   22       —      
  Contingent consideration   8       21    
  Legal settlements and loss contingencies   (1,278      20    
  Impairment of long-lived assets   432       11    
  Other operating related adjustments   17       8    
    

 

 

      

 

 

    
     (393      349    
    

 

 

      

 

 

    
  Operating income adjustments   (90      726    
    

 

 

      

 

 

    

(3)

  Financial expense (income)   68       (28   
  Tax effect   (165      (186   
  Impairment of equity investment   94       —      
  Minority interest   (8      (13   
    

 

 

      

 

 

    
  Net income adjustments   (101      499    
    

 

 

      

 

 

    
    Three Months Ended September 30, 2018 
    U.S.$ and shares in millions (except per share amounts) 
       Excluded for non GAAP measurement    
    GAAP  Amorti-
zation
of
purchased

intangible
assets
  Legal
settlements
and loss
contin-
gencies
  Impair-
ment
of long-
lived
assets
  Other
R&D
expenses
  Acquisition,
integration
and related
expenses
  Restruc-
turing
costs
  Costs
related to
regulatory
actions
taken in
facilities
  Equity
compen-
sation
  Contin-
gent
conside-
ration
  Gain on
sale of
business
  Other
non
GAAP
items
  Other
items
  Non
GAAP
 
 COGS  2,508   246        1   7     30    2,224 
 R&D  311      60      7     1    243 
 S&M  743   51         14       678 
 G&A  309          17     8    284 

  

 Other income  (35           (31    (4
 Legal settlements and loss contingencies  19    19              
 Impairments, restructuring and other  658     521    4   88     29    16     
 Financial expenses  229              (7  236 
 Corresponding tax effect  (26             (111  85 
 Share in losses of associated companies – net  10              9   1 
 Net income attributable tonon-controlling interests  11              (12  23 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 Total reconciled items   297   19   521   60   4   88   1   45   29   (31  55   (121 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 EPS—Basic  (0.27             0.95   0.68 
 EPS—Diluted  (0.27             0.95   0.68 

Thenon-GAAP diluted weighted average number of shares was 1,022 million for the three months ended September 30, 2018. For the three months ended September 30, 2018, the mandatory convertible preferred shares amounting to 66 million weighted average shares had an anti-dilutive effect on earnings per share and were therefore excluded from the outstanding shares calculation.

 

(4)Thenon-GAAP diluted weighted average number of shares was 1,020 and 1,017 million for the three months ended March 31, 2018 and 2017, respectively. For the three months ended March 31, 2018, the mandatory convertible preferred shares amounting to 64 million weighted average shares had an anti-dilutive effect on earnings per share and were therefore excluded from the outstanding shares calculation.Non-GAAP earnings per share can be reconciled with GAAP earnings per share by dividing each of the amounts included in footnotes1-3 above by the applicable weighted average share number.
    Three Months Ended September 30, 2017 
    U.S.$ and shares in millions (except per share amounts) 
       Excluded for non GAAP measurement    
    GAAP  Amorti-
zation
of
purchased

intangible
assets
  Legal
settlements
and loss
contin-
gencies
  Impair-
ment
of long-
lived
assets
  Other
R&D
expenses
  Acquisition,
integration
and related
expenses
  Restruc-
turing
costs
  Costs
related to
regulatory
actions
taken in
facilities
  Equity
compens-
ation
  Contin-
gent
conside-
ration
  Other
non
GAAP
items
  Other
items
  Non
GAAP
 

  

 COGS  2,967   310        (1  5    17    2,636 
 R&D  531      150      6    8    367 
 S&M  843   47         9    (1   788 
 G&A  372          12        360 
 Other income  (4               (4
 Legal settlements and loss contingencies  (20   (20            
 Impairments, restructuring and other  550     408    31   72     18   21     
 Financial expenses  259             30   229 
 Corresponding tax effect  (494            (629  135 
 Share in losses of associated companies – net  3                3 
 Net income attributable tonon-controlling interests  15             (11  26 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 Total reconciled items   357   (20  408   150   31   72   (1  32   18   45   (610 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 EPS—Basic  0.52             0.48   1.00 
 EPS—Diluted  0.52             0.48   1.00 

Thenon-GAAP diluted weighted average number of shares was 1,017 million for the three months ended September 30, 2017. Thenon-GAAP weighted average number of shares for the three months ended September 30, 2017 does not take into account the potential dilution of the mandatory convertible preferred shares (amounting to 59 million weighted average shares), which have an anti-dilutive effect onnon-GAAP earnings per share.

    Nine Months Ended September 30, 2018 
    U.S.$ and shares in millions (except per share amounts) 
       Excluded for non GAAP measurement    
    GAAP  Amorti-
zation
of
purchased

intangible
assets
  Goodwill
impairment
  Legal
settlements
and loss
contin-
gencies
  Impair-
ment
of long-
lived
assets
  Other
R&D
expenses
  Acquisition,
integration
and related
expenses
  Restruc-
turing
costs
  Costs
related to
regulatory
actions
taken in
facilities
  Equity
compen-
sation
  Contin-
gent
conside-
ration
  Gain on
sale of
business
  Other
non
GAAP
items
  Other
items
  Non
GAAP
 

  

 COGS  7,865   771         6   22     94    6,972 
 R&D  918       82      21     2    813 
 S&M  2,224   138          35     (4   2,055 
 G&A  954           44     12    898 
 Other income  (334            (114    (220
 Legal settlements and loss contingencies  (1,239    (1,239            —   
 Impairments, restructuring and other  2,080      1,501    9   442     84    44    —   
 Goodwill impairment  300    300              —   
 Financial expenses  736               59   677 
 Corresponding tax effect  (56              (479  423 
 Share in losses of associated companies – net  76               103   (27
 Net income attributable tonon-controlling interests  35               (32  67 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 Total reconciled items   909   300   (1,239  1,501   82   9   442   6   122   84   (114  148   (349 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 EPS—Basic  0.53               1.87   2.40 
 EPS—Diluted  0.53               1.86   2.39 

Thenon-GAAP diluted weighted average number of shares was 1,020 million for the nine months ended September 30, 2018. For the nine months ended September 30, 2018, the mandatory convertible preferred shares amounting to 68 million weighted average shares had an anti-dilutive effect on earnings per share and were therefore excluded from the outstanding shares calculation.

    Nine Months Ended September 30, 2017 
    U.S.$ and shares in millions (except per share amounts) 
       Excluded for non GAAP measurement    
    GAAP  Amorti-
zation
of
purchased

intangible
assets
  Goodwill
impairment
  Legal
settlements
and loss
contin-
gencies
  Impair-
ment
of long-
lived
assets
  Other
R&D
expenses
  Inventory
step-up
  Acquisition,
integration
and related
expenses
  Restruc-
turing
costs
  Costs
related to
regulatory
actions
taken in
facilities
  Equity
compens-
ation
  Contingent
conside-
ration
  Other
non
GAAP
items
  Other
items
  Non
GAAP
 
 COGS  8,643   944       67     48   18    37    7,529 

  

 R&D  1,432       176       17    19    1,220 
 S&M  2,745   144           30    (2   2,573 
 G&A  1,101            38    (15   1,078 
 Other income  (100             1    (101
 Legal settlements and loss contingencies  324     324             —   
 Impairments, restructuring and other  1,209      564     87   300     179   79    —   
 Goodwill impairment  6,100    6,100              —   
 Financial expenses  704               5   699 
 Corresponding tax effect  (462              (1,067  605 
 Share in losses of associated companies – net  10               2   8 
 Net income attributable tonon-controlling interests  11               (44  55 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 Total reconciled items   1,088   6,100   324   564   176   67   87   300   48   103   179   119   (1,104 
   

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  

 

 

  
 EPS - Basic  (4.85              7.93   3.08 
 EPS - Diluted  (4.85              7.92   3.07 

Thenon-GAAP diluted weighted average number of shares was 1,016 million for the nine months ended September 30, 2017. Thenon-GAAP weighted average number of shares for the nine months ended September 30, 2017 does not take into account the potential dilution of the mandatory convertible preferred shares (amounting to 59 million weighted average shares), which have an anti-dilutive effect onnon-GAAP earnings per share.

Non-GAAP Tax Rate

Non-GAAP income taxes for the firstthird quarter of 2018 were $211$85 million, or 17%10%, onpre-taxnon-GAAP income of $0.9 billion.Non-GAAP income taxes in the third quarter of 2017 were $135 million, or 11%, onpre-taxnon-GAAP income of $1.2 billion. Our tax rate for the third quarter of 2018 was mainly affected by the mix of products sold in different geographies.

Non-GAAP income taxes for the first nine months of 2018 were $423 million, or 14%, onpre-taxnon-GAAP income of $3.1 billion.Non-GAAP income taxes in the first quartercomparable period of 2017 were $240$605 million, or 17%,15% onpre-taxnon-GAAPpre-tax income of $1.4$4.0 billion.

We expect our annualnon-GAAP tax rate for 2018 to be 17%.14%, which is lower than our previous projection. This is due to changes in the geographical mix of income we expect to earn this year. Ournon-GAAP tax rate for 2017 was 15%. The expected 2018 non-GAAP tax rate is higher than our 2017non-GAAP tax rate, as we expect less tax benefits associated with the Actavis Generics acquisition as a result of the enactment of the Tax Cuts and Jobs Act in the United States.

Off-Balance Sheet Arrangements

Except for securitization transactions, which are disclosed in note 16d to our consolidated financial statements included in our annual reportAnnual Report on Form10-K for the year ended December 31, 2017, we do not have any materialoff-balance sheet arrangements.

Critical Accounting Policies

The preparation of our consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions in certain circumstances that affect the amounts reported in the accompanying consolidated financial statements and related footnotes. Actual results may differ from these estimates. We base our judgments on our experience and on various assumptions that we believe to be reasonable under the circumstances.

As applicable to our consolidated financial statements, the most significant estimates and assumptions relate to purchase price allocation on acquisitions, including determination of useful lives and contingent consideration; determining the valuation and recoverability of intangible assets and goodwill; and assessing sales reserves and allowances, uncertain tax positions, valuation allowances, contingencies, restructuring costs and inventory valuation.

Please refer to note 1 in the consolidated financial statements and critical accounting policies included in our Annual Report on Form10-K for the year ended December 31, 2017 for a summary of our significant accounting policies.

Recently Issued Accounting Pronouncements

See note 2 to our consolidated financial statements.

ITEM 3.

ITEM 3.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

There has not been any material change in our assessment of material contractual obligations and commitments as set forth in Item 7A to our Annual Report on Form10-K for the year ended December 31, 2017, other than as set forth below. These changes are the result of the significant debt movements during the first quarter of 2018, as described under Item 2 “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Liquidity and Capital Resources—2018 Debt Balance and Movements” above.

Our outstanding debt obligations, the corresponding interest rates, currency and repayment schedules as of March 31,September 30, 2018, are set forth in the table below in U.S. dollar equivalent terms, taking into account recent changes in our debt movement:

 

Currency

  Total
Amount
 Interest
Rate Ranges
 2018   2019   2020   2021   2022   2023 &
thereafter
   Total
Amount
 Interest Rate Ranges 2018   2019   2020   2021   2022   2023 & thereafter 
  (U.S. dollars in millions)   (U.S.$ in millions) 

Fixed Rate:

                              

USD

   18,433  1.70 6.75  —      2,000    700    3,620    863    11,250    18,132  1.70 6.75  —      1,700    700    3,619    861    11,252 

Euro

   9,914  0.38 3.85  —      —      2,152    587    863    6,312    9,274  0.38 4.50  —      —      1,924    587    813    5,950 

CHF

   1,521  0.13 1.50 786          367    368    1,172  0.5 1.50 458          357    357 

USD convertible debentures*

   514  0.25 0.25 514    —      —      —      —      —      514  0.25 0.25 514    —      —      —      —      —   

Floating Rate:

                              

USD

   500  2.80 2.80  —      —      —      —      —      500    500  2.80 2.80  —      —      —      —      —      500 

JPY

   —       —      —      —      —      —      —   

Others

   7  8.00 13.00 2    —      —      —      —      5    7  1.00 13.00 1    —      —      —      —      6 
  

 

    

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

  

 

  

 

   

 

   

 

   

 

   

 

   

 

 

Total:

   30,889    $1,302   $2,000   $2,852   $4,207   $2,093   $18,435    29,599    973    1,700    2,624    4,206    2,031    18,065 
  

 

    

 

   

 

   

 

   

 

   

 

   

 

   

 

  

 

  

 

  

 

   

 

   

 

   

 

   

 

   

 

 

Less debt issuance costs

   (137                (110             
  

 

              

Total:

  $30,752                 29,489              
  

 

              

 

*

Classified under short-term debt.

ITEM 4.

ITEM 4.

CONTROLS AND PROCEDURES

Disclosure Controls and Procedures

Teva maintains “disclosure controls and procedures. Our management, including our Chief Executive Officer and Chief Financial Officer, after evaluating the effectiveness of our disclosure controls and proceduresprocedures” (as defined in RuleRules13a-15(e) and15d-15(e) under the Securities Exchange Act of 1934) as of the end of the period covered by this Quarterly Report, has concluded that as of such date, Teva’s disclosure controls and procedures were effectiveare designed to ensureprovide reasonable assurance that the information required to be disclosed in theTeva’s reports that we filefiled or submitsubmitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to ourTeva’s management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.

Consistent with our conclusion in our Form10-Q for the quarter ended June 30, 2018, after evaluating the effectiveness of our disclosure controls and procedures as of September 30, 2018, our Chief Executive Officer and Chief Financial Officer concluded that, due to the existence of a material weakness in internal control over financial reporting described below, as of such date, Teva’s disclosure controls and procedures were not effective. As described below, the material weakness relates to our control designed to validate the allocation of businesses between the International Markets and Rimsa reporting units with respect to our interim goodwill impairment testing not operating effectively.

Notwithstanding the material weakness, Teva’s Chief Executive Officer and Chief Financial Officer have concluded that the interim financial statements included in the Form10-Q for the quarter ended September 30, 2018 presented fairly, in all material respects, Teva’s financial position, results of operations and cash flows for the periods presented in conformity with U.S. GAAP.

Material Weakness

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

Our internal controls did not operate effectively with respect to our interim goodwill impairment testing. Specifically, our control designed to validate the allocation of businesses between the International Markets and Rimsa reporting units did not operate effectively. This control deficiency did not result in a material misstatement of our annual or interim consolidated financial statements, account balances or disclosures. However, this control deficiency could have resulted in a misstatement of the goodwill balances and disclosures which would have resulted in a material misstatement of the consolidated financial statements that would not have been prevented or detected. Accordingly, management has concluded that this control deficiency constitutes a material weakness.

Remediation Plans

As disclosed in note 7 to our consolidated financial statements, for the purpose of future goodwill impairment testing, management combined the Rimsa/Mexico reporting unit within the International Markets reporting unit commencing July 1, 2018, and the control design will no longer incorporate the allocation process discussed above.

Management reassessed the precision of controls and the timing of internal processes relating to the performance of goodwill impairment. During the quarter ended September 30, 2018, we implemented controls according to this remediation plan. These controls will be tested when we perform our annual goodwill impairment testing for the year ending December 31, 2018, or earlier should an interim impairment assessment become necessary.

Changes in Internal control. Control over Financial Reporting

During the period covered by this Quarterly Report, there were no changesthe change described in “Remediation Plans” above was considered a change in Teva’s internal control over financial reporting that have materially affected, or areis reasonably likely to materially affect, Teva’s internal control over financial reporting.

PART II — OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

We are subject to various litigation and other legal proceedings. For a discussion of these matters, see “Commitments and Contingencies” included in note 16 to the consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form10-Q.

 

ITEM 1A.

RISK FACTORS

There are no material changes to the risk factors previously disclosed in our Annual Report on Form10-K for the year ended December 31, 2017.

 

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

Unregistered Sales of Equity Securities

There were no sales of unregistered equity securities during the three months ended March 31,September 30, 2018.

Repurchase of Shares

In December 2011, our Board of Directors authorized us to repurchase up to an aggregate amount of $3.0 billion of our ordinary shares or ADSs, of which $1.3 billion remained available for purchase, when in October 2014, the Board of Directors authorized us to increase our share repurchase program by $1.7 billion to $3.0 billion, of which $2.1 billion remained available as of March 31,September 30, 2018. We did not repurchase any of our shares during the three months ended March 31,September 30, 2018 and currently cannot do so due to our accumulated deficit. The repurchase program has no time limit. Repurchases may be commenced or suspended at any time, subject to applicable law.

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

Not applicable.

 

ITEM 4.

MINE SAFETY DISCLOSURES

Not applicable.

 

ITEM 5.

OTHER INFORMATION

Not applicable.

None.

ITEM 6.

ITEM 6.EXHIBITS

EXHIBITS

 

    4.1
10.1  Senior Indenture,Long-Term Assignment Letter for Michael McClellan dated as of March  14,August 9, 2018 among Teva Pharmaceutical Finance Netherlands III B.V., Teva Pharmaceutical Industries Limited and The Bank of New York Mellon, as trustee(1)*
    4.2First Supplemental Senior Indenture, dated as of March  14, 2018, among Teva Pharmaceutical Finance Netherlands III B.V., Teva Pharmaceutical Industries Limited and The Bank of New York Mellon, as trustee, including the form of 6.000% Senior Notes due 2024 and the form of 6.750% Senior Notes due 2028 (2)
    4.3Registration Rights Agreement, dated as of March  14, 2018, among Teva Pharmaceutical Finance Netherlands III B.V., Teva Pharmaceutical Industries Limited and the initial purchasers party thereto(3)
    4.4Senior Indenture, dated as of March  14, 2018, among Teva Pharmaceutical Finance Netherlands II B.V., Teva Pharmaceutical Industries Limited and The Bank of New York Mellon, as trustee (4)
    4.5First Supplemental Senior Indenture, dated as of March  14, 2018, among Teva Pharmaceutical Finance Netherlands II B.V., Teva Pharmaceutical Industries Limited, The Bank of New York Mellon, as trustee, and The Bank of New York Mellon, London Branch, as paying agent, including the form of 3.250% Senior Notes due 2022 and the form of 4.500% Senior Notes due 2025(5)
    4.6Registration Rights Agreement, dated as of March  14, 2018, among Teva Pharmaceutical Finance Netherlands II B.V., Teva Pharmaceutical Industries Limited and the initial purchasers party thereto(6)
31.1  Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2  Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
32  Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
101.INS  XBRL Taxonomy Instance Document
101.SCH  XBRL Taxonomy Extension Schema Document
101.CAL  XBRL Taxonomy Calculation Linkbase Document
101.DEF  XBRL Taxonomy Extension Definition Linkbase Document
101.LAB  XBRL Taxonomy Label Linkbase Document
101.PRE  XBRL Taxonomy Presentation Linkbase Document

 

*

Filed herewith.

(1)Incorporated by reference to Exhibit 4.1 to Form8-K filed on March 14, 2018.
(2)Incorporated by reference to Exhibit 4.2 to Form8-K filed on March 14, 2018.
(3)Incorporated by reference to Exhibit 4.4 to Form8-K filed on March 14, 2018.
(4)Incorporated by reference to Exhibit 4.5 to Form8-K filed on March 14, 2018.
(5)Incorporated by reference to Exhibit 4.6 to Form8-K filed on March 14, 2018.
(6)Incorporated by reference to Exhibit 4.8 to Form8-K filed on March 14, 2018.

SIGNATURESSIGNATURES

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

 

 TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Date: May 3,November 1, 2018 By: 

/s/ Michael McClellan

 Name: Michael McClellan
 Title: 

Executive Vice President,

Chief Financial Officer

(Duly Authorized Officer)

 

7880