Table of Contents
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM
10-Q
 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
For the quarterly period ended September 30, 2019
March 31, 2020
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
 
Commission file number
001-16174
 
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
(Exact name of registrant as specified in its charter)
 
   
Israel
 
Not 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)
 
Securities registered pursuant to Section 12(b) of the Act:
     
Title of each class
 
Trading
Symbol(s)
 
Name of each exchange
on which registered
American Depositary Shares, each representing one
Ordinary Share
 
TEVA
 
New York Stock Exchange
 
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 every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation
S-T
(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    
Yes  
    No  
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-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 Rule
12b-2
of the Exchange Act.
       
Large accelerated filer
 
 
Accelerated filer
 
       
Non-accelerated
filer
 
 
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 Rule
12b-2
of the Act).    Yes  
    No  
As of September 30, 2019,March 31, 2020, the registrant had 1,092,089,4211,095,524,777 ordinary shares outstanding.

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
INDEX
       
PART I.
  
       
Item 1.
 
  
5
 
       
   
5
6
 
       
   
6
7
 
       
   
7
8
 
       
   
8
9
 
       
 
10
Item 2.
40
Item 3.
61
Item 4.
61
PART II.
  
Item 1.
62
Item 1A.
62
Item 2.
62
Item 3.
63
Item 4.
63
Item 5.
63
Item 6.
64
 
       
   
11
Item 2.
46
Item 3.
78
Item 4.
78
PART II.
Item 1.
79
Item 1A.
79
Item 2.
79
Item 3.
79
Item 4.
79
Item 5.
79
Item 6.
80
81
65
 
2

Table of Contents
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 “ADS(s)” are to Teva’s American Depositary Share(s). References to “MS” are to multiple sclerosis. Market data, including both sales and share data, is based on information provided by IQVIA (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 “R&D” are to Research and Development, references to “IPR&D” are to
in-process
R&D, references to “S&M” are to Selling and Marketing and references to “G&A” are to General and Administrative. Some amounts in this report may not add up due to rounding. All percentages have been calculated using unrounded amounts. This report on Form
10-Q
contains many of the trademarks and trade names used by Teva in the United States and internationally to distinguish its products and services. Any third-party trademarks mentioned in this report are the property of their respective owners.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
In addition to historical information, this Quarterly Report on Form
10-Q,
and the reports and documents incorporated by reference in this Quarterly Report on Form
10-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; the uncertainty of commercial success of AJOVY
®
or AUSTEDO
®
; 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 tocompetition for our specialty products, bothespecially COPAXONE
®
, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and increased regulation;orally-administered alternatives; the uncertainty of commercial success of AJOVY
®
or AUSTEDO
®
; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantagedevelop and commercialize biopharmaceutical products; efforts of high-value opportunities;pharmaceutical companies to limit the difficultyuse of generics, including through legislation and expense of obtaining licenses to proprietary technologies;regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
our business and operations in general, including uncertainty regarding the magnitude, duration, and geographic reach of the
COVID-19
pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; manufacturing or quality control protocols; interruptions in our supply chain, including due to potential effects of the
COVID-19
pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the
COVID-19
pandemic and associated costs therewith; challenges associated with conducting business globally, including adverse effects of the
COVID-19
pandemic; costs resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time due to modified government operations due to the
COVID-19
pandemic, including effects on product and patent approvals due to the
COVID-19
pandemic; disruptions of information technology systems; and our ability to successfully compete in the marketplace;
our business and operations in general, including: failure to effectively executeeffectiveness of our restructuring plan announced in December 2017; uncertainties relatedour ability to attract, hire and failure to achieve, the potential benefits and success of our senior management team and organizational structure, including changes to our senior management team; harm to our pipeline of future products due to the ongoing review of our R&D programs;retain highly skilled personnel; 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 anti-corruption sanctions and other trade control laws; manufacturing or quality control problems, which may damage our reputation for quality production and require costly remediation;problems; interruptions in our supply chain; disruptions of our or third party information technology systems orsystems; 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;laws; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market;customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; implementation of a new enterprise resource planning system that, if deficient, could materially and adversely affect our operations and/or the effectiveness of our internal controls; and our prospects and opportunities for growth if we sell assets;assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
3

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S.; 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;
3

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 this Quarterly Report on Form
10-Q
and in our Annual Report on Form
10-K
for the year ended December 31, 2018,2019, including in the sections captioned “Risk Factors.” Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements.

4

PART I — FINANCIAL INFORMATION
ITEM 1.
FINANCIAL STATEMENTS
 
 
 
 
 
 
 
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED BALANCE SHEETS
(U.S. dollars in millions, except for share data)
(Unaudited)
         
 
September 30,
2019
 
 
December 31,
2018
 
ASSETS
      
Current assets:
      
Cash and cash equivalents
 $
1,241
  $
1,782
 
Trade receivables
  
5,254
   
5,822
 
Inventories
  
4,636
   
4,731
 
Prepaid expenses
  
976
   
899
 
Other current assets
  
416
   
468
 
Assets held for sale
  
18
   
92
 
         
Total current assets
  
12,542
   
13,794
 
Deferred income taxes
  
331
   
368
 
Other
non-current
assets
  
727
   
731
 
Property, plant and equipment, net
  
6,643
   
6,868
 
Operating lease
right-of-use
assets
  
468
   
—  
 
Identifiable intangible assets, net
  
11,878
   
14,005
 
Goodwill
  
24,657
   
24,917
 
         
Total assets
 $
57,246
  $
60,683
 
         
LIABILITIES AND EQUITY
      
Current liabilities:
      
Short-term debt
 $
3,130
  $
2,216
 
Sales reserves and allowances
  
6,137
   
6,711
 
Trade payables
  
1,688
   
1,853
 
Employee-related obligations
  
583
   
870
 
Accrued expenses
  
1,748
   
1,868
 
Other current liabilities
  
820
   
804
 
         
Total current liabilities
  
14,107
   
14,322
 
Long-term liabilities:
      
Deferred income taxes
  
1,462
   
2,140
 
Other taxes and long-term liabilities
  
2,546
   
1,727
 
Senior notes and loans
  
23,812
   
26,700
 
Operating lease liabilities
  
394
   
—  
 
         
Total long-term liabilities
  
28,215
   
30,567
 
         
Commitments and contingencies
, see note 16
 
 
 
 
 
 
 
 
Total liabilities
  
42,322
   
44,889
 
         
Equity:
      
Teva shareholders’ equity:
      
Ordinary shares of NIS 0.10 par value per share; September 30, 2019 and December 31, 2018: authorized 2,495 million shares; issued 1,198 million shares and 1,196 million shares, respectively
  
56
   
56
 
Additional
paid-in
capital
  
27,293
   
27,210
 
Accumulated deficit
  
(7,066
)  
(5,958
)
Accumulated other comprehensive loss
  
(2,365
)  
(2,459
)
Treasury shares as of September 30, 2019 and December 31, 2018 — 106 million ordinary shares
  
(4,128
)  
(4,142
)
         
  
13,790
   
14,707
 
         
Non-controlling
interests
  
1,134
   
1,087
 
         
Total equity
  
14,925
   
15,794
 
         
Total liabilities and equity
 $
57,246
  $
60,683
 
         
         
 
March 31,
  
December 31,
 
 
2020
  
2019
 
ASSETS
      
Current assets:
      
Cash and cash equivalents
 
$
1,804
 
 
$
1,975
 
Accounts receivables, net of allowance for credit losses of $127 million and $135 million as of March 31, 2020 and December 31, 2019
  
5,189
   
5,676
 
Inventories
  
4,290
   
4,422
 
Prepaid expenses
  
977
   
870
 
Other current assets
  
538
   
434
 
Assets held for sale
  
86
   
87
 
         
Total current assets
  
12,884
   
13,464
 
Deferred income taxes
  
440
   
386
 
Other
non-current
assets
  
550
   
591
 
Property, plant and equipment, net
  
6,221
   
6,436
 
Operating lease
right-of-use
assets
  
489
   
514
 
Identifiable intangible assets, net
  
10,256
   
11,232
 
Goodwill
  
24,490
   
24,846
 
         
Total assets
 
$
55,330
 
 
$
57,470
 
         
LIABILITIES AND EQUITY
 
 
    
Current liabilities:
 
 
    
Short-term debt
 
$
1,630
 
 
$
2,345
 
Sales reserves and allowances
  
5,662
   
6,159
 
Accounts payables
  
1,710
   
1,718
 
Employee-related obligations
  
540
   
693
 
Accrued expenses
  
1,718
   
1,869
 
Other current liabilities
  
1,061
   
889
 
         
Total current liabilities
  
12,322
   
13,674
 
Long-term liabilities:
 
 
    
Deferred income taxes
  
912
   
1,096
 
Other taxes and long-term liabilities
  
2,624
   
2,640
 
Senior notes and loans
  
24,473
   
24,562
 
Operating lease liabilities
  
411
   
435
 
         
Total long-term liabilities
  
28,420
   
28,733
 
         
Commitments and contingencies
, see note
10
      
Total liabilities
  
40,742
   
42,407
 
         
Equity:
 
 
    
Teva shareholders’ equity:
 
 
    
Ordinary shares of NIS 0.10 par value per share; March 31, 2020 and December 31, 2019: authorized 2,495 million shares; issued 1,201 million shares and 1,198 million shares, respectively
  
56
   
56
 
Additional
paid-in
capital
  
27,342
   
27,312
 
Accumulated deficit
  
(6,887
)  
(6,956
)
Accumulated other comprehensive loss
  
(2,852
)  
(2,312
)
Treasury shares as of March 31, 2020 and December 31, 2019 — 106 million ordinary shares
  
(4,128
)  
(4,128
)
         
  
13,531
   
13,972
 
         
Non-controlling
interests
  
1,057
   
1,091
 
         
Total equity
  
14,588
   
15,063
 
         
Total liabilities and equity
 
$
55,330
  
$
57,470
 
         
 
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.
5

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(U.S. dollars in millions, except share and per share data)
(Unaudited)
         
 
Three months ended
 
 
March 31,
 
 
2020
 
 
2019
 
Net revenues
 
$
4,357
 
 
$
4,149
 
Cost of sales
  
2,294
   
2,293
 
         
Gross profit
  
2,063
   
1,856
 
Research and development expenses
  
221
   
261
 
Selling and marketing expenses
  
613
   
648
 
General and administrative expenses
  
304
   
292
 
Intangible assets impairments
  
649
   
469
 
Other assets impairments, restructuring and other items
  
121
   
1
 
Legal settlements and loss contingencies
  
(25
  
57
 
Other income
  
(13
)  
(6
)
         
Operating (loss) income
  
191
   
134
 
Financial expenses, net
  
224
   
218
 
         
Income (loss) before income taxes
  
(33
)  
(84
)
Income taxes (benefit)
  
(59
)  
9
 
Share in (profits) losses of associated companies, net
  
1
   
4
 
         
Net income (loss)
  
25
   
(97
)
Net income
 (
loss)
 attributable to
non-controlling
interests
  
(44
)  
8
 
         
Net income (loss) attributable to Teva
  
69
   
(105
)
         
Net income (loss) attributable to ordinary shareholders
 $
69
  $
(105
)
         
Earnings (loss) per share attributable to ordinary shareholders:
      
Basic
 $
0.06
  $
(0.10
)
         
Diluted
 $
0.06
  $
(0.10
)
         
Weighted average number of shares (in millions):
      
Basic
  
1,093
   
1,090
 
         
Diluted
  
1,096
   
1,090
 
         
 
 
 
 
 
 
 
 
 
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.

6


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(U.S. dollars in millions, except share and per share data)
(Unaudited)
                 
 
Three months ended
September 30,
  
Nine months ended
September 30,
 
 
2019
   
2018
   
2019
    
2018
 
Net revenues
 $
4,264
  $
4,529
  $
12,896
  $
14,295
 
Cost of sales
  
2,435
   
2,552
   
7,318
   
7,970
 
                 
Gross profit
  
1,830
   
1,977
   
5,579
   
6,325
 
Research and development expenses
  
240
   
311
   
778
   
918
 
Selling and marketing expenses
  
595
   
699
   
1,908
   
2,119
 
General and administrative expenses
  
285
   
309
   
873
   
954
 
Intangible assets impairment
  
177
   
519
   
1,206
   
1,246
 
Goodwill impairment
  
   
—  
   
   
300
 
Other assets impairments, restructuring and other items
  
160
   
139
   
263
   
834
 
Legal settlements and loss contingencies
  
468
   
19
   
1,171
   
(1,239
)
Other income
  
(14
)  
(35
)  
(29
)  
(334
)
                 
Operating income (loss)
  
(81
)  
16
   
(591
)  
1,527
 
Financial expenses, net
  
211
   
229
   
635
   
736
 
                 
Income (loss) before income taxes
  
(292
)  
(213
)  
(1,226
)  
791
 
Income taxes
 (benefit
)
  
11
   
(26
)  
(159
)  
(56
)
Share in losses of associated companies, net
  
4
   
10
   
8
   
76
 
                 
Net income (loss)
  
(307
)  
(197
)  
(1,076
)  
771
 
Net income attributable to
non-controlling
interests
  
7
   
11
   
33
   
35
 
                 
Net income (loss) attributable to Teva
  
(314
)  
(208
)  
(1,108
)  
736
 
                 
Dividends on preferred shares
  
   
65
   
   
195
 
                 
Net income (loss) attributable to ordinary shareholders
 $
(314
) $
(273
) $
(1,108
) $
541
 
                 
Earnings (loss) per share attributable to ordinary shareholders:
            
Basic
 $
(0.29
) $
(0.27
) $
(1.02
) $
0.53
 
                 
Diluted
 $
(0.29
) $
(0.27
) $
(1.02
) $
0.53
 
                 
Weighted average number of shares (in millions):
            
Basic
  
1,092
   
1,018
   
1,091
   
1,018
 
                 
Diluted
  
1,092
   
1,018
   
1,091
   
1,020
 
                 
Amounts may not add up due to rounding.
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
September 30,
  
Nine months ended
September 30,
 
 
2019
  
2018
  
2019
  
2018
 
Net income (loss)
 $
 
(307)
  $
 
(197)
  $
 
(1,076)
  $
771
 
Other comprehensive income (loss), net of tax:
            
Currency translation adjustment
  
(138
)  
(105
)  
(5
)  
(577
)
Unrealized gain from derivative financial instruments
  
87
   
19
   
124
   
75
 
Unrealized gain (loss) from available-for-sale securities
  
(2
)  
1
   
(1
)  
 
 
 
Unrealized gain (loss) on defined benefit plans
  
 
 
   
1
   
(1
)  
 
 
 
                 
Total other comprehensive income (loss)
  
(53
)  
(84
)  
117
   
(502
)
                 
Total comprehensive income (loss)
  
(360
)  
(281
)  
(959
)  
269
 
Comprehensive income (loss) attributable to
non-controlling
interests
  
7
   
(26
)  
56
   
20
 
                 
Comprehensive income (loss) attributable to Teva
 $
(367
) $
(255
) $
(1,015
) $
249
 
                 
         
 
Three months ended
 
 
March 31,
 
 
2020
 
 
2019
 
Net income (loss)
 
$
25
 
 
$
(97
)
Other comprehensive income (loss), net of tax:
      
Currency translation adjustment
  
(560
)  
47
 
Unrealized gain from derivative financial instruments
  
30
   
47
 
         
Total other comprehensive income (loss)
  
(530
)  
94
 
         
Total comprehensive income (loss)
  
(505
)  
(3
)
Comprehensive income (loss) attributable to
non-controlling
interests
  
(34
  
2
 
         
Comprehensive income (loss) attributable to Teva
 
$
(471
)
 
$
(5
)
         
 
 
 
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.

7


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(Unaudited)
                                         
 
Teva shareholders’ equity
     
 
Ordinary shares
                 
 
Number of
shares
 
(in
millions)
  
Stated
value
  
MCPS
 
*
  
Additional
paid-in
capital
  
Retained
earnings
(accumulated
deficit)
  
Accumulated
other
 
compre
hensive

(loss)
  
Treasury
shares
  
Total Teva
shareholders’
equity
  
Non-
controlling

interests
  
Total
 
equity
 
 
(U.S. dollars in millions)
 
Balance at June 30, 2018
 
 
1,124
 
 
 
54
 
 
 
3,760
 
 
 
23,426
 
 
 
 
 
 
 
 
 
 
(2,864)
 
 
 
(2,289)
 
 
 
(4,149
)
 
 
17,938
 
 
 
1,430
 
 
 
19,368
 
Comprehensive loss
              
(208
)  
(46
)     
(255
)  
(26
)  
(281
)
Issuance of Shares
 
 
1
 
 
 
**
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
**
 
Issuance of Treasury Shares
 
 
 
 
 
 
 
 
 
 
 
(1
)  
 
 
 
 
 
 
3
 
 
 
2
 
 
 
 
 
 
2
 
Stock-based compensation expense
           
44
            
44
      
44
 
Dividends to preferred shareholders
        
65
   
(65
)           
 
      
 
                                         
Balance at September 30,
2018
  
1,125
  $
54
  $
3,825
  $
23,404
  $
(3,072
) $
(2,335
) 
$
(4,146
)
 $
17,730
  $
1,404
  $
19,134
 
                                         
                                     
 
Teva shareholders’ equity
  
 
 
 
 
Ordinary shares
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of
shares (in
millions)
 
 
Stated
value
 
 
Additional
paid-in
 capital
 
 
Retained
earnings
(accumulated
deficit)
 
 
Accumulated other
comprehensive
(loss)
 
 
Treasury
shares
 
 
Total Teva
shareholders’
equity
 
 
Non-
controlling
interests
 
 
Total
equity
 
 
(U.S. dollars in millions)
 
Balance at December 31, 2019
  
1,198
   
56
   
27,312
   
(6,956
)  
(2,312
)  
(4,128
)  
13,972
   
1,091
   
15,063
 
Comprehensive income (loss)
              
69
   
(540
)      
(471
)  
(34
  
(505
)
Issuance of Shares
  
3
   
*
                           
*
 
Stock-based compensation expense
          
30
               
30
       
30
 
                                     
Balance at March 31, 2020
  
1,201
  $
56
  $
27,342
  $
(6,887
) $
(2,852
) $
(4,128
) $
13,531
  $
1,057
  $
14,588
 
                                     
 
 
 
 
 
 
 
*
*
Mandatory convertible preferred shares.
**
Represents an amount less than $0.5 million.
 
 
 
 
 
 
 
                                     
 
Teva shareholders’ equity
  
 
 
 
 
Ordinary shares
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of
shares (in
millions)
 
 
Stated
value
 
 
Additional
paid-in
 capital
 
 
Retained
earnings
(accumulated
deficit)
 
 
Accumulated other
comprehensive
(loss)
 
 
Treasury
shares
 
 
Total Teva
shareholders’
equity
 
 
Non-
controlling
interests
 
 
Total
equity
 
 
(U.S. dollars in millions)
 
Balance at December 31, 2018
  
1,196
   
56
   
27,210
   
(5,958
)  
(2,459
)  
(4,142
)  
14,707
   
1,087
   
15,794
 
Comprehensive income (loss)
           
(105
  
100
      
(5
)  
2
   
(3
)
Issuance of shares
  
2
   
*
                     
*
 
Issuance of Treasury Shares
         
(3
)        
5
   
2
      
2
 
Stock-based compensation expense
        
34
            
34
      
34
 
Other
        
(6
)           
(6
)     
(6
)
                                     
Balance at March 31, 2019
  
1,198
  $
56
  $
27,234
  $
(6,063
) $
(2,359
) $
(4,137
) $
14,732
  $
1,089
  $
15,821
 
                                     
 
 
 
 
 
 
 
                                         
 
Teva shareholders’ equity
     
 
Ordinary shares
                 
 
Number of
shares
 
(in

millions)
  
Stated
value
  
MCPS
 
*
  
Additional
paid-in
capital
  
Retained
earnings
(accumulated
deficit)
  
Accumulated
other
 
comprehensive
(loss)
  
Treasury
shares
  
Total Teva
shareholders’
equity
  
Non-
controlling

interests
  
Total
 
equity
 
 
(U.S. dollars in millions)
 
Balance at June 30, 2019
  
1,198
   
56
   
   
27,258
   
(6,752
)  
(2,312
)  
(4,128
)  
14,122
   
1,128
   
15,251
 
Comprehensive income (loss)
 
 
 
   
 
   
 
   
 
   
(314
)  
(53
)  
 
   
(367
)  
7
   
(360
)
Issuance of Shares
  
**
   
**
   
 
   
 
   
 
   
 
   
 
   
 
   
 
   
**
 
Stock-based compensation expense
  
 
   
 
   
 
   
35
   
 
   
 
   
 
   
35
   
 
   
35
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance at September 30,
2019
  
1,198
  $
56
   
  $
27,293
  $
(7,066
) $
(2,365
) $
(4,128
) $
13,790
  $
1,134
  $
14,925
 
                                         
*Mandatory convertible preferred shares.
**Represents an amount less than
$
0.5 million.
 
 
 
 
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.

8

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
                                         
 
Teva shareholders’ equity
     
 
Ordinary shares
                         
 
Number of
shares
 (in

millions)
  
Stated
value
  
MCPS
 
*
  
Additional
paid-in
capital
  
Retained
earnings
(accumulated
deficit)
  
Accumulated
other
 
comprehensive
(loss)
  
Treasury
shares
  
Total Teva
shareholders’
equity
  
Non-
controlling

interests
  
Total
 
equity
 
 
(U.S. dollars in millions)
 
Balance at December
 
31,
 
2017
 
 
1,124
 
 
 
54
 
 
 
3,631
 
 
 
23,479
 
 
 
(3,803
)
 
 
(1,853
)
 
 
(4,149
)
 
 
17,359
 
 
 
1,386
 
 
 
18,745
 
Cumulative effect of new accounting standard
              
(5
)
  
5
             
Comprehensive income (loss)
              
736
   
(487
)     
249
   
20
   
269
 
Issuance of Treasury Shares
 
 
 
 
 
 
 
 
 
 
 
(1
)
 
 
 
 
 
 
 
 
 
 
3
 
 
 
2
 
 
 
 
 
 
 
2
 
Dividends to preferred shareholders
        
194
   
(194
)                  
Issuance of shares
  
1
   
**
                        ** 
Stock-based compensation expense
           
120
            
120
      
120
 
Transactions with non-controlling
 
interests
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(2
)
 
 
(2
)
                                         
Balance at September 30, 2018
  
1,125
  
$
54
  
$
3,825
  
$
23,404
  
$
(3,072
)
 
$
(2,335
)
 
$
(4,146
)
 
$
17,730
  
$
1,404
  
$
19,134
 
*Mandatory convertible preferred shares.
**
Represents an amount less than
$
0.5 million.
                                         
 
Teva shareholders’ equity
  
 
 
 
 
Ordinary shares
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Number of
shares (in
millions)
 
 
Stated
value
 
 
MCPS
 
*
 
 
Additional
paid-in
capital
 
 
Retained
earnings
(accumulated
deficit)
 
 
Accumulated
other
 
comprehensive
(loss)
 
 
Treasury
shares
 
 
Total Teva
shareholders’
equity
 
 
Non-
controlling

interests
 
 
Total
 
equity
 
 
(U.S. dollars in millions)
 
Balance at December 31, 2018
 
 
1,196
 
 
 
56
 
 
 
—  
 
 
 
27,210
 
 
 
(5,958
)
 
 
(2,459
)
 
 
(4,142
)
 
 
14,707
 
 
 
1,087
 
 
 
15,794
 
Comprehensive income (loss)
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(1,108
)
 
 
94
 
 
 
 
 
 
(1,015
)
 
 
56
 
 
 
(959
)
Issuance of Shares
 
 
2
 
 
 
**
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
**
 
Issuance of Treasury Shares
 
 
 
 
 
 
 
 
 
 
 
(8
)
 
 
 
 
 
 
 
 
14
 
 
 
6
 
 
 
 
 
 
6
 
Stock-based compensation expense
 
 
 
 
 
 
 
 
 
 
 
99
 
 
 
 
 
 
 
 
 
 
 
 
99
 
 
 
 
 
 
99
 
Transactions with
non-controlling
interests
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(8
)
 
 
(8
)
Other
 
 
 
 
 
 
 
 
 
 
 
(8
)
 
 
 
 
 
 
 
 
 
 
 
(8
)
 
 
 
 
 
(8
)
Balance at September 30,
2019
 
 
1,198
 
 
$
56
 
 
 
—  
 
 
$
27,293
 
 
$
(7,066
)
 
$
(2,365
)
 
$
(4,128
)
 
$
13,790
 
 
$
1,134
 
 
$
14,925
 
                                         
*
Mandatory convertible preferred shares.
**
Represents an amount less than
$
0.5 million.
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.
9

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in millions)
(Unaudited)
         
 
Nine months ended
September 30,
 
 
2019
  
2018
 
Operating activities:
      
Net income (loss)
 $
(1,076
) $
771
 
Adjustments to reconcile net income (loss) to net cash provided by operations:
      
Depreciation and amortization
  
1,306
   
1,460
 
Impairment of long-lived assets
  
1,302
   
1,501
 
Net change in operating assets and liabilities
  
(784
)  
(1,521
)
Deferred income taxes – net and uncertain tax positions
  
(652
)  
(650
)
Stock-based compensation
  
99
   
122
 
Net
loss (
gain
)
from sale of long-lived assets and investments
  
10
   
(53
)
Other items
  
5
   
(8
)
Goodwill impairment
  
   
300
 
Impairment of equity investment
  
   
103
 
In process research and development
  
   
54
 
         
Net cash provided by operating activities
  
210
   
2,079
 
         
Investing activities:
      
Beneficial interest collected in exchange for securitized trade receivables
  
1,108
   
1,372
 
Purchases of property, plant and equipment
  
(406
)  
(438
)
Proceeds from sales of business, investments and long-lived assets
  
169
   
880
 
Other investing activities
  
59
   
34
 
Purchases of investments and other assets
  
(5
)  
(56
)
         
Net cash provided by investing activities
  
925
   
1,792
 
         
Financing activities:
      
Repayment of senior notes and loans and other long-term liabilities
  
(1,715
)  
(6,989
)
Net change in short-term debt
  
96
   
(262
)
Tax withholding payments made on shares and dividends
  
(52
)  
(22
)
Other financing activities
  
(14
)  
(13
)
Proceeds from senior notes and loans, net of issuance costs
  
   
4,434
 
         
Net cash used in financing activities
  
(1,685
)  
(2,852
)
         
Translation adjustment on cash and cash equivalents
  
9
   
(107
)
         
Net change in cash and cash equivalents
  
(541
)  
912
 
Balance of cash and cash equivalents at beginning of period
  
1,782
   
963
 
         
Balance of cash and cash equivalents at end of period
 
$
1,241
 
 
$
1,875
 
Non-cash
financing and investing activities:
      
Beneficial interest obtained in exchange for securitized trade receivables
 $
1,123
  $
1,345
 
         
 
Three months ended
 
 
March 31,
 
 
2020
  
2019
 
Operating activities:
      
Net income (loss)
 
$
25
 
 
$
(97
)
Adjustments to reconcile net income (loss) to net cash provided by operations:
      
Depreciation and amortization
  
399
   
443
 
Impairment of long-lived assets
  
724
   
489
 
Net change in operating assets and liabilities
  
(666
)  
(805
)
Deferred income taxes – net and uncertain tax positions
  
(233
)  
(33
)
Stock-based compensation
  
30
   
34
 
Net loss (gain) from sale of long-lived assets and investments
  
24
   
(2
)
Other items
  
2
   
83
 
         
Net cash provided by operating activities
  
305
   
112
 
         
Investing activities:
      
Beneficial interest collected in exchange for securitized accounts receivables
  
368
   
362
 
Purchases of property, plant and equipment
  
(128
)  
(125
)
Proceeds from sale of long lived assets
  
6
   
11
 
Other investing activities
  
6
   
24
 
         
Net cash provided by investing activities
  
252
   
272
 
         
Financing activities:
      
Repayment of senior notes and loans and other long-term liabilities
  
(700
)  
(126
)
Tax withholding payments made on shares and dividends
  
   
(52
)
Other financing activities
  
   
(11
)
         
Net cash used in financing activities
  
(700
)  
(189
)
         
Translation adjustment on cash and cash equivalents
  
(28
  
(4
)
         
Net change in cash and cash equivalents
  
(171
)  
191
 
Balance of cash and cash equivalents at beginning of period
  
1,975
   
1,782
 
         
Balance of cash and cash equivalents at end of period
 
$
1,804
 
 
$
1,973
 
         
Non-cash
financing and investing activities:
      
Beneficial interest obtained in exchange for securitized accounts receivables
 
$
375
 
 
$
396
 
 
 
 
 
 
 
 
 
 
Amounts may not add up due to rounding
The accompanying notes are an integral part of the financial statements.
10
9


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Note 1 – Basis of presentation:
a. 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 Form
10-Q
should be read in conjunction with the consolidated financial statements and accompanying notes included in the Company’s Form
10-K
for the year ended December 31, 2018,2019, as filed with the Securities and Exchange Commission (“SEC”). Amounts as of December 31, 20182019 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.
In the process of preparing the consolidated financial statements, management makes estimates, judgments and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses and related disclosure of contingent assets and liabilities. The inputs into Teva’s judgments and estimates also consider the economic implications of COVID-19 on its critical and significant accounting estimates, most significantly in relation to sales, reserves and allowances, IPR&D assets, marketed product rights and goodwill, all of which will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain or treat it, as well as the economic impact on customers and markets. All estimates made by Teva related to the impact of COVID-19 within its financial statements may change in future periods. Actual results could differ from those estimates.
Certain comparative figures have been reclassified to conform to current presentation. The results of operations for the
nine
three months ended
September
 30, 2019 March 31, 2020 are not necessarily indicative of results that could be expected for the entire fiscal year. Certain amounts in the consolidated financial statements and associated notes may not add up due to rounding. All percentages have been calculated using unrounded amounts.
Note 2 –b. Significant accounting policies:policies
Recently adopted accounting pronouncements
In June 2018,March 2020, the FASB issued ASU
2018-072020-04
Improvement to Nonemployee Share-Based Payments Accounting.”Reference Rate Reform (Topic 848)—Facilitation of the Effects of Reference Rate Reform on Financial Reporting”. This guidance simplifies theprovides optional expedients and exceptions for applying generally accepted accounting for
non-employee
share-based payment transactions.principles to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The amendments specifyguidance applies only to contracts, hedging relationships, and other transactions that ASC 718 applies to all share-based payment transactions in which a grantor acquires goodsreference LIBOR or servicesanother reference rate expected to be used or consumed in a grantor’s own operations by issuing share-based payment awards. Teva adopted the provisionsdiscontinued because of this updatereference rate reform. This guidance is effective for all entities as of January 1, 2019 withMarch 12, 2020 through December 31, 2022. There was no material impact to the Company’s consolidated financial statements for the quarter ended March 31, 2020 as a result of adopting this standard update. The Company will continue to evaluate this guidance to determine the impact it may have in the future on its consolidated financial statements.
In August 2017, the FASB issued ASU
2017-12
“Derivatives and Hedging—Targeted Improvements to Accounting for Hedging Activities.” This guidance expands and refines hedge accounting for both
non-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. Teva adopted the provisions of this update as of January 1, 2019 with no material impact on its consolidated financial statements.
In February 2016, the FASB issued ASU
2016-02
“Leases.” The guidance establishes a
right-of-use
model (“ROU”) that requires a lessee to recognize a ROU asset and lease liability on the balance sheet for all leases with a term longer than 12 months. Leases are classified as finance or operating, with classification affecting the pattern and classification of expense recognition in the income statement. The guidance became effective on January 1, 2019. A modified retrospective transition approach is required, applying the new standard to all leases existing at the date of initial application.
Teva adopted the new accounting standard ASC 842 “Leases” and all the related amendments on January 1, 2019 and used the effective date as Teva’s date of initial application. Consequently, financial information was not updated and the disclosures required under the new standard are not provided for dates and periods before January 1, 2019.
The new standard provides a number of optional practical expedients in transition. Teva did not elect the ‘package of practical expedients’, which permits the Company not to reassess its prior conclusions regarding lease identification, lease classification and initial direct costs under the new standard. However, the Company did elect the practical expedient pertaining to the
use-of
hindsight.
The new standard also provides practical expedients for an entity’s ongoing accounting. Teva elected the short-term lease recognition exemption for all leases with a term shorter than 12 months. This means, for those leases, Teva does not recognize ROU assets or lease liabilities, including not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition. Teva also elected the practical expedient to not separate lease and
non-lease
components for all of Teva’s leases, other than leases of real estate.
Additionally, following the adoption of the new Lease Standard and in subsequent measurements, Teva applies the portfolio approach to account for the operating lease ROU assets and liabilities for certain car leases and incremental borrowing rates.
The adoption of this standard has a material effect on Teva’s financial statements. The most significant impact is reflected in: (i) 
effective as of January 1, 2019,
the recognition of approximately $553 million ROU assets and $561 million lease liabilities on Teva’s balance sheet for its operating leases of real estate, vehicles and equipment (the difference between the additional lease assets and lease liabilities did not have material impact on the retained earnings), and (ii) the requirement to provide significant new disclosures regarding Teva’s leasing activities and to enable users of financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. However, the adoption of this standard does not have a material impact on Teva’s consolidated statements of income and consolidated statements of cash flows. Also, the Company’s accounting for finance leases remained substantially unchanged. See note 20 for further discussion.
1
1

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Recently issued accounting pronouncements, not yet adopted
In April 2019, the FASB issued ASU
2019-04
“Codification Improvements to Financial Instruments—Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Financial Instruments (Topic 825).” This ASU provides clarifications forof three topics related to financial instruments accounting. The guidance will be effective for fiscal years beginning after December 15, 2019. The Company is currently evaluatingTeva adopted the provisions of this guidance to determine theupdate as of January 1, 2020 with no material impact it may have on its consolidated financial statements.
In November 2018, the FASB issued ASU
2018-18
“Collaborative Arrangements (Topic 808)—Clarifying the interaction between Topic 808 and Topic 606.” The amendments provide guidance on whether certain transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606. It also specifically (i) addresses when the participant should be considered a customer in the context of a unit of account, (ii) adds
unit-of-account
guidance in ASC 808 to align with guidance in ASC 606 and (iii) precludes presenting revenue from a collaborative arrangement together with revenue recognized under ASC 606 if the collaborative arrangement participant is not a customer. The guidance will be effective for fiscal years beginning after December 15, 2019. Early adoption is permitted and should be applied retrospectively. The Company is currently evaluatingTeva adopted the provisions of this guidance to determine theupdate as of January 1, 2020 with no material impact it may have on its consolidated financial statements.
In August 2018, the FASB issued ASU
2018-15
“Intangibles—Goodwill and
other—Internal-use
software (Subtopic
350-40):
Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract.” This guidance aligns the 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 obtain
internal-use
software. TheTeva applied the guidance will be effective for fiscal years beginningprospectively to all implementation costs incurred after December 15, 2019, although early adoption is permitted. The Company is currently evaluatingthe date of adoption. Teva adopted the provisions of this guidance to determine theupdate as of January 1, 2020 with no material impact it may have on its consolidated financial statements.
In August 2018, the FASB issued ASU
2018-13
“Fair Value Measurement (Topic 820)—Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement.” This guidance 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
10

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
period included in other comprehensive income 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 must 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 evaluatingTeva adopted the provisions of this guidance to determine theupdate as of January 1, 2020 with no material impact it may have on its consolidated financial statements.
In June 2016, the FASB issued ASU
2016-13
“Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This 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 forTeva adopted the fiscal year beginning onprovisions of this update as of January 1, 2020 including interim periods within that year. Teva is currently evaluating the potential effect of the guidancewith no impact on its consolidated financial statements.
Reclassifications of prior periodsRecently issued accounting pronouncement, not yet adopted
DuringIn December 2019, the fourth quarterFASB issued ASU
2019-12
“Income Taxes (Topic 740)—Simplifying the Accounting for Income Taxes” (“the Update”). The amendments in this Update simplify the accounting for income taxes by removing the following exceptions in ASC 740: (1) exception to the incremental approach for intra-period tax allocation when there is a loss from continuing operations and income or a gain from other items; (2) exception to the requirement to recognize a deferred tax liability for equity method investments when a foreign subsidiary becomes an equity method investment; (3) exception to the ability not to recognize a deferred tax liability for a foreign subsidiary when a foreign equity method investment becomes a subsidiary; and (4) exception to the general methodology for calculating income taxes in an interim period when a
year-to-date
loss exceeds the anticipated loss for the year.
In addition, the Update also simplifies the accounting for income taxes in certain topics as follows: (1) requiring that an entity recognize a franchise tax (or similar tax) that is partially based on income as an income-based tax and account for any incremental amount incurred as a
non-income-based
tax; (2) requiring that an entity evaluate when a step up in the tax basis of goodwill should be considered part of the business combination in which the book goodwill was originally recognized and when it should be considered a separate transaction; (3) specifying that an entity can elect (rather than be required to) allocate the consolidated amount of current and deferred tax expense to a legal entity that is not subject to tax in its separate financial statements; and (4) requiring that an entity reflect the effect of an enacted change in tax laws or rates in the annual effective tax rate computation in the interim period that includes the enactment date. The amendments in this Update are effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2020. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.
c. Revision of Previously Reported Consolidated Financial Statements
In connection with the preparation of Teva’s consolidated financial statements for the fiscal year ended December 31, 2019, Teva determined that in the full years and interim periods of fiscal years 2017 and 2018, and the Company changed its accounting policy forfirst three quarters of fiscal year 2019, it had an immaterial error in the presentation of royalty paymentsdistribution revenues from its Israeli distribution business. This business is part of the International Markets reporting segment and facilitates distribution of Teva and third party products to third partiespharmacies, hospitals and other organizations in Israel.
Specifically, the Company concluded that areit presented revenues from its Israeli distribution business on a gross basis, although it should have reported such revenues on a net basis. Because Teva has no discretion in establishing prices for any specified goods or services, limited inventory risk and is not involvedprimarily responsible for contract fulfillment, Teva does not meet the criteria for reporting revenues from such business as a principal (on a gross basis), as opposed to as an agent (on a net basis).
The Company evaluated the cumulative impact of this item on its previously issued annual financial statements for 2017 and 2018, and the interim financial statements for 2017, 2018 and the first three quarters of 2019, and concluded that, for the reasons mentioned below, the revisions were not material, individually or in the productionaggregate, to any of products.its previously-issued interim or annual financial statements. Teva previously accounted for royalty payments to such third parties as S&M expenses. Royalties paid to a party that is involvedhas revised its presentation of net revenue and cost of sales in the production process are classified as cost of sales. The Company believes thishistorical consolidated financial statements to reflect the change in accounting policythis item, as described in more detail below.
The impact of this revision is preferablea decrease in order to be alignednet revenues with industry practice of classifying all royalty payments related to currently marketed productsan offsetting decrease in cost of sales. The Company now reports all royalty payments as costThere is no impact on gross profit, operating income or earnings per share. In addition, there is no impact on Teva’s balance sheet or statement of sales. The Company has retrospectively adjusted prior periods to reflect this change and the impact of the changecash flows for the first
,
second
and thir
quarters of 2018 was an increase in cost of sales of $33 million
,
$28 million
 a
nd $
44
 million
, respectively, with a corresponding decrease in S&M expenses.
NOTE 3 – Certain transactions:
related periods.
Business acquisitions:
Actavis Generics and Anda acquisitions
11
On August 2, 2016, Teva completed the 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 completed the acquisition of Anda Inc. (“Anda”), a medicines distribution business in the United States, from Allergan, for cash consideration of $500 million. This transaction was 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. On January 31, 2018, Teva and Allergan entered into a settlement agreement and mutual releases for which Allergan made a
one-time
payment of $703 million to Teva to settle the working capital adjustments under the Master Purchase Agreement, dated July 26, 2015. As the measurement period has ended, this amount was recorded as a gain under legal settlements and loss contingencies in the first quarter of 2018.
1
2

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Rimsa
On March 3, 2016, Teva completedThe following table summarizes 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 closingimpact of the acquisition, Teva identified issues concerning Rimsa’s
pre-acquisition
quality, manufacturing and other practices, at which point Teva began an assessment of the extentrevision on net revenues and cost of remediation required to return its products to the market. In September 2016, 2 lawsuits were filed: a
pre-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 with respect to Teva’s breach of contract claim, pursuant to which the Rimsa sellers made a
one-time
payment to Teva. Teva’s breach of contract claim was subsequently dismissed by the court. As the measurement period has ended, this payment was recorded as a gain under legal settlements and loss contingenciessales in the first quarterconsolidated statement of 2018.
income for the relevant period:
 
 
 
Net revenues
  
Cost of sales
 
 
 
 
As reported
 
 
Adjustment
 
 
As revised
 
 
As reported
 
 
Adjustment
 
 
As revised
 
 
 
 
(U.S. $ in millions)
 
2019
  
Q1
   
4,295
   
(146
)  
4,149
   
2,440
   
(146
)  
2,293
 
Assets and liabilities held for sale:NOTE 2 – Certain transactions:
The table below summarizes the major classes of assets and liabilities included as held for sale as of September 30, 2019 and December 31, 2018:
         
 
September 30, 
2019
 
 
 
 
 
 
 
 
 
 
December 31, 
2018
 
 
(U.S. $ in millions)
 
Property, plant and equipment, net
  
24
   
92
 
Goodwill
  
—   
   
51
 
Adjustments of assets held for sale to fair value
  
(6
)  
(51
)
         
Total assets of the disposal group classified as held for
sale in the consolidated balance sheets
 $
18
  $
92
 
         
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 belo
w
.
below.
Eli Lilly and Alder BioPharmaceuticals
In December 2018, Teva entered into an agreement with Eli Lilly, resolving the European Patent Office opposition they had filed against Teva’s AJOVY
®
patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.
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 a
non-exclusive
license to Teva’s anti-CGRP antibodies patent portfolio to develop, manufacture and commercialize eptinezumab in the United States and worldwide, excluding Japan and Korea. Teva received a $25 
million upfront payment that was recognized as revenue during the first quarter of 2018.2018, and a
$25 
million milestone payment in March 2020 that was recognized as revenue in the first quarter of 2020. The agreement stipulates additional milestone payments to Teva of up to $175$150 million, as well as future royalties.
1
3

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
PGT Healthcare Partnership
In July 2018, Teva terminated its joint venture with the Procter & Gamble Company (“P&G”), PGT Healthcare partnership (“PGT”), which the two companies established in 2011 to market
over-the-counter
(“OTC”) OTC medicines. Teva will continue to maintain its OTC business on an independent basis.
As part of the separation, Teva transferred to P&G the shares it held in New Chapter Inc. and ownership rights in an OTC plant located in India. Teva provides certain services to P&G after the separation for a transition period.
During the first quarter of 2018, Teva classified the plant in India as an asset held for sale and recorded an impairment of $64 million under other assets impairments, restructuring and other items. In addition, Teva recorded a write-down of $94 million of its investment in New Chapter Inc. under share in 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 under the dissolution agreement.
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 manageThere are no further plans in this indication following clinical development, driving all operational aspectstrial results received in February 2020, which failed to meet their primary endpoints.
12

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to U.S. Food and Drug Administration (“FDA”) approval of AUSTEDO for the treatment of Tourette syndrome, Teva will pay Nuvelution aConsolidated Financial Statements
pre-agreed
(Unaudited)
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 AJOVY 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 AJOVY sales in Japan.
Attenukine
TM
Results for these trials were received in January 2020 indicating that primary and secondary endpoints were achieved and that no clinically significant adverse events were observed in subjects.
In December 2016, Teva entered into a license agreement for research, development, manufacture and commercializing of Attenukine technology 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.
Celltrion
In October 2016, Teva and Celltrion, Inc. (“Celltrion”) entered into a collaborative agreement to commercialize
TRUXIMA
®
and
HERZUMA
®
, two 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.creditable. Teva and Celltrion will share the profit from the commercialization of these products. These two products, TRUXIMA and HERZUMA, were approved by the FDA in November and December 2018, respectively and were launched in the United States in November 2019 and March 2020, respectively.
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 
$1 
billion. Teva made an upfront payment of $250 
$250 
million to Regeneron in the third quarter of 2016 as part of the agreement. MilestoneThe agreement stipulates additional development milestone payments of $25 million, $35 million and $60 million were paid in the second quarter of 2017, the first quarter of 2018 and the fourth quarter of 2018, respectively.
1
4
to Regeneron, as well as future royalties.
13

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 3 – Revenue from contracts with customers:
Disaggregation of revenue
The following table disaggregates Teva’s revenues by major revenue streams. For additional information on disaggregation of revenues, see note 15.
                     
 
Three months ended March 31, 2020
 
 
North
America
  
Europe
  
International
Markets
  
Other
 
activities
  
Total
 
 
(U.S. $ in millions)
 
Sale of goods
  
1,625
   
1,370
   
482
   
177
   
3,655
 
Licensing arrangements
  
25
   
12
   
3
   
1
   
41
 
Distribution
  
426
   
2
   
6
   
   
434
 
Other
  6   
19
   
74
   
129
   
227
 
                     
 $
2,082
  $
1,402
  $
565
  $
307
  $
4,357
 
                     
 
 
Three months ended March 31, 2019
 
 
North
America
  
Europe
  
International
Markets
  
Other
 
activities
  
Total
 
 
(U.S. $ in millions)
 
Sale of g
oods
  
1,637
   
1,259
   
468
   
187
   
3,551
 
Licensing arrangements
  
31
   
5
  §    
1
   
37
 
Distribution
  
379
  §    
5
   
—  
   
383
 
Other
  
  §    
48
   
128
   
176
 
                     
 $
2,047
  $
1,264
  $
521
  $
317
  $
4,149
 
                     
§Represents an amount less than $1 million.
The financial data presented in the tables above with respect to prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c.
Variable consideration
Variable consideration mainly includes sales reserves and allowances (“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 accounts receivables.
The Company recognizes these provisions at the time of sale and adjusts them if the actual amounts differ from the estimated provisions.
14

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
SR&A to U.S. customers comprised approximately 82% of the Company’s total SR&A as of March 31, 2020,
with the remaining balance primarily in Canada and Germany. The changes in SR&A for third-party sales for the three months ended March 31, 2020 and 2019 were as follows:
                                 
 
Sales Reserves and Allowances
   
 
Reserves
included in
Accounts
Receivable, net
  
Rebates
  
Medicaid and
other
governmental
allowances
  
Chargebacks
  
Returns
  
Other
  
Total reserves
included in SR&A
  
Total
 
 
(U.S. $ in millions)
 
Balance at December 31, 2019
 $
87
  $
2,895
  $
1,109
  $
1,342
  $
637
  $
176
  $
6,159
  $
6,246
 
Provisions related to sales made in current year period
  
102
   
1,370
   
233
   
2,223
   
139
   
33
   
3,998
   
4,100
 
Provisions related to sales made in prior periods
  
—  
   (106)  (29)  (16)  (1)  
4
   (148)  (148)
Credits and payments
  (106)  (1,513)  (248)  (2,396)  (112)  (35)  (4,304)  (4,410)
Translation differences
  
—  
   (21)  (2)  (6)  (4)  (10)  (43)  (43)
                                 
Balance at March 31, 2020
 $
83
   
2,625
  $
1,063
  $
1,147
  $
659
  $
168
  $
5,662
  $
5,745
 
                                 
                                 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Reserves
included in
Accounts
Receivable, net
  
Rebates
  
Medicaid and
other
governmental
allowances
  
Chargebacks
  
Returns
  
Other
  
Total reserves
included in SR&A
  
Total
 
 
(U.S.$ in millions)
 
Balance at December 31, 2018
 $
175
  $
3,006
  $
1,361
  $
1,530
  $
638
  $
176
  $
6,711
  $
6,886
 
Provisions related to sales made in current year period
  
112
   
1,350
   
324
   
2,320
   
72
   
114
   
4,180
   
4,292
 
Provisions related to sales made in prior periods
  
   
   
1
   
(5
)  
3
   
(1
)  
(2
)  
(2
)
Credits and payments
  
(125
)  
(1,613
)  
(438
)  
(2,413
)  
(117
)  
(101
)  
(4,682
)  
(4,807
)
Translation differences
  
   
(6
)  
(1
)  
   
   
   
(7
)  
(7
)
                                 
Balance at March 31, 2019
 $
162
   
2,737
  $
1,247
  $
1,432
  $
596
  $
188
  $
6,200
  $
6,362
 
                                 
Allowance for credit losses
Accounts receivable are recognized net of allowance for credit losses. Allowances for credit losses were $127 million and $135 million as of March 31, 2020 and December 31, 2019, respectively. The decrease is mainly due to currency fluctuations.
15

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 4 – Inventories:
Inventories, net of reserves, consisted of the following:
    
 
September 30,
  
December 31,
  
March 31,
  
December 31,
 
 
2019
  
2018
  
2020
  
2019
 
 
(U.S. $ in millions)
  
(U.S. $ in millions)
 
Finished products
 $
2,517
  $
2,665
  $
2,193
  $
2,504
 
Raw and packaging materials
  
1,338
   
1,328
   
1,306
   
1,183
 
Products in process
  
621
   
590
   
650
   
583
 
Materials in transit and payments on account
  
160
   
148
   
141
   
151
 
              
Total
 $
4,636
  $
4,731
  $
4,290
  $
4,422
 
              
NOTE 5 – Property, plant and equipment:
Property, plant and equipment, net, consisted of the following:
 
September 30,
  
December 31,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
Machinery and equipment
 $
5,678
  $
5,691
 
Buildings
  
3,037
   
3,143
 
Computer equipment and other assets
  
2,120
   
2,097
 
Payments on account
  
616
   
514
 
Land
  
364
   
351
 
         
  
11,816
   
11,796
 
Less—accumulated depreciation
  
(5,172
)  
(4,928
)
         
Total
 $
6,643
  $
6,868
 
         
NOTE 6 – Identifiable intangible assets:
Identifiable intangible assets consisted of the following:
            
 
Gross carrying amount
net of
 
impairment
  
Accumulated amortization
  
Net carrying amount
  
Gross carrying amount net of
impairment
 
Accumulated amortization
 
Net carrying amount
 
 
September 30,
  
December 31,
  
September 30,
  
December 31,
  
September 30,
  
December 31,
  
March 31,
  
December 31,
  
March 31,
  
December 31,
  
March 31,
  
December 31,
 
 
2019
  
2018
  
2019
  
2018
  
2019
  
2018
  
2020
  
2019
  
2020
  
2019
  
2020
  
2019
 
 
(U.S. $ in millions)
  
(U.S. $ in millions)
 
Product rights
 $
19,698
  $
20,361
  $
10,182
  $
9,565
  $
9,516
  $
10,796
  $
19,371
  $
19,663
  $
10,969
  $
10,640
  $
8,402
  $
9,023
 
Trade names
  
596
   
606
   
117
   
91
   
479
   
515
   
595
   
600
   
135
   
126
   
460
   
474
 
In process research and development
  
1,883
   
2,694
   
  
   
—  
   
1,883
   
2,694
   
1,394
   
1,735
   
   
—  
   
1,394
   
1,735
 
                                          
Total
 
$
22,177
 
 
$
23,661
 
 
$
10,299
 
 
$
9,656
 
 
$
11,878
 
 
$
14,005
 
 $
21,361
  $
21,998
  $
11,104
  $
10,766
  $
10,256
  $
11,232
 
                                          
Product rights and trade names
Product rights and trade names are assets presented at amortized cost. Product rights and trade names represent a portfolio of pharmaceutical products from various therapeutic categories from various acquisitions with a weighted average life of approximately 12 years.
12
years. Amortization of intangible assets amounted to $255
$258 million and $297 $283 
million in the three months ended September 30,March 31, 2020 and 2019, and 2018, respectively.
Amortization of intangible assets amounted to $823 million and $909 million in the
nine
months ended September 30, 2019 and 2018, respectively.
IPR&D
Teva’s IPR&D are assets that have not yet been approved in major markets. Teva’s IPR&D is comprised mainly of the following acquisitions and related assets: various generic products (Actavis Generics) – $1,626 million; various generic products (Rimsa) – $46 million; and AUSTEDO – $211 from the Actavis Generics acquisition for
$1,333 
million. IPR&D carries intrinsic risks that the asset might not succeed in advanced phases and may be impaired in future periods.
In the three months ended September 30, 2019, Teva reclassified $15 million of products from IPR&D to product rights following regulatory approval.
In the first
nine
 months of 2019, Teva reclassified $271 million of products from IPR&D to product rights following regulatory approval, mainly $174 million in connection with methylphenidate ER.
1
5

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Intangible assets impairmentimpairments
Impairments of long-lived intangible assets forin the first three months ended September 30,of
2020 and 2019 and 2018 were $177
$649 million and $519 $469 
million, respectively.
Impairments in the
third
first quarter of 20192020 consisted of:
o
f:
a)
(a)
Identifiable product rightsIPR&D assets of $99$331 million, mainlyprimarily due to: (i) $211 million related to AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States; and (ii) $106 million related to generic pipeline products acquired from Actavis Generics due to
s
upply ch
a
ll
e
nges 
development progress and changes in connection with products 
primarily marketedother key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date) in
Hong Kong
.
the United States; and
 
 
 
 
 
 
 
b)
(b)
Identifiable product rights of $318 million, mainly due to: (i) $165 million in Japan in connection with ongoing regulatory pricing reductions and generic competition; and (ii) $138 million due to updated market assumptions regarding price and volume of certain generic products primarily marketed in the United States.
Impairments in the first quarter of 2019 consisted of:
(a)
IPR&D assets of $78$265 million, mainly
due to: (i) $125 million related
to lenalidomide (generic equivalent of Revlimid
®
) due to modified competition assumptions as a result of settlements between the innovator and other generic pipelinefilers and (ii) $140 million of other generic products acquired from Actavis Generics due to development progress and changes in other key valuation indications (e.g., market size competition assumptions, legal landscape, launch date or discount rate) in the United States.
; and
 
 
 
 
 
 
Impairments
16

Table of long-lived intangible assets for themonths ended September 30, 2019 and 2018 were $1,206 million and $1,246 million, respectively. Impairments in the first
nine
months of 2019 consisted of:
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
a)
(b)
Identifiable product rights of $667$204 million, mainly due to updated market assumptions regarding price and volume of products acquired from Actavis Generics and primarily marketed in the United States.
 
 
 
17

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
b)
IPR&D assets of $539 million, mainly
related
to: (i) $355 million of
various 
generic pipeline products acquired from Actavis Generics due to development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date or discount rate) in the United States
,
(ii) $125 million related to lenalidomide (generic equivalent of R
evlimid
®
) due to modified competition assumptions as a result of settlements between the innovator and other generic filers and (iii) $59 million related to a change in assumption
s
concer
n
ing
the future market share of
a number of 
products within Teva’s Actavis Generics pipeline in Europe.
NOTE 76 – Goodwill:
The changes in the carrying amount of goodwill for the period ended September 30, 2019March 31, 2020 were as follows:
                     
 
North
America
   
Europe
   
International
Markets
   
Other
   
Total
 
 
(U.S. $ in millions)
   
Balance as of January 1, 2019 (1)
 $
11,098
  $
8,653
  $
2,479
  $
2,687
  $
24,917
 
Changes during the period:
               
Goodwill disposal
  
(23
)  
(5
)  
   
   
(28
)
Translation differences
  
11
   
(300
)  
57
   
   
(232
)
                     
Balance as of September 30, 2019 (1)
 $
11,086
  $
8,348
  $
2,536
  $
2,687
  $
24,657
 
                     
                     
 
North
 
America
  
Europe
  
International
Markets
  
Other
  
Total
 
 
(U.S. $ in millions)
   
Balance as of
December
 
3
1,
2019
 $
11,091
  $
8,536
  $
2,532
  $
2,687
  $
24,846
 
Changes during the period:
               
Translation differences
  
(31
  
(143
)  
(182
  
   
(357
)
                     
Balance as of March 31, 2020 
 $
11,060
  $
8,393
  $
2,350
  $
2,687
  $
24,490
 
                     
 
 
 
 
 
 
(1)Accumulated goodwill impairment as of September 30, 2019 and January 1, 2019 was approximately $
21.0
 billion.
Teva operates its business through three
 reporting
segments: North America, Europe and International Markets. Teva beganEach of these business segments is a reporting its financial results under this structure in the first quarter of 2018. In addition to these three segments, Teva has other sources of revenues, primarily theunit. Additional reporting units include Teva’s production and sale of APIs to third parties certain contract manufacturing services(“Teva API”) and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis. The Teva API and Medis reporting units are included under “Other” in the above table. See note 17.15 for additional segment information.
Teva determines the fair value of its reporting units using the income approach. The income approach is a forward-looking approach for estimating fair value. Within the income approach, the method used is the discounted cash flow method. Teva starts 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 applies 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,weighted average cost of capital (“WACC”), adjusted for the relevant risk associated with country-specific and business-specific characteristics. If any of these expectations were to vary materially from Teva’s assumptions, Teva could facemay record an impairment of goodwill allocated to these reporting units in the future.
First Quarter Developments
During the first quarter of 2019,2020, management assessed developments that occurred during the quarter to determine if it was more likely than not that the fair value of any of its reporting units was below its carrying amount. This includes the International Markets, Medis and Europe reporting units, which had headroom
of 6%
or less as of December 31, 2018. As part of this assessment, the Companymanagement also considered the sensitivity of its conclusions as they relate to changes in the estimates and assumptions used in the latest forecast available for each period. In addition,
Teva analyzed the aggregate fair valueevaluated qualitative factors, including expected effects of
COVID-19
on its reporting units, calculated as partbusiness. The impact of the annual goodwill impairment test performed in
COVID-19
pandemic on Teva’s business has been evaluated and it is not expected to significantly alter the fourth quarter of 2018, compared to its market capitalization. Despite the decrease in share price during the first quarter of 2019 compared to the average share price used to assess the reasonableness of the results of the cash flow projections used for the goodwill impairment analysis in the fourth quarter of 2018, management believed that its fair value assessment was reasonably supported by Teva’s market capitalization.Company’s business model at this time. Based on this assessment, management has concluded that it wasis not more likely than not that the fair value of any of the reporting units wasis below its carrying value as of March 31, 20192020 and, therefore, no quantitative assessmentsassessment was performed. If circumstances were performed
.
16

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Inchange from Teva’s expectations about the second quarterduration or impact of 2019, 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
COVID-19,
one or more likely than not that the carrying value of certain reportingbusiness units may exceed their fair value. The following analysis was performed based upon the June 30, 2019 assessment:
International Markets
Management noted a further decrease in the profitability projections in the Japanese market related to new price regulation and further generic competition. Consequently, management conducted a quantitative analysis to its International Markets reporting unit,could be impacted, which resulted in no impairment.
The percentage difference between estimated fair value and estimated carrying value for the International Markets reporting unit is 4%.
The Company used a terminal growth rate of 2.3% and a discount rate of 10.74%. If Teva holds all other assumptions constant, a reduction in the terminal value growth rate of 0.4% or an increase in discount rate of 0.3% wouldmay result in an impairment related to its International Markets reporting unit.impairment.
North America
Management believes that the sharp decline in the Company’s share price, which commenced May 2019, was mainly a result of events related to increased publicity surrounding certain litigations in the United States. Management considered the sharp decline in share price as an indication that it was more likely than not that the carrying value of its North America reporting unit exceeded its fair value.
Consequently, management conducted a quantitative analysis to its North America reporting unit, which resulted in no impairment.
The percentage difference between estimated fair value and estimated carrying value for the North America reporting unit is 9%.
The Company used a terminal growth rate of 2.0% and a discount rate of 10.0%. If Teva holds all other assumptions constant, a reduction in the terminal value growth rate of 0.9% or an increase in discount rate of 0.6% would result in an impairment related to its North America reporting unit.
Remaining reporting units
After assessing the totality of relevant events and circumstances, Teva determined that it is not more likely than not that the fair value of its remaining reporting units is less than their carrying amount.
The percentage difference between estimated fair value and estimated carrying value for the Europe, Medis and TAPI reporting units is 22%, 45% and 15%, respectively.
Market Capitalization
Teva analyzed the aggregate fair value of its reporting units, calculated as part of the annual goodwill impairment test performed in the fourth quarter of 2019, compared to its market capitalization in order to assess the reasonableness of the results of its cash flow projections used for its goodwill impairment analysis.capitalization.
During the second quarter of
At December 31, 2019, Teva noted itsTeva’s market capitalization was significantly below management’s assessment of the aggregate fair value of itsthe Company’s reporting units. Management analyzed the difference and the underlying factors
Based on research analysts’ reports reviewed by management and responses from certain analysts to Teva’s inquiries, management noted a gap in the sales projections of AJOVY in the Europe and International Markets reporting units. Management concluded that the majority of analysts do not focus on these markets in preparing their financial models and,viewed this as a result, have nottemporary situation mainly attributed value to the launch potential in these reporting units. Management believes that its fair value assessment relies on more accurate information and therefore no adjustment was incorporated to the fair value.
Management also noted a difference with regard to sales projections of AUSTEDO in North America resulting in higher fair value as analyzedan acute reaction by management compared to Teva’s market capitalization. Management believes that it has more accurate information based on its knowledge of the market and its growth through the remainder of 2019 and therefore no adjustment was incorporatedprimarily related to the fair value.
Management believes that the remaining difference in fair value is attributable to market concerns regarding certain litigation risks, namely from the opioid and price fixing litigations, and concern surroundinglitigation risks. Management continues to believe market concerns regarding the Company’s cash flow and overall liquidity. Management believes thatuncertainty of these concerns led to an acute reaction, which resulted in further declinematters are impacting its market capitalization. However, developments in the share price. Although ultimately the outcome of the relevant cases will not be known in the near term, developments in these cases, likely to occur through the end of 2019,case are expected to clarify the outlook with regards to the opioid litigation, which mayassuming the proposed settlement framework is finalized in 2020.
During 2020, Teva experienced additional volatility in its share price resulting from the impact of the
COVID-19
pandemic on equity markets and the global economy. Management believes the current market reaction is based upon the lack of information regarding the impact the pandemic might have on Teva’s business and the entire economy. The economic uncertainties in the market related to the
COVID-19
pandemic, along with the uncertainties related to Teva’s litigations, result in a share price recovery. Consequently, management believes that this disparity results from asimilar gap between book value and market value not reflectiveat the date of this filing as compared to the gap that existed at December 31, 2019. Further, as of the underlyingdate of this filing, the Company’s market capitalization plus a reasonable control premium exceeds its book value. Based on management’s assessment of the developments in the first quarter of 2020 and considering the Company’s current market capitalization as comparable to that of December 31, 2019, management concluded that the estimated fair value of its reporting units and therefore it would be inappropriate to record an impairment charge in the second quarter of 2019 related thereto.
17

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
During the third quarter of 2019, management assessed developments during the quarter to determine if it was more likely than not that the fair value of any of the Company’s reporting units was belowexceeds its carrying amount. As part of this assessment, the Company also considered the sensitivity of its conclusions as they relate to changes in the estimates and assumptions used in the latest forecast available for each period.
In October 2019, Teva reached a settlement with two counties in Ohio and confirmed that it had reached an agreement in principle with a group of
a
ttorneys
g
eneral for a global settlement framework in connection with the remaining opioids litigations. These events did not result in a material change in share price compared to the share price used in the market capitalization analysis performed in the second quarter of 2019. Although Teva’s fair value assessment is significantly higher than its market capitalization as of September 30, 2019, management still believes that its fair value assessment is reasonably supported.
Based on this assessment, management has concluded that it is not more likely than not that the fair value of any of the reporting units is below its carrying value as of September 30, 2019 and, therefore, no quantitative assessments were performed.
Management will continue to monitor business conditions and potential events or circumstances that could have a negative effect on the estimated fair value of the Company.
Based on assumptions in place at this time, if Teva’s share price does not recover in the near term, this may lead to a goodwill impairment charge of up to an aggregated amount of approximately $5,000 million in its North America and International Markets reporting units. Future impairment charges, if any, reflecting conditions at that time may be materially different.
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 diluted loss per share for the three months ended September 30, 2019 and 2018, no account was taken of the potential dilution of the assumed exercise of employee stock options and
non-vested
RSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
Additionally,
 in the t
hree months ended September 30, 2018,
 no account was taken of the potential dilution by the mandatory convertible preferred shares, amounting to 66 million
shares 
(including shares issued due to unpaid dividends
up to 
that date), since they had an anti-dilutive effect on loss per share
.
On December 17, 2018, the mandatory convertible preferred shares automatically converted into ADSs and all of the accumulated and unpaid dividends on the mandatory convertible preferred shares were paid in ADSs. As a result of this conversion, Teva issued
70.6
 million ADSs in December 2018.
In computing the diluted loss per share for the nine months ended September 30, 2019, no account was taken of the potential dilution by the assumed exercise of employee stock options and
non-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 nine months ended September 30, 2018 take into account the potential dilution that could occur upon the exercise of options and
non-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
68
 million
shares 
(including shares issued due to unpaid dividends
up 
to
that 
date) for the nine months ended September 30, 2018, as well as for the convertible senior debentures, since both had an anti-dilutive effect on earnings per share.
1
8

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 9 – Revenue from contracts with customers:
Disaggregation of revenue18
The following table disaggregates Teva’s revenues by major revenue streams. For additional information on disaggregation of revenues, see note 17.
                     
 
Three months ended September 30, 2019
 
 
North
 
America
  
Europe
 
 
 
 
International
Markets
  
Other
activities
  
Total
 
 
(U.S. $ in millions)
 
Sale of goods
  
1,674
   
1,153
   
511
   
176
   
3,514
 
Licensing arrangements
  
26
   
7
   
1
   
1
   
36
 
Distribution
  
351
   
1
   
176
   
—  
   
528
 
Other
  §   
2
   
48
   
136
   
186
 
                     
 $
 
 
 
 
 
 
2,051
  $
1,163
  $
736
  $
314
   
 
 
 
4,264
 
                     
§ Represents an amount less than $1 million.
                     
 
Three months ended September 30, 2018
 
 
North
 
America
  
Europe
 
 
 
 
 
International
Markets
  
Other
activities
  
Total
 
 
(U.S. $ in millions)
 
Sale of goods
  
1,902
   
1,210
   
525
   
166
   
3,803
 
Licensing arrangements
  
29
   
1
   
—  
   
2
   
32
 
Distribution
  
333
   
1
   
149
   
—  
   
483
 
Other
  
1
   
—  
   
52
   
158
   
211
 
                     
 $
 
 
 
 
 
 
2,265
  $
1,212
  $
726
  $
326
   $
 
 
4,529
 
                     
                     
 
Nine months ended September 30, 2019
 
 
North
 
America
  
Europe
 
 
 
 
International
Markets
  
Other
activities
  
Total
 
 
(U.S. $ in millions)
 
Sale of goods
  
4,997
   
3,586
   
1,505
   
566
   
10,653
 
Licensing arrangements
  
92
   
22
   
3
   
4
   
121
 
Distribution
  
1,080
   
1
   
491
   
   
1,572
 
Other
  §   
2
   
145
   
402
   
549
 
                     
 $
 
 
 
6,169
  $
3,611
  $
2,145
  $
972
   $
12,896
 
                     
§ Represents an amount less than $1 million.
 
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
 
                     
19

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Variable consideration
Variable consideration mainly includes sales reserves and allowances (“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.
SR&A to U.S. customers comprised approximately 82% of the Company’s total SR&A as of September 30, 2019, with the remaining balance primarily in Canada and Germany. The changes in SR&A for third-party sales for the nine months ended September 30, 2019 were as follows:
                                 
 
Sales Reserves and Allowances
   
 
Reserves
included in
Accounts
Receivable,
net
  
Rebates
  
Medicaid and
other
governmental
allowances
  
Chargebacks
  
Returns
  
Other
  
Total
 
reserves
included in
SR&A
  
Total
 
 
(U.S.
 
$ in millions)
 
Balance at December 31, 2018
 $
175
  $
3,006
  $
1,361
  $
1,530
  $
638
  $
176
  $
6,711
  $
6,886
 
Provisions related to sales made in current year period
  
334
   
4,004
   
760
   
7,196
   
195
   
308
   
12,463
   
12,797
 
Provisions related to sales made in prior periods
  
3
   
(28
)  
(2
  
(1
)  
23
   
(7
)  
(15
)  
(12
)
Credits and payments
  
(356
)  
(4,276
)  
(882
)  
(7,299
)  
(251
)  
(295
)  
(13,003
)  
(13,359
)
Translation differences
  
 
 
   
(14
)  
(4
)  
(1
)  
(1
)  
1
   
(19
)  
(19
)
                                 
Balance at
Septe
mber
 30, 2019
 $
156
   
2,692
  $
1,233
  $
1,425
  $
604
  $
183
  $
6,137
  $
6,293
 
                                 
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
   
 
Foreign
currency
translation
adjustments
  
Available-for-
sale securities
  
Derivative
financial
instruments
  
Actuarial
gains
 
(losses)
and
 
prior
service 
(costs)
c
redits
  
Total
 
 
(U.S. $ in millions)
 
Balance as of December 31, 2017*
 $
(1,316
) $
1
  $
(442
)
 
 
 $
(91
) $
(1,848
)
                     
Other comprehensive income (loss) before reclassifications
**
  
(562
)  
   
54
   
—  
   
(508
)
Amounts reclassified to the statements of income
  
—  
   
—  
   
21
   
2
   
23
 
                     
Net other comprehensive income (loss) before tax
  
(562
)  
—  
   
75
   
2
   
(485
)
Corresponding income tax
  
—  
   
—  
   
—  
   
(2
)  
(2
)
                     
Net other comprehensive income (loss) after tax
  
(562
)  
—  
   
75
   
—  
   
(487
)
                     
Balance as of September 30, 2018
 $
(1,878
) $
1
  $
(367
) $
(91
) $
(2,335
)
                     
*Following the adoption of ASU
2016-01,
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 to
non-controlling
interests.
20

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)
c
redits
  
Total
 
 
(U.S. $ in millions)
 
Balance as of December 31, 2018
 $
(2,055
) $
1
  $
(327
) $
(78
) $
(2,459
)
                     
Other comprehensive income (loss) before reclassifications
*
  
(28
)  
(1
)  
103
   
**
   
74
 
Amounts reclassified to the statements of income
  
—  
   
—  
   
21
   
   
21
 
                     
Net other comprehensive income (loss) before tax
  
(28
)  
(1
)  
124
   
**
   
95
 
Corresponding income tax
  
—  
   
—  
   
—  
   
**
   
**
 
                     
Net other comprehensive income (loss) after tax
  
(28
)  
(1
)  
124
   
(1
)  
94
 
                     
Balance as of September 30, 2019
 $
(2,083
) $
—  
  $
(203
) $
(79
) $
(2,365
)
                     
*
Amounts do not include a $
23
 million gain from foreign currency translation adjustments attributable to
non-controlling
interests.
**
Represents an amount less than $0.5 million.
NOTE 11 –
Debt obligations:
a. Short-term debt:
                 
 
Weighted average
 
interest rate as of

September 30, 2019
  
Maturity
  
September 30,
2019
  
December
 
31,

2018
 
     
(U.S. $ in millions)
 
Bank and financial institutions
  
   
—  
  $
—  
  $
2
 
Revolving Credit Facility
  
LIBOR+1.6
%  
 
 
   
100
   
 
 
 
Convertible debentures
  
0.25
%  
2026
   
514
   
514
 
Current maturities of long-term liabilities
  
2,516
   
1,700
 
         
Total short-term debt
 $
3,130
  $
2,216
 
         
��
2
1

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Management will continue to monitor business conditions, including the impact of
COVID-19,
and will consider future developments in Teva’s market capitalization when assessing whether additional goodwill impairment is required in future periods.
Long-term debt:
NOTE 7 – Debt obligations:
a.
                 
 
Weighted average interest
rate as of September 30,
 
2019
  
Maturity
  
September 30,
2019
  
December 31,
2018
 
     
(U.S. $ in millions)
 
Senior notes EUR 1,660 million
  
0.38%
   
2020
  $
1,816
  $
1,897
 
Senior notes EUR 1,500 million
  
1.13
%
   
2024
   
1,633
   
1,707
 
Senior notes EUR 1,300 million
  
1.25%
   
2023
   
1,416
   
1,480
 
Senior notes EUR 900 million
  
4.50%
   
2025
   
985
   
1,029
 
Senior notes EUR 750 million
  
1.63%
   
2028
   
814
   
850
 
Senior notes EUR 700 million
  
3.25%
   
2022
   
766
   
801
 
Senior notes EUR 700 million
  
1.88%
   
2027
   
764
   
798
 
Senior notes USD 3,500 million
  
3.15%
   
2026
   
3,494
   
3,493
 
Senior notes USD 3,000 million
  
2.20%
   
2021
   
2,998
   
2,997
 
Senior notes USD 3,000 million
  
2.80%
   
2023
   
2,994
   
2,993
 
Senior notes USD 1,556 million (1)
  
1.70%
   
2019
   
—  
   
1,700
 
Senior notes USD 2,000 million
  
4.10%
   
2046
   
1,985
   
1,985
 
Senior notes USD 1,250 million
  
6.00%
   
2024
   
1,250
   
1,250
 
Senior notes USD 1,250 million
  
6.75%
   
2028
   
1,250
   
1,250
 
Senior notes USD 844 million
  
2.95%
   
2022
   
857
   
860
 
Senior notes USD 789 million
  
6.15%
   
2036
   
782
   
782
 
Senior notes USD 700 million
  
2.25%
   
2020
   
700
   
700
 
Senior notes USD 613 million
  
3.65%
   
2021
   
619
   
621
 
Senior notes USD 588 million
  
3.65%
   
2021
   
587
   
587
 
Senior notes CHF 350 million
  
0.50%
   
2022
   
354
   
356
 
Senior notes CHF 350 million
  
1.00%
   
2025
   
354
   
356
 
Fair value hedge accounting adjustments
  
 
      
—  
   
(9
)
Total senior notes
  
26,417
   
28,483
 
Other long-term debt
  
0.96%
   
2026
   
1
   
12
 
Less current maturities
  
(2,516
)  
(1,700
)
Derivative instruments
  
—  
   
9
 
Less debt issuance costs
  
(89
)  
(104
)
Total senior notes and loans
 $
23,812
  $
26,700
 
         
Short-term debt:
 
 
 
 
 
 
 
 
 
 
 
 
                 
   
March 31,
2020
  
December 31,
2019
 
 
Weighted average interest
rate as of March 31, 2020
  
Maturity
 
     
(U.S. $ in millions)
 
Convertible debentures
  
0.25
%  
2026
  $
514
  $
514
 
Current maturities of long-term liabilities
          
1,116
   
1,831
 
         
Total short-term debt
         $
1,630
  $
2,345
 
         
 
 
 
 
 
Convertible senior debentures
Teva’s 0.25% convertible senior debentures due 2026, with $514 million principal amount outstanding as of March 31, 2020 and December 31,2019, include a “net share settlement” feature according to which the principal amount will be paid in cash and in case of conversion, only the residual conversion value above the principal amount will be paid in Teva shares. Due to the “net share settlement” feature, exercisable at any time, these convertible senior debentures are classified in the Balance Sheet under short-term debt. Holders of the convertible debentures will be able to cause Teva to redeem the debentures on February 1, 2021.
19

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Long-term debt:
                 
 
Weighted average interest
rate as of March 31, 2020
  
Maturity
  
March 31,
 
2020
  
December 31,
2019
 
     
(U.S. $ in millions)
 
Senior notes EUR 1,010 million
  
0.38
%  
2020
  $
1,116
  $
1,131
 
Senior notes EUR 1,500 million
  
1.13
%  
2024
   
1,651
   
1,673
 
Senior notes EUR 1,300 million
  
1.25
%  
2023
   
1,432
   
1,451
 
Senior notes EUR 1,000 million
  
6.00
%  
2025
   
1,105
   
1,120
 
Senior notes EUR 900 million
  
4.50
%  
2025
   
994
   
1,008
 
Senior notes EUR 750 million
  
1.63
%  
2028
   
822
   
833
 
Senior notes EUR 700 million
  
3.25
%  
2022
   
773
   
784
 
Senior notes EUR
700 million
  
1.88
%  
2027
   
771
   
782
 
Senior notes USD 3,500 million
  
3.15
%  
2026
   
3,494
   
3,494
 
Senior notes USD 1,475 million
  
2.20
%  
2021
   
1,474
   
1,474
 
Senior notes USD 3,000 million
  
2.80
%  
2023
   
2,995
   
2,995
 
Senior notes USD 2,000 million
  
4.10
%  
2046
   
1,985
   
1,985
 
Senior notes USD 1,250 million
  
6.00
%  
2024
   
1,250
   
1,250
 
Senior notes USD 1,250 million
  
6.75
%  
2028
   
1,250
   
1,250
 
Senior notes USD 1,000 million  7.13
%
  2025   1,000   1,000 
Senior notes USD 844 million
  
2.95
%  
2022
   
855
   
856
 
Senior notes USD 789 million
  
6.15
%  
2036
   
783
   
782
 
Senior notes USD 700 million
 (1)
  
2.25
%  
2020
   
   
700
 
Senior notes USD 613 million
  
3.65
%  
2021
   
618
   
618
 
Senior notes USD 588 million
  
3.65
%  
2021
   
587
   
587
 
Senior notes CHF 350 million
  
0.50
%  
2022
   
366
   
361
 
Senior notes CHF 350 million
  
1.00
%  
2025
   
366
   
362
 
                 
Total senior notes
          
25,687
   
26,496
 
Other long-term debt
  
1.14
%  
2026
   
1
   
1
 
Less current maturities
          
(1,116
)  
(1,831
)
Less debt issuance costs
          
(98
)  
(103
)
                 
Total senior notes and loans
         $
24,473
 
 $
24,562
 
         
 
 
 
 
 
 
 
 
 
 
 
 
(1)
During the first six monthsquarter of 2019, Teva repurchased and canceled approximately $
144
 million principal amount of its $
1,700
 million
1.7
% senior notes due in July 2019. In July 2019,2020, Teva repaid at maturity
$
1,556
700 million of its
1.7
% 2.25% 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, if any.
Long-term debt as of September 30, 2019March 31, 2020 is effectively denominated (taking into consideration cross currency swap agreements) in the following currencies:
66% 
in U.S. dollar, 68%,
31%
in euro 29% and
3%
in Swiss franc 3%.franc.
Teva’s principal sources of short-term liquidity are its cash on hand, existing cash investments, liquid securities and available credit facilities, primarily its $2.3
$2.3 billion revolving credit facility (“RCF”).
In April 2019, the Company entered into a $2.3 
billion unsecured syndicated RCF. The RCF agreement provides for two separate tranches, a
$1.15 billion
t
ranche A and a $1.15 billion
t
ranche B. Loans and letters of credit will be available from time to time under each tranche for Teva’s general corporate purposes. Tranche A has a maturity date of April 8, 2022, with two
one-year
extension options, of which replaced the previous $3$1.0 billion revolving credit facility.
was
 extended to April 8, 2023. Tranche B has a maturity date of April 8, 2024.
The RCF contains certain covenants, including certain limitations on incurring liens and indebtedness and maintenance of certain financial ratios, including the requirement to maintain compliance with a net debt to EBITDA ratio, which becomes more restrictive over time. The net debt to EBITDA ratio limit is 6.25x through December 31, 2019, gradually6.0x in the first and second quarters of 2020 and declines to 5.75x in the third and fourth quarters of 2020, and continues to gradually decline over the remaining term of the RCF.
The RCF can be used for general corporate purposes, including repaying existing debt. As of September 30, 2019,
 $100 million was outstanding under the RCF. As of the date of this
quarterly​​​​​​​ 
report
on Form 10-Q
,
March 31, 2020, 0 amounts
a
re were outstanding under the RCF. Based on current and forecasted results, the Company expects that it will not exceed the financial covenant thresholds set forth in the RCF within one year from the date these financial statements are issued.
22
20

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Under specified circumstances, including
non-compliance
with any of the covenants described above and the unavailability ​​​​​​​of any waiver, amendment or other modification thereto, the Company will not be able to borrow under the RCF. Additionally, violations of the covenants, under the above-mentioned circumstances, would result in an event of default in all borrowings under the RCF and, when greater than a specified threshold amount as set forth in each series of senior notes is outstanding, could lead to an event of default under the Company’s senior notes due to cross acceleration provisions.
Teva expects that it will continue to have sufficient cash resources to support its debt service payments and all other financial obligations within one year from the date that these financial statements are issued.
NOTE 12 – Fair value measurement:
Teva’s financial instruments consist mainly of cash and cash equivalents, investment in securities, current and
non-current
receivables, short-term debt, current and
non-current
payables, contingent consideration, senior notes and loans, convertible senior debentures and derivatives.
The fair value of the financial instruments included in working capital and
non-current
receivables and payables approximates their carrying value. The fair value of loans and bank facilities 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.
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 material transfers between Level 1, Level 2 and Level 3 during the first nine months of 2019.
2
3

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Financial items carried at fair value as of September 30, 2019 and December 31, 2018 are classified in the tables below in one of the three categories described above:
 
September 30, 2019
 
 
Level 1
  
Level 2
  
Level 3
  
Total
 
 
(U.S. $ in millions)
 
Cash and cash equivalents:
            
Money markets
 $
176
  $
—  
  $
—  
  $
176
 
Cash, deposits and other
  
1,065
   
—  
   
—  
   
1,065
 
Investment in securities:
            
Equity securities
  
45
   
—  
   
—  
   
45
 
Other, mainly debt securities
  
2
   
—  
   
12
   
14
 
Derivatives:
            
Asset derivatives—options and forward contracts
  
—  
   
40
   
—  
   
40
 
Asset derivatives—cross-currency swaps
     
105
   
—  
   
105
 
Liability derivatives—options and forward contracts
  
—  
   
(18
)  
—  
   
(18
)
Contingent consideration*
  
—  
   
—  
   
(430
)  
(430
)
                 
Total
 $
1,288
  $
127
  $
(418
) $
997
 
                 
    
 
December 31, 2018
 
 
Level 1
  
Level 2
  
Level 3
  
Total
 
 
(U.S. $ in millions)
 
Cash and cash equivalents:
            
Money markets
 $
203
  $
—  
  $
—  
  $
203
 
Cash, deposits and other
  
1,579
   
—  
   
—  
   
1,579
 
Investment in securities:
            
Equity securities
  
51
   
—  
   
—  
   
51
 
Other, mainly debt securities
  
2
   
—  
   
10
   
12
 
Derivatives:
            
Asset derivatives—options and forward contracts
  
—  
   
18
   
—  
   
18
 
Asset derivatives—interest rate and cross-currency swaps
  
—  
   
58
   
—  
   
58
 
Liability derivatives—options and forward contracts
  
—  
   
(26
)  
—  
   
(26
)
Liability derivatives—interest rate and cross-currency swaps
  
—  
   
(50
)  
—  
   
(50
)
Contingent consideration*
  
—  
   
—  
   
(507
)  
(507
)
                 
Total
 $
1,835
  $
—  
  $
(497
) $
1,338
 
                 
*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 United States 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.
2
4

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
The following table summarizes the activity for those financial
a
ssets and liabilities where fair value measurements are estimated utilizing Level 3 inputs:
     
 
Nine months ended
September 30, 2019
 
 
(U.S. $ in millions)
 
Fair value at the beginning of the period
 $
(497
)
Revaluation of debt securities
  
3
 
Adjustments to provisions for contingent consideration:
   
Actavis Generics transaction
  
96
 
Eagle transaction
  
(100
)
Settlement of contingent consideration:
   
Eagle transaction
  
80
 
     
Fair value at the end of the period
 $
(418
)
     
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:
         
 
Fair value*
 
 
September 30,
  
December 31,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
Senior notes included under senior notes and loans
 $
19,097
  $
23,560
 
Senior notes and convertible senior debentures included under short-term debt
  
2,933
   
2,140
 
         
Total
 $
22,030
  $
25,700
 
         
*The fair value was based on quoted market price.
NOTE 138 – Derivative instruments and hedging activities:
a.
a. Foreign exchange risk management:
In the first ninethree months of 2019,2020, approximately 50% of Teva’s revenues were denominated in currencies other than the U.S. dollar. As a result, Teva is subject to significant foreign currency risks.
The Company enters into forward exchange contracts, purchases and writes options in order to hedge the currency exposure on balance sheet items.items, revenues and expenses. In addition, the Company takes measures to reduce exposure by using natural hedging. The Company also acts to offset risks in opposite directions among the companies within the Teva group.Teva. The currency hedged items are usually denominated in the following main currencies: the new Israeli shekel (NIS),Russian ruble, the euro, (EUR), the Swiss franc, (CHF), the Japanese yen, (JPY), the British pound, (GBP), the Canadian dollar, (CAD),the Polish zloty, (PLN), the Indian rupee (INR) and other European and Latin American currencies.
Depending on market conditions, foreign currency risk is also managed through the use of foreign currency debt.
The Company hedgeshedged against possible fluctuations in foreign subsidiariessubsidiaries’ net assets (“net investment hedge”) and enteredfrom time to time enters into cross-currency swaps and forward contracts in order to hedge such an exposure.
Most of the counterparties to the derivatives are major banks and the Company is monitoring the associated inherent credit risks. The Company does not enter into derivative transactions for trading purposes.
2
5
b. Interest risk management:

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
b.
Interest risk management:
The Company raises capital through various debt instruments, including straight notes that bear a fixed or variable interest rate, bank loans, securitizations and convertible debentures. In some cases, the Company has swapped from a fixed to a floating interest rate (“fair value hedge”) and from a fixed to a fixed interest rate with an exchange from a currency other than the functional currency (“cash flow hedge”), thereby reducing overall interest expenses or hedging risks associated with interest rate fluctuations.
c. Derivative instruments notional amounts:
Derivative instruments notional amounts
The following table summarizes the notional amounts for hedged items, when transactions are designated as hedge accounting:
         
 
September 30,
  
December 31,
 
 
2019
  
2018
 
 
(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
 
         
 $
1,588
  $
2,088
 
         
         
 
March 31,
  
December 31,
 
 
2020
  
2019
 
 
(U.S. $ in millions)
 
Cross-currency swap—net investment hedge
 $
  $
1,000
 
         
 
 
 
 
 
 
 
 
 
21

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
d.
Derivative instrument outstanding:
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
 
 
September 30,
2019
  
 
 
 
 
 
 
 
 
 
 
 
December 31,
2018
  
September 30,
2019
  
 
 
 
 
 
 
 
 
 
December 31,
2018
  
March 31,
2020
  
December 31,
2019
  
March 31,
2020
  
December 31,
2019
 
Reported under
 
(U.S. $ in millions)
  (U.S. $ in millions) 
Asset derivatives:
                        
Other current assets:
                        
Option and forward contracts
 $
—  
  $
—  
  $
40
  $
18
  $
  $
—  
  $
104
  $
32
 
Other non-current assets:
            
Cross-currency swaps
cash flow hedge
  
103
   
58
      
—  
 
Cross-currency swaps—
net investment hedge
  
2
      
   
 
Liability derivatives:
                        
Other current liabilities:
                        
Cross-currency swaps—net investment hedge
  
   
(22
)  
    
Option and forward contracts
  
—  
   
—  
   
(18
)  
(26
)  
   
—  
   
(94
)  
(41
)
Other taxes and long-term liabilities:
            
Cross-currency swaps
net investment hedge
  
   
(41
)  
—  
   
—  
 
Senior notes and loans:
            
Interest rate swaps
fair value hedge
  
—  
   
(9
)  
—  
   
—  
 
The table below provides information regarding the location and amount of
pre-tax
(gains) losses from derivatives designated in fair value or cash flow hedging relationships:
                 
  Financial expenses, net  Other comprehensive
income (loss)
 
  Three months ended,  Three months ended, 
  
March 31,
2020
  March 31,
2019
  
March 31,
2020
  March 31,
2019
 
Reported under (U.S. $ in millions) 
Line items in which effects of hedges are recorded
 $
224
  $
218
  $
(530
 $
94
 
Cross-currency swaps—cash flow hedge (1)
     (1)     (20)
Cross-currency swaps—net investment hedge (2)
  
(2
  
(7
)  
(21
 
$
(20
)
Interest rate swaps—fair value hedge (3)
  
   
1
   
   
 
                 
 
Financial expenses, net
  
Other comprehensive income
 
 
Three months ended,
  
Three months ended,
 
 
September 30,
2019
  
September 30,
2018**
  
September 30,
2019
  
September 30,
2018**
 
Reported under
 
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
 $
211
  $
229
  $
53
  $
84
 
Cross-currency swaps
cash flow hedge
(1)
  
(1
)  
(1
)  
(33
)  
(4
)
Cross-currency swaps
net investment hedge
(2)
  
(7
)  
(6
)  
(39
) $
(7
)
Interest rate swaps
fair value hedge
(3)
 $
*
  $
*
  $
—  
  $
—  
 
*Represents an amount less than $0.5 million.
**Comparative figures are based on prior hedge accounting standard.
2
6

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
                 
 
Financial expenses, net
  
Other comprehensive income
 
 
Nine months ended,
  
Nine months ended,
 
 
September
 
30,
2019
  
September
 
30,
2018**
  
September
 
30,
2019
  
September
 
30,
2018**
 
Reported under
 
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
 $
635
  $
736
  $
(117
) $
502
 
Cross-currency swaps—cash flow hedge
(1)
  
(2
)  
(1
)  
(49
)  
(18
)
Cross-currency swaps
net investment hedge
(2)
  
(22
)  
(22
)  
(46
) $
(36
)
Interest rate swaps
fair value hedge
(3)
 $
2
  $
*
  $
 
 
  $
 
 
 
*Represents an amount less than $0.5 million.
**Comparative figures are based on prior hedge accounting standard.
The table below provides information regarding the location and amount of
pre-tax
(gains) losses from derivatives not designated as hedging instruments:
                 
 
Financial expenses, net
  
Net revenues
 
 
Three months ended,
  
Three months ended,
 
 
September
 
30,
2019
  
September
 
30,
2018
  
September
 
30,
2019
  
September 30,
2018
 
Reported under
 
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
  
211
   
229
   
(4,264
)  
(4,529
)
Option and forward contracts
(4)
 $
(35
) $
(6
) $
 
 
  $
 
 
 
Option and forward contracts Economic hedge
(5)
  
—  
   
 
 
   
(4
)  
1
 
       
 
Financial expenses, net
  
Net revenues
 
 
Nine months ended,
  
Nine months ended,
 
 
September 30,
2019
  
September 30,
2018
  
September 30,
2019
  
September
 
30,
2018
 
Reported under
 
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
  
635
   
736
   
(12,896
)  
(14,295
)
Option and forward contracts
(4)
 $
(42
) $
(11
) $
 
 
  $
 
 
 
Option and forward contracts Economic hedge
(5)
  
—  
   
   
*
   
*
 
 
 
Financial expenses, net
  
Net revenues
 
 
Three months ended,
  
Three months ended,
 
 
March 31,
2020
  
March 31,
2019
  
March 31,
2020
  
March 31,
2019
 
Reported under
 
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
 $
224
  $
218
  
(4,357
 
(4,149
)
Option and forward contracts (4)
  
24
   
(42
)  
   
 
Option and forward contracts economic hedge (5)
  
      
(60
)  
 
 
*Represents an amount less than $0.5 million.
(1)
With respect to cross-currency swap agreements, Teva recognized gains which mainly reflect the differences between the fixed interest rate and the floating interest rate. In the fourth quarter of 2019, Teva terminated cross-currency swap agreements against its outstanding 3.65% senior notes maturing in November 2021. The settlement of these transactions resulted in cash proceeds of $95 million. The cash flow hedge accounting adjustments of these instruments, which are recorded under senior notes and loans, are amortized under financial
expenses-net
over the life of the debt as additional interest expense.
22

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
(2)
In each of the first and second quarters of 2017, Teva entered into a cross currency swap agreement with a notional amount of $500 million maturing in 2020. These cross currency swaps were designated as a net investment hedge of Teva’s foreign subsidiaries euro denominated net assets, in order to reduce the risk of adverse exchange rate fluctuations. With respect to these cross currency swap agreements, Teva recognized gains which mainly reflect the differences between the
float-for-float
interest rates paid and received. No amounts were reclassified from accumulated other comprehensive income into income related toIn the salefirst quarter of a subsidiary.2020, these cross-currency swap agreements
 expired
. The settlement of these transactions resulted in cash proceeds of $3 million.
(3)
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. With respect to this interest rate swap agreement, Teva recognized a loss which mainly reflects the differences between the fixed interest rate and the
floating
interest
rate.
In the
third quarter of 2
019,2019, Teva terminated this interest rate swap agreement. The settlement of these transactions resulted in a gain position of $10 million. The fair value hedge accounting adjustments of these instruments, which are recorded under senior
notes and loans, are amortized under financial
expenses-net
over the life of the debt as additional interest ex
pense
.
expense.
(4)
Teva uses foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, Teva recognizes gains or losses that offset the revaluation of the balance sheet items also recorded under financial expenses—expenses
-
net.
(5)
Teva entered into option and forward contracts designed to limit the exposure of foreign exchange fluctuations on the
e
uro (EUR),projected revenues and expenses recorded in euro, the British
p
ound (GBP), pound, the Russian
r
uble (RUB) ruble and some other currencies denominated revenues with respect toduring the quarter for which such instruments are purchased.transacted. These derivative instruments do not meet the criteria for hedge accounting, however, they are accounted for as economic hedge. These derivative instruments, which may include hedging transactions against future projected revenues and expenses, are recognized on the balance sheet at their fair value with changeson a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. Changes in the fair value of the derivative instruments are recognized underin the same line item in the statements of income as the underlying exposure being hedged. In the first quarter of 2020, the positive impact from these derivatives recognized under revenues was $60 million, partially offset by a $5 million negative impact recognized under cost of sales. The cash flows associated with these derivatives are reflected as cash flows from operating activities in the consolidated statements of cash flows
.
flows.
27

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
e.
(Unaudited)
e.
Matured forward starting interest rate swaps and treasury lock agreements:
Commencing in the third quarter of 2015, Teva entered into forward starting interest rate swapswaps 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).agreements:
Certain of the forward starting interest rate swaps and treasury lock agreements matured
during the first half of 2016. Inwere terminated in July 2016 in connection with theTeva’s debt issuances, Teva terminated the remaining forward starting interest rate swaps and treasury lock agreements.issuances. The termination of these transactions resulted in a loss position of $
493
$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 in other comprehensive income (loss) will beand is 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 thethese forward starting interest rate swaps and treasury lock agreements
,
losses of $8 million and $7 million were recognized under financial expenses, net for the three months ended September 30,March 31, 2020 and 2019, and 2018, and losses of $22 million and $21 million were recognized under financial expenses, net for the nine months ended September 30, 2019 and 2018
, respectively
.respectively.
In the third quarter of 2016,2019, Teva terminated $500 million interest rate swap agreements designated as a fair value hedge relating to its 2.95%2.8% senior notes due 20222023 with respect to $844 million notional amount and its 3.65% senior notes due 2021 with respect to $450$3,000 million notional amount. Settlement of these transactions resulted in a gain positioncash proceeds of $41$10 million. The fair value hedge accounting adjustments of these instruments, which
were 
are recorded under senior notes and loans, are amortized under financial
expenses
netexpenses-net
over the life of the debtdebt.
In the fourth quarter of 2019, Teva terminated $588 million cross-currency swap agreements against its outstanding 3.65% senior notes maturing in November 2021. Settlement of these transactions resulted in cash proceeds of $95 million. The cash flow hedge accounting adjustments of these instruments, which are recorded under senior notes and loans, are amortized under financial
expenses-net
over the life of the debt.
In the first quarter of 2020, a $1,000 million cross currency swap agreement designated as additional interest expense.a net investment hedge of Teva’s foreign subsidiaries euro denominated net assets expired. Settlement of these transactions resulted in cash proceeds of $3 million.
With respect to the interest rate
swap and cross-currency
swap agreements,
terminated in 2016 and in 2019 as described above,
gains of $3
$1 million and $2
million were recognized under financial expenses, net for the three months ended September 30,March 31, 2020 and 2019, and 2018,
respectively
,
and gains of $6 million
and $5 million
were recognized under financial expenses, net for the nine months ended September 30, 2019 and 2018
, respectively
.
NOTE 14 – Other assets impairments, restructuring and other items:
 
Three months ended
  
Nine months ended
 
 
September 30,
  
September 30,
 
 
2019
  
2018
  
2019
  
2018
 
 
(U.S. $ in millions)
 
Impairments of long-lived tangible assets
(1)
 
$
28
 
 
$
2
 
 
$
96
 
 
$
255
 
Contingent consideration
  
51
   
29
   
4
   
84
 
Restructuring
  
61
   
88
   
140
   
442
 
Other
  
21
   
20
   
24
   
53
 
                 
Total
 
$
160
 
 
$
139
 
 
$
263
 
 
$
834
 
                 
(1)Including impairments related to exit and disposal activities
Impairments
Impairments of long-lived tangible assets for the three months ended September 30, 2019 and 2018 were $
28
 million and $
2
 million, respectively.
Impairments of long-lived tangible assets for the nine months ended September 30, 2019 and 2018 were $
96
 million and $
255
 million, respectively.
Teva may record additional impairments in the future, to the extent it changes its plans on any given asset and/or the assumptions underlying such plans as a result of its plant rationalization plan.
Contingent consideration
In the three months ended September 30, 2019, Teva recorded an expense of $51 million for contingent consideration, compared to an expense of $29 million in the three months ended September 30, 2018. The expenses in the third quarter of 2019 were mainly related to a change in the estimated future royalty payments from Eagle Pharmaceuticals, Inc. (“Eagle”) in connection with bendamustine sales.
In the nine months ended September 30, 2019, Teva recorded an expense of $4 million for contingent consideration, compared to an expense of $84 million in the nine months ended September 30, 2018. The expense in the first nine months of 2019 were mainly related to a change in the estimated future royalty payments from Eagle in connection with bendamustine sales and an increase in the expected future royalty payments to Eagle due to the orphan drug status granted to BENDEKA
®
, offset by the change in the future royalty payments in connection with lenalidomide (generic equivalent of Revlimid
®
), which was part of the Actavis Generics acquisition.
28

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Restructuring
In the three months ended September 30, 2019, Teva recorded $61 million of restructuring expenses, compared to $88 million in the three months ended September 30, 2018.
In the nine months ended September 30, 2019, Teva recorded $140 million of restructuring expenses, compared to $442 million in the nine months ended September 30, 2018.
Since the announcement of its restructuring plan, Teva reduced its global headcount by 11,554 full-time-equivalent employees.
During the three months ended September 30, 2019 and 2018, Teva recorded impairments of property, plant and equipment related to restructuring costs of $8 million and $2 million, respectively.
During the nine months ended September 30, 2019 and 2018, Teva recorded impairments of property, plant and equipment related to restructuring costs of $29 million and $155 million, respectively.
The following tables provide the components of costs associated with Teva’s restructuring plan, including other costs associated with Teva’s restructuring plan and recorded under different items:
 
Three months ended
 
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
Restructuring
      
Employee termination
 $
49
  $
62
 
Other
  
11
   
26
 
         
Total
 $
 
 
61
  
$
 
88
 
         
    
 
Nine months ended
 
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
Restructuring
 
 
 
 
 
 
 
 
Employee termination
 $
105
  $
380
 
Other
  
34
   
62
 
         
Total
 $
140
  $
442
 
         
The following table provides the components of and changes in the Company’s restructuring accruals:
 
Employee
termination costs
  
Other
  
Total
 
 
(U.S. $ in millions )
 
Balance as of January 1, 2019
 $
(204
) $
(29
) $
(233
)
Provision
  
(105
)  
(34
)  
(140
)
Utilization and other*
  
108
   
56
   
164
 
             
Balance as of September 30, 2019
 $
(201
) $
(7
) $
(208
)
             
*Includes adjustments for foreign currency translation.
Significant regulatory events
In July 2018, the FDA completed an inspection of Teva’s manufacturing plant in Davie, Florida in the United States, and issued a Form FDA-483 to the site. In October 2018, the FDA notified Teva that the inspection of the site is classified ​​​​​​​as “official action indicated” (OAI). On February 5, 2019, Teva received a warning letter from the FDA that contains four enumerated concerns related to production, quality control, and investigations at this site.
Teva is working diligently to remediate the FDA’s concerns in a manner consistent with current good manufacturing practice (CGMP) requirements, and to address those concerns as quickly and as thoroughly as possible. If Teva is unable to remediate the warning letter findings to the FDA’s satisfaction, it may face additional consequences, including delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. Teva expects to generate approximately $63
million in revenues from this site in the remainder of 2019 and approximately $
230
million
in
2020
, assuming remediation or enforcement does not cause any unscheduled slowdown or stoppage at the facility.
29

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 a previously unknown impurity called NDMA found in valsartan API supplied to Teva by Zhejiang Huahai Pharmaceutical. Since July 2018, Teva has been actively engaged with regulatory agencies around the world in reviewing its valsartan and other sartan products for NDMA and other related impurities and, where necessary, has initiated additional voluntary recalls.
As of September 30, 2019, the accumulated impact of this recall on Teva’s financial statements
was $55 million, primarily related to inventory reserves and returns. Teva expects to continue to experience loss of revenues and profits in connection with this matter. In addition, multiple lawsuits have been filed in connection with this matter, for which litigation costs are currently being incurred. Teva may also incur additional customer penalties, impairments ​​​​​​​and litigation costs going forward.
NOTE 159 – Legal settlements and loss contingencies:
In the
third
first quarter of 2019,2020, Teva recorded an expenseincome of $468$25 million in legal settlements and loss contingencies, compared to $19 million in the
third
quarter of 2018.
The expense in the third quarter of 2019 was mainly related to an increase in the estimated settlement provision recorded in connection with the remaining opioid cases.
In the first nine months of 2019, Teva recorded an expense of $1,171 million in legal settlements and loss contingencies, compared to income of $1,239$57 million in the first nine monthsquarter of 2018.2019. The expenseincome in the first nine monthsquarter of 20192020 was mainly relateddue to
a settlement of an estimated settlement provision recorded in connection withaction brought against the remaining opioid cases.sellers of Auden McKenzie (an acquisition made by Actavis Generics). 
23

TEVA
PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
As of September 30, 2019March 31, 2020 and December 31, 2018,2019, Teva’s provision for legal settlements and loss contingencies recorded under accrued expenses was $1,601$1,539 million and $562$1,580 million, respectively.
NOTE 1610 – 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.
For income tax contingencies, see note 15 to Teva’s Annual Report on Form
10-K
for the year ended December 31, 2018.
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.
3
0Teva could also be sued for patent infringement outside of the context of the Hatch-Waxman Act. For example, Teva could be sued for patent infringement after commencing sales of a product. In addition, for biosimilar products, Teva could be sued according to the “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA).

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 is also involved in litigation regarding patents in other cou
n
triescountries where it does business, particularly in Europe. 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.
24

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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. 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 including
pre-
or post-judgment interest.interest
or a multiplier for willfulness. Following post-trial motions filed by the parties, on March 28, 2018, the district 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 court also denied Teva’s motion seeking to overturn the jury verdict with respect to invalidity.
The provision that was originally included in the financial statements following the damage
s
damages verdict
in
this matter was reversed following the opinion overturning the verdict as the exposure was no longer considered probable.
On May 
25
,
2018
, A hearing on an appeal filed by both parties filed an appeal. A hearing
was
held on
September 
4,
,
2019
and Teva awaits the Court’s decision.
If the appeal of the district court’s decision is decided against Teva, the case would be remanded to the district court for it to consider Teva’s other legal and equitable defenses that have not yet been considered by the district court.
In 2014, Teva Canada succeeded in its challenge of the bortezomib (the g
e
neric eq
u
ivalentgeneric equivalent of Velcade
®
) product and mannitol ester patents under the Patented Medicines (Notice Of Compliance) Regulations (“PM(NOC)PM
(NOC)”). At the time of Teva’s launch in 2015, annual sales of Velcade were approximately 94 million Canadian dollars. Additionally, Teva commenced an action under Section 8 of PM(NOC)PM
(NOC) to recover damages for being kept off of the market during the PM(NOC)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. In 2017, Teva entered into an agreement with Janssen and Millennium which limits the damages payable by either party depending on the outcome of the infringement/impeachment action. As a result, the most Janssen and Millennium could recover is 200 million
Canadian dollars plus post-judgment interest. In June 2018, the court ruled that Janssen and Millennium pay Teva 5 million Canadian dollars in Section 8 damages. Janssen and Millennium filed an appeal,
which was denied by the appellate court on November 4, 2019. On January 3, 2020, Janssen
and
Millennium may applyapplied for a leave to
appeal
to the Canadian Supreme Court.
 I
f If the decision is
ultimately
overturned, Teva could owe the capped damages set forth above. In addition to the potential damages that could be awarded, Teva could be ordered 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 U.S. District Court for the District 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 U.S. Supreme Court, which was granted. On January 22, 2019, the Supreme Court affirmed the appellate court’s decision finding the asserted patent invalid. Helsinn has no further opportunity to appeal this patent decision. Separately, in October 2014, Helsinn filed an additional claim on later-acquired patents. On January 30, 2018, the district court denied Helsinn’s request for a preliminary injunction based on these later acquired patents. Teva launched its generic palonosetron IV solution after obtaining final regulatory approval on March 23, 2018. Teva and Helsinn agreed on a settlement in principle to settle their dispute regarding palonosetron, pending completion of final documentation. A provision with respect to the settlement in principle was included in the financial statements.
In July 2015, Janssen sued Actavis and Teva (along with 10 other filers) over their filing of an ANDA to market their abiraterone acetate tablets, 250mg (generic versions of Zytiga
®
). In August 2017, Janssen sued Teva over its ANDA filing to market a 500mg generic version of Zytiga. In both cases, Janssen asserted a method of treatment patent. In January 2018, following a petition fo
r
inter partes
review, the Patent Trials and Appeals Board (“PTAB”) found the patent to be invalid. In October 2018, the District Court for the District of New Jersey also found the patent to be invalid. Teva launched its generic 250mg product in November 2018. On May 14, 2019, the U.S. Court of Appeals affirmed that Janssen’s patent is invalid. That decision became final on June 20, 2019. Janssen
did not 
seek U.S. Supreme Court review of this decision
so 
this
 matter is considered closed.
3
1

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 insurance it desires, or any 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 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 tripled 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.
2
5

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
In June 2013, the U.S. 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.
InBeginning 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 allegesPennsylvania with allegations 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 casecases also allegesallege that Cephalon improperly asserted its PROVIGIL patent against the generic pharmaceutical companies. The first lawsuit was filed by a purported class of direct purchasers. Similar complaints were also filed by a purported class of indirect purchasers, certain 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 court found the patent to be invalid and unenforceable based on inequitable conduct. Teva has either settled or reached agreements in principle to settle with all of the plaintiffs in the Philadelphia Modafinil Action. Additionally, Cephalon and Teva reached a settlement with 48 state attorneys general, which was approvedsuch cases, except for an action brought by the court on November 7, 2016, and on July 23, 2019, reached aState of Louisiana. The settlement with the State of California whichthat was reached in 2019 is still pending final court approval, and is fullyapproval. All settlements entered into in connection with the above proceeding are covered by the settlement fund explained below.
3
2

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
In May 2015, Cephalon entered into a consent decree with the FTC (the “Modafinil Consent Decree”) under which the FTC dismissed its claims against Cephalon in the FTC Modafinil Action in exchange for payment of $1.2 billion (less
set-offs
for prior settlements) by Cephalon and Teva into a settlement fund. The settlement fund does not cover any judgments or settlements outside the United States. Under the Modafinil 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 remaining balance of the settlement fund after consideration of the
settlement with the
State of California noted above is approximately $
19
$19 million. In February 2019, in connection with the settlement of other unrelated FTC antitrust lawsuits, as described below, Teva and the FTC agreed to amend certain non
-non-financial
financial provisions of the Modafinil Consent Decree and to restart its
ten-year
term.
Additionally, following an investigation initiated by the European Commission in April 2011 regarding a modafinil patent settlement in Europe, the European 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. No final decision regarding infringementliability has yet been taken by the European Commission. The sales of modafinil in the European Economic Area during the last full year of the alleged infringementbreach 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”), from wh
ich
which Teva later acquired certain assets and liabilities, 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 retailer plaintiffs filing separately) and the various actions were consolidated in a multidistrict litigation in Georgia federal court. On February 22, 2019, the FTC stipulated to the dismissal of its claims against Watson, in exchange for Teva’s agreement to amend the Modafinil Consent Decree, as described above. Teva also settled with most of the retailer plaintiffs in April 2019.
O
n On July 16, 2018, the direct purchaser plaintiffs’ motion for class certification was denied. Asdenied, and in December 2019, Teva reached a result,settlement agreement with the three direct purchasers that had sought class certification are now proceeding as individual plaintiffs, and trial on their claims has been scheduled to begincertification. Settlement amounts were paid in February 2020.full. In addition, in August 2019, certain other direct-purchaser plaintiffs (who would have been members of the direct purchaser class, had it been certified) filed their own claims in federal court in Philadelphia, challenging (in one complaint) both the September 2006 settlement between Watson and Solvay referenced above, as well as Teva’s December 2011 settlement with AbbVie involving AndroGel
®
and TriCor
®
, referenced below. The defendants have moved the Philadelphia court to transfer all of these claims to the same Georgia federal court that has been presiding over the multidistrict litigation, and that motion remains pending. Annual sales of AndroGel
®
1% were approximately
$350 $350 million at the time of the settlement and approximately $140 million
at the time Actavis launched its generic version of AndroGel
®
1% in November 2015. A provision for this case was included in the financial statements.
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 U.S. 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, in August 2017, the Third Circuit reversed the district court’s decision and remanded for further proceedings. In March 2020, the district court temporarily stayed discovery and referred the case to mediation. Annual sales of Effexor XR
®
were approximately $2.6 billion at the time of settlement and at the time Teva launched its generic version of Effexor XR
®
in July 2010.
2
6

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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, but in June 2015, the U.S. Court of Appeals for the Third Circuit reversed and remanded for further proceedings. In December 2018, the district court granted the direct-purchaser plaintiffs’ motion for class certification. On March 18, 2019,certification, but on April 22, 2020, the appeals court granted the defendants’ petitionThird Circuit reversed that ruling and remanded for immediate appellate review and the district court has stayed the litigation pending the outcome of the appeal.further class certification proceedings. Annual sales of Lamictal
®
were approximately $950 million at the time of the settlement and approximately $2.3 billion at the time Teva launched its generic version of Lamictal
®
in July 2008.
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 purchaserdirect-purchaser
opt-out
plaintiffs filed complaints with allegations nearly identical to those of the direct purchaserpurchasers’ class and, in
August 2019, the district court certified
the direct-purchaser class,
, although the court has yet to rule on the
indirect
 purchaser’ purchasers’ pending motion
for class certification. In October 2016, the District Attorney for Orange County, California, filed a similar complaint in California state court, which has since been amended, in California state court, alleging violations of state law. Defendants moved to strike the District Attorney’s claims for restitution and civil penalties to the extent not limited to alleged activity occurring in Orange County. The Superior Court denied that motion. The Court of AppealAppeals subsequently reversed the decision and review of the Appellate Court decision is now pending before the California Supreme Court. Annual sales of Niaspan
®
were
were approximately $416 million at the time of the settlement and approximately $1.1  
billion at the time Teva launched its generic version of Niaspan
®
in September 2013.
33

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
In NovemberBeginning in 2013, aseveral putative class action wasactions were 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 and
end-payer
plaintiffs, as well as retailers acting in their individual capacities, and thoseThe cases were consolidated as a multidistrict litigation in federal court in California. On February 21, 2017, the court granted both the indirect purchaser plaintiffs’California and the direct purchaser plaintiffs’ motions for class certification. Tevawere settled the multidistrict litigation with the various plaintiff groups in the first quarter of 2018 and a provision was included in the financial statements.2018. The FTC also filed suit to challenge the Lidoderm
®
settlement, initially bringing antitrust claims against Watson, Endo and Allerganalthough in Pennsylvania federal court in March 2016. The FTC later voluntarily dismissed those claims and refiled them (along with a stipulated order for permanent injunction to settle its claims against Endo) 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 its own complaint against Allergan and Watson, and that complaint was also assigned to the California federal court presiding over the multidistrict litigation. On February 22, 2019, the FTC dismissed its claims against Actavis and Allergan, in exchange for Teva’s agreement to amend the Modafinil Consent Decree, as described above. OnIn July 23, 2019, Teva andalso settled a complaint brought by the State of California also reached a settlement agreement.
California. On September 16, 2019,
end-payers
Blue Cross Blue Shield of Michigan and Blue Care Network of Michigan filed their own lawsuit against Watson, and other defendants, in Michigan state court. That lawsuit was subsequently removed to federal court and that lawsuit remains pending.
Since November 2013, numerous lawsuits have been filed in various federal courts by purported classes On January 24, 2020, the State 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. On April 11, 2017, the Orange County District AttorneyMississippi filed a complaint for violations of California’s Unfair Competition Law based onlawsuit against Teva and Watson in Mississippi state court, which the Aggrenox
®
patent litigation settlement. Teva has settled with the putative classes of direct purchasers and end payers, as well as with the
opt-out
direct purchaser plaintiffs, and with two of the
opt-out
end payer plaintiffs. A provision with respectdefendants have moved to the settlements was included in the financial statements. The district court overruled certain objections to the end payer settlement, including objections made by the Orange County District Attorney, and approved the 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 U.S. Court of Appeals for the Second Circuit. Those appeals remaindismiss, which motion remains pending. Annual sales of Aggrenox
®
were approximately $
340
 million at the time of the settlement and approximately $
455
 million at the time Teva launched its authorized generic version of Aggrenox
®
in July 2015.
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
end-payers
for, and direct purchasersdirect-purchasers of, Actos
®
and Actoplus Met (pioglitazone and pioglitazone plus metformin) against Takeda, the innovator, and several generic manufacturers, including Teva, Actavis and Watson. The lawsuits allege, among other things, that the settlement agreements between Takeda and the generic manufacturers violated the antitrust laws. The court dismissed the end payer
end-payers’
lawsuits against all defendants in September 2015. 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 following the Second Circuit’s decision,
, but on October 8, 2019, the district court dismissed, with prejudice,
the direct purchasers’
claims against the generic manufacturers (including Teva, Actavis,
, and
Watson).
At the time of the settlement, annual sales of Actos
®
and Actoplus Met were
approximately $3.7 billion and approximately $500 million, respectively. At the time Teva launched its authorized generic version of Actos
®
and Actoplus Met in August 2012, annual sales of Actos
®
and Actoplus Met were approximately $2.8 billion and approximately $430 million, respectively.
In September 2014, the FTC sued AbbVie Inc. and certain of its affiliates (“AbbVie”) as well as Teva in
federal court in Philadelphia
alleging that they violated the antitrust laws when they enteredby entering into a
December 2011settlement
2011 settlement agreement to resolve the AndroGel
®
patent litigation on AndroGel
®
and a supply agreement under which AbbVie agreed to supply Teva with an authorized generic version of TriCor
®
. 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 dismissed 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, followingsecured 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.judgement against AbbVie. The FTC then filed a notice of appeal, including as to among other things,the claims against Teva that had been dismissed by the district court’s May 2015 dismissal of the FTC’s claim against Teva,court, but in February 2019, the FTC stipulated to dismiss Teva from its appeal, in exchange for Teva’s agreement to amend the Modafinil Consent Decree, as described above.
I
n In August 2019, two groups of direct-purchaser plaintiffs filed similar claims against AbbVie and Teva, in the same federal court in Philadelphia where the FTC’s claims had been pending. In December 2019, Teva reached a settlement agreement with one group of plaintiffs. The first group is challengingsecond group’s claims challenge both Teva’s December 2011 settlement with AbbVie while the second group is challenging that settlement, as well asand the September 2006 AndroGel
®
settlement between Watson and Solvay, referenced above. The defendants have moved to transfer the second group’sThose claims to the Georgia federal court that is presiding over the multidistrict litigation related to the September 2006 settlement between Watson and Solvay. That motion remainsremain pending.
34

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
In May 2015, a purported class of end payers for Namenda IR
®
(memantine hydrochloride) filed a lawsuit against Forest Laboratories, LLC (“Forest”), the innovator, and several generic manufacturers, including Teva. TheIn November 2019, two additional plaintiffs filed a similar lawsuit alleges,– purportedly as
opt-outs
from the end payers’ class – against the same defendants. These lawsuits allege, among other things, that settlement agreements between Forest and the generic manufacturers to resolve patent litigation over Namenda IR
®
violated the antitrust laws. Annual sales of Namenda IR
®
at the time of the settlement were approximately $1.1 billion and approximately $550 million at the time other manufacturers first launched generic versions of Namenda IR
®
in July 2015.
On December 16, 2016, the U.K. Competition and Markets Authority (“CMA”) issued a statement2
7

Table of objections (a provisional finding of infringement of the Competition Act) in respect of certain allegations against Allergan, Actavis UK and certain Auden Mckenzie entities alleging competition law breaches in connection with the supply of 10mg and 20mg hydrocortisone tablets in the U.K. On December 18, 2017, the CMA issued a Statement of Draft Penalty Calculation. No final decision regarding infringement of competition law has yet been issued. On March 3, 2017, the CMA issued a second statement of objections in respect of certain additional allegations (relating to the same products and covering part of the same time period as in the first statement of objections) against Actavis UK, Allergan and certain Auden Mckenzie entities. On February 28, 2019, the CMA issued a third statement of objections with allegations of additional infringements relating to the supply of 10mg and 20mg hydrocortisone tablets in the U.K against certain Auden Mckenzie entities and others. 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 against Actavis UK in relation to the December 18, 2017 and March 3, 2017 statements of objections, and resulting from conduct prior to the closing date of the sale. In addition, Teva agreed to indemnify Allergan against losses arising from this matter, pursuant to the agreement the parties entered into on January 31, 2018. See note 3. 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.
Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Since November 2016, several putative indirect purchaser and direct purchaser class actions were filed in federal courts in Wisconsin, Massachusetts and Florida against Shire U.S., Inc. and Shire LLC (collectively, “Shire”), Actavis and Teva, 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. All cases are now in Massachusetts federal court.
 In August 2019, the court denied the indirect purchasers’ motion for class certification, and they filed a petition for immediate appellate review, which remains pending. The court granted the direct purchasers’ motion for class certification in September 2019.
Annual sales of Intuniv
®
were approximately $335 million at the time of the settlement and approximately $327 million at the time Actavis launched its generic version of Intuniv
®
in 2014.
In January 2019, generic manufacturer Cipla Limited filed a lawsuit aga
i
nstagainst Amgen in Delaware federal court, alleging, among other things, that a January 2, 2019 settlement agreement between Amgen and Teva, resolving patent litigation over cinacalcet (generic Sensipar
®
), violated the antitrust laws. In March 2019, Cipla Limited amended its complaint to name Teva as an additional defendant, and putative classes of direct-purchaser and
end-payer
plaintiffs have also filed antitrust lawsuits in (since(which have since been consolidated in federal court in Delaware) against Amgen and Teva related to the January 2, 2019 settlement. Both Cipla Limited and the putative class plaintiffs seek damages and injunctive relief and the defendants moved to dismiss their claims on October 15, 2019. Those motions remain pending.
Annual sales of Sensipar
®
in the United States were approximately $1.4 billion at the time Teva launched its generic version of Sensipar
®
in December 2018, and at the time of the January 2, 2019 settlement.
On December 16, 2016, the U.K. Competition and Markets Authority (“CMA”) issued a statement of objections (a provisional finding of breach of the Competition Act) in respect of certain allegations against Allergan, Actavis UK and certain Auden Mckenzie entities alleging competition law breaches in connection with the supply of 10mg and 20mg hydrocortisone tablets in the U.K. On December 18, 2017, the CMA issued a Statement of Draft Penalty Calculation. On March 3, 2017 and February 28, 2019, the CMA issued second and third statements of objections in respect of certain additional allegations relating to the same products and covering part of the same time periods as in the first statement of objections. On February 12, 2020, the CMA issued a supplementary statement of objections effectively combining the three previously issued statements referenced above. On January 9, 2017, Teva completed the sale of Actavis UK to Accord Healthcare Limited, in connection with which Teva will indemnify Accord Healthcare for potential fines imposed by the CMA and/or damages awarded by a court against Actavis UK in relation to the December 16, 2016 and March 3, 2017 statements of objections, and resulting from conduct prior to the closing date of the sale. In addition, Teva agreed to indemnify Allergan against losses arising from this matter in the event of any such fines or damages. A liability for this matter has been recorded in the financial statements.
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
In 2015 and 2016, Actavis and Teva USA each respectively received subpoenas from the U.S. Department of these investigations originate through what are known as
qui tam
complaints, in whichJustice (“DOJ”) Antitrust Division seeking documents and other information relating to the government reviewsmarketing and pricing of certain Teva USA generic products and communications with competitors about such products. In May 2018, Teva received a complaint filed under seal by a whistleblower (a “relator”) that alleges violations ofcivil 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. The government considers whether to investigateTeva is cooperating with these subpoena requests.
In 2015 and 2016, Actavis and Teva USA each respectively received a subpoena from the allegations and will, in many cases, issue subpoenas requestingConnecticut Attorney General seeking documents and other information including conducting witness interviews. The government must decide whetherrelating to intervene and pursue the claims as the plaintiff. Oncepotential state antitrust law violations. Subsequently, on December 15, 2016, a decision is madecivil action was brought by the government,attorneys general of twenty states against Teva USA and several other companies asserting claims under federal antitrust law alleging price fixing of generic products in the United States. That complaint is unsealed. Ifwas later amended to add new states as named plaintiffs, as well as new allegations and new state law claims, and on June 18, 2018, the government decidesattorneys general of 49 states plus Puerto Rico and the District of Columbia filed a consolidated amended complaint against Actavis and Teva, as well as other companies and individuals. On May 10, 2019, most (though not all) of these attorneys general filed yet another antitrust complaint against Actavis, Teva and other companies and individuals, alleging price-fixing and market allocation with respect to intervene, thenadditional generic products. On November 1, 2019, 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 certainan amended complaint, bringing the total number of its subsidiaries relating to reimbursements or drug price reporting under Medicaid or other programs. Such price reporting is alleged to have causedplaintiff states and othersterritories to pay inflated reimbursements for covered drugs.54. The amended complaint alleges that Teva was at the center of a conspiracy in the generic pharmaceutical industry, and asserts that Teva and its subsidiaries have reached settlements in most of these cases. On October 4, 2018, Teva settled longstanding litigation filed by the State of Illinois against subsidiaries of Tevaothers fixed prices, rigged bids, and Watson for a total settlement amount of $135 million, the majority of which was paid in December 2018. Teva accepted the settlement while denying any liabilityallocated customers and market share 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 a separate case brought by the Statecertain additional products, many of Mississippi against Watson, pursuant to which Watson was ordered to pay compensatory damages amounting to $12.4 million. In March 2014, the Mississippi court amended the judgment to also include punitive damageswere not previously at issue in the amountPennsylvania MDL. In the various complaints described above, 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 $17.9 million. The judgment was affirmed in all respects by the Mississippi Supreme Court in January 2018various state and has since been satisfied in full. Certain Actavis subsidiaries were dismissed by the trial court in an action brought by the State of Utah. That dismissal was affirmed by the Utah Court of Appeals on February 28, 2019. The State’s time to seek further appellate review has expiredgovernmental entities and the matter is now concluded. A provision for these cases was included in the financial statements.
Several
qui tam
consumers, civil penalties and costs. All such complaints have been unsealed in recent years as a result of government decisions nottransferred to participatethe generic drug multidistrict litigation in the cases. The following is a summaryEastern District of certain government investigations,
qui tam
actions and related matters.Pennsylvania (“Pennsylvania MDL”).
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 and indirect purchaser
opt-out
plaintiffs. These complaints, which allege that the defendants engaged in conspiracies to fix prices and/or allocate market share of generic products have been brought against various manufacturer defendants, including Teva and Actavis. The plaintiffs generally seek injunctive relief and damages under federal antitrust law, and damages under various state laws. On April 6, 2017, these cases were transferred to the Pennsylvania MDL. Additional cases were transferred to that court and the
352
8
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
In January 2014, Teva receivedplaintiffs filed consolidated amended complaints on August 15, 2017. On October 16, 2018, the court denied certain of the defendants’ motions to dismiss as to certain federal claims, and on February 15, 2019, the court granted in part and denied in part defendants’ motions to dismiss as to certain state law claims. On July 18, 2019, certain individual plaintiffs commenced a civil investigative demand fromaction in the U.S. Att
o
rneyPennsylvania Court of Common Pleas of Philadelphia County against many of the defendants in the Pennsylvania MDL, including Teva and Actavis, but no complaint has been filed and the case has been placed in deferred status. On November 13, 2019, several counties in New York commenced a civil action against many of the defendants in the Pennsylvania MDL, including Teva and Actavis, and the complaint has been transferred to the Pennsylvania MDL. On March 1, 2020, Harris County in Texas filed a complaint against several generic manufacturers including Teva and Actavis in the District Court for the Southern District of New York seekingTexas. This complaint largely mirrors certain allegations in the complaints in the Pennsylvania MDL. This case has not been transferred to the Pennsylvania MDL.
On March 21, 2017, Teva received a subpoena from the U.S. Attorney’s office in Boston, Massachusetts requesting documents and information from January 1, 2006 related to sales, marketingTeva’s donations to patient assistance programs. Teva is cooperating in responding to the subpoena. 
In December 2016, Teva resolved certain claims under the U.S. Foreign Corrupt Practices Act (“FCPA”) with the SEC and promotionthe DOJ. The settlement included a fine, disgorgement and prejudgment interest, a three-year deferred prosecution agreement (“DPA”) for Teva and the retention of COPAXONE
®
and AZILECT
®
, focusing on educational and speaker programs. The demand states thatan independent compliance monitor for a period of three years. In February 2020 the government is investigating possible civil violationsterm of the federal False Claims Act. In March 2015, the docket in this matter and a False Claims Act civil qui tam complaint concerning this matter were unsealedmonitorship provided for by the court afterDPA and Teva’s consent judgement with the government declinedSEC expired and on March 4, 2020, following Teva’s certification to intervene. In February 2016, the court denied Teva’s motionsSEC and the DOJ confirming that Teva had complied with its disclosure obligations under the DPA, the DOJ filed a motion 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. Teva’s motion for summary judgment on all claims was denied on February 27, 2019. Teva has reached an agreement in principle to resolve relators’ claims, for which an estimated provision was included in the financial statements for the second quarter of 2019 with the remainder of such provisions recorded in the third quarter of 2019. Pending the parties’ efforts to finalize the settlement agreement and related matters and obtain necessary approvals, the court adjourned the previously scheduled trial date of August 19, 2019 until January 6, 2020.
In January 2014, a
qui tam
complaint was filed in 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. The
qui 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 moved to dismiss the complaint. The DOJ also moved to dismiss the complaint, arguing that it lacked merit and was not in the government’s interest to continue. Both motions are pending.
On September 27, 2019, the Court granted the DOJ’s motion to dismiss.
In May 2017, a
qui tam
action wasinformation filed against a number of Teva subsidiaries. The
qui tam
actionat the time the DPA 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 and the DOJ moved to dismiss the case. These motions are pending.
entered into.
Opioids Litigation
Since May 2014,
more than
2,000 2,900 complaints have been 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, other governmental agencies,
, tribes
and private plaintiffs (including various putative class actions of individuals) in both state and federal courts. Most of the federal cases have been consolidated into a multidistrict litigation in the Northern District of Ohio (“MDL Opioid Proceeding”) and many of the cases filed in state court have been removed to federal court and consolidated into the MDL Opioid Proceeding.
Other cases remain pending in various states. In some jurisdictions, such as Illinois, New York, Pennsylvania, South Carolina, Texas, Utah and Utah,West Virginia, certain state court cases have been transferred to a single court within their respective state court systems for coordinated pretrial proceedings. Absent resolutions, trials are expected to proceed in several states in 2020
.
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 FENTORA
®
. The complaints also assert claims related to Teva’s generic opioid products. In addition, personal injury plaintiffs, including various putative class actions of individuals, have asserted personal injury and wrongful death claims. Furthermore, approximately
350
600 complaints 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. Certain plaintiffs assert that the measure of damages is the entirety of the costs associated with addressing the abuse of opioids and opioid addiction and certain plaintiffs specify multiple billions of dollars in the aggregate as alleged damages. In many of these cases, plaintiffs are seeking joint and several damages among all defendants. An adverse resolution of any of these lawsuits or investigations may involve large monetary penalties, damages, and/or other forms of monetary and
non-monetary
relief and could have a material and adverse effect on Teva’s reputation, business, results of operations and cash flows.
Absent resolutions, trials are expected to proceed in several states in 2020 and 2021. A court in New York had set a date, for a liability trial only, to start in March 2020. However, that trial has been postponed due to the impact of
COVID-19.
A new trial date has not been set. It is also anticipated that a court in California may reset a trial date, most recently scheduled for June 2020, to the second half of 2020. It is difficult to predict when or if trials will occur in 2020 given the current impact of
COVID-19
on the United States and the U.S. judicial system.
In May 2019, Teva settled the Oklahoma litigation brought by the Oklahoma Attorney General (State of Oklahoma, ex. rel. Mike Hunter, Attorney General of Oklahoma vs. Purdue Pharma L.P., et. al.) for
$85 $85 million.
The settlement did not include any admission of violation of law for any of the claims or allegations made. As the Company demonstrated a willingness to settle part of the litigation, for accounting purposes, management considered a portion of opioid-related cases as probable and, as such, recorded an estimated provision in the second quarter of 2019. Given the relatively early stage of the cases, management viewed no amount within the range to be the most likely outcome. Therefore, management recorded a provision for the reasonably estimable minimum amount in the assessed range for such opioid-related cases in accordance with Accounting Standards Codification 450 “Accounting for Contingencies.”
On October 21, 2019, Teva reached a settlement with the two plaintiffs in the MDL Opioid Proceeding that was scheduled for trial for the Track One case, Cuyahoga and Summit Counties of Ohio. Under the terms of the settlement, Teva will provide the two counties with opioid treatment medication,
,
buprenorphine naloxone (sublingual tablets),
known by the brand name Suboxone®Suboxone
®
, with a value of
$25 $25 million at wholesale acquisition cost and distributed over three years to help in the care and treatment of people suffering from addiction, and a cash payment in the amount of $20 million, to be paid in 4 payments over three years.
29

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Also on October 21, 2019, Teva and certain other defendants reached an agreement in principle with a group of Attorneys General from North Carolina, Pennsylvania, Tennessee and Texas for a nationwide settlement framework. The framework is designed to provide a mechanism by which the Company attempts to seek resolution of remaining potential and
pending opioid claims by both the U.S. states and political subdivisions
(i.e. (i.e., counties, tribes and other plaintiffs)
thereof. Under this agreement, Teva would
provide
buprenorphine naloxone (sublingual tablets) with an estimated value of up to approximately $23 billion at wholesale acquisition cost over
a
ten year
period
. period. In addition, Teva would also provide cash paymen
ts
payments of up to $250 million over a ten year period. The Company cannot predict if the nationwide settlement framework will be finalized.finalized
.
36

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Following these devel
o
pments,developments, the Company considered a range of potential settlement outcomes. No single outcome in the range was considered to be more likely than any other outcome; accordingly, in the third quarter of 2019, Teva accrued to the new low end of the range, resulting in an increase in ourTeva’s previously recorded estimated liability. There was no change in this estimate in the first quarter of 2020.
Separately,
on April 27,
, 2018,
, Teva received subpoena requests from the DOJUnited States Attorney’s office in the Western District of Virginia and the Civil Division seeking documents relating to the manufacture, marketing and sale of branded opioids. In August 2019,
, Teva received a grand jury subpoena from the United States Attorney’s Office for the Eastern District of New York for documents related to the Company’s anti-diversion policies and procedures and distribution of its opioid medications, in what the Company understands to be part of a broader investigation into manufacturers’ and distributors’ monitoring programs and reporting under the Controlled Substances Act. In September 2019,
, Teva received subpoenas from the New York State Department of Financial Services (NYDFS) as part of an industry-wide inquiry into the effect of opioid prescriptions on New York health insurance premiums. The Company is cooperating with NYDFS’s inquiry and producing documents in response to the various subpoenas and requests for information.
Currently, Teva cannot predict how the nationwide settlement framework agreement (if finalized) will affect these investigations.
In addition, a number of 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 and cannot predict their outcome at this time.
In addition, several jurisdictions in Canada have initiated litigation regarding opioids alleging similar claims as those in the United States. The cases in Canada are likely to be consolidated and are in their early stages.
On June 21, 2016, Teva USA received a subpoena from the DOJ Antitrust Division seeking documents and other information relating to the marketing and pricing of certain Teva USA generic products and communications with competitors about such products. Actavis received a similar subpoena in June 2015. Teva and Actavis are cooperating 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 received a similar subpoena from the Connecticut Attorney General.
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 alleging price fixing of generic products in the United States. That complaint was later amended to add new states as named plaintiffs, as well as new allegations and new state law claims, and on June 18, 2018, the attorneys general of 49 states plus Puerto Rico and the District of Columbia filed a consolidated amended complaint against Actavis and Teva, as well as other companies and individuals. On May 10, 2019, most (though not all) of these same attorneys general filed yet another antitrust complaint against Actavis and Teva, plus other companies and individuals, alleging price-fixing and market allocation as concerns additional generic products. The complaint alleges that Teva was at the center of a conspiracy in the generic pharmaceutical industry, and asserts that Teva and others fixed prices, rigged bids, and allocated customers and market share with respect to certain additional products, many of which were not previously at issue in the Pennsylvania MDL. In the various complaints described above, 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. All such complaints have been transferred to the generic drug multidistrict litigation in the Eastern District of Pennsylvania (“Pennsylvania MDL”).
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 purchaser
opt-out
plaintiffs. These complaints, which allege that the defendants engaged in conspiracies to fix prices and/or allocate market share of generic products have been brought against various manufacturer defendants, including Teva and Actavis. The plaintiffs generally seek injunctive relief and damages under federal antitrust law, and damages under various state laws. On April 6, 2017, these cases were transferred to the Pennsylvania MDL. Additional cases were transferred to that court and the plaintiffs filed consolidated amended complaints on August 15, 2017. On October 16, 2018, the court denied certain of the defendants’ motions to dismiss as to certain federal claims, and on February 15, 2019, the court granted in part and denied in part defendants’ motions to dismiss as to certain state law claims.
On July 18, 2019, certain individual plaintiffs commenced a civil action in the Pennsylvania Court of Common Pleas of Philadelphia County against many of the defendants in the Pennsylvania MDL, including Teva and Actavis, but no complaint has been filed.
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 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 in responding to the subpoena.
In December 2016, Teva resolved certain claims under the U.S. Foreign Corrupt Practices Act (“FCPA”) with the SEC and the DOJ. The settlement included a fine, disgorgement and prejudgment interest; a three-year deferred prosecution agreement (“DPA”) for Teva and the retention of an independent compliance monitor for a period of three years. If, 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 additional fines or penalties, including the deferred charges. Following the above resolution with the SEC and DOJ, Teva has had requests for documents and information from various Russian government entities. In addition, on January 14, 2018, Teva entered into an arrangement for the Contingent Cessation of Proceedings pursuant to the Israeli Securities Law with the Government of Israel that ended the investigation of the Israeli government into the conduct that was subject to the FCPA investigation, and provided a payment of approximately $22 million.
37

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 and directors. After those twoThose 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 (the “Ontario Teachers Securities Litigation”). TheOn December 13, 2019, the lead plaintiff thenin that action filed a consolidatedan amended complaint. On April 3, 2018, the court dismissed the case without prejudice. The 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.May 10, 2019. The secondamended complaint asserts that Teva and certain of its current and former officers and
directors violated federal securities and common laws in connection with Teva’s alleged failure to disclose pricing strategies for various drugs in its generic drug portfolio and by making allegedly false or misleading statements in certain offering materials issued during the class period.materials. The secondamended complaint seeks unspecified damages, legal fees, interest, and costs. TevaIn July 2017, August 2017, and the current and former officer and director defendants filed motions to dismiss the second complaint on September 14, 2018.
On September 25,June 2019, the court denied in substantial part and granted in part the defendants’ motions to dismiss. The court has yet to establish a pre-trial schedule
.
On July 17, 2017, a lawsuit wasother putative securities class actions were 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 controlsother federal courts based on the facts underpinning Teva’s FCPA DPAsimilar allegations, and also based on allegations substantially similar to those in the Ontario Teachers Securities Litigation. On November 29, 2017, the court granted Teva’s motion to transfer the litigationcases have been transferred to the U.S. District Court for the District of Connecticut where the Ontario Teachers Securities Litigation is pending. On February 12, 2018, the district court stayed the case pending resolution of the motions to dismissConnecticut. Between August 2017 and January 2020, eighteen complaints were filed in the Ontario Teachers Securities Litigation described above.
 Following the September 25, 2019 decision on the motions to dismiss in the Ontario Teachers Securities Litigation, Teva is awaiting the court’s pre-trial schedule for this case.
On August 3, 2017, a lawsuit was filed in the U.S. District Court for the District of Connecticut by OZ ELS Master Fund, Ltd. and related entities. The complaint asserts thatagainst 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 Ontario Teachers Securities Litigation described above.
 Following the September 25, 2019 decision on the motions to dismiss in the Ontario Teachers Securities Litigation, Teva is awaiting the court’s a pre-trial schedule for this case.
On August 21 and 30, 2017, Elliot Grodko and Barry Baker filed putative securities class actions 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, 2017directors seeking unspecified damages, legal fees, interest, and costs. The complaints 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 court granted Teva’s motion to transfer the consolidated action to the District of Connecticut where the Ontario Teachers Securities Litigation is currently pending.
 Following the September 25, 2019 decision on the motions to dismiss in the Ontario Teachers Securities Litigation, Teva is awaiting the court’s pre-trial schedule for this case.
Between August 2018 and Ju
ly
2019,
sixteen
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 allegationssimilar claims in these complaints are substantially similar to the allegations in the Ontario Teachers Securities Litigation, but have been brought on behalf of plaintiffs, in various forums across the country, who have indicated that have “opted out” they intend to
“opt-out”
of the putativeplaintiffs’ class if one is certified in the Ontario Teachers Securities Litigation. The plaintiffs in these
“opt-out”
cases filed their complaints inOn March 10, 2020, the Court of Common Pleas of Montgomery County, Pennsylvania, the U.S. District Court for the Eastern District of Pennsylvania and the U.S. District Court for the District of Connecticut. Teva and the current and former officer and director defendants filed motions or stipulations to transfer the cases filed in Pennsylvania to the U.S. District Court for the District of Connecticut, whereconsolidated the Ontario Teachers Securities Litigation is pending.
Teva is awaiting the court’s pre-trial schedule for the
cases filed in, or transferred to,
the District of
Connecticut.
On June 21, 2019, the Employees’ Retirement Systemwith all of the City of St. Petersburg, Florida filed aabove-referenced putative securities class actionactions for all purposes and the
“opt-out”
cases for pretrial purposes. The case is now in the U.S. District Court for the Eastern District of Pennsylvania purportedly on behalf of purchasers of Teva’s securities between August 4, 2017 and May 10, 2019 seeking unspecified damages, legal fees, interest, and costs. The complaint alleges similar claims to the Ontario Teachers Securities Litigation described above.
discovery.
Teva has filed a motion to transfer the case to the United States District Court for the District of Connecticut, which motion remains pending.
Motions to approve derivative actions against certain past and present directors and officers have been filed in Israel alleging 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 derivative actions were filed with respect to executive compensation, several patent settlement agreements, opioids and the U.S. price-fixing investigations. Motions to approve securities class actions against Teva and certain of its current and former directors and officers were filed in Israel based on allegations of improper disclosure of the above-mentioned pricing investigation, as well as lack of disclosure of negative developments in the generic sector, including price erosion with respect to Teva’s products. OtherVarious motions were filed in Israel to approve a derivative action, discovery and a class action related to claims regarding Teva’s above-mentioned FCPA resolution with the SEC and DOJ.
The parties have reached an agreement in principle to settle these proceedings and the settlement was approved by the Tel Aviv District Court on April 6, 2020.
38
30

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 clean 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
clean-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,
clean-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
clean-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). Defendants moved to dismiss the complaint and on December 28, 2018, the court granted the motion in part and dismissed all of plaintiffs’ claims, except for their claim against Cephalon for breach of contract.
NOTE 11 – Income taxes:
In the first quarter of 2020, Teva recognized a tax benefit of $59 million, on
pre-tax
loss of $33 million. In the first quarter of 2019, Teva recognized a tax expense of $9 million, on
pre-tax
loss of $84 million. Teva’s tax rate for the first quarter of 2020 was mainly affected by impairments in jurisdictions in which tax rates are higher than Teva’s average tax rate
on its ongoing business operations.
The statutory Israeli corporate tax rate is 23% in 2020. Teva’s tax rate differs from the Israeli statutory tax rate, mainly due to generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate, tax benefits in Israel and other countries, as well as infrequent or nonrecurring items.
Teva filed a claim seeking the refund of withholding taxes paid to the Indian tax authorities in 2012. Trial in this case is scheduled to begin in
July 2020
. A final and binding decision against Teva in this case may lead to an impairment in the amount of $136 million.
31

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 12 – Other assets impairments, restructuring and other items:
 
Three months ended
 
 
March 31,
 
 
2020
 
 
2019
 
 
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
 $
75
  $
20
 
Contingent consideration
  
6
   
(71
)
Restructuring
  
39
   
32
 
Other
  
—  
   
20
 
         
Total
 $
121
  $
1
 
         
(1)
Including impairments related to exit and disposal activities.
Impairme
nts
Impairments of tangible assets for the first three months of 2020
and 2019
were
$75 million and $20 million, respectively.
The impairments in the first three months of 2020
are mainly related to plant rationalization.
Teva may record additional impairments in the future, to the extent it changes its plans on any given asset and/or the assumptions underlying such plans, as a result of its plant rationalization plan.
Contingent consideration
In the three months ended March 31, 2020, Teva recorded an expense
of
$6 
million for contingent consideration, compared to an income of
$71 
million 
in the three months ended March 31, 2019. The income in the first quarter of 2019 was mainly related to a decrease in royalty payments expected in connection with lenalidomide (generic equivalent of Revlimid
®
) which was part of the Actavis Generics acquisition.
Restructuring
In the three months ended March 31, 2020, Teva
recorded $
39
million of restructuring expenses, compared
to $
32
 million
in the three months ended March 31, 2019. The expenses in the first quarter of 2020 were primarily related to residual expenses of the restructuring plan announced in 2017.
The following tables provide the components of costs associated with Teva’s restructuring plan, including other costs associated with Teva’s restructuring plan and recorded under different items:
  
Three months ended
 
March 31,
 
 
2020
  
2019
 
 
(U.S. $ in millions)
 
Restructuring
      
Employee termination
 $
33
  $
20
 
Other
  
6
   
12
 
         
Total
 $
39
  $
32
 
         
The following table provides the components of and changes in the Company’s restructuring accruals:
 
Employee termination
costs
  
Other
  
Total
 
 
(U.S. $ in millions )
 
Balance as of January 1, 2020
 $
(208
) $
(7
) $
(215
)
Provision
  
(33
)  
(6
)  
(39
)
Utilization and other*
  
69
   
6
   
75
 
Balance as of March 3
1
, 2020
 $
(172
) $
(7
) $
(179
)
             
*Includes adjustments for foreign currency translation.


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Significant regulatory events
In July 2018, the FDA completed an inspection of Teva’s manufacturing plant in Davie, Florida in the United States, and issued a Form
FDA-483
to the site. In October 2018, the FDA notified Teva that the inspection of the site is classified as “official action indicated” (OAI). On February 5, 2019, Teva received a warning letter from the FDA that contained four additional enumerated concerns related to production, quality control, and investigations at this site. Teva has been working diligently to address the FDA’s concerns in a manner consistent with current good manufacturing practice (cGMP) requirements, and to address those concerns as quickly and as thoroughly as possible.
An FDA follow up inspection occurred in January 2020, resulting in some follow up findings, and Teva received a letter from the FDA dated April 24, 2020 notifying that the site continues to be classified as OAI
. If Teva is unable to remediate the findings to the FDA’s satisfaction, it may face additional consequences. These would potentially include delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. Teva expects to generate
approximately
$230 
million in revenues
from this site in 2020, assuming remediation or enforcement does not cause any unscheduled slowdown or stoppage at the facility, however delays in FDA approvals of future products from the site may occur.
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 a previously unknown nitrosamine impurity called NDMA found in valsartan API supplied to Teva by Zhejiang Huahai Pharmaceuticals Co. Ltd. (“Huahai”). Since July 2018, Teva has been actively engaged with regulatory agency requests around the world in reviewing its sartan and other products to determine whether NDMA and/or other related nitrosamine impurities are present in specific products. Where necessary, Teva has initiated additional voluntary recalls. The aggregate direct impact of the sartan recalls on Teva’s 2018 and 2019 financial statements was
$54 million,
primarily related to inventory write-downs and returns. As a result of this loss, Teva initiated negotiations with Huahai and in December 2019, Teva reached a settlement with Huahai resolving its claims related to certain sartan API supplied by Huahai to Teva. Under the settlement agreement, Huahai agreed to compensate Teva for some of the direct losses suffered by Teva and provide Teva prospective cost reductions for API. The settlement does not release Huahai from liability for any losses Teva may incur as a result of third party personal injury or product liability claims relating to the sartan API at issue. In addition, multiple lawsuits have been filed in connection with this matter, which may lead to additional customer penalties, impairments and litigation costs. Teva expects additional expenses and loss of revenues and profits in connection with this matter going forward.
NOTE 13 – 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 diluted earnings per share for the three months ended March 31, 2020, basic earnings per share were adjusted to take into account the potential dilution that could occur upon the exercise of options and
non-vested
RSUs granted under employee stock compensation plans, using the treasury stock method. No account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
In computing diluted loss per share for the three months ended March 31, 2019, no account was taken of the potential dilution by the assumed exercise of employee stock options and
non-vested
RSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
Basic and diluted earnings per share were $0.06 in the first quarter of 2020, compared to basic and diluted loss per share of $0.10 in the first quarter of 2019.
33

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 1714 – 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
   
 
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 as of December 31, 2019
 $
(1,794
) $
  $
(420
) $
(98
) $
(2,312
)
                     
Other comprehensive income (loss) before reclassifications
  
(570
)  
   
22
   
   
(548
)
Amounts reclassified to the statements of income
  
—  
   
   
8
   
   
8
 
                     
Net other comprehensive income (loss) before tax
  
(570
)  
   
30
   
   
(540
)
                     
Net other comprehensive income (loss) after tax*
  
(570
)  
   
30
   
   
(540
)
                     
Balance as of March 31, 2020
 $
(2,364
) $
  $
(390
) $
(98
) $
(2,852
)
                     
*
Amounts do not include a $10 million loss from foreign currency translation adjustments attributable to
non-controlling
interests.
 
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 as of December 31, 2018
 $
(1,878
) $
1
  $
(504
) $
(78
) $
(2,459
)
                     
Other comprehensive income (loss) before reclassifications
  
53
      
40
   
—   
   
93
 
Amounts reclassified to the statements of income
  
—   
   
—   
   
7
   
  
   
7
 
                     
Net other comprehensive income (loss) before tax
  
53
   
—   
   
47
   
  
   
100
 
                     
Net other comprehensive income (loss) after tax*
  
53
   
—   
   
47
       
100
 
                     
Balance as of March 31, 2019
 $
(1,825
) $
1
  $
(457
) $
(78
) $
(2,359
)
                     
*
Amounts do not include a $6 million loss from foreign currency translation adjustments attributable to
non-controlling
interests.
34

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 15 – Segments:
Teva operates its business and reports its financial results in 3three segments:
(a)North America segment, which includes the United States and Canada.
(b)Europe segment, which includes the European Union and certain other European countries.
(c)International Markets segment, which includes all countries other than those in the North America and Europe segments.
The Company began reporting its financial results under this structure in the first quarter of 2018. This change was reflected through retroactive revision of prior period segment information.
In addition to these three segments, Teva has other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through its affiliate Medis.
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 International 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.
39

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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
from time to time
.time. 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.
6
.
a.
Segment information:
 
Three months ended September 30,
 2019
 
 
North America
  
Europe
  
International
 
Markets
 
 
(U.S. $ in millions)
 
Revenues
 $
2,051
  $
1,163
  $
736
 
Gross profit
  
1,048
   
662
   
295
 
R&D expenses
  
156
   
63
   
21
 
S&M expenses
  
219
   
206
   
114
 
G&A expenses
  
112
   
56
   
32
 
Other income
  
(5
)  
(4
)  
(1
)
             
Segment profit
 $
565
  $
341
  $
130
 
             
 
Three months ended September 30
, 2018
 
 
North America
  
Europe
  
International
 
Markets
 
 
(U.S. $ in millions)
 
Revenues
 $
2,265
  $
1,212
  $
726
 
Gross profit
  
1,196
   
676
   
301
 
R&D expenses
  
158
   
62
   
21
 
S&M expenses
  
265
   
242
   
120
 
G&A expenses
  
128
   
74
   
37
 
Other (income) expense
  
(4
)  
1
   
—  
 
             
Segment profit
 $
649
  $
297
  $
123
 
             
 
Nine months ended September 30, 2019
 
 
North America
 
 
Europe
 
 
International Markets
 
 
(U.S. $ in millions)
 
Revenues
 
$
6,169
 
 
$
3,611
 
 
$
2,145
 
Gross profit
 
 
3,155
 
 
 
2,066
 
 
 
877
 
R&D expenses
 
 
497
 
 
 
199
 
 
 
66
 
S&M expenses
 
 
756
 
 
 
637
 
 
 
348
 
G&A expenses
 
 
342
 
 
 
175
 
 
 
102
 
Other income
 
 
(6
)
 
 
(5
)
 
 
(2
)
 
 
 
 
 
 
 
 
 
 
 
 
 
Segment profit
 
$
1,566
 
 
$
1,060
 
 
$
363
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Nine months ended September 30, 2018
 
 
North America
 
 
Europe
 
 
International Markets
 
 
(U.S. $ in millions)
 
Revenues
 
$
7,059
 
 
$
3,982
 
 
$
2,265
 
Gross profit
 
 
3,778
 
 
 
2,195
 
 
 
942
 
R&D expenses
 
 
528
 
 
 
208
 
 
 
70
 
S&M expenses
 
 
813
 
 
 
725
 
 
 
384
 
G&A expenses
 
 
357
 
 
 
243
 
 
 
115
 
Other income
 
 
(206
)
 
 
(1
)
 
 
(11
)
 
 
 
 
 
 
 
 
 
 
 
 
 
Segment profit
 
$
2,286
 
 
$
1,020
 
 
$
384
 
 
Three months ended March 31,
 
 
2020
 
 
North
 
America
  
Europe
  
International Markets
 
 
(U.S. $ in millions)
 
Revenues
 $
2,082
  $
1,402
  $
565
 
Gross profit
  
1,062
   
823
   
305
 
R&D expenses
  
146
   
55
   
15
 
S&M expenses
  
251
   
202
   
106
 
G&A expenses
  
118
   
66
   
34
 
Other income
  
(2
  
(1
  
(6
             
Segment profit
 $
550
  $
502
  $
156
 
             
    
 
Three months ended March 31,
 
 
2019
 
 
North
 
America
  
Europe
  
International Markets
*
 
 
(U.S. $ in millions)
 
Revenues
 $
2,047
  $
 
1,264
  $521 
Gross profit
  
1,039
   
730
   
269
 
R&D expenses
  
165
   
66
   
22
 
S&M expenses
  
268
   
215
   
115
 
G&A expenses
  
112
   
48
   
36
 
Other (income) expense
  
(4
  
(1
  
—   
 
             
Segment profit
 $
 498
  $
 403
  $
 97
 
             
4
0
 
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c for additional information.
35

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
The following table presents a reconciliation of our segment profits to our consolidated operating income (loss) and to consolidated income (loss) before income taxes for the three months ended March 31, 2020 and 2019:
                 
 
Three months ended
  
Nine
 months ended
 
 
September 30,
  
September 30,
 
 
2019
  
2018
  
2019
  
2018
 
 
(U.S. $ in millions)
  
(U.S. $ in millions)
 
North America profit
 
$
565
 
 
$
649
 
 
$
1,566
 
 
$
2,286
 
Europe profit
 
 
341
 
 
 
297
 
 
 
1,060
 
 
 
1,020
 
International Markets profit
 
 
130
 
 
 
123
 
 
 
363
 
 
 
384
 
Total segment
s
profit
 
 
1,036
 
 
 
1,069
 
 
 
2,989
 
 
 
3,690
 
Profit of other activities
 
 
16
 
 
 
35
 
 
 
92
 
 
 
87
 
 
 
1,051
 
 
 
1,104
 
 
 
3,081
 
 
 
3,777
 
Amounts not allocated to segments:
 
 
 
 
 
 
 
 
 
 
 
 
Amortization
 
 
255
 
 
 
297
 
 
 
823
 
 
 
909
 
Other assets impairments, restructuring and other items
 
 
160
 
 
 
139
 
 
 
263
 
 
 
834
 
Goodwill impairment
 
 
—  
 
 
 
—  
 
 
 
—  
 
 
 
300
 
Intangible asset impairments
 
 
177
 
 
 
519
 
 
 
1,206
 
 
 
1,246
 
G
ain on divestitures, net of divestitures related costs
 
 
(3
)
 
 
(31
)
 
 
(12
)
 
 
(114
)
Other R&D expenses
 (income)
 
 
(7
)
 
 
60
 
 
 
(7
)
 
 
82
 
Costs related to regulatory actions taken in facilities
 
 
11
 
 
 
1
 
 
 
28
 
 
 
6
 
Legal settlements and loss contingencies
 
 
468
 
 
 
19
 
 
 
1,171
 
 
 
(1,239
)
Other unallocated amounts
 
 
72
 
 
 
84
 
 
 
201
 
 
 
226
 
Consolidated operating income (loss)
 
 
(81
)
 
 
16
 
 
 
(591
)
 
 
1,527
 
Financial expenses, net
 
 
211
 
 
 
229
 
 
 
635
 
 
 
736
 
Consolidated income (loss) before income taxes
 
$
(292
)
 
$
(213
)
 
$
(1,226
)
 
$
791
 
 
Three months
 
ended
March 31,
 
 
2020
 
 
2019
 
 
(U.S. $ in millions)
 
North America profit
 $
550
  $
498
 
Europe profit
  
502
   
403
 
International Markets profit
  
156
   
97
 
         
Total reportable segments profit
  
1,208
   
998
 
Profit of other activities
  
36
   
21
 
         
Total segments profit
  
1,244
   
1,019
 
Amounts not allocated to segments:
      
Amortization
  
258
   
283
 
Other assets impairments, restructuring and other items
  
121
   
1
 
Intangible asset impairments
  
649
   
469
 
Legal settlements and loss contingencies
  
(25
)  
57
 
Other unallocated amounts
  
49
   
75
 
Consolidated operating income (loss)
  
191
   
134
 
Financial expenses, net
  
224
   
218
 
Consolidated income (loss) before income taxes
 $
(33
) $
(84
)
         
b. Segment revenues by major products and activities:
The following tables present revenues by major products and activities for the three months ended March 31, 2020 and the nine months ended September 30, 2019 and 2018:2019:
North America
 
Three months ended
March 31,
 
     
2020
  
2019
 
 
Three months ended
September 30,
  
(U.S. $ in millions)
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
No
rth Ameri
ca
 
 
 
 
 
 
 
 
Generic products
 $
914
  $
922
  $
952
  $
966
 
AJOVY
  
29
   
20
 
AUSTEDO
  
122
   
74
 
BENDEKA/TREANDA
  
105
   
122
 
COPAXONE
  
271
   
463
   
198
   
208
 
BENDEKA/TREANDA
  
124
   
161
 
ProAir*
  
71
   
107
   
59
   
59
 
QVAR
  
60
   
36
   
45
   
64
 
AJOVY
  
25
   
—  
 
AUSTEDO
  
105
   
62
 
Anda
  
351
   
333
   
426
   
379
 
Other
  
131
   
182
   
146
   
155
 
              
Total
 $
2,051
  $
2,265
  $
2,082
  $2,047 
              
*Does not include sales ofrevenues from the ProAir authorized generic, which are included under genericsgeneric products.
         
  
Nine months ended
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
North America
 
 
 
 
 
 
 
 
Generic products
 $
2,826
  $
 
 
2,957
 
COPAXONE
  
753
   
1,403
 
BENDEKA/TREANDA
  
353
   
502
 
ProAir*
  
194
   
352
 
QVAR
  
183
   
173
 
AJOVY
  
68
   
—  
 
AUSTEDO
  
276
   
136
 
Anda
  
1,080
   
984
 
Other
  
436
   
554
 
         
Total
 
$
 
6,169
 
 
$
7,059
 
         
*Does not include sales of ProAir authorized generic, which are included under generics products.
4
1
3
6

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
    
Europe
 
Three months
 
ended
March 31,
 
     
2020
  
2019
 
 
Three months ended
September 30,
  
(U.S. $ in millions)
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
Europe
        
Generic products
 $
836
  $
845
  $1,032  $919 
COPAXONE
  
106
   
124
   
109
   
114
 
Respiratory products
  
87
   
93
   
106
   
91
 
AJOVY
  
4
   
 
Other
  
134
   
150
   
151
   
140
 
            
Total
 $
1,163
  $
1,212
  $
1,402
  $
1,264
 
            
         
  
Nine months ended
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
Europe
        
Generic products
 $
2,599
  $
2,749
 
COPAXONE
  
327
   
417
 
Respiratory products
  
267
   
312
 
Other
  
417
   
504
 
         
Total
 $
3,611
  $
3,982
 
         
         
  
Three months ended
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
International markets
        
Generic products
 $
474
  $
498
 
COPAXONE
  
20
   
14
 
Distribution
  
176
   
149
 
Other
  
66
   
65
 
         
Total
 
$
 
736
  
$
 
726
 
         
         
  
Nine months ended
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
International markets
        
Generic products
 $
1,404
  $
1,523
 
COPAXONE
  
46
   
52
 
Distribution
  
491
   
456
 
Other
  
204
   
233
 
         
Total
 $
2,145
  $
2,265
 
         
 
International markets
*
 
Three months
 
ended
March
 31,
 
 
 
2020
  
2019
 
 
 
(U.S. $ in millions)
 
Generic products
 $
449
  $
441
 
COPAXONE
  
12
   
13
 
Other
  
104
   
67
 
         
Total
 $
 
 
 
565
  $
 
 
 
521
 
         
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 launch of generic competition, even in the form of
non-equivalent
products, can result in a substantial decrease in revenues for a particular specialty medicine in a very short time. Any expiration or loss of such intellectual property rights could therefore significantly adversely affect Teva’s results of operations and financial condition.
42
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c for additional information.
37
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 1816Other income:Fair value measurement:
Financial items carried at fair value as of March 31, 2020 and December 31, 2019 are classified in the tables below in one of the three categories of fair value levels:
                 
 
Three months ended
 
September 30,
  
Nine months ended
 
September 30,
 
 
2019
  
2018
  
2019
  
2018
 
 
(U.S. $ in millions)
  
(U.S. $ in millions)
 
Gain
 
on divestitures, net of divestitures related costs (1)
 
$
3
 
 
 
31
 
 
$
12
 
 
 
114
 
Section 8 and similar payments (2)
 
 
 
 
 
1
 
 
 
 
 
 
195
 
Gain (loss) on sale of assets
 
 
3
 
 
 
1
 
 
 
(1
)
 
 
9
 
Other, net
 
 
8
 
 
 
2
 
 
 
19
 
 
 
16
 
Total other income
 
$
14
 
 
$
35
 
 
$
29
 
 
$
334
 
                 
 
March 31, 2020
 
 
Level 1
  
Level 2
  
Level 3
  
Total
 
 
(U.S. $ in millions)
 
Cash and cash equivalents:
            
Money markets
 $
260
  $
  $
  $
260
 
Cash, deposits and other
  
1,544
   
   
   
1,544
 
Investment in securities:
            
Equity securities
  
31
   
   
   
31
 
Other, mainly debt securities
  
2
   
   
12
   
14
 
Derivatives:
            
Asset derivatives—options and forward contracts
  
   
104
   
   
104
 
Liability derivatives—options and forward contracts
  
   
(94
)  
   
(94
)
Contingent consideration*
  
   
   
(435
)  
(435
)
                 
Total
 $
1,837
  $
10
  $
(423
) $
1,424
 
                 
    
 
December 31, 2019
 
 
Level 1
  
Level 2
  
Level 3
  
Total
 
 
(U.S. $ in millions)
 
Cash and cash equivalents:
            
Money markets
 $
577
  $
—  
  $
—  
  $
577
 
Cash, deposits and other
  
1,398
   
—  
   
—  
   
1,398
 
Investment in securities:
            
Equity securities
  
42
   
—  
   
—  
   
42
 
Other, mainly debt securities
  
2
   
—  
   
12
   
14
 
Derivatives:
            
Asset derivatives—options and forward contracts
  
—  
   
32
   
—  
   
32
 
Liability derivatives—options and forward contracts
  
—  
   
(41
)  
—  
   
(41
)
Liability derivatives—interest rate and cross-currency swaps
  
—  
   
(22
)  
—  
   
(22
)
Contingent consideration*
  
—  
   
—  
   
(460
)  
(460
)
                 
Total
 $
2,019
  $
(31
 $
(448
) $
1,540
 
                 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
(1)*Mainly related to the divestment of the women’s health business and the dissolution of PGTContingent consideration represents liabilities recorded at fair value in 2018.connection with acquisitions.
 
 
 
 
 
 
 
 
(2)Section 8 of the Patented Medicines (Notice of Compliance) Regulation relates to recoveries of lost revenue related to patent infringement proceedings in Canada.
NOTE 19 – Income taxes:
In the third quarter of 2019, Teva recognized a tax
expense
 of
$
11
 million
,
 on
pre-tax
loss
of
$
292
 million
. In the third quarter of 2018, Teva recognized a tax benefit of
$
26
 million
, or 12%, on
pre-tax
loss of
$
213
million
. Teva’s tax rate for the third quarter of 2019 was mainly affected by impairments, amortization
, legal settlements with low corresponding tax effect
 and interest disallowance as a result of the U.S. Tax Cuts and Jobs Act.
In the first
nine
months of 2019, Teva recognized a tax benefit of
$
159
 million
, or 13%, on
pre-tax
loss of
$
1,226
million
. In the first
nine
months of 2018, Teva recognized a tax benefit of
$
56
million 
on
pre-tax
income of
$
791
 million
. Teva’s tax rate for the first
nine
 months of 2019 was mainly affected by impairments, amortization
, legal settlements with low corresponding tax effect
and interest disallowance as a result of the U.S. Tax Cuts and Jobs Act.
The statutory Israeli corporate tax rate is 23
%
in 2019.
Teva’s tax rate differs from the Israeli statutory tax rate, mainly due to generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate, tax benefits in Israel and other countries, as well as infrequent or nonrecurring items.
Teva filed a claim seeking the refund of withholding taxes paid to the Indian tax authorities in 2012. Trial in this case is scheduled to begin in November 2019. A final and binding decision against Teva in this case may lead to an impairment in the amount of $146 million.
NOTE 20 – Leases:
Leases prior to the adoption of the new Lease Standard
Teva leases real estate, cars and equipment for use in its operations, which are classified as operating leases. In addition to rent, the leases may require Teva to pay directly for fees, insurance, maintenance and other operating expenses. Rental expense for the nine months ended September 30, 201
8
 and the 12 months ended December 31, 201
8
, was $131 million and $175 million, respectively. The Company also has capital leases for properties.
Leases following the adoption of the new Lease Standard
Teva adopted the new accounting standard ASC 842 “Leases” and all the related amendments on January 1, 2019 and used the effective date as Teva’s date of initial application.
Teva determines if an arrangement is a lease at inception. Lease classification is governed by five criteria in ASC 842-10-25-2. If any of these five criteria is met, Teva classifies the lease as a finance lease. Otherwise, Teva classifies the lease as an operating lease. When determining lease classification, Teva’s approach in assessing two of the mentioned criteria is: (i) generally 75% or more of the remaining economic life of the underlying asset is a major part of the remaining economic life of that underlying asset; and (ii) generally 90% or more ofdetermined the fair value of the underlying asset comprises substantially allliability 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 United States and Europe, and the risk adjusted discount rate for fair value measurement.
A probability of success factor ranging from 80% to 100% was used in the fair value calculation to reflect inherent regulatory and commercial risk of the contingent payments and IPR&D. The discount rate applied ranged from 8% to 9
%. The weighted average discount rate, calculated based on the relative fair value of our contingent consideration obligations, was 8.6%.
The contingent consideration is evaluated quarterly, or more frequently, if circumstances dictate. Changes in the fair value of the underlying asset.
Operating leasescontingent consideration are includedrecorded in operating lease
right-of-use
(“ROU”) assets, other current liabilities, and operating lease liabilities in the consolidated balance sheets. Finance leases are included in property, plant and equipment, other current liabilities, and other long-term liabilities in the consolidated balance sheets. Finance leases of land include long-term leasehold rights in various locations, with useful lives between 30 and 99 years.
4
3
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.
The following table summarizes the activity for those financial assets and liabilities where fair value measurements are estimated utilizing Level 3 inputs:
38

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
ROU assets represent Teva’s right to use an underlying asset for the lease term and lease liabilities represent Teva’s obligation to make lease payments arising from the lease. Operating and finance lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. Teva uses its incremental borrowing rate based on the information available at the commencement date to determine the present value of the lease payments.
For finance leases, Teva recognizes interest on the lease liability separately from amortization of the ROU assets in the statement of comprehensive income. For operating leases, lease expenses are recognized on a straight-line basis over the lease term.
The new standard also provides practical expedients for an entity’s ongoing accounting. Teva elected the short-term lease recognition exemption for all leases with a term shorter than 12 months. This means that for those leases, Teva does not recognize ROU assets or lease liabilities, including not recognizing ROU assets or lease liabilities for existing short-term leases of those assets in transition, but recognizes lease expenses over the lease term on a straight line basis. Teva also elected the practical expedient to not separate lease and
non-lease
components for all of Teva’s leases, other than leases of real estate.
Lease terms will include options to extend or terminate the lease when it is reasonably certain that Teva will exercise or not exercise the option to renew or terminate the lease.
Teva’s lease agreements have remaining lease terms ranging from 1 year to 80 years. Some of these agreements include options to extend the leases for up to 15 years and some include options to terminate the leases immediately. Certain leases also include options to purchase the leased property.
The depreciable life of leasehold improvements is limited by the expected lease term, unless there is a transfer of title or a purchase option for the leased asset reasonably certain of exercise.
Some of Teva’s vehicle lease agreements include rental payments based on the actual usage of the vehicles and other lease agreements include rental payments adjusted periodically for inflation. Teva’s lease agreements do not contain any material residual value guarantees.
The new Lease Standard will have no impact on Teva’s debt-covenant compliance under its RCF.
Teva rents out or subleases certain real estate to third parties, which has an immaterial impact on Teva’s consolidated financial statements.
The components of operating lease cost for the three months ended and nine months ended September 30, 2019 were as follows:
         
 
Three months
ended
 
September 30,
  
Nine months
ended
 
September 30,
 
 
2019
 
 
(U.S. $ in millions)
 
Operating lease cost:
      
Fixed payments and variable payments that depend on an index or rate
 $
45
  $
123
 
Variable lease payments not included in the lease liability
  
 
 
   
4
 
Short-term lease cost
  
1
   
4
 
         
Total operating lease cost
 $
46
  $
131
 
         
Supplemental cash flow information related to operating leases was as follows:
    
Nine months ended
 
September 30, 
2019
 
(U.S. $ in millions)
 
Cash paid for amounts included in the measurement of lease
liabilities:
  
Operating cash flows from operating leases
$
130
 
Right-of-use
assets obtained in exchange for lease obligations
(non-cash):
  
Operating leases
$
70
 
     
 
Three months ended
March 31, 2020
 
 
(U.S. $ in millions)
 
Fair value at the beginning of the period
 $
(448
)
Adjustments to provisions for contingent consideration:
   
Actavis Generics transaction
  
(5
)
Eagle transaction
  
(1
)
Settlement of contingent consideration:
   
Eagle transaction
  
31
 
     
Fair value at the end of the period
 $
(423
)
     
 
 
 
 
 
 
 
 
44
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 (level 1 inputs):

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Supplemental balance sheet information related to operating leases was as follows:
     
September 30, 2019
 
(U.S. $ in millions)
 
Operating leases:
 $ 
Operating lease ROU assets
  
468
 
Other current liabilities
  
116
 
Operating lease liabilities
  
394
 
     
Total operating lease liabilities
 $
510
 
 
 
     
     
   
 
September 30, 2019
 
Weighted average remaining lease term
   
Operating leases
  
7.4
 years
 
Weighted average discount rate
   
Operating leases
  
5.9
%
         
 
Fair value*
 
 
March 31,
  
December 31,
 
 
2020
  
2019
 
 
(U.S. $ in millions)
 
Senior notes included under senior notes and loans
 $
21,960
  $
22,686
 
Senior notes and convertible senior debentures included under short-term debt
  
1,583
   
2,318
 
         
Total
 $
23,543
  $
25,004
 
         
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Maturities of operating lease liabilities were as follows:
     
 
September 30,
 
2019
 
 
(U.S. $ in millions)
 
2019 (excluding the nine months ended September 30, 2019)
 $
38
 
2020
  
128
 
2021
  
98
 
2022
  
73
 
2023
  
51
 
2024 and thereafter
  
253
 
     
Total operating lease payments
 $
641
 
Less: imputed interest
  
131
 
     
Present value of lease liabilities
 $
510
 
     
    
 
December 31,
 
2018
 
 
(U.S. $ in millions)
 
2019
 $
193
 
2020
  
154
 
2021
  
118
 
2022
  
91
 
2023
  
66
 
2024 and thereafter
  
283
 
     
Total lease payments
 $
905
 
     
*Based on quoted market price. See note 7 for carrying value.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
As of September 30, 2019, Teva has additional operating leases for office space which have yet to commence, with undiscounted future payments of $92 million. These operating leases will commence during fiscal year 
2020
with lease terms of 9 to 12 years.
On October 10, 2019, Teva entered into an agreement to sell and lease back the land and building of its distribution center in Israel. Net proceeds from the asset sale amounted to $
128
 million.39
As of September 30, 2019, Teva’s total finance lease assets and finance lease liabilities are $77 million and $29 million, respectively. The difference between those amounts is mainly due to prepaid payments.
45

ITEM 2.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
 
 
Business Overview
We are a global pharmaceutical company, committed to helping patients around the world to access affordable medicines and benefit from innovations to improve their health. Our mission is to be a global leader in generics, specialty medicines and biopharmaceuticals, improving the lives of patients.
We operate worldwide, with headquarters in Israel and a significant presence in the United States, Europe and many other markets around the world. Our key strengths include our world-leading generic medicines expertise and portfolio, focused specialty medicines portfolio and global infrastructure and scale.
Teva was incorporated in Israel on February 13, 1944 and is the successor to a number of Israeli corporations, the oldest of which was established in 1901.
Our Business Segments
We operate our business through three segments: North America, Europe and International Markets. Each business segment manages our entire product portfolio in its region, including generics, specialty medicines and OTC products. This structure enables strong alignment and integration between operations, commercial regions, R&D and our global marketing and portfolio function, optimizing our product lifecycle across therapeutic areas.
In addition to these three segments, we have other activities, primarily the sale of APIsAPI to third parties, and certain contract manufacturing services.services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis.
The
COVID-19
Pandemic
In December 2017,As a leading global pharmaceutical company, Teva provides essential medicines to millions of patients around the world every day. Our priorities remain focused on the health and well-being of our employees and on our responsibility to continue to provide our medicines to the nearly 200 million patients who depend on us every day. 
Our industry plays a critical role, particularly during such challenging times. We are working with governments to do all they can, in partnership with our industry, to maintain the development, production, supply and distribution of high quality medicines for patients worldwide during this unprecedented global health crisis.
Business Continuity
The supply chain supporting our key products – specialty, generics and API – remains largely uninterrupted, and with adequate product inventory across our network. Additionally, based on analysis of potential scenarios, we announcedcurrently have inventory and redundancy plans in place to address potential shortfalls, if any. We are closely monitoring the evolving situation in our key manufacturing locations and commercial markets, and are accordingly adapting our business continuity plans. All our facilities that research, manufacture, order, pack, distribute and provide critical customer and patient services are currently functioning to meet demand for essential medicines for patients throughout the world.
Teva has worked since the early days of the
COVID-19
pandemic to support efforts of governments and health services to curb the impact of the virus. Our global manufacturing network has been tirelessly focused on securing and scaling production of both API and finished doses for potential treatments that may prove essential in treating the condition nearly everywhere Teva does business. Teva will continue to work with governments and international organizations throughout the world to support emerging needs related to this crisis, while doing everything possible to also continue to supply our vast portfolio of medicines to patients.
R&D and New Launches
We do not expect a comprehensive restructuring planmaterial impact on our ongoing clinical research programs and product launches as a result of the
COVID-19
pandemic; however, if the pandemic continues for an extended period of time, we may experience delays in clinical trials due to cessation of recruitment for patient studies and suspended regulatory inspections, delays in regulatory approvals of new products due to reduced capacity or
re-prioritization
of regulatory agencies and delays in
pre-commercial
launch activities. All of our new product launches have been risk-assessed based on upcoming manufacturing and regulatory inspections.
Workforce Policy and Measures
Our employees across all aspects of our business are safeguarding the continuity of our activities and we are committed to supporting their efforts and caring for their personal health and safety. We are enacting appropriate measures to ensure the safe supply and transport of our medicines and APIs, and have established measures intended to significantly reduceensure our cost base, unifysites remain open, allowing us to maintain our business, R&D and simplifymanufacturing operations. We have reduced the number of people in our organizationfacilities to only those who are essential and improve business performance, profitability, cash flow generation and productivity. This plan is intendedmay not work remotely. By doing our part to reduce proximity to one another, we hope to better protect our total cost base by $3 billionoverall workforce, and ultimately, the communities in which we live.
40

As we work through this health crisis, we are starting to plan our strategy for returning to usual operations at all organizational levels, under guiding principles to protect our business, maximize organizational productivity and efficiency while simultaneously ensuring a safe workplace.
Trends
We have limited insight into the extent to which our business may be impacted by the end
COVID-19
pandemic and there are many unknowns facing our industry and society at large. At this stage of 2019.
the pandemic, we are not experiencing material delays in development, production and distribution of medicines or disruptions in our supply chains; however, longer term affects cannot be predicted at this time and would depend on the duration and severity of the pandemic and the restrictive measures put in place to control its impact. We are experiencing increasing demand for certain medicines, as would be expected during a global crisis of this nature, and cannot assess whether such increased demand is the result of stocking by wholesalers or patients. Although no one can predict future demand for pharmaceutical products, market dynamics or the scope or duration of the financial and other challenges arising from the pandemic, it is possible that we will see a compensating effect during the remainder of the year, but we do not currently anticipate a material negative impact on our 2020 financial results due to the evolving global pandemic.
Highlights
Significant highlights in the thirdfirst quarter of 20192020 included:
Revenues in the thirdfirst quarter of 20192020 were $4,264$4,357 million, a decreasean increase of 6%5%, or 5% in both U.S. dollar and local currency terms, compared to the thirdfirst quarter of 2018,2019, mainly due to generic competition to COPAXONE
®
, a decline inhigher revenues from BENDEKA
®
/ TREANDA
®
generics and certain other specialty productsOTC sales in the United States, as well as declines in revenues in Russia and Japan, partially offset byEurope, higher revenues from AUSTEDO
®
, AJOVYand Anda in North America and higher revenues from our International Markets segment, partially offset by lower revenues from generics in the U.S. and lower revenues from QVAR
®
and QVARBENDEKA
®
/TREANDA
®
in the United States.North America.
 
 
Our North America segment generated revenues of $2,051$2,082 million and profit of $565$550 million in the thirdfirst quarter of 2019.2020. Revenues decreasedincreased by 9%2% compared to the thirdfirst quarter of 2018,2019, mainly due to a declinean increase in revenues from COPAXONEof AUSTEDO and certain other specialty products,Anda as well as a milestone payment related to our anti-CGRP intellectual property, partially offset by higherlower revenues from AUSTEDO, AJOVY QVAR, BENDEKA/TREANDA, COPAXONE
®
and QVAR.generic products. Profit decreasedincreased by 13%10%, mainly due to the changes in revenues described above, partially offset by cost reductions and efficiency measures as part of the restructuring plan.above.
 
 
Our Europe segment generated revenues of $1,163$1,402 million and profit of $341$502 million in the thirdfirst quarter of 2019.2020. Revenues decreasedincreased by 4%11%. In local currency terms, revenues were flatincreased by 13% compared to the thirdfirst quarter of 2018,2019, mainly due to stronghigher demand for certain products resulting from the impact of the
COVID-19
pandemic on purchasing patterns as well as continuing growth in generics and new generic product launches, and higher salespartially offset by price declines for oncology products as a result of OTC products, mostly offset bygeneric competition and a decline in COPAXONE revenues due to competing glatiramer acetate products. Profit increased by 15%25%, mainly due to strong new generic product launches, cost reductionshigher revenues and efficiency measures as part of the restructuring plan, partially offset by the impact of currency fluctuations.lower expenses.
 
 
Our International Markets segment generated revenues of $736$565 million and profit of $130$156 million in the thirdfirst quarter of 2019.2020. Revenues increased by 1%8% in both U.S. dollars andor 5% in local currency terms, compared to the thirdfirst quarter of 2018.2019. The increase in revenues was mainly due to higher distribution activitiessales in Israel,Latin America, Asia-Pacific, Ukraine and Russia, partially offset by lower sales in Japan and Russia.Japan. The revenues in the first quarter of 2020 included $35 million from a positive hedging impact. Profit increased by 6%61%, mainly due to cost reductionshigher sales and efficiency measures as part of the restructuring plan.
positive impact from hedging activity.
 
 
Intangible asset impairments
Impairment of identifiable intangible assets were $177$649 million in the thirdfirst quarter of 2019,2020, compared to $519$469 million in the thirdfirst quarter of 2018. The impairment2019. Impairment expenses in the thirdfirst quarter of 20192020 related to IPR&D assets were related to$331 million and identifiable product rights of $99 million and IPR&D assets of $78were $318 million. These impairments were mainly related to products acquired from Actavis Generics in the United States and Hong Kong.
 
 
Operating loss was $81 million
No goodwill impairments were recorded in the third quarterfirst quarters of 2019, compared to income of $16 million in the third quarter of 2018. The decrease was mainly due to higher provisions in connection with legal settlementsboth 2020 and loss contingencies, partially offset by lower intangible asset impairments, lower R&D expenses and higher profit in our Europe segment.
2019.
 
 
We recorded expenses of $121 million for other asset impairments, restructuring and other items in the first quarter of 2020, compared to expenses of $1 million in the first quarter of 2019.
In the thirdfirst quarter of 2019,2020, we recorded an expenseincome of $468$25 million in legal settlements and loss contingencies, compared to $19an expense of $57 million in the thirdfirst quarter of 2018.2019. The expenseincome in the thirdfirst quarter of 20192020 was mainly related to a settlement of an increase inaction brought against the estimated settlement provision recorded in connection with the remaining opioid cases.sellers of Auden McKenzie (an acquisition made by Actavis Generics).
 
 
Operating income was $191 million in the first quarter of 2020, compared to $134 million in the first quarter of 2019. The increase in the first quarter of 2020 was mainly due to higher profit in our Europe, International Markets and North America segments and income from legal settlements (compared to an expense in the first quarter of 2019), partially offset by higher intangible asset impairments and higher other assets impairments, restructuring and other items in the first quarter of 2020.
 
 
41

Financial expenses were $224 million in the first quarter of 2020, compared to $218 million in the first quarter of 2019. Financial expenses in the first quarter of 2020 were mainly comprised of interest expenses of $241 million. Financial expenses in the first quarter of 2019 were mainly comprised of interest expenses of $227 million.
In the first quarter of 2020, we recognized a tax benefit of $59 million, on
pre-tax
loss of $33 million. In the first quarter of 2019, we recognized a tax expense of $9 million, on
pre-tax
loss of $84 million. Our tax rate for the first quarter of 2020 was mainly affected by impairments in jurisdictions in which tax rates are higher than Teva’s average tax rate 
on
its ongoing business operations
.
Exchange rate movements between the thirdfirst quarter of 2020 and the first quarter of 2019, and the third quarternet of 2018hedging, negatively impacted overall revenues by $55$3 million and positively impacted operating income by $19$27 million.
 
 


As of September 30, 2019,March 31, 2020, our debt was $26,942$26,103 million, compared to $28,726$26,908 million as of June 30,December 31, 2019. TheThis decrease was mainly due to repayment at maturity of our $1,556$700 million 1.7%2.25% senior notes, as well as decreased exchange rate fluctuations.
 
 
Cash flow generated from operating activities during the thirdfirst quarter of 20192020 was $325$305 million, compared to $421$112 million in the thirdfirst quarter of 2018. The decrease2019. This increase in cash flow in the thirdfirst quarter of 20192020 was mainly due to higher operating profit in each of our three segments, as well as lower revenues and a reductionperformance incentive payments to employees paid in sales reserves associated with the revenue decline.
first quarter of 2020, compared to the amounts paid in the first quarter of 2019.
 
 
Cash
During the first quarter of 2020, we generated free cash flow of $551 million, which we define as comprising $305 million in cash flow generated from operating activities, $368 million in the third quarter of 2019, net of cash received for capital investments and beneficial interest collected in exchange for securitized tradeaccounts receivables was $551and $6 million in proceeds from sale of property, plant and equipment and intangible assets, partially offset by $128 million in cash used for capital investment. This increase compared to $704 million in the third quarter of 2018. The decrease in cash flow in the thirdfirst quarter of 2019, wasresulted mainly due to the reasons mentioned above, as well asfrom higher capital investments during the third quartercash flow generated from operating activities, including significant consumption of 2019 compared to the third quarter of 2018.
inventories.
 
 
Transactions
On October 10, 2019, we entered into an agreement to sell and lease back the land and building of our distribution center in Israel. Net proceeds from the asset sale amounted to $128 million. See also note 20 to our consolidated financial statements.
Changes in Senior Management
In August 2019, we announced the departure of Mr. Michael McClellan from his role as Executive Vice President and Chief Financial Officer. On November 7, 2019, we announced that Mr. Eli Kalif was appointed Executive Vice President and Chief Financial Officer and a member of Teva Executive Management, effective December 22, 2019. In the interim period between Mr. McClellan’s departure on November 8, 2019 and the beginning of Mr. Kalif’s service on December 22, 2019, our President and Chief Executive Officer, Mr. Kåre Schultz, will perform the chief financial officer’s functions. 
In October 2019, we announced the departure of Dr. Carlo de Notaristefani from his role as Executive Vice President, Global Operations. Effective October 2, 2019, Mr. Eric Drapé was appointed Executive Vice President, Global Operations and a member of Teva Executive Management. Prior to this appointment, Mr. Drapé served as Executive Vice President and Chief Quality Officer.
In October 2019, Iris Beck-Codner stepped down from her role as Executive Vice President, Global Brand and Communications. Mark Sabag, Executive Vice President, Global Human Resources, assumed the responsibilities of the Global Brand and Communications function.
Results of Operations
Comparison of Three Months Ended September 30, 2019March 31, 2020 to Three Months Ended September 30, 2018March 31, 2019
The following table sets forth, for the periods indicated, certain financial data derived from our financial statements:statements, presented according to generally accepted accounting principles in the United States (“U.S. GAAP”), presented as percentages of net revenues, and the percentage change for each item as compared to the previous year:
      
 
Percentage of Net Revenues
  
Percentage
Change
 
 
Three Months Ended
       
 
September 30,
  
Percentage of Net Revenues
Three Months Ended
March 31,
 
Percentage
Change
 
 
2019
  
2018
  
2019
 -
 2018
  
2020
  
2019
  
2020 - 2019
 
 
%
  
%
  
%
  
%
  
%
  
%
 
Net revenues
  
100
   
100
   
(6
)  
100
   
100
   
5
 
Gross profit
  
43
   
44
   
(7
)  
47
   
45
   
11
 
Research and development expenses
  
6
   
7
   
(23
)  
5
   
6
   
(15
)
Selling and marketing expenses
  
14
   
15
   
(15
)  
14
   
16
   
(5
)
General and administrative expenses
  
7
   
7
   
(8
)  
7
   
7.0
   
4
 
Intangible assets impairment
  
4
   
11
   
(66
)
Intangible assets impairments
  
15
   
11
   
38
 
Other assets impairments, restructuring and other items
  
4
   
3
   
15
   
3
   
§
   
NA
 
Legal settlements and loss contingencies
  
11
   
§
   
NA
   
(1
)  
1
   
NA
 
Other income
  
§
   
(1
)  
—  
 
Operating income (loss)
  
(2
)  
§
   
—  
 
Other income (loss)
  
§
   
§
   
115
 
Operating income
  
4
   
3
   
43
 
Financial expenses, net
  
5
   
5
   
(8
)  
5
   
5
   
3
 
Income (loss) before income taxes
  
(7
)  
(5
)  
37
   
(1
)  
(2
)  
(61
)
Income taxes (benefit)
  
§
   
(1
)  
—  
   
(1
)  
§
   
—  
 
Share in losses (income) of associated companies, net
  
§
   
§
   
NA
 
Share in losses (profits) of associated companies, net
  
§
   
§
   
NA
 
Net income attributable to
non-controlling
interests
  
§
   
§
   
NA
   
(1
)  
§
   
NA
 
Net income (loss) attributable to Teva
  
(7
)  
(5
)  
51
   
2
   
(3
)  
—  
 
Dividends on preferred shares
  
—  
   
1
   
NA
 
Net income (loss) attributable to ordinary shareholders
  
(7
)  
(6
)  
15
   
2
   
(3
)  
—  
 
 
 
 
§Represents an amount less than 0.5%.
 
 

42

Segment Information
North America Segment
The following table presents revenues, expenses and profit for our North America segment for the three months ended September 30, 2019March 31, 2020 and 2018:2019:
                
 
Three months ended September 30,
  
Three months ended March 31,
 
 
2019
 
2018
  
2020
 
2019
 
 
(U.S. $ in millions / % of Segment Revenues)
  
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
 $
 
 
 
2,051
   
100
% $
 
 
2,265
   
100.0
% $
2,082
   
100
% $
2,047
   
100.0
%
Gross profit
  
1,048
   
51.1
%  
1,196
   
52.8
%  
1,062
   
51.0
%  
1,039
   
50.8
%
R&D expenses
  
156
   
7.6
%  
158
   
7.0
%  
146
   
7.0
%  
165
   
8.1
%
S&M expenses
  
219
   
10.7
%  
265
   
11.7
%  
251
   
12.1
%  
268
   
13.1
%
G&A expenses
  
112
   
5.5
%  
128
   
5.7
%  
118
   
5.6
%  
112
   
5.5
%
Other (income) expense
  
(5
)  
§
   
(4
)  
§
   
(2
)  
§
   
(4
)  
§
 
                        
Segment profit*
 $
 
 
565
   
 
 
27.5
% $
 
649
   
 
 
28.7
% $
550
   
26.4
% $
498
   
24.3
%
                        
 
 
 
*Segment profit does not include amortization and certain other items.
 
 
§Represents an amount less than 0.5%.
 
 
North America Revenues
Our North America segment includes the United States and Canada. Revenues from our North America segment in the thirdfirst quarter of 20192020 were $2,051$2,082 million, a decreasean increase of $214$36 million, or 9%2%, compared to the thirdfirst quarter of 2018,2019, mainly due to a declinean increase in revenues of COPAXONEAUSTEDO and certain other specialty products,Anda as well as a milestone payment related to our anti-CGRP intellectual property (see note 2 to our consolidated financial statements), partially offset by higherlower revenues from AUSTEDO, AJOVYQVAR, BENDEKA/TREANDA, COPAXONE and QVAR.generic products.
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 September 30, 2019March 31, 2020 and 2018:2019:
            
 
Three months ended
September 30,
 
Percentage
Change
  
Three months ended
March 31,
 
Percentage
Change
 
 
2019
  
2018
  
2019-2018
  
2020
  
2019
  
2019-2020
 
 
(U.S. $ in millions)
   
(U.S. $ in millions)
  
Generic products
 $
914
  $
922
   
(1
%) $
952
  $
966
   
(1
%)
COPAXONE
  
271
   
463
   
(41
%)
BENDEKA/TREANDA
  
124
   
161
   
(23
%)
ProAir
®
*
  
71
   
107
   
(34
%)
QVAR
  
60
   
36
   
68
%
AJOVY
  
25
   
—  
   
NA
   
29
   
20
   
44
%
AUSTEDO
  
105
   
62
   
71
%  
122
   
74
   
64
%
BENDEKA/TREANDA
  
105
   
122
   
(14
%)
COPAXONE
  
198
   
208
   
(5
%)
ProAir*
  
59
   
59
   
1
%
QVAR
  
45
   
64
   
(29
%)
Anda
  
351
   
333
   
5
%  
426
   
379
   
13
%
Other
  
131
   
182
   
(28
%)  
146
   
155
   
(6
%)
                 
Total
 $
2,051
  $
2,265
   
(9
%) $
2,082
  $
2,047
   
2
%
                
 
 
 
*Does not include sales ofrevenues from the ProAir authorized generic, which are included under genericsgeneric products.
 
 
Generic products
revenues in our North America segment (including biosimilars) in the thirdfirst quarter of 20192020 were $914$952 million, flata decrease of 1% compared to the thirdfirst quarter of 2018,2019. This decrease was mainly due to new generic product launches, offset by market dynamics, including product mix and price erosion in our U.S. generics business.product portfolio and lower royalty income, offset by an increase in revenues from launches of new products, including TRUXIMA and from our ProAir
®
authorized generic due to higher demand related to the
COVID-19
pandemic.
43

Among the most significant generic products we sold in North America in the thirdfirst quarter of 20192020 were albuterol sulfate inhalation aerosol (ProAir HFA authorized generic of our specialty product), epinephrine injectioninjectable solution (the generic equivalent of EpiPen
®
and EpiPen Jr.
®
), albuterol sulfate inhalation aerosol (ProAirTRUXIMA (the biosimilar to Rituxan
®
HFA authorized generic of Teva’s specialty product)), lidocaine transdermal patch (the generic equivalent of Lidoderm Patch
®
), and amphetamine salt tablets (the generic equivalent of Adderall IR
®
) and icatibant acetate injection.
We launched HERZUMA for Injection (the generic equivalent of Firazyrbiosomilar to Herceptin
®
). in the United States in March 2020. HERZUMA and TRUXIMA were also launched in Canada in January 2020 and February 2020, respectively. On May 4, 2020, TRUXIMA became available in the U.S. for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis (Wegener’s Granulomatosis) and microscopic polyangiitis.
In the thirdfirst quarter of 2019,2020, we led the U.S. generics market in total prescriptions and new prescriptions, with approximately 391389 million total prescriptions (based on trailing twelve months), representing 10.6%10.4% of total U.S. generic prescriptions according to IQVIA data.
AJOVY
®
revenues in our North America segment in the first quarter of 2020 were $29 million, an increase of $9 million, or 44% compared to the first quarter of 2019, mainly due to growth in volume in the first quarter of 2020. AJOVY was approved by the FDA and launched in the United States in September 2018 for the preventive treatment of migraine in adults. On January 27, 2020, the FDA approved an auto-injector device for AJOVY in the U.S., which became commercially available in April 2020. In addition, AJOVY was approved in Canada on April 14, 2020.

On May 12, 2017, we entered into a license and collaboration agreement with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) providing Otsuka with an exclusive license to conduct phase 2 and 3 clinical trials for AJOVY in Japan and, once approved, to commercialize the product in Japan. Results for these trials were received in January 2020 indicating that primary and secondary endpoints were achieved and that no clinically significant adverse events were observed in subjects.
AJOVY is also in clinical development to evaluate safety and efficacy in the treatment of post traumatic headache and fibromyalgia.

TableAJOVY is protected by patents expiring in 2026 in Europe and in 2027 in the United States. Applications for patent term extensions have been submitted in various markets around the world. An additional patent relating to the use of ContentsAJOVY in the treatment of migraine is issued in the United States and will expire in 2035. This patent is also pending in other countries. AJOVY will also be protected by regulatory exclusivity for 12 years from marketing approval in the United States and 10 years from marketing approval in Europe.
We have filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.’s (“Lilly”) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents. Lilly has also submitted IPR (inter partes review) petitions to the Patent Trial and Appeal Board, challenging the validity of the nine patents asserted against it in the litigation. The litigation in the district court was stayed pending resolution of the IPR petitions. On February 18, 2020, the Patent Trial and Appeal Board issued decisions on the first six IPRs, finding the six patents invalid as being obvious. On April 21, 2020, we filed notices of appeal in connection with these decisions. On March 31, 2020 the Patent Trial and Appeal Board issued a decision upholding the 3 method of treatment patents. The litigation stay ended following the issuance of the most recent IPR decisions, and the parties are proceeding with the litigation. In addition, we have entered into separate agreements with Alder Biopharmaceuticals, Inc. and Lilly, resolving the European Patent Office oppositions that they filed against our AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.
COPAXONEAUSTEDO
revenues in our North America segment in the thirdfirst quarter of 2019 decreased2020 increased by 41%64%, to $271$122 million, compared to $74 million in the thirdfirst quarter of 2018,2019. This increase was mainly due to generic competitiongrowth in volume in the United States.first quarter of 2020.
COPAXONE revenuesIn April 2017, AUSTEDO was approved by the FDA and launched in the United States were $257 million infor the third quartertreatment of 2019.chorea associated with Huntington disease. In August 2017, the FDA approved AUSTEDO for the treatment of tardive dyskinesia.
RevenuesWe do not have further plans for the development of COPAXONEAUSTEDO for the treatment of Tourette syndrome in our North America segment were 68% of global COPAXONE revenues in the third quarter of 2019, compared to 77% in the third quarter of 2018.
COPAXONE global sales accounted for approximately 9% of our global revenues in the third quarter of 2019 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 2017pediatric patients in the United States. Hybrid versions of COPAXONE 20 mg/mL and 40 mg/mL were also approvedStates, which was being developed under a partnership agreement with Nuvelution Pharma, Inc. (“Nuvelution”), following clinical trial results received in February 2020, which failed to meet their primary endpoints.
AUSTEDO is protected in the European Union.United States by five Orange Book patents expiring between 2031 and 2033 and in Europe by two patents expiring in 2029.
COPAXONE 40 mg/mL is protected by one European patent expiring in 2030. This patent is being challenged in various jurisdictions. In October 2017, the U.K. High Court found this patent invalid and our application for permission to appeal this decision was rejected. The patent was upheld by the Opposition Division of the European Patent Office in April 2019. A hearing for an appeal in this case has been set for June 2020.
The market for MS treatments continues to develop, particularly with the approvals of generic versions of COPAXONE discussed above, as well as additional generic versions expected to be approved in the future. Oral treatments for MS, such as Tecfidera
®
, Gilenya
®
and Aubagio
®
, continue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies.
BENDEKA
and
TREANDA
combined revenues in our North America segment in the thirdfirst quarter of 20192020 decreased by 23%14% to $124$105 million, compared to the thirdfirst quarter of 2018,2019, mainly due to the June 2018 launchemergence of alternative novel therapies and continued competition from Belrapzo
®
(a
ready-to-dilute
bendamustine hydrochloride) byhydrochloride product from Eagle Pharmaceuticals, Inc. (“Eagle”)).
44

In July 2018, Eagle 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’sOn March 13, 2020, this decision but barring a reversal bywas upheld in the appellate court,court. As a result, drug applications referencing BENDEKA, TREANDA or any other bendamustine product will not be approved by the FDA until the orphan drug exclusivity expires in December 2022. It is unclear whether the FDA or the intervening generic defendants will further appeal this ruling. In April 2019, we signed an amendment to the license agreement with Eagle extending the royalty term applicable to the United States to the full period for which we sell BENDEKA and increasing the royalty rate. In addition,consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses. In September 2019, a patent infringement action against four of the five ANDA filers for generic versions of BENDEKA was tried in the United States District Court for the District of Delaware. We awaitOn April 27, 2020, the District Court upheld the validity of all of the asserted patents and found that all four ANDA filers infringe these patents. As a decision fromresult, the court, which could come as early as the first half of 2020. The assertedANDA filers should be enjoined until these patents expire in 2031.
Additionally, in July 2018, Teva and Eagle filed suit against Hospira, Inc. (“Hospira”) related to its 505(b)(2) new drug application (“NDA”) referencing BENDEKA in the U.S. District Court for the District of Delaware. Hospira’s
30-month
stay expires in December 2020. On December 16, 2019, the Delaware District Court dismissed the case against Hospira on all but one of the asserted patents, which expires in 2031. Trial against Hospira on that patent is scheduled to begin on November 15, 2021.
We have U.S. Orange Book patents for TREANDA expiring between 2026 and 2031. One 505(b)(2) NDA was filed for a liquid version of bendamustine and 21 ANDAs were filed for generic versions of the lyophilized form of TREANDA. We have reached final settlements with all 22 filers, providing for the launch of generic versions of TREANDA prior to patent expiration.
COPAXONE
revenues in our North America segment in the first quarter of 2020 decreased by 5% to $198 million, compared to the first quarter of 2019, mainly due to generic competition in the United States.
The market for MS treatments continues to develop, particularly with the approvals of generic versions of COPAXONE discussed above, as well as additional generic versions expected to be approved in the future. Oral treatments for MS, such as Tecfidera
®
, Gilenya
®
and Aubagio
®
, continue to present significant and increasing competition. COPAXONE also continues to face competition from existing injectable products, as well as from monoclonal antibodies, such as Ocrevus
®
.
ProAir
revenues in our North America segment in the thirdfirst quarter of 2019 decreased by 34% to $712020 were $59 million, flat compared to the thirdfirst quarter of 2018, mainly due to lower volumes and lower net pricing.2019. In January 2019, we launched our own ProAir authorized generic in the United States following the launch of a generic version of Ventolin
®
HFA, another albuterol inhaler. Revenues from our ProAir HFA authorized generic are included in “generic products” above. ProAir is the second-largestfourth-largest short-acting beta-agonist in the market, with an exit market share of 25.3% (46.5%15.5% (37.5% including our ProAir HFA authorized generic)generic, making our overall albuterol product the largest in the market) in terms of total number of prescriptions for albuterol inhalers during the thirdfirst quarter of 2019,2020, compared to 45.2%27.6% in the thirdfirst quarter of 2018.2019. In June 2014, we settled a patent challenge to ProAir HFA with Perrigo PharmaceuticalsCompany plc (“Perrigo”), under which Perrigo is now permitted to launch its generic product. In February 2020, Perrigo obtained FDA approval of its generic product and announced initial release of limited supplies. In November 2017, we settled another patent challenge to ProAir HFA with Lupin Pharmaceuticals, Inc. (“Lupin”), et al. permitting Lupin to launch its generic product on September 23, 2019, or earlier under certain circumstances. To date, no generic competition has been launched.
QVAR
revenues in our North America segment in the thirdfirst quarter of 2019 increased2020 decreased by 68%29% to $60$45 million, compared to the thirdfirst quarter of 2018, which was a transition period2019, mainly due to the launch of QVAR
®
RediHaler
.increased price competition and lower volumes. QVAR maintained its second-place position in the inhaled corticosteroids category in the United States, with an exit market share of 19.9%20.8% in terms of total number of prescriptions during the thirdfirst quarter of 2019,2020, compared to 21.7% in the thirdfirst quarter of 2018.
AJOVY
revenues in our North America segment in the third quarter of 2019 were $25 million. AJOVY was approved by the FDA and launched in the United States in September 2018 for the preventive treatment of migraine in adults.
On May 12, 2017, we entered into a license and collaboration agreement with Otsuka Pharmaceutical Co., Ltd. (“Otsuka”) providing Otsuka with an exclusive license to conduct phase 2 and 3 clinical trials for AJOVY in Japan and, once approved, to commercialize the product in Japan.
AJOVY is protected by patents expiring in 2026 in Europe and in 2027 in the United States, with possibility for extension in various markets. An additional patent relating to the use of AJOVY in the treatment of migraine is issued in the United States and will expire in 2035. This patent is also pending in other countries. AJOVY is protected by regulatory exclusivity for 12 years from marketing approval in the United States and 10 years from marketing approval in Europe.


We have filed a lawsuit in the U.S. District Court for the District of Massachusetts alleging that Eli Lilly & Co.’s (“Lilly”) marketing and sale of its galcanezumab product for the treatment of migraine infringes nine Teva patents. Lilly has also submitted IPR (inter partes review) petitions to the Patent Trial and Appeal Board, challenging the validity of the nine patents asserted against it in the litigation, and the litigation in the district court has been stayed pending resolution of the IPRs. The patent office hearing on the first set of six IPRs is scheduled for November 22, 2019 and the hearing on the remaining three IPRs is scheduled for January 8, 2020. In addition, we have entered into separate agreements with Alder Biopharmaceuticals and Lilly, resolving the European Patent Office oppositions that they filed against our AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.
AUSTEDO
revenues in our North America segment in the third quarter of 2019 increased by 71%, to $105 million, compared to $62 million in the third quarter of 2018.
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.
2019.
Anda
revenues in our North America segment in the thirdfirst quarter of 20192020 increased by 5%13% to $351$426 million, compared to $333$379 million in the thirdfirst quarter of 2018,2019, mainly due to higher volumes.volume increases primarily related to the
COVID-19
pandemic. Anda, our distribution business in the United States, 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, competitive pricing and offering next day delivery throughout the United States.
45

Product Launches and Pipeline
In the thirdfirst quarter of 2019,2020, we launched the generic version of the following branded products in North America:
             
Product Name
 
Brand Name
  
Launch
Date
  
Total Annual U.S.
Branded Sales at Time
of Launch
(U.S. $ in millions
(IQVIA))
*
 
Oseltamivir phosphate for oral suspension, 6 mg / mL
  
Tamiflu
®  
July
  $
281
 
Icatibant injection, 30 mg / 3 mL
  
Firazyr
®  
July
  $
304
 
Pregabalin capsules, 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg & 300 mg
  
Lyrica
®  
July
  $
5,456
 
Ramelteon tablets, 8 mg
  
Rozerem
®  
July
  $
91
 
Bisoprolol fumarate and hydrochlorothiazide tablets, 2.5 mg/6.25 mg, 5 mg/6.25 mg & 10 mg/6.25 mg **
  
Ziac
®  
August
  $
42
 
Doxycycline hyclate delayed-release tablets, USP, 50 mg & 200 mg
  
Doryx
®  
August
  $
20
 
Mycophenolic acid delayed-release tablets, USP, 180 mg & 360 mg
  
Myfortic
®
DR
   
August
  $
180
 
Epinephrine injection, USP (auto-injector), 0.15 mg/0.3 mL
  
EpiPen
®
 and EpiPen Jr
®  
August
  $
201
 
Minocycline hydrochloride extended-release tablets, USP, 55 mg
  
Solodyn
®
ER
   
August
  $
44
 
Fulvestrant injection, 250 mg / 5 mL (50 mg/mL)
  
***  
   
August
   
—  
 
Triamcinolone acetonide injectable suspension, USP, 40 mg/mL (40 mg), 40 mg/mL (200 mg) & 40 mg/mL (400 mg)
  
Kenalog
®
-40
   
August
  $
135
 
Acyclovir cream, 5% ****
  
Zovirax
®  
August
  $
97
 
Fosaprepitant for injection, 150 mg/Vial
  
***  
   
September
   
—  
 
Treprostinil Injection, 1 mg/mL (20 mg), 2.5 mg/mL (50 mg), 5 mg/mL (100 mg) & 10 mg/mL (200 mg)
  
Remodulin
®  
September
  $
3
 
             
Product Name
 
Brand Name
  
Launch
Date
  
Total Annual U.S.
Branded Sales at Time
of Launch
(U.S. $ in millions
(IQVIA))
*
 
Doxepin tablets, 3 mg & 6 mg
  
Silenor
®  
January
  $
50
 
HERZUMA
®
(trastuzumab-pkrb) for injection, 150 mg/vial & 420 mg/vial
  
Herceptin
®**  
March
  $
3,042
 
 
 
 
*The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or
re-launch
.
 
 
**Authorized generic – Teva brand.Biosimilar.
 
 
***  Approved via 505(b)(2) regulatory pathway; not equivalent to a brand product.
****  Authorized generic.


Our generic products pipeline in the United States includes, as of September 30, 2019, 244March 31, 2020, 242 product applications awaiting FDA approval, including 8179 tentative approvals. This total reflects all pending ANDAs, supplements for product line extensions and tentatively approved applications and includes some instances where more than one application was submitted for the same reference product. Excluding overlaps, the branded products underlying these pending applications had U.S. sales for the twelve months ended June 30, 2019March 31, 2020 exceeding $112$119 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 9890 of these products, or 119112 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first to file opportunities represent over $73$77 billion in U.S. brand sales for the twelve months ended June 30, 2019,March 31, 2020, according to IQVIA.
IQVIA reported brand sales are one of the many indicators of future potential value of a launch, but equally important are the mix and timing of competition, as well as cost effectiveness. The potential advantages of being the first filer with respect to some of these products may be subject to forfeiture, shared exclusivity or competition from
so-called
“authorized generics,” which may ultimately affect the value derived.
In the thirdfirst quarter of 2019,2020, we receiveddid not receive any tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications.equivalents. A “tentative approval” indicates that the FDA has substantially completed its review of an application and final approval is expected once the relevant patent expires, a court decision is reached, a
30-month
regulatory stay lapses or a
180-day
exclusivity period awarded to another manufacturer either expires or is forfeited.
         
Generic Name
 
Brand Name
  
Total U.S. Annual Branded
Market (U.S. $
in millions (IQVIA))*
 
Ivermectin lotion, 0.5%
  
Sklice
® $
81
 
Sildenafil, 10mg/mL
  
Revatio
® $
189
 
*For the twelve months ended in the calendar quarter immediately prior to the receipt of tentative approval.


Below is a description of key products in our specialty pipeline as of September 30, 2019:March 31, 2020:
         
Product
 
Potential
Indication(s)
 
Route of
Administration
 
Development Phase
(date entered phase 3)
 
Comments
CNS, Neurology and
Neuropsychiatry
   
  
AUSTEDO (deutetrabenazine)
 
Tourette syndrome
 
Oral
  
3 (December 2017)No further plans in this indication.
  
Teva and Nuvelution entered into a partnership agreement on September 19, 2017 to develop AUSTEDO for the treatment of tics associated with Tourette syndrome in pediatric patients in the United States. Nuvelution will fund and manage phase 3 clinical development, leading all operational aspects of the program. Teva will lead the regulatory process and be responsible for commercialization.
 
Dyskinesia in cerebral palsy
 
Oral
 
3 (September 2019)
TV-46000
(risperidone LAI)
Schizophrenia
LAI
3 (April 2018)
 
         
TV-46000
(risperidone LAI)
Schizophrenia
Subcutaneous
3 (April 2018)
46

  
Product
Potential
Indication(s)
Route of
Administration
Development Phase
(date entered phase 3)
Comments
Migraine and Pain
   
  
fremanezumab (anti CGRP)
 
Post traumatic
headache
 
Subcutaneous
 
2
 
 
 
fibromyalgia
 
Subcutaneous
 
2
 
 
fasinumab
 
Osteoarthritis pain
 
Subcutaneous
 
3 (March 2016)
 
Developed in collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”).
In August 2018, Regeneron and Teva announced positive topline phase 3 results in patients with chronic pain from osteoarthritis of the knee or hip with the remaining low dose 1mg every month (1mg4W) and 1mg every two months (1mg8W).
Fasinumab is protected by patents expiring in 2028 and will also be protected by regulatory exclusivity of 12 years from marketing approval in the United States and 10 years from marketing approval in Europe.
Chronic lower
back pain
Subcutaneous
  
3 (December 2017)
  
Respiratory
    
CINQAIR/CINQAERO
Severe asthma with
eosinophilia
Subcutaneous
  
3 (August 2015)
  
Discontinued.
ProAir
 e-RespiClick
 
Bronchospasm and exercise induced bronchitis
 
Oral inhalation
 
Approved by FDA
(December 2018)
 
 
AirDuo
®
Digihaler
TM®
 
Treatment of asthma in patients aged 12 years and older
 
Oral inhalation
 
Approved by FDA (July 2019)
 
Oncology
    
TRUXIMA
ArmonAir
®
 (formerlyDigiHaler
 CT-P10)®
 
(biosimilar to
Rituxan
®
US)Treatment of asthma in patients aged 12 years and older
 
Oral inhalation
 
Approved by FDA (November 2018)(February 2020)
Approved in Canada (April 2019)
  
Expected to launch in the U.S. in November 2019.
HERZUMA
GoResp
®
 (formerlyDigiHaler
CT-P06)®
/ DuoResp
®
DigiHaler
®
 
(biosimilar to
Herceptin
®
US)Treatment of asthma in patients aged 12 years and older and COPD
 
Oral inhalation
 
Approved byUnder regulatory review
FDA (December 2018)
Approved in Canada (September 2019)
 
 
 

52

North America Gross Profit
Gross profit from our North America segment in the thirdfirst quarter of 20192020 was $1,048$1,062 million, a decreasean increase of 12%2%, compared to $1,196$1,039 million in the thirdfirst quarter of 2018. The decrease2019. This increase was mainly due to lowerthe change in mix of revenues, from COPAXONE, as well as a decline in sales of certain other specialty products, partially offset by increases in sales of AUSTEDO, QVAR and AJOVY.discussed above.
Gross profit margin for our North America segment in the thirdfirst quarter of 2019 decreased2020 increased to 51.1%51.0%, compared to 52.8%50.8% in the thirdfirst quarter of 2018. The decrease was mainly due to lower revenues from COPAXONE and certain other specialty products, partially offset by improved gross profit margin of generic products.2019.
North America R&D Expenses
R&D expenses relating to our North America segment in the thirdfirst quarter of 20192020 were $156$146 million, a decrease of 1%12%, compared to $158$165 million in the thirdfirst quarter of 2018.2019.
For a description of our R&D expenses in the thirdfirst quarter of 2019,2020, 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 thirdfirst quarter of 20192020 were $219$251 million, a decrease of 17%6%, compared to $265$268 million in the thirdfirst quarter of 2018. The2019. This decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan, partially offset by increased expenses related to AJOVY.measures.
North America G&A Expenses
G&A expenses relating to our North America segment in the thirdfirst quarter of 20192020 were $112$118 million, a decreasean increase of 12%5%, compared to $128$112 million in the thirdfirst quarter of 2018. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan, partially offset by legal expenses.2019.
North America Other Income (Expense)
Other income from our North America segment in the thirdfirst quarter of 20192020 was $5$2 million, compared to other income of $4 million in the thirdfirst quarter of 2018.2019.
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.
47

Profit from our North America segment in the thirdfirst quarter of 20192020 was $565$550 million, a decreasean increase of 13%10%, compared to $649$498 million in the thirdfirst quarter of 2018. The decrease2019. This increase was mainly due to higher revenues and lower revenues from COPAXONE,expenses as well as a decline in sales of certain other specialty products, partially offset by increases in sales of AUSTEDO, QVAR and AJOVY, as well as cost reductions and efficiency measures as part of the restructuring plan.discussed above.

53

Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the three months ended September 30, 2019March 31, 2020 and 2018:2019:
                
 
Three months ended September 30,
  
Three months ended March 31,
 
 
2019
 
2018
  
2020
 
2019
 
 
(U.S. $ in millions / % of Segment Revenues)
  
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
 $
1,163
   
100
% $
1,212
   
100
% $
1,402
   
100
% $
1,264
   
100
%
Gross profit
  
662
   
56.9
%  
676
   
55.8
%  
823
   
58.7
%  
730
   
57.8
%
R&D expenses
  
63
   
5.4
%  
62
   
5.1
%  
55
   
3.9
%  
66
   
5.2
%
S&M expenses
  
206
   
17.7
%  
242
   
20.0
%  
202
   
14.4
%  
215
   
17.0
%
G&A expenses
  
56
   
4.9
%  
74
   
6.1
%  
66
   
4.7
%  
48
   
3.8
%
Other (income) expense
  
(4
)  
§
   
1
   
§
   
(1
)  
§
   
(1
)  
§
 
   ��                    
Segment profit*
 $
 
 
341
   
 
 
29.3
% $
 
 
297
   
 
 
 
24.5
% $
502
   
35.8
% $
403
   
31.9
%
                        
 
 
 
*Segment profit does not include amortization and certain other items.
 
 
§Represents an amount less than 0.5%.
 
 
Europe Revenues
Our Europe segment includes the European Union and certain other European countries. Revenues from our Europe segment in the thirdfirst quarter of 20192020 were $1,163$1,402 million, a decreasean increase of 4%11% or $49$138 million, compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues were flat,increased by 13%, mainly due to stronghigher demand for certain products resulting from the impact of the
COVID-19
pandemic on purchasing patterns as well as continuing growth in generics and new generic product launches, and higher salespartially offset by price declines for oncology products as a result of OTC products, mostly offset bygeneric competition and a decline in COPAXONE revenues due to competing glatiramer acetate products.
Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the three months ended September 30, 2019March 31, 2020 and 2018:2019:
            
 
Three months ended
September 30,
 
Percentage
Change
  
Three months ended
March 31,
 
Percentage
Change
 
 
2019
  
2018
  
2018-2019
  
2020
  
2019
  
2019-2020
 
 
(U.S. $ in millions)
   
(U.S. $ in millions)
  
Generic products
 $
836
  $
845
   
(1
%) $
1,032
  $
919
   
12
%
COPAXONE
  
106
   
124
   
(14
%)  
109
   
114
   
(4
%)
Respiratory products
  
87
   
93
   
(7
%)  
106
   
91
   
16
%
AJOVY
  
4
   
—  
   
NA
 
Other
  
134
   
150
   
(10
%)  
151
   
140
   
7
%
                 
Total
 $
1,163
  $
1,212
   
(4
%) $
1,402
  $
1,264
   
11
%
                 
 
 
Generic products
revenues in our Europe segment in the thirdfirst quarter of 2019,2020, including OTC products, decreasedincreased by 1%12% to $836$1,032 million, compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues increased by 4%16% compared to the thirdfirst quarter of 2018,2019, mainly due to stronghigher demand for certain products resulting from the impact of the
COVID-19
pandemic on purchasing patterns as well as continuing growth in generics and new generic product launches and higher saleslaunches. We estimate that the impact of OTC products.the
COVID-19
pandemic on advanced purchasing patterns was approximately $100 million.
COPAXONE
revenues in our Europe segment in the thirdfirst quarter of 20192020 decreased by 14%4% to $106$109 million, compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues decreased by 10%1%, mainly due to price reductions and a decline in volume decline resulting from competing glatiramer acetate products.products, partially offset by higher demand due to the impact of the
COVID-19
pandemic on purchasing patterns.
RevenuesCOPAXONE 40 mg/mL is protected by one European patent expiring in 2030. This patent is being challenged in various European jurisdictions. In October 2017, the U.K. High Court found this patent invalid and our application for permission to appeal this decision was rejected. The patent was upheld by the Opposition Division of COPAXONEthe European Patent Office in our Europe segment were 27% of global COPAXONE revenuesApril 2019. A hearing for an appeal in the third quarter of 2019, compared to 21% in the third quarter of 2018.this case has been set for June 2020.
48
For further information about COPAXONE, see “—North America Revenues—Revenues by Major Product” above.

Respiratory products
revenues in our Europe segment in the thirdfirst quarter of 2019 decreased2020 increased by 7%16% to $87$106 million, compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues decreasedincreased by 2%20%, mainly due to lower sales inhigher demand attributed to the United Kingdom.impact of the
COVID-19
pandemic.
AJOVY
revenues in our Europe segment in the first quarter of 2020 were $4 million.
AJOVY was granted a Marketing Authorization in the European Union by the European Medicines Agency (“EMA”) in the European Union in a centralized process in April 2019. We commenced launching AJOVY launched in Germany oncertain European markets in May 15, 2019 and we continueare moving forward with plans to progress with launcheslaunch in other European countries. In October 2019, we received approval from the EMA for AJOVY’s auto-injector submission in the European Union countries.and we commenced launch in March 2020. For information about AJOVY patent protection, see “—North America Revenues—Revenues by Major Product” above.


Product Launches and Pipeline
As of September 30, 2019,March 31, 2020, our generic products pipeline in Europe included 50988 generic approvals relating to 6627 compounds in 13549 formulations, andno EMA approvals received. In addition, approximately 1,1401,115 marketing authorization applications pending approval in 37 European countries, relating to 135119 compounds in 276 formulations in 30 countries.236 formulations. No applications are pending with the EMA.
For information regarding our specialty pipeline and launches in the thirdfirst quarter of 2019,2020, see “—North America Segment —Product Launches and Pipeline.”Pipeline” above.
Europe Gross Profit
Gross profit from our Europe segment in the thirdfirst quarter of 20192020 was $662$823 million, a decreasean increase of 2%13% compared to $676$730 million in the thirdfirst quarter of 2018. The decrease2019. This increase was mainly due to a decline in COPAXONEhigher revenues, and the impact of currency fluctuations, partially offset by new generic product launches.as discussed above.
Gross profit margin for our Europe segment in the thirdfirst quarter of 20192020 increased to 56.9%58.7%, compared to 55.8%57.8% in the thirdfirst quarter of 2018. The2019. This increase was mainly due to a favorable mix of generic products and lower cost of goods sold related to network optimization.inventory write-offs.
Europe R&D Expenses
R&D expenses relating to our Europe segment in the thirdfirst quarter of 20192020 were $63$55 million, an increasea decrease of 2%17% compared to $62$66 million in the thirdfirst quarter of 2018.2019.
For a description of our R&D expenses in the thirdfirst quarter of 2019,2020, 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 thirdfirst quarter of 20192020 were $206$202 million, a decrease of 15%6% compared to $242$215 million in the thirdfirst quarter of 2018. The2019. This decrease was mainly due to cost reductionslower marketing and efficiency measures as part oftravel costs attributed to travel restrictions related to the restructuring plan.
COVID-19
pandemic.
Europe G&A Expenses
G&A expenses relating to our Europe segment in the thirdfirst quarter of 20192020 were $56$66 million, a decreasean increase of 24%37% compared to $74$48 million in the thirdfirst quarter of 2018. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.2019.
Europe Profit
Profit of our Europe segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our Europe segment in the thirdfirst quarter of 20192020 was $341$502 million, an increase of 15%25%, compared to $297$403 million in the thirdfirst quarter of 2018. The2019. This increase was mainly due to strong new generic product launcheshigher revenues and cost reductions and efficiency measureslower expenses as partdiscussed above.
49

International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the three months ended September 30, 2019March 31, 2020 and 2018:2019:
                
 
Three months ended September 30,
  
Three months ended March 31,
 
 
2019
 
2018
  
2020
 
2019
 
 
(U.S. $ in millions / % of
Segment Revenues)
  
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
 $
736
   
100
% $
726
   
100
% $
565
   
100
% $
521
   
100
%
Gross profit
  
295
   
40.1
%  
301
   
41.4
%  
305
   
54.0
%  
269
   
51.7
%
R&D expenses
  
21
   
2.8
%  
21
   
2.9
%  
15
   
2.7
%  
22
   
4.2
%
S&M expenses
  
114
   
15.4
%  
120
   
16.5
%  
106
   
18.8
%  
115
   
22.0
%
G&A expenses
  
32
   
4.3
%  
37
   
5.1
%  
34
   
6.0
%  
36
   
6.8
%
Other (income) expense
  
(1
)  
§
   
—  
   
§
   
(6
)  
(1.1
%)  
—  
   
§
 
                        
Segment profit*
 $
130
   
17.7
% $
123
   
16.9
% $
156
   
27.6
% $
97
   
18.6
%
                        
 
 
*Segment profit does not include amortization and certain other items.
 
§Represents an amount less than 0.5%.
 
**The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c to our consolidated financial statements for additional information.
 
International Markets Revenues
Our International Markets segment includes all countries in which we operate other than those in our North America and Europe segments. The International Markets segment includes more than 35 countries, covering a substantial portion of the global pharmaceutical market. Our key international markets are Israel, Japan, Russia and Russia.Israel. The countries in this category range fromour International Markets segment include 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 AmericanAmerica markets and Asia Pacific markets.hybrid markets such as Japan.


Revenues from our International Markets segment in the thirdfirst quarter of 20192020 were $736$565 million, an increase of $10$44 million, or 1%8%, compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues increased 1%by 5% compared to the thirdfirst quarter of 2018,2019, mainly due to higher distribution activitiessales in Israel,Latin America, Asia-Pacific, Ukraine and Russia, partially offset by lower sales in JapanJapan. The revenues in the first quarter of 2020 included $35 million from a positive hedging impact, which are included in “Other” in the table below. See note 8d to our consolidated financial statements.
The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and Russia.cost of sales in the consolidated financial statements. See note 1c to our consolidated financial statements for additional information.
Revenues by Major Products and Activities
The following table presents revenues for our International Markets segment by major products and activities for the three months ended September 30, 2019March 31, 2020 and 2018:2019:
             
 
Three months ended
September 30,
  
Percentage
Change
 
 
2019
  
2018
  
2018-2019
 
 
(U.S. $ in millions)
   
Generic products
 $
474
  $
498
   
(5
%)
COPAXONE
  
20
   
14
   
39
%
Distribution
  
176
   
149
   
18
%
Other
  
66
   
65
   
3
%
             
Total
 $
736
  $
726
   
1
%
             
             
 
Three months ended
March 31,
  
Percentage
Change
 
 
2020
  
2019
  
2019-2020
 
 
(U.S. $ in millions)
   
Generic products
 $
449
  $
441
   
2
%
COPAXONE
  
12
   
13
   
(11
%)
Other
  
104
   
67
   
57
%
             
Total
 $
565
  $
521
   
8
%
             
 
*The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c to our consolidated financial statements for additional information.
50

Generic products
revenues in our International Markets segment in the thirdfirst quarter of 2019,2020, which include OTC products, decreasedincreased by 5%2% to $474$449 million, compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues decreasedincreased by 5%6%, mainly due to higher sales in Latin America, Asia-Pacific, Ukraine and Russia, partially offset by lower sales in Japan resulting from generic competition to
off-patented
products, as well as lower sales in Russia.products.
COPAXONE
revenues in our International Markets segment in the thirdfirst quarter of 2019 increased2020 decreased by 39%11% to $20$12 million, compared to $14$13 million in the thirdfirst quarter of 2018.2019. In local currency terms, revenues increaseddecreased by 46%1%.
For further information about COPAXONE, see “—North America Revenues—Revenues by Major Product” above.
Distribution
revenues in our International Markets segment in the third quarter of 2019 increased by 18% to $176 million, compared to $149 million in the third quarter of 2018. In local currency terms, revenues increased by 15%, mainly due to agreements with new distribution partners.
International Markets Gross Profit
Gross profit from our International Markets segment in the thirdfirst quarter of 20192020 was $295$305 million, a decreasean increase of 2%13% compared to $301$269 million in the thirdfirst quarter of 2018.2019.
Gross profit margin for our International Markets segment in the thirdfirst quarter of 2019 decreased2020 increased to 40.1%54.0%, compared to 41.4%51.7% in the thirdfirst quarter of 2018. The decrease2019. This increase was mainly due to changes in product mix.higher sales and the positive impact from the hedging activity discussed above.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in the thirdfirst quarter of 20192020 were $21$15 million, flata decrease of 31% compared to $22 million in the thirdfirst quarter of 2018.2019.
For a description of our R&D expenses in the thirdfirst quarter of 2019,2020, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
International Markets S&M Expenses
S&M expenses relating to our International Markets segment in the thirdfirst quarter of 20192020 were $114$106 million, a decrease of 5%8% compared to $120$115 million in the thirdfirst quarter of 2018. The2019. This decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.a decline in distribution fees paid in Japan.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in the thirdfirst quarter of 20192020 were $32$34 million, a decrease of 15%5% compared to $37$36 million in the thirdfirst quarter of 2018. The decrease was mainly due to cost reductions and efficiency measures as part of the restructuring plan.2019.
International Markets Profit
Profit of our International Markets segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our International Markets segment in the thirdfirst quarter of 20192020 was $130$156 million, an increase of 6%61%, compared to $123$97 million in the thirdfirst quarter of 2018. The2019. This increase was mainly due to cost reductionshigher sales and efficiency measures as part of the restructuring plan.positive impact from the hedging activity discussed above.


Other Activities
We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments described above.
Our revenues from other activities in the thirdfirst quarter of 20192020 were $314$307 million, a decrease of 4%3% compared to the thirdfirst quarter of 2018.2019. In local currency terms, revenues decreased by 2%.
API sales to third parties in the thirdfirst quarter of 20192020 were $176$177 million, an increasea decrease of 3%5%, in both U.S. dollar and local currency terms, compared to the thirdfirst quarter of 2018.2019. This decrease was mainly due to timing of certain orders and divestment of certain activities.
Teva Consolidated Results
The
data presented with respect to revenues, gross profit, R&D expenses, S&M expenses, G&A expenses and operating income (loss) for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c to our consolidated financial statements for additional information.
Revenues
Revenues in the thirdfirst quarter of 20192020 were $4,264$4,357 million, a decreasean increase of 6%, or 5% in both U.S. dollar and local currency terms, compared to the thirdfirst quarter of 2018,2019. This increase was mainly due to generic competition to COPAXONE, a decline inhigher revenues from BENDEKA/TREANDAgenerics and certain other specialty productsOTC sales in the United States, as well as a decline in revenues in Russia and Japan, partially offset byEurope, higher revenues from AUSTEDO AJOVY and QVARAnda in North America and higher revenues from our International Markets segment, partially offset by lower revenues from generics in the United States.U.S. and lower revenues from QVAR and BENDEKA/TREANDA in North America. See “—North America Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.
Exchange rate movements during the thirdfirst quarter of 20192020, net of hedging, negatively impacted revenues by $55$3 million compared to the thirdfirst quarter of 2018.2019. See note 8d to our consolidated financial statements.
51

Gross Profit
Gross profit in the thirdfirst quarter of 20192020 was $1,830$2,063 million, a decreasean increase of 7%11% compared to the thirdfirst quarter of 2018. The decrease2019. This increase was mainly a result of the factors discussed above under “—North America Gross Profit,” “—Europe Gross Profit” and “—International Markets Gross Profit.”
Gross profit as a percentage of revenues was 42.9%47.3% in the thirdfirst quarter of 2019,2020, compared to 43.7%44.7% in the thirdfirst quarter of 2018.2019.
The decreaseincrease in gross profit as a percentage of revenues was mainly due to lowerhigher profitability in each of our three segments, primarily higher revenues from AUSTEDO, a favorable mix of generic products in North America, resulting mainlya favorable mix of generic products in Europe and International Markets and a positive impact from a decline in COPAXONE revenues due to generic competition,our hedging activity, partially offset by higher revenues from Anda, which has lower amortization expenses and higher profitability in Europe, resulting mainly from lower cost of goods sold related to network optimization.profitability.
Research and Development (R&D) Expenses
Net R&D expenses in the thirdfirst quarter of 20192020 were $240$221 million, a decrease of 23%15% compared to the thirdfirst quarter of 2018.2019.
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 thirdfirst quarter of 2019,2020, our R&D expenses wererelated primarily related to generic products in our North America segment, as well as specialty product candidates in the pain, migraine, headache and respiratory therapeutic areas, with additional activities in selected other areas.areas and generic products.
Our lower R&D expenses in the thirdfirst quarter of 2020, compared to the first quarter of 2019, compared toresulted primarily from the third quarterlife cycle and stage of 2018, primarily resulted from cost of labor reductions, pipeline optimization and project terminations, partially offset by increased investment in early stagevarious projects.
R&D expenses as a percentage of revenues were 5.6%5.1% in the thirdfirst quarter of 2019,2020, compared to 6.9%6.3% in the thirdfirst quarter of 2018.2019.


Selling and Marketing (S&M) Expenses
S&M expenses in the thirdfirst quarter of 20192020 were $595$613 million, a decrease of 15%5% compared to the thirdfirst quarter of 2018.2019. Our S&M expenses were primarily the result of the factors discussed above under “—North America Segment— S&M Expenses,” “—Europe Segment— S&M Expenses” and “—International Markets Segment— S&M Expenses.”
S&M expenses as a percentage of revenues were 13.9%14.1% in the thirdfirst quarter of 2019,2020, compared to 15.4%15.6% in the thirdfirst quarter of 2018.2019.
General and Administrative (G&A) Expenses
G&A expenses in the thirdfirst quarter of 20192020 were $285$304 million, a decreasean increase of 8%4% compared to the thirdfirst quarter of 2018. 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 “—International Markets Segment— G&A Expenses.”2019.
G&A expenses as a percentage of revenues were 6.7%7.0% in the thirdfirst quarter of 2019,2020, flat compared to 6.8% in the thirdfirst quarter of 2018.2019.
Intangible Asset Impairments
We recorded expenses of $177$649 million for identifiable intangible asset impairments in the thirdfirst quarter of 2019,2020, compared to expenses of $519$469 million in the thirdfirst quarter of 2018.2019. See note 65 to our consolidated financial statements.
Goodwill Impairment
No goodwill impairments were recorded in the third quarterfirst quarters of 2019both 2020 and 2018.2019. See note 6 to our consolidated financial statements.
52

Other AssetsAsset Impairments, Restructuring and Other Items
We recorded expenses of $160$121 million for other assetsasset impairments, restructuring and other items in the thirdfirst quarter of 2019,2020, compared to expenses of $139$1 million in the thirdfirst quarter of 2018.2019. See note 1412 to our consolidated financial statements.
Significant regulatory events
In July 2018, the FDA completed an inspection of our manufacturing plant in Davie, Florida in the United States, and issued a Form
FDA-483
to the site. In October 2018, the FDA notified us that the inspection of the site is classified as “official action indicated” (OAI). On February 5, 2019, we received a warning letter from the FDA that containscontained four additional enumerated concerns related to production, quality control and investigations at this site. We arehave been working diligently to remediateaddress the FDA’s concerns in a manner consistent with current good manufacturing practice (CGMP)(cGMP) requirements as quickly and as thoroughly as possible. An FDA follow up inspection occurred in January 2020, resulting in some follow up findings, and we received a letter from the FDA dated April 24, 2020 notifying us that the site continues to be classified as OAI. If we are unable to remediate the warning letter findings to the FDA’s satisfaction, we may face additional consequences, includingconsequences. These would potentially include delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. We expect to generate approximately $63$230 million in revenues from this site in the remainder of 2019 and approximately $230 million in 2020, assuming remediation or enforcement does not cause any unscheduled slowdown or stoppage at the facility.facility, however delays in FDA approvals of future products from the site may occur.
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 a previously unknown nitrosamine impurity called NDMA found in valsartan API supplied to us by Zhejiang Huahai Pharmaceutical.Pharmaceuticals Co. Ltd. (“Huahai”). Since July 2018, we have been actively engaged with regulatory agenciesagency requests around the world in reviewing our valsartansartan and other sartan products forto determine whether NDMA andand/or other related nitrosamine impurities and, whereare present in specific products. Where necessary, we have initiated additional voluntary recalls. As of September 30, 2019, the accumulatedThe aggregate direct impact of this recallthe sartan recalls on our 2018 and 2019 financial statements was $55$54 million, primarily related to inventory reserveswrite-downs and returns. We expectAs a result of this loss, we initiated negotiations with Huahai and in December 2019, we reached a settlement with Huahai resolving our claims related to continuecertain sartan API supplied by Huahai to experience lossTeva. Under the settlement agreement, Huahai agreed to compensate Teva for some of revenuesthe direct losses suffered by Teva and profits in connection with this matter.provide Teva prospective cost reductions for API. The settlement does not release Huahai from liability for any losses we may incur as a result of third party personal injury or product liability claims relating to the sartan API at issue. In addition, multiple lawsuits have been filed in connection with this matter. Wematter, which may also incurlead to additional customer penalties, impairments and litigation costscosts. We expect additional expenses and loss of revenues and profits in connection with this matter going forward.
Restructuring
In the thirdfirst quarter of 2019,2020, we recorded $61$39 million of restructuring expenses, compared to $88$32 million in the thirdfirst quarter of 2018.2019. The expenses in the thirdfirst quarter of 20192020 were primarily related to headcount reductions across all functions as partresidual expenses of the restructuring plan announced in 2017.
The
two-year
restructuring plan announced in 2017 is intended to reduce our total cost base by $3 billion by the end of 2019.


Since the announcement, we reduced our global headcount by 11,554 full-time-equivalent employees.
Legal Settlements and Loss Contingencies
In the thirdfirst quarter of 2019,2020, we recorded an expenseincome of $468$25 million in legal settlements and loss contingencies, compared to $19an expense of $57 million in the thirdfirst quarter of 2018.2019. The expenseincome in the thirdfirst quarter of 20192020 was mainly relateddue to a settlement of an increase inaction brought against the estimated settlement provision recorded in connection with the remaining opioid cases. See note 16 to our consolidated financial statements.sellers of Auden McKenzie (an acquisition made by Actavis Generics).
Other Income
Other income in the thirdfirst quarter of 20192020 was $14$13 million, compared to $35$6 million in the thirdfirst quarter of 2018.2019.
Operating Income (Loss)
Operating lossincome was $81$191 million in the thirdfirst quarter of 2019,2020, compared to operating income of $16$134 million in the thirdfirst quarter of 2018.2019.
Operating income (loss) as a percentage of revenues was 1.9%4.4% in the thirdfirst quarter of 2019,2020, compared to 0.4%3.2% in the thirdfirst quarter of 2018. The decrease2019. This increase was mainly due to higher provisions in connection with legal settlements and loss contingencies, partially offset by lower intangible asset impairments, lower R&D expenses and higher profit in our Europe, segment.International Markets and North America segments and income from legal settlements (compared to an expense in the first quarter of 2019), partially offset by higher intangible asset impairments and higher other assets impairments, restructuring and other items in the first quarter of 2020.
Financial Expenses, Net
Financial expenses were $211$224 million in the thirdfirst quarter of 2019,2020, compared to $229$218 million in the thirdfirst quarter of 2018.2019. Financial expenses in the thirdfirst quarter of 2020 and 2019 were mainly comprised of interest expenses of $219 million. Financial expenses in the third quarter$241 million and $227 million, respectively.
53

The following table presents a reconciliation of our segment profits to our consolidated operating income (loss) and to consolidated income (loss) before income taxes for the three months ended September 30, 2019March 31, 2020 and 2018:2019:
         
 
Three months ended
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
North America profit
 $
565
  $
649
 
Europe profit
  
341
   
297
 
International Markets profit
  
130
   
123
 
         
Total segments profit
  
1,036
   
1,069
 
Profit of other activities
  
16
   
35
 
         
  
1,051
   
1,104
 
Amounts not allocated to segments:
      
Amortization
  
255
   
297
 
Other assets impairments, restructuring and other items
  
160
   
139
 
Goodwill impairment
  
—  
   
—  
 
Intangible asset impairments
  
177
   
519
 
Gain on divestitures, net of divestitures related costs
  
(3
)  
(31
)
Other R&D expenses (income)
  
(7
)  
60
 
Costs related to regulatory actions taken in facilities
  
11
   
1
 
Legal settlements and loss contingencies
  
468
   
19
 
Other unallocated amounts
  
72
   
84
 
         
Consolidated operating income (loss)
  
(81
)  
16
 
         
Financial expenses, net
  
211
   
229
 
         
Consolidated income (loss) before income taxes
 $
(292
) $
(213
)
         
         
 
Three months ended
March 31,
 
 
2020
  
2019
 
 
(U.S. $ in millions)
 
North America profit
 $
550
  $
498
 
         
Europe profit
  
502
   
403
 
International Markets profit
  
156
   
97
 
         
Total reportable segments profit
  
1,208
   
998
 
Profit of other activities
  
36
   
21
 
         
Total segments profit
  
1,244
   
1,019
 
Amounts not allocated to segments:
      
Amortization
  
258
   
283
 
Other assets impairments, restructuring and other items
  
121
   
1
 
Intangible asset impairments
  
649
   
469
 
Legal settlements and loss contingencies
  
(25
)  
57
 
Other unallocated amounts
  
49
   
75
 
         
Consolidated operating income (loss)
  
191
   
134
 
         
Financial expenses, net
  
224
   
218
 
         
Consolidated income (loss) before income taxes
 $
(33
) $
(84
)
         
 


Tax Rate
In the thirdfirst quarter of 2020, we recognized a tax benefit of $59 million, on
pre-tax
loss of $33 million. In the first quarter of 2019, we recognized a tax expense of $11$9 million, on
pre-tax
loss of $292 million. In the third quarter of 2018, we recognized a tax benefit of $26 million, or 12%, on
pre-tax
loss of $213$84 million. Our tax rate for the thirdfirst quarter of 20192020 was mainly affected by impairments amortization, legal settlements with low correspondingin jurisdictions in which tax effect and interest disallowance as a result of the U.S. Tax Cuts and Jobs Act.rates are higher than Teva’s average tax rate on its ongoing business operations.
The statutory Israeli corporate tax rate is 23% in 2019.2020. Our tax rate differs from the Israeli statutory tax rate, mainly due to generation of profits in various jurisdictions in which tax rates are different than the Israeli tax rate, tax benefits in Israel and other countries, as well as infrequent or nonrecurring items.
Share inIn Losses (Income) of Associated Companies, Net
Share in losses of associated companies, net in the thirdfirst quarter of 20192020 was $4$1 million, compared to $10$4 million in the thirdfirst quarter of 2018.2019.
Net Income (Loss) Attributable to Teva
Net lossincome attributable to Teva was $314and net income attributable to ordinary shareholders were $69 million in the thirdfirst quarter of 2019,2020, compared to net loss of $208$105 million in the thirdfirst quarter of 2018.
Net loss attributable to ordinary shareholders was $314 million in the third quarter of 2019, compared to net loss of $273 million in the third quarter of 2018.2019.
Diluted Shares Outstanding and Earnings (Loss) per Share
The weighted average diluted shares outstanding used for the fully diluted share calculation for the three months ended September 30,March 31, 2020 and 2019 and 2018 were 1,0921,096 million and 1,0181,090 million shares, respectively.
In computing diluted earnings per share for the three months ended March 31, 2020, basic earnings per share were adjusted to take into account the potential dilution that could occur upon the exercise of options and
non-vested
RSUs granted under employee stock compensation plans, using the treasury stock method. No account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
In computing diluted loss per share for the three months ended September 30,March 31, 2019, and 2018, no account was taken of the potential dilution by the assumed exercise of employee stock options and
non-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 66 million shares (including shares issued due to unpaid dividends up to that date) for the three months ended September 30, 2018, since they had an anti-dilutive effect on loss per share.
54
On December 17, 2018, the mandatory convertible preferred shares automatically converted into ADSs and all

Diluted lossearnings per share was $0.29were $0.06 in the thirdfirst quarter of 2019,2020, compared to diluted loss per share of $0.27$0.10 in the thirdfirst quarter of 2018.2019.
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”) and the conversion of our convertible senior debentures, in each case, at period end.
As of September 30,March 31, 2020 and 2019, and 2018, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,1071,118 million and 1,1111,107 million, respectively.
Impact of Currency Fluctuations on Results of Operations
In the thirdfirst quarter of 2019,2020, approximately 50% of our revenues were denominated in currencies other than the U.S. dollar. Because our results are reported in U.S. dollars, we are subject to significant foreign currency risks. Accordingly, changes in the rate of exchange between the U.S. dollar and the local currencies in the markets in which we operate (primarily the euro, British pound, Japanese yen, new Israeli shekel, Canadian dollar and Russian ruble) impact our results.
During the thirdfirst quarter of 2019,2020, the following main currencies relevant to our operations decreased in value against the U.S. dollar (each on a quarterly average compared to quarterly average basis): Argentinian peso by 37%, euro by 3% and British pound by 5% and euro by 4%2%. The following main currencies relevant to our operations increased in value against the U.S. dollar: Japanese yen by 4% and new Israeli shekel by 3%4% and Japanese yen by 1%.
As a result, exchange rate movements during the thirdfirst quarter of 20192020, net of hedging, negatively impacted overall revenues by $55$3 million and positively impacted our operating income by $19$27 million, in comparison with the thirdfirst quarter of 2018.2019. In the first quarter of 2020, the positive hedging impact recognized under revenues was $60 million, partially offset by a $5 million negative impact recognized under cost of sales. Hedging transactions against future projected revenues and expenses are recognized on the balance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. See note 8d to our consolidated financial statements.
Commencing in the third quarter of 2018, the cumulative inflation in Argentina exceeded 100% or more over a three-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.


Comparison of Nine Months Ended September 30, 2019 to Nine Months Ended September 30, 2018
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, 2019 and 2018. 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
  
Percentage
Change
2019
 -
  2018
 
 
Nine Months Ended
September 30,
  
 
2019
  
2018
  
 
%
  
%
  
%
 
Net revenues
  
100.0
   
100.0
   
(10
)
Gross profit
  
43.3
   
44.2
   
(12
)
Research and development expenses
  
6.0
   
6.4
   
(15
)
Selling and marketing expenses
  
14.8
   
14.8
   
(10
)
General and administrative expenses
  
6.8
   
6.7
   
(8
)
Other asset impairments, restructuring and other items
  
2.0
   
5.8
   
(69
)
Goodwill impairment
  
—  
   
2.1
   
—  
 
Legal settlements and loss contingencies
  
9.1
   
(8.7
)  
—  
 
Other income
  
(0.2
)  
(2.3
)  
(91
)
Operating income (loss)
  
(4.6
)  
10.8
   
—  
 
Financial expenses, net
  
4.9
   
5.1
   
(14
)
Income (loss) before income taxes
  
(9.5
)  
5.6
   
—  
 
Income taxes (benefit)
  
(1.2
)  
(0.4
)  
184
 
Share in (profits) losses of associated companies, net
  
0.1
   
0.5
   
(89
)
Net income (loss) attributable to
non-controlling
interests
  
(0.3
)  
0.2
   
—  
 
Net income (loss) attributable to Teva
  
(8.6
)  
5.1
   
—  
 
Dividends on preferred shares
  
—  
   
1.4
   
—  
 
Net income (loss) attributable to ordinary shareholders
  
(8.6
)  
3.8
   
—  
 
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, 2019 and 2018:
                 
 
Nine months ended September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
 $
6,169
   
100%
  $
7,059
   
100.0
%
Gross profit
  
3,155
   
51.1
%  
3,778
   
53.5
%
R&D expenses
  
497
   
8.0
%  
528
   
7.5
%
S&M expenses
  
756
   
12.3
%  
813
   
11.5
%
G&A expenses
  
342
   
5.5
%  
357
   
5.1
%
Other (income) expense
  
(6
)  
§
   
(206
)  
(2.9
%)
                 
Segment profit*
 $
1,566
   
25.4
% $
2,286
   
32.4
%
                 
*Segment profit does not include amortization and certain other items.
§  Represents an amount less than 0.5%.


North America Revenues
Our North America segment includes the United States and Canada. Revenues from our North America segment in the first nine months of 2019 were $6,169 million, a decrease of $890 million, or 13%, compared to the first nine months of 2018.
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, 2019 and 2018:
             
 
Nine months ended
September 30,
  
Percentage
Change
2018-2019
 
 
2019
  
2018
 
 
(U.S. $ in millions)
   
Generic products
 $
2,826
  $
2,957
   
(4
%)
COPAXONE
  
753
   
1,403
   
(46
%)
BENDEKA/TREANDA
  
353
   
502
   
(30
%)
ProAir*
  
194
   
352
   
(45
%)
QVAR
  
183
   
173
   
6
%
AJOVY
  
68
   
—  
   
N/A
 
AUSTEDO
  
276
   
136
   
103
%
Anda
  
1,080
   
984
   
10
%
Other
  
436
   
554
   
(21
%)
             
Total
 $
6,169
  $
7,059
    
             
*Does not include sales of ProAir authorized generic, which are included under generics products.


North America Gross Profit
Gross profit from our North America segment in the first nine months of 2019 was $3,155 million, a decrease of 17%, compared to $3,778 million in the first nine months of 2018.
Gross profit margin for our North America segment in the first nine months of 2019 decreased to 51.1% from 53.5% in the first nine months of 2018.
North America R&D Expenses
R&D expenses relating to our North America segment in the first nine months of 2019 were $497 million, a decrease of 6%, compared to $528 million in the first nine months of 2018.
North America S&M Expenses
S&M expenses relating to our North America segment in the first nine months of 2019 were $756 million, a decrease of 7%, compared to $813 million in the first nine months of 2018.
North America G&A Expenses
G&A expenses relating to our North America segment in the first nine months of 2019 were $342 million, a decrease of 4%, compared to $357 million in the first nine months of 2018.
North America Other Income (Expense)
Other income from our North America segment in the first nine months of 2019 was $6 million, compared to $206 million in the first nine months of 2018.
North America Profit
Profit from our North America segment in the first nine months of 2019 was $1,566 million, a decrease of 31%, compared to $2,286 million in the first nine months of 2018.


Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the nine months ended September 30, 2019 and 2018:
                 
 
Nine months ended September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
 $
3,611
   
100
%
 
 
 $
3,982
   
100
%
Gross profit
  
2,066
   
57.2
%  
2,195
   
55.1
%
R&D expenses
  
199
   
5.5
%  
208
   
5.2
%
S&M expenses
  
637
   
17.6
%  
725
   
18.2
%
G&A expenses
  
175
   
4.8
%  
243
   
6.1
%
Other (income) expense
  
(5
)  
§
   
(1
)  
§
 
                 
Segment profit*
 $
 
 
 
1,060
   
 
 
29.4
% $
 
 
 
1,020
   
 
 
25.6
%
                 
*Segment profit does not include amortization and certain other items.
§  Represents an amount less than 0.5%.
Europe Revenues
Our Europe segment includes the European Union and certain other European countries. Revenues from our Europe segment in the first nine months of 2019 were $3,611 million, a decrease of 9% or $371 million, compared to the first nine months of 2018. In local currency terms, revenues decreased by 4% compared to the first nine months of 2018, mainly due to a decline in COPAXONE revenues due to competing glatiramer acetate products and the termination of the PGT joint venture, 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 nine months ended September 30, 2019 and 2018:
             
 
Nine months ended
September 30,
  
Percentage
Change
2018-2019
 
 
2019
  
2018
 
 
(U.S. $ in millions)
   
Generic products
 $
2,599
  $
2,749
   
(5
%)
COPAXONE
  
327
   
417
   
(22
%)
Respiratory products
  
267
   
312
   
(14
%)
Other
  
417
   
504
   
(17
%)
             
Total
 $
3,611
  $
3,982
   
(9
%)
             


Europe Gross Profit
Gross profit from our Europe segment in the first nine months of 2019 was $2,066 million, a decrease of 6% compared to $2,195 million in the first nine months of 2018.
Gross profit margin for our Europe segment in the first nine months of 2019 increased to 57.2% from 55.1% in the first nine months of 2018.
Europe R&D Expenses
R&D expenses relating to our Europe segment in the first nine months of 2019 were $199 million, a decrease of 4%, compared to $208 million in the first nine months of 2018.
Europe S&M Expenses
S&M expenses relating to our Europe segment in the first nine months of 2019 were $637 million, a decrease of 12%, compared to $725 million in the first nine months of 2018.
Europe G&A Expenses
G&A expenses relating to our Europe segment in the first nine months of 2019 were $175 million, a decrease of 28%, compared to $243 million in the first nine months of 2018.
Europe Profit
Profit from our Europe segment in the first nine months of 2019 was $1,060 million, an increase of 4%, compared to $1,020 million in the first nine months of 2018.
International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the nine months ended September 30, 2019 and 2018:
                 
 
2019
  
2018
 
 
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
 $
2,145
   
100
% $
2,265
   
100
%
Gross profit
  
877
   
40.9
%  
942
   
41.6
%
R&D expenses
  
66
   
3.1
%  
70
   
3.1
%
S&M expenses
  
348
   
16.2
%  
384
   
16.9
%
G&A expenses
  
102
   
4.7
%  
115
   
5.1
%
Other (income) expense
  
(2
)  
§
   
(11
)  
§
 
                 
Segment profit*
 $
 
 
 
363
   
 
 
16.9
%
 
 $
 
 
 
384
  
 
 
 
16.9
%
                 
*Segment profit does not include amortization and certain other items.
§  Represents an amount less than 0.5%.
International Markets Revenues
Our International Markets segment includes all countries other than those in our North America and Europe segments. Revenues from our International Markets segment in the first nine months of 2019 were $2,145 million, a decrease of $120 million, or 5%, compared to the first nine months of 2018. In local currency terms, revenues decreased by 1% compared to the first nine months of 2018.


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, 2019 and 2018:
             
 
Nine months ended
September 30,
  
Percentage
Change
2018-2019
 
 
2019
  
2018
 
 
(U.S. $ in millions)
   
Generic products
 $
1,404
  $
1,523
   
(8
%)
COPAXONE
  
46
   
52
   
(12
%)
Distribution
  
491
   
456
   
8
%
Other
  
204
   
233
   
(13
%)
             
Total
 $
2,145
  $
2,265
   
(5
%)
             
International Markets Gross Profit
Gross profit from our International Markets segment in the first nine months of 2019 was $877 million, a decrease of 7%, compared to $942 million in the first nine months of 2018.
Gross profit margin for our International Markets segment in the first nine months of 2019 decreased to 40.9%, from 41.6% in the first nine months of 2018. The decrease was mainly due to lower sales in Japan.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in the first nine months of 2019 were $66 million, a decrease of 5%, compared to $70 million in the first nine months of 2018.
International Markets S&M Expenses
S&M expenses relating to our International Markets segment in the first nine months of 2019 were $348 million, a decrease of 9%, compared to $384 million in the first nine months of 2018.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in the first nine months of 2019 were $102 million, a decrease of 12%, compared to $115 million in the first nine months of 2018.
International Markets Profit
Profit from our International Markets segment in the first nine months of 2019 was $363 million, a decrease of 6%, compared to $384 million in the first nine months of 2018.


Other Activities
Our revenues from other activities in the first nine months of 2019 decreased by 2% to $972 million, compared to the first nine months of 2018. In local currency terms, revenues were flat.
API sales to third parties in the first nine months of 2019 increased by 6%, in both U.S. dollar and local currency terms, to $566 million, compared to the first nine months of 2018.
Teva Consolidated Results
Revenues
Revenues in the first nine months of 2019 were $12,896 million, a decrease of 10% or 7% in local currency terms, compared to the first nine months of 2018.
Exchange rate movements during the first nine months of 2019, compared to the first nine months of 2018, negatively impacted revenues by $357 million.
Gross Profit
Gross profit in the first nine months of 2019 was $5,579 million, a decrease of $746 million compared to the first nine months of 2018.
Gross profit as a percentage of revenues was 43.3% in the first nine months of 2019, compared to 44.2% in the first nine months of 2018.
Research and Development (R&D) Expenses
Net R&D expenses in the first nine months of 2019 were $778 million, a decrease of 15% compared to the first nine months of 2018.
R&D expenses as a percentage of revenues were 6.0% in the first nine months of 2019, compared to 6.4% in the first nine months of 2018.


Selling and Marketing (S&M) Expenses
S&M expenses in the first nine months of 2019 were $1,908 million, a decrease of 10% compared to the first nine months of 2018.
S&M expenses as a percentage of revenues were 14.8% in the first nine months of 2019, flat compared to the first nine months of 2018.
General and Administrative (G&A) Expenses
G&A expenses in the first nine months of 2019 were $873 million, a decrease of 8% compared to the first nine months of 2018.
G&A expenses as a percentage of revenues were 6.8% in the first nine months of 2019, compared to 6.7% in the first nine months of 2018.
Intangible Asset Impairments
We recorded expenses of $1,206 million for identifiable intangible asset impairments, in the first nine months of 2019, compared to expenses of $1,246 million in the first nine months of 2018. See note 6 to our consolidated financial statements.
Goodwill Impairment
In the first nine months of 2019, no goodwill impairments were recorded, compared to a $300 million goodwill impairment charge recorded in the first nine months of 2018. See note 7 to our consolidated financial statements.
Other Asset Impairments, Restructuring and Other Items
We recorded expenses of $263 million for other asset impairments, restructuring and other items in the first nine months of 2019, compared to expenses of $834 million in the first nine months of 2018. See note 14 to our consolidated financial statements.


Legal Settlements and Loss Contingencies
In the first nine months of 2019, we recorded an expense of $1,171 million in legal settlements and loss contingencies, compared to an income of $1,239 million in the first nine months of 2018. The expense in the first nine months of 2019 was mainly related to an estimated settlement provision recorded in connection with the remaining opioid cases. See note 16 to our consolidated financial statements.
Other Income
Other income in the first nine months of 2019 was $29 million, compared to $334 million in the first nine months of 2018.
Other income as a percentage of revenues was 0.2% in the first nine months of 2019, compared to 2.3% in the first nine months of 2018.
Operating Income (Loss)
Operating loss was $591 million in the first nine months of 2019, compared to an operating income of $1,527 million in the first nine months of 2018.
Financial Expenses, Net
Financial expenses were $635 million in the first nine months of 2019, compared to $736 million in the first nine months of 2018.
Financial expenses in the first nine months of 2019 were mainly comprised of interest expenses of $672 million, partially offset by $36 million of interest income. Financial expenses in the first nine months of 2018 were mainly comprised of interest expenses of $689 million, $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, as well as a $22 million loss resulting from our hedging and derivatives activities, partially offset by $33 million of interest income.
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, 2019 and 2018:
         
 
Nine months ended
September 30,
 
 
2019
  
2018
 
 
(U.S. $ in millions)
 
North America profit
 $
1,566
  $
2,286
 
Europe profit
  
1,060
   
1,020
 
International Markets profit
  
363
   
384
 
         
Total segments profit
  
2,989
   
3,690
 
Profit (loss) of other activities
  
92
   
87
 
         
  
3,081
   
3,777
 
Amounts not allocated to segments:
      
Amortization
  
823
   
909
 
Other asset impairments, restructuring and other items
  
263
   
834
 
Goodwill impairment
  
—  
   
300
 
Intangible asset impairments
  
1,206
   
1,246
 
Gain on divestitures, net of divestitures related costs
  
(12
)  
(114
)
Other R&D expenses
  
(7
)  
82
 
Costs related to regulatory actions taken in facilities
  
28
   
6
 
Legal settlements and loss contingencies
  
1,171
   
(1,239
)
Other unallocated amounts
  
201
   
226
 
         
Consolidated operating income (loss)
  
(591
)  
1,527
 
         
Financial expenses, net
  
635
   
736
 
         
Consolidated income (loss) before income taxes
 $
(1,226
) $
791
 
         


Tax Rate
In the first nine months of 2019, we recognized a tax benefit of $159 million, or 13%, on
pre-tax
loss of $1,226 million. In the first nine months of 2018, we recognized a tax benefit of $56 million, on
pre-tax
income of $791 million. Our tax rate for the first nine months of 2019 was mainly affected by impairments, amortization, legal settlements with low corresponding tax effect and interest disallowance as a result of the U.S. Tax Cuts and Jobs Act.
Share in Losses (Income) of Associated Companies, Net
Share in losses of associated companies, net in the first nine months of 2019 was $8 million, compared to share in losses of $76 million in the first nine months of 2018.
Net Income (Loss)
Net loss attributable to Teva was $1,108 million in the first nine months of 2019, compared to net income attributable to Teva of $736 million in the first nine months of 2018.
Net loss attributable to ordinary shareholders was $1,108 million in the first nine months of 2019, compared to net income of $541 million in the first nine months of 2018.
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, 2019 and 2018 were 1,091 million and 1,020 million shares, respectively.
In computing diluted loss per share for the nine months ended September 30, 2019, no account was taken of the potential dilution by the assumed exercise of employee stock options and
non-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 nine months ended September 30, 2018 take into account the potential dilution that could occur upon the exercise of options and
non-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 68 million shares (including shares issued due to unpaid dividends up to that date) for the nine months ended September 30, 2018, as well as for the convertible senior debentures, since both had an anti-dilutive effect on earnings per share.
Diluted loss per share was $1.02 in the first nine months of 2019, compared to diluted earnings per share of $0.53 in the first nine months of 2018.
Impact of Currency Fluctuations on Results of Operations
In the first nine months of 2019, approximately 50% of our revenues were denominated in currencies other than the U.S. dollar. Because our results are reported in U.S. dollars, we are subject to significant foreign currency risks and, accordingly, changes in the exchange rate between the U.S. dollar and local currencies in the markets in which we operate (primarily the euro, British pound, Japanese yen, Israeli shekel, Canadian dollar and Russian ruble) impact our results. During the first nine months of 2019, the following main currencies relevant to our operations decreased in value against the U.S. dollar: Argentinean peso by 44%, Polish zloty by 7%, Russian ruble by 6%, euro by 6% and British pound by 6% (all compared on a nine-month average basis).
As a result, exchange rate movements during the first nine months of 2019 negatively impacted overall revenues by $357 million and our operating income by $110 million, in comparison to the first nine months of 2018.
Liquidity and Capital Resources
Total balance sheet assets were $57,246$55,330 million as of September 30, 2019,March 31, 2020, compared to $59,424$57,470 million as of June 30,December 31, 2019.
Our working capital balance, which includes tradeaccounts receivables net of SR&A, inventories, prepaid expenses and other current assets, tradeaccounts payables, employee-related obligations, accrued expenses and other current liabilities, was $306$302 million as of September 30, 2019,March 31, 2020, compared to negative $65$74 million as of June 30,December 31, 2019.


Accrued expensesEmployee-related obligations, as of September 30, 2019,March 31, 2020, were $1,748$540 million, compared to $2,335$693 million as of June 30,December 31, 2019. The lower accrued expensesdecrease in the thirdfirst quarter of 2019 resulted2020 was mainly from a reclassification of provisions made under legal settlements and loss contingencies in the second quarter of 2019due to long-term liabilities.performance incentive payments to employees for 2019.
InvestmentCash investment in property, plant and equipment in the thirdfirst quarter of 20192020 was approximately $169$128 million, compared to $112$119 million in the secondfourth quarter of 2019. Depreciation in the thirdfirst quarter of 20192020 was $151$141 million, compared to $153 million in the secondfourth quarter of 2019.
Cash and cash equivalents and short-term and long-term investments as of September 30, 2019March 31, 2020 were $1,301$1,850 million, compared to $2,232$2,033 million as of June 30,December 31, 2019.
The decrease in the thirdfirst quarter of 20192020 was mainly due to repayment at maturity of our $1,556$700 million 1.7%2.25% senior note in July 2019,March 2020, partially offset by cash generated during the quarter.
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 cash on hand, existing cash investments, liquid securities and available credit facilities, primarily our $2.3 billion unsecured syndicated revolving credit facility entered into in April 2019 (“RCF”RCF���).
InThe RCF agreement provides for two separate tranches, a $1.15 billion tranche A and a $1.15 billion tranche B. Loans and letters of credit will be available from time to time under each tranche for Teva’s general corporate purposes. Tranche A has a maturity date of April 2019, we entered into8, 2022, with two
one-year
extension options, of which $1.0 billion were extended to April 8, 2023. Tranche B has a $2.3 billion unsecured syndicated RCF, which replaced the previous $3 billion revolving credit facility. maturity date of April 8, 2024.
55

The RCF contains certain covenants, including certain limitations on incurring liens and indebtedness and maintenance of certain financial ratios, including the requirement to maintain compliance with a net debt to EBITDA ratio, which becomes more restrictive over time. The net debt to EBITDA ratio limit is 6.25x through December 31, 2019, gradually6.0x in the first and second quarters of 2020 and declines to 5.75x in the third and fourth quarters of 2020, and continues to gradually decline over the remaining term of the RCF.
The RCF can be used for general corporate purposes, including repaying existing debt. As of September 30, 2019, $100 million were outstanding under the RCF. As of the date of this quarterly report on Form 10-Q,March 31, 2020, no amounts arewere outstanding under the RCF. Based on current and forecasted results, we expect that we will not exceed the financial covenant thresholds set forth in the RCF within one year from the date the financial statements are issued.
Under specified circumstances, including
non-compliance
with any of the covenants described above and the unavailability of any waiver, amendment or other modification thereto, we will not be able to borrow under the RCF. Additionally, violations of the covenants, under the above-mentioned circumstances, would result in an event of default in all borrowings under the RCF and, when greater than a specified threshold amount as set forth in each series of senior notes is outstanding, could lead to an event of default under our senior notes due to cross acceleration provisions.
We expect that we will continue to have sufficient cash resources to support our debt service payments and all other financial obligations within one year from the date that the financial statements are issued.
Debt Balance and Movements
As of September 30, 2019,March 31, 2020, our debt was $26,942$26,103 million, compared to $28,726$26,908 million as of June 30,December 31, 2019. TheThis decrease was mainly due to repayment at maturity of our $1,556$700 million 1.7%2.25% senior notes, as well as exchange rate fluctuations.
During the first quarter of 2019, we repurchased and canceled approximately $126 million principal amount of our $1,700 million 1.7% senior notes due July 2019.
During the second quarter of 2019, we repurchased and canceled approximately $18 million principal amount of our $1,574 million 1.7% senior notes due July 2019.
In July 2019,March 2020, we repaid at maturity our $1,556$700 million 1.7%2.25% senior notes.
During the third quarter of 2019, we borrowed $500 million under the RCF and repaid $400 million of such borrowings. As of September 30, 2019, $100 million was outstanding under the RCF. As of the date of this Quarterly Report on Form
10-Q,
no amounts were outstanding under the RCF.
Our debt as of September 30, 2019March 31, 2020 was effectively denominated in the following currencies: 65%64% in U.S. dollars, 32%33% in euros and 3% in Swiss francs.
The portion of total debt classified as short-term as of September 30, 2019March 31, 2020 was 12%6%, compared to 10%9% as of June 30,December 31, 2019.
Our financial leverage was 64% as of September 30, 2019, a slight decrease comparedMarch 31, 2020, similar to 65%the financial leverage as of June 30,December 31, 2019.
Our average debt maturity was approximately 6.6 years as of March 31, 2020, compared to 6.4 years as of September 30, 2019, compared to 6.3 years as of June 30,December 31, 2019.
Total Equity
Total equity was $14,925$14,588 million as of September 30, 2019,March 31, 2020, compared to $15,251$15,063 million as of June 30,December 31, 2019. TheThis decrease was mainly due to $307 million of net loss and thea negative impact of $138$560 million from exchange rate fluctuations, partially offset by $87 million of unrealized gain from derivative financial instruments in the third quarter of 2019.fluctuations.
Exchange rate fluctuations affected our balance sheet, as approximately 36% of our net assets in the thirdfirst quarter of 20192020 (including both
non-monetary
and monetary assets) were in currencies other than the U.S. dollar. When compared to June 30,December 31, 2019, changes in currency rates had a negative impact of $138$560 million on our equity as of September 30, 2019,March 31, 2020, mainly due to the changes in value against the U.S. dollar of: the Mexican peso by 26%, the Russian ruble by 28%, the Canadian dollar by 8%, the Polish zloty by 7%8%, the British pound by 6%, Indian rupee by 6%, the Chilean peso by 7%, the euro by 4%, the Bulgarian levCroatian kuna by 4% and the British poundeuro by 3%2%. All comparisons are on a
quarter-end
to
quarter-end
basis.


Cash Flow
Cash flow generated from operating activities during the thirdfirst quarter of 20192020 was $325$305 million, compared to $421$112 million in the thirdfirst quarter of 2018.2019. The decreaseincrease in the thirdfirst quarter of 20192020 was mainly due to higher operating profit in each of our three segments, as well as lower revenues and a reductionperformance incentive payments to employees paid in sales reserves associated with the revenue decline.first quarter of 2020 compared to the amounts paid in the first quarter of 2019.
CashDuring the first quarter of 2020, we generated free cash flow of $551 million, which we define as comprising $305 million in cash flow generated from operating activities, $368 million in the third quarter of 2019, net of cash received for capital investments and beneficial interest collected in exchange for securitized tradeaccounts receivables was $551 million, compared to $704and $6 million in proceeds from sale of property, plant and equipment and intangible assets, partially offset by $128 million in cash used for capital investment. During the thirdfirst quarter of 2018. The decrease2019, we generated free cash flow of $360 million, comprising $112 million in cash flow was mainly due togenerated from operating activities, $362 million in beneficial interest collected in exchange for securitized accounts receivables and $11 million in proceeds from sale of property, plant and equipment and intangible assets, partially offset by $125 million in cash used for capital investment. The increase in the reasons mentioned above, as well as higher capital investments during the thirdfirst quarter of 2019 compared to the third quarter2020 resulted mainly from higher cash flow generated from operating activities, including significant consumption of 2018.inventories.
Dividends
We have not paid dividends on our ordinary shares or ADSs since December 2017.
56

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. MilestoneThe agreement stipulates additional development milestone payments of $25 million, $35 million and $60 million were paid in the second quarter of 2017, the first quarter of 2018 and the fourth quarter of 2018, respectively.to Regeneron, as well as future royalties.
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.creditable. We will share the profit from the commercialization of these products with Celltrion. These two products, TRUXIMA and HERZUMA, were approved by the FDA in November and December 2018, respectively. TRUXIMA is expected to launchrespectively, and were launched in the U.S.United States in November 2019.2019 and March 2020, respectively.
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 manageThere are no further plans in this indication following 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 subjecttrial results received in February 2020, which failed to FDA approval of AUSTEDO for Tourette syndrome, we will pay Nuvelution a
pre-agreedmeet their primary endpoints.
return.
We are committed to pay royalties to owners of
know-how,
partners in alliances and certain other arrangements, and to parties that financed R&D at a wide range of rates as a percentage of sales of certain products, as defined in the agreements. In some cases, the royalty period is not defined; in other cases, royalties will be paid over various periods not exceeding 20 years.
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.
20192020 Aggregated Contractual Obligations
There have not been any material changes in our assessment of material contractual obligations and commitments as set forth in Item 7 of our Annual Report on Form
10-K
for the year ended December 31, 2018, other than as set forth below.
For a description of our new revolving credit facility entered into in April 2019, see “—Liquidity and Capital Resources” above.
2019.
Supplemental
Non-GAAP
Income Data
We utilize certain
non-GAAP
financial measures to evaluate performance, in conjunction with other performance metrics. The following are examples of how we utilize the
non-GAAP
measures:
our management and Board of Directors use the
non-GAAP
measures to evaluate our operational performance, to compare against work plans and budgets, and ultimately to evaluate the performance of management;
 
 
our annual budgets are prepared on a
non-GAAP
basis; and
 
 
senior management’s annual compensation is derived, in part, using these
non-GAAP
measures. While qualitative factors and judgment also affect annual bonuses, the principal quantitative element in the determination of such bonuses is performance targets tied to the work plan, which is based on the
non-GAAP
presentation set forth below.
 
 


Non-GAAP
financial measures have no standardized meaning and accordingly have limitations in their usefulness to investors. We provide such
non-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. These
non-GAAP
financial measures are presented solely to permit investors to more fully understand how management assesses our performance. The limitations of using
non-GAAP
financial measures as performance measures are that they provide a view of our results of operations without including all events during a period and may not provide a comparable view of our performance to other companies in the pharmaceutical industry.
Investors should consider
non-GAAP
financial measures in addition to, and not as replacements for, or superior to, measures of financial performance prepared in accordance with GAAP.
In arriving at our
non-GAAP
presentation, we exclude items that either have a
non-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 such 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:
57

amortization of purchased intangible assets;
 
 
legal settlements and/or loss contingencies, due to the difficulty in predicting their timing and scope;
 
 
impairments of long-lived assets, including intangibles, property, plant and equipment and goodwill;
 
 
restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to the rationalization of our plants or to certain other strategic activities, such as the realignment of R&D focus or other similar activities;
 
 
acquisition- or divestment- related items, including changes in contingent consideration, integration costs, banker and other professional fees, inventory
step-up
and
in-process
R&D acquired in development arrangements;
 
 
expenses related to our equity compensation;
 
 
significant
one-time
financing costs and devaluation losses;
 
 
deconsolidation charges;
unusual tax items;
 
 
other awards or settlement amounts, either paid or received;
 
 
other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as impacts due to changes in accounting, significant costs for remediation of plants, such as inventory write-offs or related consulting costs, or other unusual events; and
 
 
corresponding tax effects of the foregoing items.
 
 
The following tables present supplemental
non-GAAP
data, in U.S. dollar, which we believe facilitates an understanding of the factors affecting our business. In these tables, we exclude the following amounts:

58

The following table presents the GAAP measures, related
non-GAAP
adjustments and the corresponding
non-GAAP
amounts for the applicable periods:
                                                         
   
Three Months Ended September 30, 2019
 
   
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
contingencies
  
Impair-
ment
of long-
lived
assets
  
Restruc-
turing
costs
  
Costs
related 
to
regulatory
actions
taken in
facilities
  
Equity
compens-
ation
  
Contin-
gent
conside-
ration
  
Gain on
sale of
business
  
Other
non
GAAP
items
  
Other
items
  
Corres-
ponding
tax
effect
  
Non
GAAP
 
 
  
  
Cost of sales
  
2,435
   
220
            
11
   
7
         
35
         
2,162
 
   
R&D expenses
  
240
                  
5
         
(7
)        
242
 
   
S&M expenses
  
595
   
35
               
9
                  
551
 
   
G&A expenses
  
285
                  
14
         
1
         
270
 
   
Other (income) expense
  
(14
)                       
(3
)           
(11
)
   
Legal settlements and loss contingencies
  
468
      
468
                              
 
   
Other assets impairments,
restructuring and other items
  
160
         
28
   
61
         
51
      
21
         
 
   
Intangible assets impairment
  
177
         
177
                           
0
 
   
Financial expenses, net
  
211
                              
3
      
208
 
   
Income taxes
  
11
                                 
(172
)  
183
 
   
Share in losses of associated companies – net
  
4
                                    
4
 
    
Net income (loss) attributable to
non-controlling
interests
  
7
                                       
(12)
       
19
 
                                          
    
Total reconciled items
      
255
   
468
   
204
   
61
   
11
   
35
   
51
   
(3
)  
51
   
(9
)  
(172
)    
                                          
   
EPS—Basic
  
(0.29
)                                
0.87
   
0.58
 
   
EPS—Diluted
  
(0.29
)                                
0.87
   
0.58
 
                                                 
 
Three Months Ended March 31, 2020
 
 
U.S. $ and shares in millions (except per share amounts)
 
 
Excluded for
non-GAAP
measurement
 
 
GAAP
  
Amortization of
purchased
intangible
assets
  
Legal
settlements and
loss
contingencies
  
Impairment
of long lived
assets
  
Other
R&D
expenses
  
Restructuring
costs
  
Costs related
to regulatory
actions taken
in facilities
  
Equity
compensation
  
Contingent
consideration
  
Other
 non-
GAAP items
  
Other
items
  
Non-GAAP
 
Cost of sales
  
2,294
   
223
               
4
   
6
      
15
      
2,046
 
R&D expenses
  
221
            
(4
)        
5
      
—  
      
221
 
S&M expenses
  
613
   
35
                  
9
      
—  
      
570
 
G&A expenses
  
304
                     
10
      
4
      
290
 
Other (income) expense
  
(13
)                          
0
      
(13
)
Legal settlements and loss contingencies
  
(25
)     
(25
)                          
—  
 
Other assets impairments, restructuring and other items
  
121
         
75
      
39
         
6
   
1
      
—  
 
Intangible assets impairments
  
649
         
649
                        
—  
 
Financial expenses, net
  
224
                              
11
   
213
 
Income taxes
  
(59
)                             
(234
)  
175
 
Share in losses of associated companies – net
  
1
                              
—  
   
1
 
Net income (loss) attributable to
non-controlling
interests
  
(44
)                             
(63
)  
20
 
                                                 
Total reconciled items
     
258
   
(25
)  
724
   
(4
)  
39
   
4
   
30
   
6
   
20
   
(286
)   
                                                 
EPS - Basic
  
0.06
                              
0.70
   
0.76
 
EPS - Diluted
  
0.06
                              
0.70
   
0.76
 
 
 
The
non-GAAP
diluted weighted average number of shares was 1,0931,096 million for the three months ended September 30, 2019.March 31, 2020.

59

                                                           
  
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
contingencies
  
Impair-
ment
of long-
lived
assets
  
Other
R&D
expenses
  
Acquisition,
integration
and related
expenses
  
Restru-
cturing
costs
  
Costs
related to
regulatory
actions
taken in
facilities
  
Equity
compens-
ation
  
Contin-
gent
conside-
ration
  
Other
non
GAAP
items
  
Other
items
  
Corres-
ponding
tax
effect
  
Non
GAAP
 
 
Cost of sales
  
2,552
   
246
                  
1
   
7
      
30
         
2,268
 
 
R&D expenses
  
311
            
60
            
7
      
1
         
243
 
 
S&M expenses
  
699
   
51
                     
14
               
634
 
  
 
G&A expenses
  
309
                        
17
      
8
         
284
 
 
Other (income) expense
  
(35)
                              
(31
)        
(4
)
 
Legal settlements and loss contingencies
  
19
      
19
                                 
—  
 
 
Other assets impairments, restructuring and other items
  
139
         
2
      
4
   
88
         
29
   
16
         
—  
 
 
Intangible assets impairment
  
519
         
519
                              
—  
 
 
Financial expenses, net
  
229
                                 
(7
)     
236
 
 
Income taxes
  
(26)
                                    
(111
)  
85
 
 
Share in losses of associated companies – net
  
10
                                 
9
      
1
 
 
Net income (loss) attributable to
non-controlling
interests
  
11
                                 
(12
)     
23
 
                                                           
 
Total reconciled items
     
297
   
19
   
521
   
60
   
4
   
88
   
1
   
45
   
29
   
24
   
(10
)  
(111
)   
                                                           
 
EPS—Basic
  
(0.27)
                                    
0.95
   
0.68
 
 
EPS—Diluted
  
(0.27)
                                    
0.95
   
0.68
 
                                                         
 
Three Months Ended March 31, 2019
 
 
U.S. $ and shares in millions (except per share amounts)
 
 
Excluded for
non-GAAP
measurement
 
 
GAAP
  
Amortization
of purchased
intangible
assets
  
Legal
settlements
and loss
contingencies
  
Impairment
of long lived
assets
  
Acquisition,
integration
and related
expenses
  
Restructuring
costs
  
Costs related to
regulatory actions
taken in facilities
  
Equity
compensation
  
Contingent
consideration
  
Other
non-
GAAP
items
  
Other
items
  
Corresponding
tax effect
  
Unusual
tax item*
  
Non-
GAAP
 
Cost of sales**
  
2,293
   
248
               
4
   
7
      
35
            
1,999
 
R&D expenses
  
261
                     
6
      
—  
            
255
 
S&M expenses
  
648
   
35
                  
10
                  
602
 
G&A expenses
  
292
                     
12
      
—  
            
280
 
Other (income) expense
  
(6
)                                      
(6
)
Legal settlements and loss contingencies
  
57
      
57
                                 
—  
 
Other assets impairments, restructuring and other items
  
1
         
20
   
2
   
32
         
(71
)  
19
            
—  
 
Intangible assets impairments
  
469
         
469
                              
—  
 
Financial expenses, net
  
218
                              
(2
)        
220
 
Income taxes
  
9
                                 
(177
)  
61
   
125
 
Share in losses of associated companies – net
  
4
                              
—  
         
4
 
Net income (loss) attributable to
non-controlling
interests
  
8
                              
(8
)        
16
 
                                                         
Total reconciled items
     
283
   
57
   
489
   
2
   
32
   
4
   
34
   
(71
)  
54
   
(10
)  
(177
)  
61
    
                                                         
EPS - Basic
  
(0.10
)                                   
0.70
   
0.60
 
EPS - Diluted
  
(0.10
)                                   
0.70
   
0.60
 
The
non-GAAP
diluted weighted average number of shares was 1,022 million for the three months ended September 30, 2018.


                                                             
 
Nine Months Ended September 30, 2019
 
 
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
  
Acquisition,
integration
and related
expenses
  
Restruc-
turing
costs
  
Costs
related to
regulatory
actions
taken in
facilities
  
Equity
compens-
ation
  
Contin-
gent
consider-
ation
  
Gain on
sale of
business
  
Other
non
GAAP
items
  
Other
items
  
Corres-
ponding
tax
effect
  
Unusual
tax
item*
  
Non
GAAP
 
Cost of sales
  
7,318
   
717
               
28
   
21
         
96
            
6,456
 
R&D expenses
  
778
                     
17
         
(7
)           
768
 
S&M expenses
  
1,908
   
105
                  
29
                     
1,774
 
G&A expenses
  
873
                     
37
                     
836
 
Other (income) expense
  
(29)
                           
(12
)              
(17
)
Legal settlements and loss contingencies
  
1,171
      
1,171
                                    
—  
 
Other assets impairments, restructuring and other items
  
263
         
96
   
2
   
140
         
4
      
22
            
—  
 
Intangible assets impairment
  
1,206
         
1,206
                                 
—  
 
Financial expenses, net
  
635
                                 
9
         
626
 
Income taxes
  
(159)
                                    
(662
)  
61
   
442
 
Share in losses of associated companies – net
  
8
                                          
8
 
Net income (loss) attributable to
non-controlling
interests
  
33
                                 
(28
)        
61
 
                                                             
Total reconciled items
     
823
   
1,171
   
1,302
   
2
   
140
   
28
   
104
   
4
   
(12
)  
111
   
(19
)  
(662
)  
61
    
                                                             
EPS—Basic
  
(1.02)
                                       
2.80
   
1.78
 
EPS—Diluted
  
(1.02)
                                       
2.80
   
1.78
 
The
non-GAAP
diluted weighted average number of shares was 1,093 million for the nine months ended September 30, 2019.
*Interest disallowance as a result of the U.S. Tax Cuts and Jobs Act.
**The data presented for prior periods have been revised to reflect a revision in the presentation of net revenues and cost of sales in the consolidated financial statements. See note 1c to our consolidated financial statements for additional information.


                                                                   
  
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
  
Good
will
impai
rment
  
Legal
settle
ments
and
loss
conting
encies
  
Impair-
ment of
long-
lived
assets
  
Other
R&D
expenses
  
Acquisition,
integration
and related
expenses
  
Restruct-
uring
costs
  
Costs
related to
regulatory
actions
taken in
facilities
  
Equity
compen-
sation
  
Contin
gent
consider-
ation
  
Gain on
sale of
business
  
Other
non
GAAP
items
  
Other
items
  
Corres-
ponding
tax
effect
  
Non
GAAP
 
 
Cost of sales
  
7,970
   
771
                     
6
   
22
         
94
         
7,077
 
 
R&D expenses
  
918
               
82
            
21
         
2
         
813
 
 
S&M expenses
  
2,119
   
138
                        
35
         
(4
)        
1,950
 
 
G&A expenses
  
954
                           
44
         
12
         
898
 
 
Other (income) expense
  
(334
)                                
(114
)           
(220
)
 
Legal settlements and loss contingencies
  
(1,239
)        
(1,239
)                                   
 
 
Other assets impairments, restructuring and other items
  
834
            
255
      
9
   
442
         
84
      
44
         
 
 
Intangible assets impairment
  
1,246
            
1,246
                                 
 
  
 
Goodwill impairment
  
300
      
300
                                       
 
 
Financial expenses, net
  
736
                                       
59
      
677
 
 
Income taxes
  
(56
)                                         
(479
)  
423
 
 
Share in losses of associated companies – net
  
76
                                       
103
      
(27
)
 
Net income (loss) attributable to
non-controlling
interests
  
35
                                       
(32
)     
67
 
 
Total reconciled items
                                         ��      
                                                                   
 
Total reconciled items
     
909
   
300
   
(1,239
)  
1,501
   
82
   
9
   
442
   
6
   
122
   
84
   
(114
)  
148
   
130
   
(479
)   
                                                                   
 
EPS—Basic
  
0.53
                                          
1.87
   
2.40
 
 
EPS—Diluted
  
0.53
                                          
1.86
   
2.39
 
The
non-GAAP
diluted weighted average number of shares was 1,0201,093 million for the ninethree months ended September 30, 2018.March 31, 2019.

60

Non-GAAP
Tax Rate
Non-GAAP
income taxes for the thirdfirst quarter of 20192020 were $183$175 million or 22%17%, on
pre-tax
non-GAAP
income of $843$1,030 million.
Non-GAAP
income taxes in the thirdfirst quarter of 20182019 were $85$125 million, or 10%16%, on
pre-tax
non-GAAP
income of $868$799 million. Our
non-GAAP
tax rate for the thirdfirst quarter of 20192020 was mainly affected by legal settlements with low correspondingthe mix of products we sold and lower interest expense disallowance compared to the first quarter of 2019.
We expect our annual non-GAAP tax effect,rate for 2020 to be 17%-18%, slightly lower than our non-GAAP tax rate for 2019, which was 18%. This is due to lower amounts of interest expense disallowance and other changes to tax positions and deductions.
Non-GAAP
income taxes for the first nine months of 2019 were $442 million, or 18%, on
pre-tax
non-GAAP
income of $2,454 million.
Non-GAAP
income taxes in the first nine months of 2018 were $423 million, or 14% on
pre-tax
non-GAAP
income of $3,100 million.
We expect our annual
non-GAAP
tax rate for 2019 to be 18%, which is higher than our previous projections and our
non-GAAP
tax rate for 2018. This is due to legal settlements with low corresponding tax effect, interest expense disallowance and other changes to tax positions and deductions. Our
non-GAAP
tax rate for 2018 was 14%.
Off-Balance
Sheet Arrangements
Except for securitization transactions, which are disclosed in note 16(d)10(f) to our consolidated financial statements included in our Annual Report on Form
10-K
for the year ended December 31, 2018,2019, we do not have any material
off-balance
sheet arrangements.
Critical Accounting Policies
For a summary of our significant accounting policies, see note 1 to our consolidated financial statements and “Critical Accounting Policies” included in our Annual Report on Form
10-K
for the year ended December 31, 2018.2019.
Recently Issued Accounting Pronouncements
See note 21 to our consolidated financial statements.
ITEM 3.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
There has not been any material change in our assessment of market risk as set forth in Item 7A to our Annual Report on Form
10-K
for the year ended December 31, 2018.
2019.
ITEM 4.
CONTROLS AND PROCEDURES
Disclosure Controls and Procedures 
Teva maintains “disclosure controls and procedures” (as defined in Rules
 13a-15(e)
 and
 15d-15(e)
 under the Securities Exchange Act of 1934, as amended) that are designed to provide reasonable assurance that information required to be disclosed in Teva’s reports filed or submitted under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to Teva’s management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective.
After evaluating the effectiveness of our disclosure controls and procedures as of September 30, 2019,March 31, 2020, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, Teva’s disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
InDuring the third quarter of 2019 Teva completed the implementation of a company-wide enterprise resource planning (ERP) system in the U.S. to upgrade certain operational and financial processes. In connection with this ERP implementation,ended March 31, 2020, there have beenwere no changes in internal control over financial reporting during the quarter ended September 30, 2019 that have materially affected or are reasonably likely to materially affect the Company’sTeva’s internal control over financial reporting.

61

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 1610 to the consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form
10-Q.
ITEM 1A.
RISK FACTORS
Except as set forth below, there are no material changes to the risk factors previously disclosed in our Annual Report on Form
10-K
for the year ended December 31, 2018.
2019.
Public concern over the abuseThe widespread outbreak of opioid medications inan illness or any other communicable disease, or any other public health crisis, such as the United States, including increased legal and regulatory action,
COVID-19
pandemic, could negativelyadversely affect our business.
Certain governmental and regulatory agencies are focused on the abuse of opioid medications in the United States. Federal, state and local governmental and regulatory agencies are conducting investigations of us, other pharmaceutical manufacturers and other supply chain participants with regard to the manufacture, sale, marketing and distribution of opioid medications. A number of state attorneys general, including a coordinated multistate effort, are investigating our sales and marketing of opioids and we have received subpoena requests from the U.S. Department of Justice seeking documents relating to the manufacture, marketing and sale of opioid medications. In addition, we are currently litigating civil claims brought by various states and political subdivisions as well as private claimants, against various manufacturers, distributors and retail pharmacies throughout the United States in connection with our manufacture, sale and distribution of opioids. On October 21, 2019, Teva and certain other defendants reached an agreement in principle with a group of Attorneys General from North Carolina, Pennsylvania, Tennessee and Texas for a nationwide settlement framework. The framework is designed to provide a mechanism by which Teva attempts to seek resolution of remaining potential and pending opioid claims by both the U.S. states and political subdivisions (i.e., counties, tribes and other plaintiffs) thereof. Under this agreement, Teva would provide buprenorphine naloxone (sublingual tablets), in quantities with an estimated value up to approximately $23 billion at wholesale acquisition cost over a ten year period. In addition, Teva would also provide cash payments of up to $250 million over a ten year period. This global settlement framework is predicated on settlement with all U.S. states and related subdivisions. Teva cannot predict if the nationwide settlement framework will be finalized. Responding to governmental investigations and managing legal proceedings is costly and involves a significant diversion of management attention. Such proceedings are unpredictable and may develop over lengthy periods of time. An adverse resolution of any of these lawsuits or investigations may involve substantial monetary penalties and could have a material and adverse effect on our reputation, business, results of operations and cash flows. See “Government Investigationsfinancial condition.
The novel coronavirus outbreak, or
COVID-19,
has affected segments of the global economy and Litigation Relatingmay materially affect our operations, including potentially interrupting our manufacturing, supply chain, clinical trial and
pre-commercial
launch activities.
COVID-19
originated in Wuhan, China, in December 2019 and was declared a pandemic by the World Health Organization in March 2020. The virus has since spread to Pricing and Marketing” in note 16multiple countries, including to the consolidatedUnited States and Israel, where we currently manufacture most of our products and conduct our clinical trials. The
COVID-19
pandemic has negatively impacted the global economy, disrupted global supply chains, and created significant volatility and disruption of financial statements includedmarkets.
At present, we are not experiencing significant impact or delays from
COVID-19
on our business operations. However, as we expect to be able to continue our operations and to satisfy the higher demand for our products, while protecting the health and safety of our employees and customers, the uncertainty surrounding the severity and continued spread of the coronavirus may result in Part I, Item 1a period of this Quarterly Reportbusiness disruption.
COVID-19
may impact our operations, including potential delays in supply and manufacturing or material interruptions to supply chains, clinical trials and
pre-commercial
launch activities and regulatory reviews and approvals.
COVID-19
may also affect our employees and employees and operations at third-party manufacturers or suppliers that may result in delays or disruptions in manufacturing and supply. Any
COVID-19
related disruption could have a material adverse impact on Form 10-Q.our business and our results of operation and financial condition. Changes in patient behavior resulting in less visits to physicians and medical facilities, or increased layoffs in the U.S. employment market, which may affect healthcare benefits coverage, may cause a decline or slower growth in the number of patients diagnosed with diseases for which we produce treatments, and as a result our revenues could be adversely affected. In addition, a recession or market correction resulting from the spread of
COVID-19
could materially affect our business and the value of our shares.
Additionally, if the
COVID-19
pandemic has a significant impact on our business and financial results for an extended period of time, our credit losses, liquidity and cash resources could be negatively impacted. We may be required to draw down funds from our RCF or pursue additional sources of financing to fund our operations. Capital and credit markets have been disrupted by the crisis and foreign exchanges have experienced increased volatility. As a result, access to additional financing may be challenging and is largely dependent upon evolving market conditions and other factors.    
We have taken precautionary measures, and may take additional measures, intended to minimize the risk of
COVID-19
to our employees and operations. The extent of the impact of
COVID-19
on our operational and financial performance, including our ability to execute our business strategies in the expected time frame or at all, will depend on future developments, such as the duration and spread of the
COVID-19
pandemic and related restrictions and implications, all of which are uncertain and cannot be predicted.
ITEM 2.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
Unregistered Sales of Equity Securities
There were no sales of unregistered equity securities during the three months ended September 30, 2019.March 31, 2020.
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 September 30, 2019. We did not repurchase any of our shares during the three months ended September 30, 2019March 31, 2020 and currently cannot do soconduct share repurchases or pay dividends 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.
62

ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
ITEM 5.
OTHER INFORMATION
None.

63

ITEM 6.
EXHIBITS
     
     
 
31.1
  
     
 
31.2
  
     
 
32
  
     
 
101.INS
  
Inline XBRL Taxonomy Instance Document (The instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document)
     
 
101.SCH
  
Inline XBRL Taxonomy Extension Schema Document
     
 
101.CAL
  
Inline XBRL Taxonomy Extension Calculation Linkbase Document
     
 
101.DEF
  
Inline XBRL Taxonomy Extension Definition Linkbase Document
     
 
101.LAB
  
Inline XBRL Taxonomy Extension Labels Linkbase Document
     
 
101.PRE
  
Inline XBRL Taxonomy Extension Presentation Linkbase Document
     
 
104
  
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
*Filed herewith.
80
64

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
     
 
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
     
Date: NovemberMay 7, 20192020
 
By:
 
/s/ Michael McClellanEli Kalif
 
Name:
 
Michael McClellanEli Kalif
 
Title:
 
Executive Vice President,
Chief Financial Officer
(Duly Authorized Officer)
8165