Table of Contents
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM
10-Q
 
FORM
10-Q
 
 
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 20212022
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
 
No
t Applicable
Not Applicable
(State or other jurisdiction of
incorporation or organization)
 
(IRS Employer
Identification Number)
5 Basel Street, Petach Tikva,124 Dvora HaNevi’a St., Tel Aviv, ISRAEL
 
4951033
6944020
(Address of principal executive offices)
 
(Zip code)
+972
(3)
914-8213
(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 June 30, 2021,2022, the registrant had 1,102,885,659
 1,110,564,656 ordinary shares outstanding.
 
 
 

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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, a provider of market research to the pharmaceutical industry (“IQVIA”), unless otherwise stated. References to “R&D” are to Research and Development, references to “IPR&D” are to
in-process
R&D, references to “S&M” are to Selling and Marketing and references to “G&A” are to General and Administrative. Some amounts in this report may not add up due to rounding. All percentages have been calculated using unrounded amounts. This report on Form
10-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; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; our ability to develop and commercialize biopharmaceutical products; competition for our specialty products, including AUSTEDO
®
, AJOVY
®
and COPAXONE
®
; our ability to achieve expected results from investments in our product pipeline; our ability to develop and commercialize additional pharmaceutical products; and the effectiveness of our patents and other measures to protect our intellectual property rights;
 
our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
 
our business and operations in general, including: uncertainty regarding the
COVID-19
pandemic and its impact on our business, financial condition, operations, cash flows,the governmental and liquidity and on the economy in general;societal responses thereto; 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; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the
COVID-19
pandemic; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
 
compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice (“DOJ”) criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks; and the impact of Environmental, Social and Governance (“ESG”) issues;
 
other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); 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;
 
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TEVA PHARMACEUTICAL INDUSTRIES LIMITED
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, 2020,2021, 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.
 
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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)
 
   
June 30,
  
December 31,
 
   
2021
  
2020
 
ASSETS
         
Current assets:
         
Cash and cash equivalents
  $2,436  $2,177 
Accounts receivables, net of allowance for credit losses of $120 million and $126 million as of June 30, 2021 and December 31, 2020
   4,488   4,581 
Inventories
   4,362   4,403 
Prepaid expenses
   1,022   945 
Other current assets
   484   710 
Assets held for sale
   29   189 
   
 
 
  
 
 
 
Total current assets
   12,822   13,005 
Deferred income taxes
   645   695 
Other
non-current
assets
   530   538 
Property, plant and equipment, net
   6,127   6,296 
Operating lease
right-of-use
assets
   531   559 
Identifiable intangible assets, net
   8,120   8,923 
Goodwill
   20,421   20,624 
   
 
 
  
 
 
 
Total assets
  $49,195  $50,640 
   
 
 
  
 
 
 
LIABILITIES AND EQUITY
         
Current liabilities:
         
Short-term debt
  $3,530  $3,188 
Sales reserves and allowances
   4,453   4,824 
Accounts payables
   1,551   1,756 
Employee-related obligations
   511   685 
Accrued expenses
   1,807   1,780 
Other current liabilities
   838   933 
   
 
 
  
 
 
 
Total current liabilities
   12,691   13,164 
Long-term liabilities:
         
Deferred income taxes
   932   964 
Other taxes and long-term liabilities
   2,215   2,240 
Senior notes and loans
   21,602   22,731 
Operating lease liabilities
   444   479 
   
 
 
  
 
 
 
Total long-term liabilities
   25,193   26,414 
   
 
 
  
 
 
 
Commitments and contingencies
, see note 10
       
Total liabilities
   37,884   39,579 
   
 
 
  
 
 
 
Equity:
         
Teva shareholders’ equity:
         
Ordinary shares of NIS 0.10 par value per share; June 30, 2021 and December 31, 2020: authorized 2,495 million shares; issued 1,209 million shares and 1,202 million shares, respectively
   57   57 
Additional
paid-in
capital
   27,503   27,443 
Accumulated deficit
   (10,662  (10,946
Accumulated other comprehensive loss
   (2,446  (2,399
Treasury shares as of June 30, 2021 and December 31, 2020 — 106 million ordinary shares
   (4,128  (4,128
   
 
 
  
 
 
 
    10,324   10,026 
   
 
 
  
 
 
 
Non-controlling
interests
   987   1,035 
   
 
 
  
 
 
 
Total equity
   11,311   11,061 
   
 
 
  
 
 
 
Total liabilities and equity
  $49,195  $50,640 
   
 
 
  
 
 
 
   
June 30,
  
December 31,
 
   
2022
  
2021
 
ASSETS
   
Current assets:
   
Cash and cash equivalents
  $2,058  $2,165 
Accounts receivables, net of allowance for credit losses of $95 million and $90 million as of June 30, 2022 and December 31, 2021
   4,471   4,529 
Inventories
   4,049   3,818 
Prepaid expenses
   1,052   1,075 
Other current assets
   518   965 
Assets held for sale
   16   19 
   
 
 
  
 
 
 
Total current assets
   12,164   12,573 
Deferred income taxes
   1,595   596 
Other
non-current
assets
   454   515 
Property, plant and equipment, net
   5,740   5,982 
Operating lease
right-of-use
assets
   441   495 
Identifiable intangible assets, net
   6,700   7,466 
Goodwill
   18,837   20,040 
   
 
 
  
 
 
 
Total assets
  $45,932  $47,666 
   
 
 
  
 
 
 
LIABILITIES AND EQUITY
         
Current liabilities:
         
Short-term debt
  $1,719  $1,426 
Sales reserves and allowances
   3,880   4,241 
Accounts payables
   1,901   1,686 
Employee-related obligations
   467   563 
Accrued expenses
   2,112   2,208 
Other current liabilities
   916   903 
   
 
 
  
 
 
 
Total current liabilities
   10,996   11,027 
Long-term liabilities:
         
Deferred income taxes
   532   784 
Other taxes and long-term liabilities
   3,842   2,578 
Senior notes and loans
   20,363   21,617 
Operating lease liabilities
   371   416 
   
 
 
  
 
 
 
Total long-term liabilities
   25,107   25,395 
   
 
 
  
 
 
 
Commitments and contingencies
, see note 10
       
Total liabilities
   36,103   36,422 
   
 
 
  
 
 
 
Equity:
         
Teva shareholders’ equity:
         
Ordinary shares of NIS 0.10 par value per share; June 30, 2022 and December 31, 2021: authorized 2,495 million shares; issued 1,216 million shares and 1,209 million shares, respectively.
   57   57 
Additional
paid-in
capital
   27,625   27,561 
Accumulated deficit
   (11,716)  (10,529
Accumulated other comprehensive loss
   (2,801  (2,683
Treasury shares as of June 30, 2022 and December 31, 2021: 106 million ordinary shares
   (4,128  (4,128
   
 
 
  
 
 
 
    9,037   10,278 
   
 
 
  
 
 
 
Non-controlling
interests
   791   966 
   
 
 
  
 
 
 
Total equity
   9,828   11,244 
   
 
 
  
 
 
 
Total liabilities and equity
  $45,932
  $47,666 
   
 
 
  
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.
 
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TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(U.S. dollars in millions, except share and per share data)
(Unaudited)
 
   
Three months ended
  
Six months ended
 
   
June 30,
  
June 30,
 
   
2021
  
2020
  
2021
  
2020
 
Net revenues
  $3,910  $3,870  $7,892  $8,227 
Cost of sales
   2,037   2,107   4,141   4,402 
Gross profit
   1,873   1,763   3,750   3,826 
Research and development expenses
   248   225   501   446 
Selling and marketing expenses
   615   597   1,200   1,210 
General and administrative expenses
   242   264   532   567 
Intangible assets impairments
   195   120   274   768 
Other assets impairments, restructuring and other items
   28   381   165   502 
Legal settlements and loss contingencies
   6   13   110   (12
Other income
   (43  (9  (48  (22
   
 
 
  
 
 
  
 
 
  
 
 
 
Operating income (loss)   582   173   1,015   364 
Financial expenses, net
   274   223   564   448 
   
 
 
  
 
 
  
 
 
  
 
 
 
Income (loss) before income taxes
   308   (51  451   (84
Income taxes (benefit)
   98   (104  159   (163
Share in (profits) losses of associated companies, net
   (11  0     (14  0 
   
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss)
   221   53   306   78 
Net income (loss) attributable to
non-controlling
interests
   14   (87  21   (131
   
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss) attributable to Teva
   207   140   284   209 
   
 
 
  
 
 
  
 
 
  
 
 
 
Earnings (loss) per share attributable to ordinary shareholders:
                 
Basic
  $0.19  $0.13  $0.26  $0.19 
   
 
 
  
 
 
  
 
 
  
 
 
 
Diluted
  $0.19  $0.13  $0.26  $0.19 
   
 
 
  
 
 
  
 
 
  
 
 
 
Weighted average number of shares (in millions):
                 
Basic
   1,103   1,096   1,101   1,095 
   
 
 
  
 
 
  
 
 
  
 
 
 
Diluted
   1,109   1,100   1,108   1,098 
   
 
 
  
 
 
  
 
 
  
 
 
 
   
Three months ended
  
Six months ended
 
   
June 30,
  
June 30,
 
   
2022
  
2021
  
2022
  
2021
 
Net revenues
  $3,786  $3,910  $7,447  $7,892 
Cost of sales
   1,992   2,037   3,913   4,141 
   
 
 
  
 
 
  
 
 
  
 
 
 
Gross profit
   1,794   1,873   3,534   3,750 
Research and development expenses
   228   248   453   501 
Selling and marketing expenses
   594   615   1,178   1,200 
General and administrative expenses
   313   242   609   532 
Intangible assets impairments
   51   195   199   274 
Goodwill impairment
   745   —     745   —   
Other assets impairments, restructuring and other items
   118   28   246   165 
Legal settlements and loss contingencies
   729   6   1,854   110 
Other income
   (34  (43)  (87)  (48)
 
   
 
 
  
 
 
  
 
 
  
 
 
 
Operating income (loss)
   (949  582   (1,662)  1,015 
Financial expenses, net
   211   274   468   564 
   
 
 
  
 
 
  
 
 
  
 
 
 
Income (loss) before income taxes
   (1,160  308   (2,131)  451 
Income taxes (benefit)
   (900  98   (899)  159 
Share in (profits) losses of associated companies, net
      (11  (21)  (14
   
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss)
   (259  221   (1,211)  306 
Net income (loss) attributable to
non-controlling
interests
   (27  14   (24  21 
   
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss) attributable to Teva
   (232)  207   (1,187)  284 
   
 
 
  
 
 
  
 
 
  
 
 
 
Earnings (loss) per share attributable to ordinary shareholders:
                 
Basic
  $(0.21) $0.19  $(1.07)  $0.26 
   
 
 
  
 
 
  
 
 
  
 
 
 
Diluted
  $(0.21) $0.19  $(1.07) $0.26 
   
 
 
  
 
 
  
 
 
  
 
 
 
Weighted average number of shares (in millions):
                 
Basic
   1,110   1,103   1,109   1,101 
   
 
 
  
 
 
  
 
 
  
 
 
 
Diluted
   1,110   1,109   1,109   1,108 
   
 
 
  
 
 
  
 
 
  
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.
 
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TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)
(U.S. dollars in millions)
(Unaudited)
 
   
Three months ended
  
Six months ended
 
   
June 30,
  
June 30,
 
   
2021
   
2020
  
2021
  
2020
 
Net income (loss)
  $221   $53  $306  $78 
Other comprehensive income (loss), net of tax:
                  
Currency translation adjustment
   79    144   (130  (416
Unrealized gain (loss) from derivative financial instruments, net
   7    7   14   37 
Unrealized loss on defined benefit plans
   1    0     1   0   
   
 
 
   
 
 
  
 
 
  
 
 
 
Total other comprehensive income (loss)
   87    151   (115  (379
   
 
 
   
 
 
  
 
 
  
 
 
 
Total comprehensive income (loss)
   308    204   191   (301
Comprehensive income (loss) attributable to
non-controlling
interests
   13    (85  (47  (119
   
 
 
   
 
 
  
 
 
  
 
 
 
Comprehensive income (loss) attributable to Teva
  $295   $289  $238  $(182
   
 
 
   
 
 
  
 
 
  
 
 
 
   
Three months ended
   
Six months ended
 
   
June 30,
   
June 30,
 
   
2022
  
2021
   
2022
  
2021
 
Net income (loss)
  $(259 $221   $(1,211 $306 
Other comprehensive income (loss), net of tax:
                  
Currency translation adjustment
   (219  79    (282  (130
Unrealized gain (loss) from derivative financial instruments, net
   7   7    14   14 
Unrealized loss on defined benefit plans
   —     1    —     1 
   
 
 
  
 
 
   
 
 
  
 
 
 
Total other comprehensive income (loss)
   (212  87    (268  (115
   
 
 
  
 
 
   
 
 
  
 
 
 
Total comprehensive income (loss)
   (471  308    (1,479  191 
Comprehensive income (loss) attributable to
non-controlling
interests
   (125)  13    (174)  (47
   
 
 
  
 
 
   
 
 
  
 
 
 
Comprehensive income (loss) attributable to Teva
  $(346) $295   $(1,305) $238 
   
 
 
  
 
 
   
 
 
  
 
 
 
Amounts may not add up due to rounding.
The accompanying notes are an integral part of the financial statements.
 
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TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
 
  
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 March 31, 2021
  1,208   57   27,474   (10,869  (2,534  (4,128  10,000   975   10,975 
Net Income (loss)
              207           207   14   221 
Other comprehensive income (loss)
                  88       88   (1  87 
Issuance of Shares
  01   0*                   0*       0* 
Stock-based compensation expense
          29               29      29 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2021
  1,209  $57  $27,503  $(10,662 $(2,446 $(4,128 $10,324  $987  $11,311 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
  
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 March 31, 2022
  1,216   57   27,587   (11,484  (2,687  (4,128  9,344   916   10,260 
Net Income (loss)
              (232)          (232)  (27  (259
Other comprehensive income (loss)
                  (114      (114  (98  (212
Issuance of Shares
  *   *                   *       * 
Stock-based compensation expense
          39               39       39 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2022
  1,216  $57  $27,625  $(11,716) $(2,801 $(4,128 $9,037  $791  $9,828 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
*
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 March 31, 2020
  1,201   56   27,342   (6,887  (2,852  (4,128  13,531   1,057   14,588 
Net Income (loss)
              140           140   (87  53 
Other comprehensive income (loss)
                  149       149   2   151 
Issuance of Shares
  1   0*                           0* 
Stock-based compensation expense
          32               32       32 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2020
  1,202  $57  $27,374  $(6,747 $(2,703 $(4,128 $13,852  $972  $14,824 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
  
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 March 31, 2021
  1,208   57   27,474   (10,869  (2,534  (4,128  10,000   975   10,975 
Net Income (loss)
              207           207   14   221 
Other comprehensive income (loss)
                  88       88   (1  87 
Issuance of Shares
  1   *                   *       * 
Stock-based compensation expense
          29               29       29 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2021
  1,209  $57  $27,503  $(10,662 $(2,446 $(4,128 $10,324  $987  $11,311 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
*
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, 2020
  1,202   57   27,443   (10,946  (2,399  (4,128  10,026   1,035   11,061 
Net Income (loss)
              284           284   21   306 
Other comprehensive income (loss)
                  (47      (47  (68  (115
Issuance of Shares
  6   0*                   0*       0* 
Stock-based compensation expense
          60               60      60 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2021
  1,209  $57  $27,503  $(10,662 $(2,446 $(4,128 $10,324  $987  $11,311 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
  
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, 2021
  1,209   57   27,561   (10,529  (2,683  (4,128  10,278   966   11,244 
Net Income (loss)
              (1,187)          (1,187)  (24  (1,211
Other comprehensive income (loss)
                  (118      (118  (150  (268
Issuance of Shares
  7   *   1               1       1 
Stock-based compensation expense
          63               63       63 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2022
  1,216  $57  $27,625  $(11,716) $(2,801 $(4,128 $9,037  $791  $9,828 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
*
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
7

Table of Contents
  
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 
Net Income (loss)
                  209           209   (131  78 
Other comprehensive income (loss)
                      (391      (391  12   (379
Issuance of shares
   4    0*                     0*       0* 
Stock-based compensation expense
             62                62       62 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2020
   1,202   $57   $27,374   $(6,747 $(2,703 $(4,128 $13,852  $972  $14,824 
   
 
 
   
 
 
   
 
 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 

  
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, 2020
  1,202   57   27,443   (10,946  (2,399  (4,128  10,026   1,035   11,061 
Net Income (loss)
              284           284   21   306 
Other comprehensive income (loss)
                  (47      (47  (68  (115
Issuance of shares
  6   *                   *       * 
Stock-based compensation expense
          60               60       60 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2021
  1,209  $57  $27,503  $(10,662 $(2,446 $(4,128)�� $10,324  $987  $11,311 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
*
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
8

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in millions)
(Unaudited)
 
   
Six months ended
 
   
June 30,
 
   
2021
  
2020
 
Operating activities:
         
Net income (loss)
  $306  $78 
Adjustments to reconcile net income (loss) to net cash provided by operations:
         
Depreciation and amortization
   681   781 
Impairment of long-lived assets and assets held for sale
   354   1,120 
Net change in operating assets and liabilities
   (1,679  (1,002
Deferred income taxes – net and uncertain tax positions
   5   (502
Stock-based compensation
   60   62 
Net loss (gain) from investments and from sale of long lived assets
   93   24 
Other items
   (7  17 
   
 
 
  
 
 
 
Net cash provided by (used in) operating activities
   (187  578 
   
 
 
  
 
 
 
Investing activities:
         
Beneficial interest collected in exchange for securitized accounts receivables
   881   769 
Purchases of property, plant and equipment
   (263  (259
Proceeds from sale of business and long lived assets
   254   45 
Proceeds from sale of investments 
   153   9 
Other investing activities  
 
(36
)
 
  
 
1
 
   
 
 
  
 
 
 
Net cash provided by investing activities
   989   565 
   
 
 
  
 
 
 
Financing activities:
         
Repayment of senior notes and loans and other long-term liabilities
   0     (700
Redemption of convertible senior notes
   (491  0   
Other financing activities
   (3  (3)
   
 
 
  
 
 
 
Net cash used in financing activities
   (494  (703
   
 
 
  
 
 
 
Translation adjustment on cash and cash equivalents
   (49  (13
   
 
 
  
 
 
 
Net change in cash and cash equivalents
   259   427 
Balance of cash and cash equivalents at beginning of period
   2,177   1,975 
   
 
 
  
 
 
 
Balance of cash and cash equivalents at end of period
  $2,436  $2,402 
   
 
 
  
 
 
 
Non-cash
financing and investing activities:
         
Beneficial interest obtained in exchange for securitized accounts receivables
  $878  $728 
   
Six months ended
 
   
June 30,
 
   
2022
  
2021
 
Operating activities:
   
Net income (loss)
  $(1,211 $306 
Adjustments to reconcile net income (loss) to net cash provided by operations:
         
Depreciation and amortization
   681   681 
Impairment of goodwill, long-lived assets and assets held for sale   975   354 
Net change in operating assets and liabilities
   913   (1,679
Deferred income taxes – net and uncertain tax positions
   (1,258  5 
Stock-based compensation
   63   60 
Other items
   (77  (7
Net loss (gain) from investments and from sale of long lived assets
   (12  93 
   
 
 
  
 
 
 
Net cash provided by (used in) operating activities
   74   (187
   
 
 
  
 
 
 
Investing activities:
         
Beneficial interest collected in exchange for securitized trade receivables
   592   881 
Proceeds from sale of business and long lived assets
   43   254 
Acquisition of businesses, net of cash acquired
   (7  —   
Purchases of property, plant and equipment
   (284  (263
Purchases of investments and other assets
   (4  (36
Proceeds from sale of investments
   3   153 
Other investing activities
   (2  —   
   
 
 
  
 
 
 
Net cash provided by (used in) investing activities
   341   989 
   
 
 
  
 
 
 
Financing activities:
         
Redemption of convertible senior notes
   —     (491
Repayment of senior notes and loans
   (296)  —   
Other financing activities
   (40)  (3
   
 
 
  
 
 
 
Net cash provided by (used in) financing activities
   (336  (494
   
 
 
  
 
 
 
Translation adjustment on cash and cash equivalents
   (185  (49
   
 
 
  
 
 
 
Net change in cash, cash equivalents and restricted cash
   (107  259 
Balance of cash, cash equivalents and restricted cash at beginning of period
   2,198   2,177 
   
 
 
  
 
 
 
Balance of cash, cash equivalents and restricted cash at end of period
  $2,091  $2,436 
   
 
 
  
 
 
 
Reconciliation of cash, cash equivalents and restricted cash reported in the consolidated balance sheets:
         
Cash and cash equivalents
   2,058   2,436 
Restricted cash included in other current assets
   33   —   
   
 
 
  
 
 
 
Total cash, cash equivalents and restricted cash shown in the statement of cash flows
   2,091   2,436 
   
 
 
  
 
 
 
Non-cash
financing and investing activities:
         
Beneficial interest obtained in exchange for securitized accounts receivables
  $590  $878 
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 normal and 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 Annual Report on Form
10-K
for the year ended December 31, 2020,2021, as filed with the Securities and Exchange Commission (“SEC”). The
year-end
balance sheet data was derived from the audited consolidated financial statements as of December 31, 2020,2021, 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 the
COVID-19
pandemic 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 the
COVID-19
pandemic and the actions taken to contain or treat it, as well as the economic impact on Teva’s employees, third-party manufacturers and suppliers, customers and markets. All estimates made by Teva related to the impact of the
COVID-19
pandemic within its financial statements may change in future periods. Actual results could differ from those estimates.
In February 2022, Russia launched an invasion of Ukraine. As of the date of this Quarterly Report on Form
10-Q,
sustained conflict and disruption in the region is ongoing. Russia and Ukraine markets are included in Teva’s International Markets segment results. Teva has no manufacturing or R&D facilities in these markets. As part of the Company’s annual goodwill analysis, it identified an increase in the discount rate, which led to a goodwill impairment charge in its International Markets and Teva’s API reporting units. This increase was a result of an increase in certain components of the discount rate that were partially attributed to higher risk associated with country-specific characteristics of several countries, such as Russia, that might be a consequence of the conflict. Other than its impact on the goodwill impairment charge, during the three and six months ended June 30, 2022, the impact of this conflict on Teva’s results of operations and financial condition was immaterial. See also note 6.
The results of operations for the three and six months ended June 30, 20212022 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.
 
 
b.
Significant accounting policies
Recently adopted accounting pronouncements
In August 2020, the FASB issued ASU
2020-06
“Debt – Debt with Conversion and Other Options (Subtopic
470-20)
and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The adoption of this guidance did not have a significant impact on the Company’s consolidated financial statements.
In March 2020, the FASB issued ASU
2020-04
“Reference Rate Reform (Topic 848)—Facilitation of the Effects of Reference Rate Reform on Financial Reporting.” This guidance provides optional expedients and exceptions for applying generally accepted accounting principles to contracts, hedging relationships, and other transactions affected by reference rate reform if certain criteria are met. The guidance applies only to contracts, hedging relationships, and other transactions that reference LIBOR or another reference rate expected to be discontinued because of reference rate reform. This guidance is effective for all entities as of March 12, 2020 through December 31, 2022. There was no material impact to the Company’s consolidated financial statements for the period ended June 30, 20212022 as a result of adopting this standard update. The Company is continuinghas completed negotiations to evaluatetransform the facility base rate of its securitization program and evaluated the potential impact of the replacement of the LIBOR benchmark on its interest rate risk management activities and has started initial negotiations to transform the facility base rate of its securitization program. However, it is not expected to have a material impact on the consolidated financial results of operations, financial position or cash flows.
In December 2019, the FASB 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 accounting for basis differences for equity method investments when a foreign subsidiary becomes an equity method investment; and (3) exception to accounting for basis differences 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. Teva adopted the provisions of this update as of January 1, 2021.
11

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Based on the Company’s evaluation of the above provisions, the Company notes that items (1) and (4) of this paragraph are not material.activities. The adoption of this guidance did not have a material impact on the Company’s consolidated financial results of operations, financial position or cash flows.
Recently issued accounting pronouncements, not yet adopted
I10
n August 2020, the FASB issued ASU
2020-06
“Debt – Debt with Conversion and Other Options (Subtopic
470-20)
and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815 – 40).” This guidance simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The amendments to this guidance are effective for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years. The adoption of this guidance will not have a significant impact on the Company’s consolidated financial statements.
12

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
Recently issued accounting pronouncements, not yet adopted
In November 2021, the FASB issued ASU
2021-10
“Government Assistance (Topic 832)”, which requires annual disclosures that increase the transparency of transactions involving government grants, including (1) the types of transactions, (2) the accounting for those transactions, and (3) the effect of those transactions on an entity’s financial statements. The amendments in this update are effective for financial statements issued for annual periods beginning after December 15, 2021. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.
In October 2021, the FASB issued ASU
2021-08
“Business Combinations (Topic 805), Accounting for Contract Assets and Contract Liabilities from Contracts with Customers”, which requires contract assets and contract liabilities acquired in a business combination to be recognized and measured by the acquirer on the acquisition date in accordance with ASC 606, Revenue from Contracts with Customers. The guidance will result in the acquirer recognizing contract assets and contract liabilities at the same amounts recorded by the acquiree. The guidance should be applied prospectively to acquisitions occurring on or after the effective date. The guidance is effective for fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. Early adoption is permitted, including in interim periods, for any financial statements that have not yet been issued. Adoption in an interim period other than the first fiscal quarter requires an entity to apply the new guidance to all prior business combinations that have occurred since the beginning of the annual period in which the new guidance is adopted. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements.

NOTE 2 – Certain transactions:
The Company has entered into alliances and other arrangements with third parties to acquire rights to products it does not have, to access markets it does not operate in and to otherwise share development costs or business risks. The Company’s most significant agreements of this nature are summarized below.
Alvotech PartnershipMODAG
In October 2021, Teva announced a license agreement with MODAG GmbH (“Modag”) that will provide Teva an exclusive global license to develop, manufacture and commercialize Modag’s lead compound
(TEV-56286)
and a related compound
(TEV-56287).
TEV-56286
was initially developed for the treatment of Multiple System Atrophy (“MSA”) and Parkinson’s disease, and has the potential to be applied to other treatments for neurodegenerative disorders, such as Alzheimer’s disease. A phase 1b clinical trial is currently being completed for
TEV-56286.
In the fourth quarter of 2021, Teva made an upfront payment of $10 million to Modag that was recorded as an R&D expense. Modag may be eligible for future development milestone payments, totaling an aggregate amount of up to $70 million, as well as future commercial milestones and royalties.
Alvotech
In August 2020, Teva entered into a partnershipan agreement with biopharmaceutical company Alvotech for the exclusive commercialization in the U.S. of five biosimilar product candidates. The initial pipeline for this partnershipcollaboration contains biosimilar candidates addressing multiple therapeutic areas, including a proposed biosimilar to Humira
®
. Under this agreement, Alvotech is responsible for the development, registration and supply of the biosimilar product candidates and Teva will exclusively commercialize the products in the United States. Teva paid an upfront payment in the third quarter of 2020 and additional upfront and milestone payments in the second quarter of 2021 that were recorded as R&D expenses. Additional development and commercial milestone payments of up to $450 
$455 
million, as well as royalty payments, may be payable by Teva over the next few years. Teva and Alvotech will share profit from the commercialization of these biosimilars. In March 2021,Alvotech was previously involved in litigation involving certain IP and trade secrets claims filed by Abbvie sued Alvotech for allegedly misappropriating confidential information relatingin relation to Alvotech’s proposed biosimilar to Humira
®
., all of which were settled on March 8, 2022. Pursuant to that settlement, Alvotech has disputed these claims. In addition, thereand Teva may sell Alvotech’s proposed biosimilar to Humira
®
in the United States beginning on July 1, 2023, provided that U.S. regulatory approval is pending patent litigation between Abbvie and Alvotech.obtained by that date.
11

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Eli Lilly and Alder BioPharmaceuticals
In December 2018, Teva entered into an agreement with Eli Lilly & Co. (“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 intellectual property 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 received 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.Japan. Teva received a $25 million upfront payment that was recognized as revenue during the first quarter of 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 development and commercial milestone payments to Teva of up to $150 million, as well as future royalties.
AUSTEDO
®
On September 19, 2017, Teva entered into a partnership agreement with Nuvelution Pharma, Inc. (“Nuvelution”) for development of AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States. There are no further plans in this indication following clinical trial results received in February 2020, which failed to meet their primary endpoints. The partnership agreement was terminated on February 5, 2021.
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 2develop and 3 clinical trials forcommercialize 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. 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 the third quarter of 2020, Otsuka submitted an application to obtain manufacturing and marketing approval for AJOVY in Japan and, as a result, paid Teva a milestone payment of $15 million, which was recognized as revenue in the third quarter of 2020. On June 23, 2021, AJOVY was approved in Japan.
Japan in June 2021 and launched on August 30, 2021. As a result of the launch, Otsuka paid Teva a milestone payment of $35 million, which was recognized as revenue in the third quarter of 2021. Teva may receive additional milestone payments upon achievement of certain development and revenue targets. Otsuka will also paypays Teva royalties on AJOVY sales in Japan.
13

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Celltrion
Takeda
In OctoberDecember 2016, Teva and Celltrion, Inc. (“Celltrion”) entered into a collaborativelicense agreement to commercialize Truxima
®
and Herzuma
®
with a subsidiary of Takeda Pharmaceutical Company Ltd. (“Takeda”), two biosimilar products for the U.S.research, development, manufacture and Canadian markets. Teva paid Celltrion $160 million,commercialization of which
Attenukine
®
technology.
Teva received an aggregate credita $30 million upfront payment as well as a milestone payment of $60$20 million in 2017. During the second quarter of 2022, Takeda initiated Phase II study of modakafusp alfa (formerly TAK 573 or TEV 48573) and as a result paid Teva a milestone payment of March 31, 2021. Teva and Celltrion 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$25 million, which was recognized as revenues in the United States in November 2019 and March 2020, respectively. Nosecond quarter of 2022. The license agreement stipulates additional milestone payments are expected.to Teva of up to $519 million in respect of this product, as well as future royalties.
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 in the global commercial rights to this product (excluding Japan, Korea and nine other Asian countries), as well as ongoing associated R&D costs of approximately $1 billion. Teva made an upfront payment of $250 million to Regeneron in the third quarter of 2016 and additional payments for achievement of development milestones in an aggregate amount of $120 million were paid during 2017 and 2018. The agreement stipulates additional development and commercial milestone payments of up to $2,230 million, as well as future royalties. Currently, all
non-essential
activities and related expenditures for fasinumab have been put on hold. Next steps will be assessed together with Regeneron, with the intention of discussing data with the FDA.
AssetsMedinCell
In November 2013, Teva entered into an agreement with MedinCell for the development and Liabilities Held For Sale:commercialization of multiple long-acting injectable products. The lead product candidate selected was risperidone LAI
(TV-46000)
suspension for subcutaneous use for the treatment of schizophrenia. In August 2021, the FDA accepted the new drug application (“NDA”) for risperidone LAI, based on phase 3 data from two pivotal studies. Teva leads the clinical development and regulatory process and is responsible for commercialization of this product candidate. MedinCell may be eligible for development milestones, and future commercial milestones of up to $112 million in respect of risperidone LAI. Teva will also pay MedinCell royalties on net sales. In April 2022, the FDA issued a Complete Response Letter (“CRL”) regarding the NDA for risperidone LAI. Teva is working to address the issues raised in the CRL with a view to resubmission.
Certain assets of Teva’s business venture in Japan
Teva operated its business in Japan, which was part of Teva’s International Market segment, through a business venture with The Takeda Pharmaceutical Company Limited (“Takeda”), in which Teva owned a 51% stake and Takeda owned the remaining 49%.
In July 2020, Teva and Takeda entered into a purchase agreement to sell the majority of the business venture’s generic and operational assets. This transaction was completed on February 1, 2021.
Until the closing date Teva accounted for the business venture assets and liabilities that were sold, as held for sale and determined that the fair value less cost of sale did not exceed the carrying value, resulting in an impairment charge of $247 million in other assets impairments, restructuring and other items recognized in 2020 and in the first quarter of 2021.
General
Assets held for sale as of June 30, 2021 include certain manufacturing assets that are expected to be sold within the next year. Assets held for sale as of December 31, 2020 included the Teva-Takeda business venture assets sold during the first quarter of 2021, certain OTC assets sold during the second quarter of 2021 and other manufacturing assets.
The table below summarizes all Teva assets included as held for sale as of June 30, 2021 and December 31, 2020:
   
June 30,
   
December 31,
 
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Inventories
   7    146 
Property, plant and equipment, net and others
   55    312 
Goodwill
   9    27 
Adjustments of assets held for sale to fair value
   (42   (296
   
 
 
   
 
 
 
Total assets of the disposal group classified as held for sale in the consolidated balance sheets
  $29   $189 
   
 
 
   
 
 
 
14
12

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 June 30, 2021
 
   
North

America
   
Europe
  
International
Markets
   
Other
activities
   
Total
 
   (U.S. $ in millions) 
Sale of goods
   1,621    1,185   462    198    3,465 
Licensing arrangements
   9    7   2    1    19 
Distribution
   316       15    0      330 
Other
   (2)    (8  7    99    96 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
   $1,943   $1,184  $485   $298   $3,910 
   
 
 
   
 
 
  
 
 
   
 
 
   
 
 
 
§ Represents an amount less than $1 million.
   
Three months ended June 30, 2020
 
   
North
America
   
Europe
  
International
Markets
   
Other
activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   1,658   1,000   457    211    3,326 
Licensing arrangements
   17   3   1    1    22 
Distribution
   374   0     7    0      381 
Other
   (2)   (2  23    123    141 
   
 
 
  
 
 
  
 
 
   
 
 
   
 
 
 
   $2,047  $1,001  $488   $335   $3,870 
   
 
 
  
 
 
  
 
 
   
 
 
   
 
 
 
   
Six months ended June 30, 2021
 
   
North

America
  
Europe
   
International
Markets
   
Other

activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   3,289   2,363    902    374    6,928 
Licensing arrangements
   40   21    5    2    68 
Distribution
   605       34    0      639 
Other
   (2)   14    35    210    257 
   
 
 
  
 
 
   
 
 
   
 
 
   
 
 
 
   $3,932  $2,398   $975   $587   $7,892 
   
 
 
  
 
 
   
 
 
   
 
 
   
 
 
 
§ Represents an amount less than $1 million.
15

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
   
Six months ended June 30, 2020
 
   
North
America
   
Europe
   
International
Markets
   
Other
activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   3,283    2,370    939    388    6,981 
Licensing arrangements
   42    15    4    2    63 
Distribution
   800    2    13    0      815 
Other
   4    17    97    252    369 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   $4,129   $2,404   $1,053   $642   $8,227 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Assets and Liabilities Held For Sale:
General
Assets held for sale as of June 30, 2022 included certain assets that are expected to be sold within the next year. Assets and liabilities held for sale as of December 31, 2021 included certain manufacturing assets sold during the first and second quarters of 2022.
The table below summarizes all Teva assets and liabilities included as held for sale as of June 30, 2022 and December 31, 2021:
   
June 30,
   
December 31,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Inventories
   —      2 
Property, plant and equipment, net and others
   46    86 
Goodwill
   —      7 
Adjustments of assets held for sale to fair value
   (30   (76
   
 
 
   
 
 
 
Total assets of the disposal group classified as held for sale in the consolidated balance sheets
  $16   $19 
   
 
 
   
 
 
 
Total liabilities of the disposal group classified as held for sale in the consolidated balance sheets, recorded under accrued expenses and other long-term liabilities
  $—     $(43
   
 
 
   
 
 
 
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.
13

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
   
Three months ended June 30, 2022
 
   
North
America
   
Europe
   
International
Markets
  
Other
activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   1,538    1,127    448    176    3,289 
Licensing arrangements
   54    13    4    1    72 
Distribution
   308    §    10    —      318 
Other
   3    31    (9)   81    106 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   $1,904   $1,171   $454   $257   $3,786 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
§ Represents an amount less t
han $0.5 
million.    
   
Three months ended June 30, 2021
 
   
North
America
   
Europe
  
International
Markets
   
Other
activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   1,621   1,185   462    198    3,465 
Licensing arrangements
   9   7   2    1    19 
Distribution
   316   §   15    —      330 
Other
   (2)   (8  7    99    96 
   
 
 
  
 
 
  
 
 
   
 
 
   
 
 
 
   $1,943  $1,184  $485   $298   $3,910 
   
 
 
  
 
 
  
 
 
   
 
 
   
 
 
 
§ Represents an amount less than $0.5 million.
   
Six months ended June 30, 2022
 
   
North
America
   
Europe
   
International
Markets
   
Other
activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   2,915    2,261    894    356    6,425 
Licensing arrangements
   74    26    8    2    110 
Distribution
   650    §    26    —      677 
Other
   1    39    19    175    234 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   $3,641   $2,327   $946   $532    7,447 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
§ Represents an amount less than $0.5 million.
   
Six months ended June 30, 2021
 
   
North
America
   
Europe
   
International
Markets
   
Other
activities
   
Total
 
   
(U.S. $ in millions)
 
Sale of goods
   3,289   2,363    902    374    6,928 
Licensing arrangements
   40   21    5    2    68 
Distribution
   605   §    34    —      639 
Other
   (2)   14    35    210    257 
   
 
 
  
 
 
   
 
 
   
 
 
   
 
 
 
   $3,932  $2,398   $975   $587   $7,892 
   
 
 
  
 
 
   
 
 
   
 
 
   
 
 
 
§ Represents an amount less than $0.5 million.
14

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 accounts 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 78%
74
% of the Company’s total SR&A as of June 30,
2021
, 2022, with the remaining balance primarily in Canada and Germany. The changes in SR&A for third-party sales for the six months ended June 30, 20212022 and 20202021 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, 2020
  $80 $2,054 $828 $1,108 $686 $148 $4,824 $4,904 
Provisions related to sales made in current year
   192 
 
2,139
 391 3,995 143    177  6,845 7,037 
Provisions related to sales made in prior periods
   (5)(82)(35)(11)(40)   (23) (191)(196)
Credits and payments
   (196)(2,355)(362)(3,934)(186)    (176) (7,013)(7,209)
Translation differences
   
 
 
 (8)(3)(1)(1)   1  (12)(12)
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance at June 30, 2021
  $71    1,748   $819   $1,157   $602   $127   $4,453   $4,524 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
16
15
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
   
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, 2021
  $68   $1,655   $854   $1,085   $535   $112   $4,241   $4,309 
Provisions related to sales made in current year
   181    1,889    446    3,836    147    152    6,470    6,651 
Provisions related to sales made in prior periods
   —      (102   20    (8   (16   (2   (108)   (108)
Credits and payments
   (185   (1,901   (497   (3,922   (211   (145   (6,676)   (6,861)
Translation differences
   —      (33   (6   (7   (4   3    (47)   (47)
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance at June 30, 2022
  $64    1,508   $817   $984   $451   $120   $3,880   $3,944 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
   
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, 2020
  $80  $2,054  $828  $1,108  $686  $148  $4,824  $4,904 
Provisions related to sales made in current year
   192   2,139   391   3,995   143   177   6,845   7,037 
Provisions related to sales made in prior periods
   (5  (82  (35  (11  (40  (23  (191  (196
Credits and payments
   (196  (2,355  (362  (3,934  (186  (176  (7,013  (7,209
Translation differences
   —     (8  (3  (1  (1  1   (12  (12
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2021
  $71  $1,748  $819  $1,157  $602  $127  $4,453  $4,524 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
   
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
   193   2,588   434   4,325   216   50   7,613   7,806 
Provisions related to sales made in prior periods
   —     (191  (105  (15  18   —     (293  (293
Credits and payments
   (206  (3,064  (505  (4,416  (211  (64  (8,260  (8,466
Translation differences
   —     (9  —     (2  (2  (5  (18  (18
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance at June 30, 2020  $74   2,219  $933  $1,234  $658  $157  $5,201  $5,275 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
NOTE 4 – Inventories:
Inventories, net of reserves, consisted of the following:
 
   
June 30,
2021
   
December 31,
2020
 
   
(U.S. $ in millions)
 
Finished products
  $2,223   $2,378 
Raw and packaging materials
   1,333    1,231 
Products in process
   642    605 
Materials in transit and payments on account
   164    189 
   
 
 
   
 
 
 
Total
  $4,362   $4,403 
   
 
 
   
 
 
 
   
June 30,
2022
   
December 31,
2021
 
   
(U.S. $ in millions)
 
Finished products
  $1,875   $1,932 
Raw and packaging materials
   1,346    1,136 
Products in process
   624    587 
Materials in transit and payments on account
   204    163 
   
 
 
   
 
 
 
Total
  $4,049   $3,818 
   
 
 
   
 
 
 
16

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 5 – Identifiable intangible assets:
Identifiable intangible assets consisted of the following:
 
   
Gross carrying amount net

of impairment
   
Accumulated

amortization
   
Net carrying amount
 
   
June 30,
   
December 31,
   
June 30,
   
December 31,
   
June 30,
   
December 31,
 
   
2021
   
2020
   
2021
   
2020
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Product rights
  $19,226   $19,650   $12,171   $12,094   $7,055   $7,556 
Trade names
   648    621    219    165    429    456 
In process research and development
   636    911    —      —      636    911 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $20,510   $21,182   $12,390   $12,259   $8,120   $8,923 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
Gross carrying amount net

of impairment
   
Accumulated

amortization
   
Net carrying amount
 
   
June 30,
   
December 31,
   
June 30,
   
December 31,
   
June 30,
   
December 31,
 
   
2022
   
2021
   
2022
   
2021
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Product rights
  $17,987   $18,815   $12,181   $12,318   $5,806   $6,497 
Trade names
   570    590    211    198    359    392 
In process research and development
   535    577    —      —      535    577 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $19,092   $19,982   $12,392   $12,516   $6,700   $7,466 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
   
 
 
 
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 10 years.
17
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Amortization of intangible assets was $173$212 million and $249$173 million in the three months ended June 30, 2022 and 2021, and 2020,
respectively.
Amortization of intangible assets was $414$412 million and $507
$414 million in the six months ended June 30, 2022 and 2021, and 2020,
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 various generic products from the Actavis Generics acquisition of $601$503 million. IPR&D carries intrinsic risks that the asset might not succeed in advanced phases and may be impaired in future periods.
In the first six months of 2021, Teva reclassified $162 million of products from IPR&D to product rights, of which $123
million were reclassified in connection with lenalidomide
(generic equivalent of Revlimid®).
Intangible assets impairments
Impairments of long-lived intangible assets for the three months ended June 30, 2022 and 2021 were $51 million and 2020, were $195 million, and $120 million, respectively.
Impairments in the second quarter of 2022 consisted of:
(a)
Identifiable product rights of $32 million related to updated market assumptions regarding price and volume of products acquired from Actavis Generics, and
(b)
IPR&D assets of $19 million due to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date).
Impairments in the second quarter of 2021 consisted of:
 
 (a)
Identifiable product rights of $168 million due to:
(i) $30$138 million, mainly related to updated market assumptions regarding price and

volume of products acquired from Actavis Generics that are primarily marketed in the United States, and (ii)
$30 million related to

lenalidomide (generic equivalent of Revlimid
®
), resulting from modified competition assumptions as a result of settlements between the

innovator and other generic filers, and (ii) $138 million, mainly related to updated market assumptions regarding price and volume of products acquired from Actavis Generics that are primarily marketed in the United States; and
 
 (b)
IPR&D assets of $27 million due to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date) in the United States.
Impairments in the second quarter of 2020 consisted of:
(a)
Identifiable product rights of $103 million, mainly due to updated market assumptions regarding price and volume of products acquired from Actavis Generics; and
(b)
IPR&D assets of
$17 
million, mainly due to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date or discount rate).
Impairments of long-lived intangible assets for the six months ended June 30, 2022 and 2021 were $199 million and 2020, were $274 million, and $768 million, respectively.
17

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Impairments in the first
six
months of 2021
2022
consisted mainly of:
 
 (a)
Identifiable product rights of $196$161 million due to: (i) $30 million related to lenalidomide (generic equivalent of Revlimid
®
), resulting from modified competition assumptions as a result of settlements between the innovator and other generic filers, and (ii) $166 million, mainly related to updated market assumptions regarding price and volume of products acquired from Actavis Generics, that are primarily marketed in the United States; and
 
 (b)
IPR&D assets of
$78 
$21 million due to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date) in the United States.
Impairments in the first six months of 20202021 consisted of:
 
 (a)
Identifiable product rights of $420$196 million mainly
due to: (i) $232 $166 million
million due, mainly related to updated market assumptions regarding price and

volume of products acquired from Actavis Generics;Generics that are primarily marketed in the United States
,
 and (ii)
$165
30 million in Japan in connection with ongoing regulatory pricing reductionsrelated to lenalidomide (generic equivalent of Revlimid
®
), resulting from modified competition assumptions as a result of settlements between the innovator and other generic competition; and filers
.
18
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 (b)
IPR&D assets of $348$78 million, primarily due to: (i) $211 million related to AUSTEDO for the treatment of Tourette syndrome in pediatric patients in the United States following clinical trial results received in February 2020, which failed to meet their primary endpoints; and (ii) $117 million related to generic pipeline products acquired from Actavis Generics resulting from development progress and changes in other key valuation indications (e.g., market size, competition assumptions, legal landscape, launch date) in the United States.
The fair value measurement of the impaired intangible assets in the first six months of 20212022 is based on significant unobservable inputs in the market and thus represents a Level 3 measurement within the fair value hierarchy. The discount rate applied ranged from 7.25% to 10%8.25%. A probability of success factor ranging from 20% to 90% was used in the fair value calculation to reflect inherent regulatory and commercial risk of IPR&D.

NOTE 6 – Goodwill:
The changes in the carrying amount of goodwill for the period ended June 30, 20212022 were as follows:
 
                     
   
North America
   
Europe
  
International
Markets
  
Other
   
Total
 
   
(U.S. $ in millions)
     
Balance as of December 31, 2020 (1)
  $6,473   $9,102  $2,362  $2,687   $20,624 
Changes during the period:
                       
Goodwill reclassified as assets held for sale
        (7           (7
Translation differences
   12    (198  (10       (196
   
 
 
   
 
 
  
 
 
  
 
 
   
 
 
 
Balance as of June 30, 2021 (1)
  $6,485   $8,897  $2,352  $2,687   $20,421 
   
 
 
   
 
 
  
 
 
  
 
 
   
 
 
 
   
North America
  
Europe
  
International
Markets
  
Other
  
Total
 
   
(U.S. $ in millions)
    
Balance as of December 31, 2021 (1)
  $6,474  $8,544  $2,328  $2,694  $20,040 
Changes during the period:
                     
Goodwill impairment
   —     —     (479  (266  (745
Goodwill acquired
               12   12 
Translation differences
   (4  (320  (16)  (130  (470
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Balance as of June 30, 2022 (1)
  $6,470  $8,224  $1,833  $2,310  $18,837 
   
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
 
(1)
Accumulated goodwill impairment as of June 30, 20212022 and December 31, 20202021 was approximately $26.3 billion and $25.6 billion.billion, respectively.

Teva operates its business through three reporting segments: North America, Europe and International Markets. Each of these business segments is a reporting unit. Additional reporting units include Teva’s production and sale of APIs to third parties (“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 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 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 may record an impairment of goodwill allocated to these reporting units in the future. The current projections related to AUSTEDO are a significant assumption in Teva’s future projections. Additionally, certain parts of its business volumes were impacted by the COVID-19 pandemic. Management continues to analyze the expected pace of recovery of volumes and the related impact of the COVID-19 pandemic on Teva’s business.

First Quarter Developments
During the first quarter of 2021, 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.
Based on this assessment, management concluded that it was not more likely than not that the fair value of any of the reporting units was below its carrying value as of March 31, 2021 and, therefore, no quantitative assessment was performed.
 
19
18

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Second Quarter DevelopmentsDuring
During the second quarterqu
arter of 2021,
2022
, Teva 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.
Additionally, Teva conducted a quantitative analysis of all reporting units as part of its annual goodwill impairment test with the assistance of an independent valuation expert.
Teva identified an increase in certain components of the discount rate, mainly attributable to: (i) the risk-free interest rate, which resulted in an increase in the WACC; and (ii) the risk associated with country-specific characteristics of several countries.
Based on this quantitative analysis, no goodwill impairment charge was recorded duringin the second quarter of 2021. Changes to Teva’s current assessment regarding the impact2022, Teva recorded a goodwill impairment charge of the
COVID-19
pandemic on its projections and its long-term forecast$745 
million as follows: (i)
$479 
million related to AUSTEDO could resultits International Markets reporting unit, mainly due to the increase in future impairments.the discount rate; and (ii)
$266 
million related to its Teva’s API reporting unit, mainly due to the increase in the discount rate, as well as updated assumptions supporting the cash flow projections, including certain revenue growth assumptions and the associated operating profit margins. Teva’s API reporting unit is included under “Other” in the table above.
Following the goodwill impairment charges recorded in relation to Teva’s International Markets and Teva’s API reporting units, the carrying values of
those reporting units
equaled their fair value as of June 30, 2022. Therefore, if business conditions or expectations were to change materially, it may be necessary to record further impairment charges to Teva’s International Markets or Teva’s API reporting units in the future.
The estimated fair value of Teva’s Europe reporting unit exceeds its estimated carrying amount by 9% based on a terminal growth rate of 1.41% and a discount rate of 10.04%. If Teva holds all other assumptions constant, a reduction in the terminal growth rate of 0.50% to 0.91% or an increase in the discount rate of 0.50% to 10.54% would result in a reduction of the excess of fair value over carrying amount with respect to Teva’s Europe reporting unit to 5%.
Teva’s
North America and Medis reporting units have
 a
fair value in excess of 10% over their book values as of June 30, 2022
.
Teva noted its market capitalization has been below management’s assessment of the aggregated fair value of the Company’s reporting units. However, as of June 30, 2022, the Company’s market capitalization plus a reasonable control premium exceeded its book value.
NOTE 7 – Debt obligations:
a. Short-term debt:
                 
   
Weighted average interest
rate as of June 30, 2021
  
Maturity
   
June 30,

2021
   
December 31,

2020
 
          
(U.S. $ in millions)
 
Convertible senior debentures
   0.25  2026   
$

23   $514 
Current maturities of long-term liabilities (1)
 
   3,507    2,674 
            
 
 
   
 
 
 
Total short-term debt
 
  $3,530   $3,188 
            
 
 
   
 
 
 
 
(1)
          
June 30,
   
December 31,
 
                
   
Weighted average interest
rate as of June 30, 2022
  
Maturity
   
2022
   
2021
 
          
(U.S. $ in millions)
 
Convertible senior debentures
   0.25  2026    23    23 
Current maturities of long-term liabilities
            1,696    1,403 
            
 
 
   
 
 
 
Total short-term debt
           $1,719   $1,426 
            
 
 
   
 
 
 
In July 2021, Teva
repaid $
1,475 million of its 2.2
% senior notes at maturity.
Convertible senior debentures
The principal amount of Teva’s 0.25% convertible senior debentures due 2026 was $23 million as of June 30, 20212022 and $514 million as of December 31, 2020.2021. These convertible senior debentures 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 senior debentures exercised their optional repurchase right and redeemed $491 million of the convertible senior debentures on February 1, 2021, which was the date to exercise this right.
b. Long-term debt:
                 
   
Weighted average interest
rate as of June 30, 2021
  
Maturity
   
June 30,

2021
  
December 31,
2020
 
          
(U.S. $ in millions)
 
Senior notes EUR 1,500 million
   1.13  2024   $1,780   $1,839 
Senior notes EUR 1,300 million
   1.25  2023    1,544    1,595 
Senior notes EUR 1,000 million
   6.00  2025    1,190    1,230 
Senior notes EUR 900 million
   4.50  2025    1,071    1,107 
Senior notes EUR 750 million
   1.63  2028    885    916 
Senior notes EUR 700 million
   3.25  2022    832    861 
Senior notes EUR 700 million
   1.88  2027    832    860 
Senior notes USD 3,500 million
   3.15  2026    3,495    3,495 
Senior notes USD 1,475 million (1)
   2.20  2021    1,474    1,472 
Senior notes USD 3,000 million
   2.80  2023    2,997    2,996 
Senior notes USD 2,000 million
   4.10  2046    1,986    1,986 
Senior notes USD 1,250 million
   6.00  2024    1,250    1,250 
Senior notes USD 1,250 million
   6.75  2028    1,250    1,250 
Senior notes USD 1,000 million
   7.13  2025    1,000    1,000 
Senior notes USD 844 million
   2.95  2022    851    853 
Senior notes USD 789 million
   6.15  2036    783    783 
Senior notes USD 613 million
   3.65  2021    614    616 
Senior notes USD 588 million
   3.65  2021    588    586 
Senior notes CHF 350 million
   0.50  2022    380    397 
Senior notes CHF 350 million
   1.00  2025    381    398 
            
 
 
   
 
 
 
Total senior notes
 
   25,183    25,490 
Other long-term debt
   1.10  2026    1    1 
Less current maturities
 
   (3,507   (2,674
Less debt issuance costs
 
   (75   (86
            
 
 
   
 
 
 
Total senior notes and loans
 
  $21,602   $22,731 
            
 
 
   
 
 
 
(
1)
In July 2021, Teva repaid 
$
1,475 million of its 2.2
% senior notes at maturity. 
 
20
19
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
b. Long-term debt:

   
Weighted average interest
rate as of June 30, 2022
  
Maturity
   
June 30,

2022
  
December 31,
2021
 
          
(U.S. $ in millions)
 
Senior notes EUR 1,500 million
   1.13  2024    653    708 
Sustainability-linked senior notes EUR 1,500 million (1)
 
(*)
   4.38  2030    1,566    1,699 
Senior notes EUR 1,300 million
   1.25  2023    616    670 
Sustainability-linked senior notes EUR 1,100 million (2)
 
(*)
   3.75  2027    1,150    1,246 
Senior notes EUR 1,000 million
   6.00  2025    1,043    1,134 
Senior notes EUR 900 million
   4.50  2025    942    1,020 
Senior notes EUR 750 million
   1.63  2028    779    844 
Senior notes EUR 700 million (3)
   3.25  2022    —      307 
Senior notes EUR 700 million
   1.88  2027    729    792 
Senior notes USD 3,500 million
   3.15  2026    3,496    3,496 
Senior notes USD 3,000 million
   2.80  2023    1,453    1,453 
Senior notes USD 2,000 million
   4.10  2046    1,986    1,986 
Senior notes USD 1,250 million
   6.00  2024    1,250    1,250 
Senior notes USD 1,250 million
   6.75  2028    1,250    1,250 
Senior notes USD 1,000 million
   7.13  2025    1,000    1,000 
Sustainability-linked senior notes USD 1,000 million (2)
 
(*)
   4.75  2027    1,000    1,000 
Sustainability-linked senior notes USD 1,000 million (1)
 
(*)
   5.13  2029    1,000    1,000 
Senior notes USD 844 million
   2.95  2022    715    715 
Senior notes USD 789 million
   6.15  2036    783    783 
Senior notes CHF 350 million
   0.50  2022    366    382 
Senior notes CHF 350 million
   1.00  2025    367    383 
            
 
 
   
 
 
 
Total senior notes
            22,144    23,118 
Other long-term debt
            2    2 
Less current maturities
            (1,696   (1,403
Less debt issuance costs
            (87   (100
            
 
 
   
 
 
 
Total senior notes and loa
n
s
           $20,363   $21,617 
(1)
If Teva fails to achieve certain sustainability performance targets, the interest rate shall increase by
0.125%-0.375%
per annum, from and including May 9, 2026. 
(2)
If Teva fails to achieve certain sustainability performance targets, a
one-time
premium payment of
0.15%-0.45%
out of the principal amount will be paid at maturity or upon earlier redemption, if such redemption is on or after May 9, 2026.
(3)
In April 2022, Teva repaid $296 million of its 3.25% senior notes at maturity.
(*)
Interest rate adjustments and a potential
one-time
premium payment related to the sustainability-linked bonds are treated as bifurcated embedded derivatives. See note 8
c
.
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. The long-term debt outlined in the above table is generally redeemable at any time at varying redemption prices plus accrued and unpaid interest.

Long-term
Teva’s
debt as of June 30, 2021 is 2022
was
effectively denominated in the following currencies: 63% in U.S. dollar, 34% in euro and 3% in Swiss franc.
Teva’s principal sources of short-term liquidity are its cash on hand, existing cash investments, liquid
securities
and available credit facilities, primarily, as of June 30, 2022, its $2.3$1.8 billion unsecured syndicated sustainability-linked revolving credit facility 
entered into in April 20192022 (“RCF”).
The RCF agreement provides for two separate tranches, a $1.15In April 2022, Teva entered into an unsecured syndicated sustainability-linked revolving credit facility of $1.8 billion tranche A and a $1.15 billion tranche B. Tranche A hadwith a maturity date of April 8, 2022, of which an amount of $1.065 billion was extended twice, initially to April 8, 2023 and then to April 8, 2024. Tranche B has a maturity date of April 8, 2024. Loans and letters of credit will be available from time to time under each tranche for Teva’s general corporate purposes. 2026, with two
one-year
extension options. 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 EBITDAmaximum leverage ratio, which becomes more restrictive over time. In addition, the RCF is linked to two sustainability performance targets, (i) the company’s S&P ESG Score and (ii) number of new regulatory submissions in low and middle-income countries. The net debtRCF margin may increase or decrease depending on the Company’s sustainability performance.
20

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to EBITDAConsolidated Financial Statements
(Unaudited)
Under the terms of the RCF, the leverage ratio limit was 5.50x through June 30, 2021, gradually declines to 5.00x in the third and fourth quarters of 2021,shall not exceed 4.50x in the firstsecond and secondthird quarters of 2022, and continues to gradually decline over4.25x in the remaining termfourth quarter of the RCF to 3.50x2022, 4.00x in the first, second and third quarters of 2023, 3.75x in the fourth quarter of 2023.2023 and 3.50x in 2024 and onwards.
The RCF can be used for general corporate purposes, including repaying existing debt. As of June 30, 2021,2022 and as of the date of this Quarterly Report on Form 10-Q, no amounts were outstanding under the RCF. During July 2021, 
$500 
million was drawn down 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 thesethe 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, 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 and sustainability-linked senior notes is outstanding, could lead to an event of default under the Company’s senior notes and sustainability-linked 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 thesethe financial statements are issued.
NOTE 8 – Derivative instruments and hedging activities:
a. Foreign exchange risk management:
In the first six months of 2021,2022, approximately 47%48% 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.
21
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
The Company enters into forward exchange contracts, purchases and writes options in order to hedge the currency exposure on balance sheet 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 subsidiaries within Teva. The currency hedged items are usually denominated in the following main currencies: the euro, the Swiss franc, the Japanese yen, the British pound, the Russian ruble, the Canadian dollar, the Polish zloty, new Israeli shekel, the Indian rupee 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 may choose to hedge against possible fluctuations in foreign subsidiaries net assets (“net investment hedge”) and entered into cross currency swaps and forward contracts in the past 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.
b. Interest risk management:
The Company raises capital through various debt instruments, including straightsenior notes, sustainability-linked senior notes, bank loans, convertible debentures and syndicated revolving credit facility that bear a fixed or variable interest rate, bank loans and convertible debentures.rate. In some cases, the Company has swapped from a fixed to a floatingvariable 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. Bifurcated embedded derivatives:
Upon issuance of sustainability-linked senior notes, Teva recognized embedded derivatives related to interest rate adjustments and a potential
one-time
premium payment upon failure to achieve certain sustainability performance targets, such as access to medicines in
low-to-middle-income
countries and absolute greenhouse gas emissions reduction, which were bifurcated and are accounted for separately as derivative financial instruments. As of June 30, 2022
,
the fair value of these derivative instruments is negligible.
c. Derivative instruments outstanding:
The following table summarizes the classification and fair values of derivative instruments:
   
Fair value
 
   
Not designated as hedging

instruments
 
   
June 30,

2021
   
December 31,

2020
 
Reported under
  
(U.S. $ in millions)
 
Asset derivatives:
          
Other current assets:
          
Option and forward contracts
  $30   $24 
Liability derivatives:
          
Other current liabilities:
          
Option and forward contracts
   (25   (79
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,
 
   
June 30,

2021
   
June 30,
2020
  
June 30,

2021
   
June 30,

2020
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
  $274   $223  $87   $151 
Cross-currency swaps - net investment hedge (1)
   0      0     0      0   
2221

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)

   
Financial expenses, net
   
Other comprehensive income (loss)
 
   
Six months ended,
   
Six months ended,
 
   
June 30,

2021
   
June 30,

2020
   
June 30,

2021
   
June 30,

2020
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are r
e
corde
d
  $564   $448   $(115  $(379
Cross-currency swaps - net investment hedge (1)
   0      (2   0      (21
d. Derivative instruments outstanding:
The following table summarizes the classification and fair values of derivative instruments:
   
Fair value
 
         
   
Not designated as hedging

instruments
 
         
   
June 30,
2022
   
December 31,
2021
 
   
 
 
 
         
Reported under
  
(U.S. $ in millions)
 
         
Asset derivatives:
          
Other current assets:
          
Option and forward contracts
  $69   $30 
Liability derivatives:
          
Other current liabilities:
          
Option and forward contracts
   (37   (23
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,
 
   
June 30,

2021
   
June 30,
2020
   
June 30,

2021
   
June 30,
2020
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
  $274   $223   $(3,910  $(3,870
Option and forward contracts (2)
   27    13    0—      0—   
Option and forward contracts economic hedge (3)
   0—      0—      15    20 
   
Financial expenses, net
   
Net revenues
 
                 
   
Three months ended,
   
Three months ended,
 
                 
   
June 30,
2022
   
June 30,
2021
   
June 30,
2022
   
June 30,
2021
 
                 
Reported under
  
(U.S. $ in millions)
 
                 
Line items in which effects of hedges are recorded
  $211   $274   $(3,786  $(3,910
Option and forward contracts (1)
   (38   27    —      —   
Option and forward contracts economic hedge (2)
   —      —      (16   15 
   
Financial expenses, net
   
Net revenues
 
                 
   
Six months ended,
   
Six months ended,
 
                 
   
June 30,
2022
   
June 30,
2021
   
June 30,
2022
   
June 30,
2021
 
                 
Reported under
  
(U.S. $ in millions)
 
                 
Line items in which effects of hedges are recorded
  $468   $564   $(7,447  $(7,892
Option and forward contracts (1)
   (43   (43   —      —   
Option and forward contracts economic hedge (2)
   —      —      (35   (13
 
   
Financial expenses, net
   
Net revenues
 
   
Six months ended,
   
Six months ended,
 
   
June 30,

2021
   
June 30,

2020
   
June 30,

2021
   
June 30,

2020
 
Reported under
  
(U.S. $ in millions)
 
Line items in which effects of hedges are recorded
  $564   $448   $(7,892  $(8,227
Option and forward contracts (2)
   (43   37    0—
  
    0—
  
 
Option and forward contracts economic hedge (3
)
   0—
  
    0—
  
    (13   (40
(1)
In each of the first and second quarters of 2017, Teva entered into a cross currency swap agreement with a notional amount of $500 million maturing in 2020. These cross currency swaps were designated as a net investment hedge of Teva’s foreign subsidiaries euro denominated net assets, in order to reduce the risk of adverse exchange rate fluctuations. With respect to these cross currency swap agreements, Teva recognized gains which mainly reflect the differences between the
float-for-float
interest rates paid and received. In the first quarter of 2020, these cross-currency swap agreements expired. The settlement of these transactions resulted in cash proceeds of $3 million.
(2)
Teva uses foreign exchange contracts (mainly option and forward contracts) to hedge balance sheet items from currency exposure. These foreign exchange contracts are not designated as hedging instruments for accounting purposes. In connection with these foreign exchange contracts, Teva recognizes gains or losses that offset the revaluation of the balance sheet items also recorded under financial expenses, net
.
net.
23

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
(3)(2)
Teva entered into option and forward contracts designed to limit the exposure of foreign exchange fluctuations on projected revenues and expenses recorded in euro, the Swiss franc, the Japanese yen, the British pound, the Russian ruble, the Canadian dollar and some other currencies to protect its projected operating results for 2022 and 2021. These derivative instruments do not meet the criteria for hedge accounting, however, they are accounted for as an economic hedge. These derivative instruments, which may include hedging transactions against future projected revenues and expenses, are
22

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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. In 2020, Tevathe first six months of 2022, the positive impact from these derivatives recognized a loss of $27 
million in relation with the 2021 hedging program Teva entered into in the second half of 2020.under revenues was $35 million. In the first six months of 2021, the positive impact from these derivatives recognized under revenues was
$13 $13 million. Changes in the fair value of the derivative instruments are recognized in the same line item in the statements of income as the underlying exposure being hedged. The cash flows associated with these derivatives are reflected as cash flows from operating activities in the consolidated statements of cash flows.
d.e. Amortizations due to terminated derivative instruments:
Forward starting interest rate swaps and treasury lock agreements
In 2015, Teva entered into forward starting interest rate swaps and treasury lock agreements to protect the Company from interest rate fluctuations in connection with a future debt issuance the Company was planning. These forward starting interest rate swaps and treasury lock agreements were terminated in July 2016 upon the debt issuance. The termination of these transactions resulted in a loss position of $493 million, which was recorded in other comprehensive income (loss) and is amortized under financial expenses, net over the life of the debt.
With respect to these forward starting interest rate swaps and treasury lock agreements, losses of $7 million and $8 
million were recognized under financial expenses, net for each of the three months ended June 30, 20212022 and 2020,2021, respectively, and losses of
$16 
$15 million and $16 million were recognized under financial expenses, net for each of the six months ended June 30, 2022 and 2021, and 2020, respectively.
Fair value hedge
In the third quarter of 2016, Teva terminated interest rate swap agreements designated as a fair value hedge relating to its 2.95% senior notes due 2022 with respect to $844 million notional amount and its 3.65% senior notes due 2021 with respect to $450 million notional amount. Settlement of these transactions resulted in a gain position of $41 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 expense.
In the third quarter of 2019, Teva terminated $500 million interest rate swap agreements designated as a fair value hedge relating to its 2.8% senior notes due 2023 with respect to $3,000 million notional amount. Settlement of these transactions resulted in cash proceeds 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.
Cash flow hedge
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.
With respect to the interest rate swap and cross-currency swap agreements,
gains of $
$1
million were recognized under financial expenses, net for each of the three months ended June 
30
,
2022
and
2021 and 2020,
, respectively, and gains of $
2
$1 million and $2$
1
 million were recognized under financial expenses, net for the six months ended June 
30 2021
,
202
2
and 2020,
202
1
, respectively.

NOTE 9 – Legal settlements and loss contingencies:
In the second quarter of 2021,2022, Teva recorded an expenseexpenses of $6$729 million in legal settlements and loss contingencies, compared to $13$6 million in the second quarter of 2020.2021. The expenseexpenses in the second quarter of 20202022 were mainly related to an update of the estimated settlement provision recorded in connection with the remaining opioid cases.
 See note 10.
In the first six months of 2022, Teva recorded an expense of $1,854 million in legal settlements and loss contingencies, compared
to an 
expense of $110 million in the first six months of 2021. The expense in the first six months of 2022 was mainly related to an update of the estimated settlement provision recorded in connection with the remaining opioid cases. The expense in the first six months of 2021 was mainly due to an increase in athe provision for settlementthe carvedilol patent litigation.
As of certain product liability claims in the United StatesJune 30, 2022 and December 31, 2021, Teva’s provision for legal settlements and loss contingencies recorded under accrued expenses and other minor provisions, partially offset by proceeds received following a settlementtaxes and long-term liabilities was $3,928 million and $2,710 million, respectively. In connection with Teva’s provision for legal settlements and loss contingencies as of December 31, 2021, related to the FCPA derivative proceedings in Israel.Ontario Teachers Securities Litigation, Teva also recognized an insurance receivable.
 
24 
23


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
In the first six months of 2021, Teva recorded an expense of $110 million in legal settlements and loss contingencies, compared to income of $12 
million in the first six months of 2020. The expense in the first six months of 2021 was mainly due to the provision for the carvedilol patent litigation (see note 10).
The income in the first six months of 2020 was mainly due to proceeds received following a settlement of the FCPA derivative proceedings in Israel and settlement of an action brought against the sellers of Auden McKenzie (an acquisition made by Actavis Generics), partially offset by an increase in a provision for settlement of certain products liability claims in the United States and other minor provisions.
As of June 30, 2021 and December 31, 2020, Teva’s provision for legal settlements and loss contingencies recorded under accrued expenses and other taxes and long-term liabilities was $1,737 million and 1,625 million, respectively.
NOTE 10 – 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.
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 where the exposures were fully resolved in the prior year, o
r
or determined to no longer meet the materiality threshold for disclosure, or were substantially resolved.
If one or more of such proceedings described below were to result in final judgments against Teva, such judgments could be material to its results of operations and cash flows in a given period. In addition, Teva incurs significant legal fees and related expenses in the course of defending its positions even if the facts and circumstances of a particular litigation do not give rise to a provision in the financial statements.
In connection with third-party agreements, Teva may under certain circumstances be required to indemnify, and may be indemnified by, in unspecified amounts, the parties to such agreements against third-party claims. Among other things, Teva’s agreements with third parties may require Teva to indemnify them, or require them to indemnify Teva, for the costs and damages incurred in connection with product liability claims, in specified or unspecified amounts.
Except as otherwise noted, all of the litigation matters disclosed below involve claims arising in the United States. Except as otherwise noted, all third party sales figures given below are based on IQVIA (formerly IMS Health Inc.) data.
Intellectual Property Litigation
From time to time, Teva seeks to develop generic and biosimilar versions of patent-protected pharmaceuticals and biopharmaceuticals 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. For many biosimilar products that are covered by patents, Teva participates in the “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA), which allow for the challenge to originator patents prior to obtaining biosimilar product approval. 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 or biosimilar version of the product 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.
2
5

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Teva could also be sued for patent infringement outside of the context of the Hatch-Waxman Act.Act or BPCIA. For example, Teva could be sued for patent infringement after commencing sales of a product. In addition, forThis type of litigation can involve any of Teva’s pharmaceutical products, not just its generic and biosimilar products, Teva could be sued according to the “patent dance” procedures of the Biologics Price Competition and Innovation Act (BPCIA).products.
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.
24

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Teva is also involved in litigation regarding patents in other countries where it does business, particularly in Europe. The laws concerning generic pharmaceuticals and patents differ from country to country. Damages for patent infringement in Europe may include lost profits or a reasonable royalty, but enhanced damages for willful infringement are generally not available.
In July 2014, GlaxoSmithKline (“GSK”) sued Teva in the District Court for the District of Delaware federal court for infringement of a patent 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 or a multiplier for willfulness. Thereafter, the judge overturned the jury verdict, finding no induced infringement by Teva and that Teva did not owe any damages. On October 2, 2020, in a
two-to-one
decision,August 5, 2021, the Court of Appeals for the Federal Circuit overturnedissued a
two-to-one
decision reinstating the judge’s ruling$235.5 million verdict and reinstated the jury verdict. Teva’s requestfinding Teva liable for rehearing was granted, and the October 2020 decision was vacated.patent infringement. On February 23, 2021,11, 2022, the same three-judge panelCourt of Appeals for the Federal Circuit heard additional oral argumentdenied rehearing. Teva appealed this decision to the U.S. Supreme Court on the issue of whether thereJuly 11, 2022. While that appeal is enough evidence to support the jury’s verdict of induced infringement during the period from January 8, 2008 through April 30, 2011 (the “skinny label” period). If further appeals are decided against Teva,pending, the case would beis remanded to the district court for it to considerproceedings on Teva’s other legal and equitable defenses that have not yet been considered by the district court. In the first quarter of 2021, Teva recognized a provision based on its offer to settle such matter.
In October 2016, Adapt and Emergent Biosciences Inc. (“EBSI”) sued Teva in the District Court for the District of New Jersey, asserting infringement of its patents expiring in 2035, as a result of Teva’s filing of its Abbreviated New Drug Application (“ANDA”) seeking to market a generic version of Narcan
®
nasal spray. In June 2020, the court issued a decision finding all of EBSI’s patents expiring in 2035, to be invalid. On December 22, 2021, Teva launched its generic version of Narcan
®
nasal spray. On February 10, 2022, the Court of Appeals for the Federal Circuit affirmed the lower court decision finding that EBSI’s patents are invalid. On May 5, 2022, the Court of Appeals for the Federal Circuit denied EBSI’s petition for rehearing. EBSI still has the opportunity to seek further review from the U.S. Supreme Court. If Teva ultimately loses the case, Teva may be ordered to cease commercial sales or donations of its generic product and/or pay damages to EBSI. Annual sales of Narcan
®
in the U.S. were approximately $434 million at the time Teva launched its generic version in December 2021.
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,types of insurance, 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.
Teva and its subsidiaries are parties to litigation relating to previously unknown nitrosamine impurities discovered in certain products. The discovery led to a global recall of single and combination valsartan medicines around the world starting in July 2018 and to subsequent recalls on other products. The nitrosamine impurities in valsartan are allegedly found in the active pharmaceutical ingredient (API)(“API”) supplied by multiple API manufacturers. Teva’s products allegedly at issue in the various nitrosamine-related litigations pending in the United States include valsartan, losartan, metformin and ranitidine. There are currently two Multi-District Litigations (“MDL”) pending in the United States District Courts against Teva and numerous other manufacturers. One MDL is pending in the United States District Court for the District of New Jersey for valsartan, losartan and irbesartan. Teva is not named in complaints with respect to irbesartan. The second MDL is pending in the United States District Court for the Southern District of Florida for ranitidine. The lawsuits against Teva in the MDLs consist of individual personal injury and/or product liability claims and economic damages claims brought by consumers and end payors on behalf of purported classes of other consumers and end payors as well as medical monitoring class claims. Defendants’ motions to dismiss in the valsartan, losartan and irbesartan MDL were denied in part and granted in part. Plaintiffspart and plaintiffs have movedfiled amended complaints. In the ranitidine MDL, the generics manufacturers’ motions to file amended complaints, which defendantsdismiss have opposed. On December 31, 2020, thebeen granted, although certain plaintiffs have appeals pending. Teva, as well as
25

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
other generic manufacturers, is also named in several state court actions asserting allegations similar to those in the ranitidine MDL grantedand the generic defendants’ motion to dismiss on the grounds of preemptionvalsartan and deficient pleading, allowing plaintiffs to
re-plead
certain claims. Certain plaintiffs appealed the decision. Plaintiffslosartan MDL. The state court valsartan and losartan actions are pending in theNew Jersey and Delaware and are currently stayed. The state court ranitidine MDL filed amended complaints, and on March 24, 2021, defendants moved to dismiss those amended complaints. On July 8, 2021, the district court entered an order granting dismissal of the generic manufacturer defendants, includingcases naming Teva and its affiliates, without leave to further amend. Teva was also recently named in a consolidated proceedingare pending in California, state court with similar allegations as the ranitidine MDL.Illinois, Pennsylvania and New York. In addition to these MDLs, Teva has also been named in a consolidated proceeding pending in the United States District Court for the District of New Jersey brought by individuals and end payors seeking economic damages on behalf of purported classes of consumers and end payors who purchased Teva’s, as well as other generic manufacturers’ metformin products. The defendants’Defendants’ motion to dismiss the plaintiffs’ amended metformin complaint from June 2021, was granted without prejudice with respect to the consumer economic loss plaintiffs and on June 21, 2021, plaintiffs filed angranted in part and denied in part with respect to the end payor plaintiffs. Plaintiffs were granted leave to file a second amended complaint. Teva has also been named in one personal injury metformin case in Florida state court. Similar lawsuits are pending in Canada and Germany.
26

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 oftensome of whom assert claims on behalf of classes of all direct and indirect purchasers, and they typically allege that (1)(i) Teva received something of value from the innovator in exchange for an agreement to delay generic entry, and (2)(ii) significant savings could have been realized if there had been no settlement agreement and generic competition had commenced earlier. These class action casesplaintiffs 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 often 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.
In June 2013, the U.S. Supreme Court held, in Federal Trade Commission (“FTC”) v. Actavis, Inc. (the “AndroGel case”), that a rule of reason test should be applied in analyzing whether such settlements potentially violate the federal antitrust laws. The Supreme Court held that a trial court must analyze each agreement in its entirety in order to determine whether it violates the antitrust laws. This new test has resulted in increased scrutiny of Teva’s patent settlements, additional action by the FTC and state and local authorities, and an increased risk of liability in Teva’s currently pending antitrust litigations.
In May 2015, Cephalon Inc., a Teva subsidiary (“Cephalon”), entered into a consent decree with the FTC (the “Modafinil Consent Decree”) under which the FTC dismissed antitrust claims against Cephalon related to certain finished modafinil products (marketed as PROVIGIL
®
) in exchange for Cephalon and Teva agreeing to, among other things, abide by certain restrictions and limitations, for a period of ten years, when entering into settlement agreements to resolve patent litigation in the United States. Those restrictions and limitations were further refined in connection with the settlement of other unrelated FTC antitrust lawsuits as described below, and the term of the Modafinil Consent Decree was extended until 2029.
In November 2020, the European Commission issued a final decision in its proceedings against both Cephalon and Teva, finding that the 2005 settlement agreement between the parties had the object and effect of hindering the entry of generic modafinil, and imposed fines totaling €60.5euro 60.5 million on Teva and Cephalon. Teva and Cephalon filed an appeal against the decision in February 2021. A provision for this matter was included in the financial
statements. Teva has provided the European Commission with a bank guarantee in the amount of the imposed fines.
2
7

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Teva and its affiliates have been named as defendants in lawsuits alleging that multiple patent litigation settlement agreements relating to AndroGel® 1% (testosterone gel) violate the antitrust laws. The first of these lawsuits (the “Georgia AndroGel Litigation”) was filed in January 2009 in California federal court, and later transferred to Georgia federal court, with the FTC and the State of California, and later private plaintiffs, challenging a September 2006 patent litigation settlement between Watson Pharmaceuticals, Inc. (“Watson”), from which Teva later acquired certain assets and liabilities, and Solvay Pharmaceuticals, Inc. (“Solvay”). The second lawsuit (the “Philadelphia AndroGel Litigation”) was filed by the FTC in September 2014 in federal court in Philadelphia, challenging Teva’s December 2011 patent litigation settlement with AbbVie. The FTC stipulated to dismiss Teva from both litigations, in exchange for Teva’s agreement to amend the Modafinil Consent Decree, as described above. On July 16, 2018, the direct purchaser plaintiffs’ motion for class certification in the Georgia AndroGel Litigation was denied and Teva later settled with the retailer plaintiffs in the Georgia AndroGel Litigation as well as the three direct purchasers that had sought class certification, thus leaving no remaining claims in the Georgia AndroGel Litigation. In August 2019, certain other direct-purchaser plaintiffs (who would have been members of the direct purchaser class in the Georgia AndroGel Litigation, had it been certified) filed their own claims in the federal court in Philadelphia (where the Philadelphia AndroGel Litigation has been pending), challenging (in one complaint) both the September 2006 settlement between Watson and Solvay, and the December 2011 settlement between Teva and AbbVie.
Those claims remain pending. Annual sales of AndroGel
®
1% were approximately
$
350
 million at the time of the earlier Watson/Solvay settlement and approximately $
140
 million at the time Actavis launched its generic version of AndroGel
®
1
% in
November 2015
. A provision for these matters 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 November 2005 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, and discovery remains stayed. 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.
26

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®Lamictal
®
) entered into in February 2005. The plaintiffs claim that the settlement agreement unlawfully delayed generic entry and seek unspecified damages. In December 2018, the district court granted the direct-purc
h
aser plaintiffs’ motion for class certification, but on April 22, 2020, the Third Circuit reversed that ruling and remanded for further class certification proceedings. On April 9, 2021, the district court, which had previously granted an initial motion for class certification by the direct purchaser plaintiffs but was reversed on that ruling by the Third Circuit in April 2020, denied the direct purchaser plaintiffs’ renewed motion for class certification, but allowed additional briefing on whether plaintiffs cancertification. Plaintiffs thereafter sought leave to file a supplemental expert report in an effort to show that they could still meet the class certification standard on certain of their claims.claims, but on January 21, 2022, the district court denied that request in full, and on April 21, 2022, the court entered a schedule for additional briefing on the remaining class certification issues. Annual sales of Lamictal® 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-purchaser
opt-out
plaintiffs filed complaints with allegations nearly identical to those of the direct purchasers’ class. In August 2019, the district court certified the direct-purchaser class, but in June 2020, the court denied the indirect purchasers’ motion for class certification without prejudice. On September 4, 2020, the indirect purchasers filed a renewed motion for class certification, which remains pending.was subsequently denied with prejudice by the district court and is now on appeal before the Court of Appeals for the Third Circuit. In October 2016, the District Attorney for Orange County, California, filed a similar complaint in California state court, which has since been amended, alleging violations of state law. Defendants moved to strike the District Attorney’s claims forlaw and seeking 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 Appeals subsequently reversed the decision and in June 2020, the California Supreme Court reversed the Court of Appeals’ decision, allowing the District Attorney’s claims to proceed.penalties. Annual sales of Niaspan
®
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.
28

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Since January 2014, numerous lawsuits have been filed in the U.S. District Court for the Southern District of New York by purported classes of
end-payers
for, and direct-purchasers of, Actos
®
and 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-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 Teva’s 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 January 2019, generic manufacturer Cipla LimitedPutative classes of direct-purchaser and
end-payer
plaintiffs have filed a lawsuitantitrust lawsuits (which have since been coordinated in federal court in Delaware) against Amgen which was later amended to includeand Teva as a defendant, in Delaware federal court, alleging among other things, that athe January 2, 2019 settlement agreement between Amgen and Teva, resolving patent litigation over cinacalcet (generic Sensipar
®
), violated the antitrust laws. On August 14, 2020, Cipla Limited agreed to dismiss its claims against Teva, with prejudice, and those claims have since been dismissed. Putative classes of direct-purchaser and
end-payer
plaintiffs have also filed antitrust lawsuits (which have since been coordinated in federal court in Delaware) against Amgen and Teva related to the January 2, 2019 settlement. On July 22, 2020, a magistrate judge recommended that plaintiffs’ claims be dismissed and on November 30, 2020, the district court overruled the magistrate judge’s recommendation, denied Teva’s motion to dismiss in part, and instructed plaintiffs to file amended complaints, which plaintiffs filed on February 16, 2021.2021, plaintiffs filed amended complaints. On March 30, 2021, Teva again moved to dismiss those complaints on March 30, 2021,claims based on plaintiffs’ failure to allege both (a) that the settlement violated the antitrust laws and (b) that the settlement caused any actual injury to plaintiffs,plaintiffs. On March 11, 2022, the district court denied Teva’s motion to dismiss in part. Teva has requested that the district court certify its rulings for review by the United States Court of Appeals for the Third Circuit, and Teva’s motions remain pending.is awaiting the court’s decision. 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.
27

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
In August 2019, certain direct-purchaser plaintiffs filed claims in federal court in Philadelphia naming Teva and its affiliates as defendants alleging that certain patent litigation settlement agreements relating to AndroGel
®
1% (testosterone gel) violate the antitrust laws, specifically the September 2006 patent litigation settlement between Watson Pharmaceuticals, Inc. (“Watson”), from which Teva later acquired certain assets and liabilities, and Solvay Pharmaceuticals, Inc. (“Solvay”), and a December 2011 settlement between Teva and AbbVie. Those claims remain pending. Annual sales of AndroGel
®
1% were approximately $350 million at the time of the earlier Watson/Solvay settlement and approximately $140 million at the time Actavis launched its generic version of AndroGel
®
1% in November 2015. A provision for these matters and related litigations in Georgia that have since been settled was included in the financial statements.
Between September 1, 2020 and December 20, 2020, separate plaintiffs purporting to represent putative classes of direct and indirect purchasers and
opt-out
retailer purchasers of Bystolic
®
(nebivolol hydrochloride) filed separate complaints in the U.S. District Court for the Southern District of New York against several generic manufacturers, including Teva, Actavis, and Watson, alleging, among other things, that the settlement agreements these generic manufacturers entered into with Forest Laboratories, Inc., the innovator, to resolve patent litigation over Bystolic
®
violated the antitrust laws. The cases were coordinated and on March 15, 2021, plaintiffs filed amended complaints, which Teva, Actavis, and Watson moved to dismiss. On January 24, 2022, the court dismissed plaintiffs’ amended complaints without prejudice. The plaintiffs filed amended complaints on February 22, 2022, which defendants (including Teva, Actavis and Watson) moved to dismiss on April 19, 2022, and those motions remain pending. Annual sales of Bystolic
®
in the United States were approximately $700 million at the time of Watson’s 2013 settlement with Forest.
In February 2021, the State of New Mexico filed a lawsuit against Teva and certain other defendants related to various medicines used to treat HIV. Between September and December 2021, several private plaintiffs including retailers and health insurance providers filed similar claims in federal court in the Northern District of California and in the District of Minnesota. As they relate to Teva, the lawsuits challenge settlement agreements Teva entered into with Gilead in 2013 and 2014 to resolve patent litigation relating to Teva’s generic versions of Viread
®
, Truvada
®
, and Atripla
®
. Plaintiffs allege that the settlements contain improper reverse payments that delayed the availability of Teva’s generic products, in violation of the federal antitrust laws and state law. Several recently filed cases are in the process of being coordinated with the existing litigation in the Northern District of California, and any effect those cases may have on the overall case schedule remains unclear. On February 16, 2022, Teva moved to dismiss the claims by certain private plaintiffs but that motion was denied. However, Teva has successfully moved to limit the potential damages period as to certain private plaintiffs. On August 5, 2021, Teva moved to dismiss the complaint brought by the State of New Mexico, and on December 20, 2021, the trial court denied Teva’s motion. The trial court certified the decision as appropriate for interlocutory appeal, but on April 8, 2022, the appellate court in New Mexico declined to accept the appeal. Teva has appealed the decision to the New Mexico Supreme Court, and that appeal remains pending. Annual sales in the United States at the time of the settlement of Viread
®
, Truvada
®
and Atripla
®
were approximately $582 million, $2.4 billion, and $2.9 billion, respectively. Annual sales in the United States at the time Teva launched its generic version of Viread
®
in 2017, Truvada
®
in 2020 and Atripla
®
in 2020 were approximately $728 million, $2.1 billion and $444 million, respectively.
In March 2021, following the 2019 European Commission’s inspection of Teva and subsequent request for information, the European Commission opened a formal antitrust investigation to assess whether Teva may have abused a dominant position by delaying the market entry and uptake of medicines that compete with COPAXONE. Annual sales of COPAXONE in the European Economic Area for 2021 were approximately $373 million.
On July 15, 2021, the U.K. Competition and Markets Authority (“CMA”) issued a decision imposing fines for breaches of U.K. competition law by Allergan, Actavis UK and Auden Mckenzie and a number of other companies in connection with the supply of 10mg and 20mg hydrocortisone tablets in the U.K. The decision combines the CMA’s three prior investigations into the supply of hydrocortisone tablets in the U.K. and encompasses those allegations which were subject to prior statements of objections (a provisional finding of breach of the Competition Act), in particular those under case
50277-1
(unfair pricing, originally subject to a statement of objections on December 16, 2016), case
50277-2
(anti-competitive agreement with AMCo, originally subject to a statement of objections on March 3, 2017) as well as the CMA’s subsequent investigation relating to an anti-competitive agreement with Waymade. 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. On October 6, 2021, Accord UK and Auden Mckenzie appealed the CMA’s decision. A provision for the estimated exposure for Teva related to the fines and/or damages has been recorded in the financial statements.
In March 2021, following the 2019 European Commission’s inspection of Teva and subsequent request for information, the European Commission opened a formal antitrust investigation to assess whether Teva may have abused a dominant position by delaying the market entry and uptake of medicines that compete with COPAXONE. Annual sales of COPAXONE in the European Economic Area for the past calendar year were approximately
 $380 million.
Between September 1, 2020 and December 20, 2020, separate plaintiffs purporting to represent putative classes of direct and indirect purchasers and opt-out retailer purchasers of Bystolic® (nebivolol hydrochloride) filed separate complaints in the U.S. District Court for the Southern District of New York against several generic manufacturers, including Teva, Actavis, and Watson, alleging, among other things, that the settlement agreements these generic manufacturers entered into with Forest Laboratories, Inc., the innovator, to resolve patent litigation over Bystolic® violated the antitrust laws. The cases were coordinated and on March 15, 2021, plaintiffs filed amended complaints, which Teva, Actavis, and Watson have moved to dismiss on the grounds (among others) that the allegations do not plausibly demonstrate any improper payment from Forest to Watson that could create antitrust liability. Those motions remain pending. Annual sales of Bystolic® in the United States were approximately 
$700 million at the time of Watson’s 2013 settlement with Forest.
 
2
9
28

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
In August 2021, a plaintiff filed a putative class action suit in the United States District Court for the Eastern District of Pennsylvania against Takeda and several generic manufacturers, including Watson and Teva, alleging violations of the antitrust laws in connection with their settlement of patent litigation involving colchicine tablets (generic Colcrys
®
), entered into in January 2016. Plaintiff claims that the settlement was part of a horizontal conspiracy among Takeda and the generic manufacturers to unlawfully restrict output of colchicine by delaying generic entry. Defendants moved to dismiss the complaint for failure to state a claim. On December 28, 2021, the Court granted the defendants’ motion to dismiss, finding that plaintiff’s allegations were implausible, but granted plaintiff leave to amend, and on January 18, 2022, plaintiff filed its amended complaint, making substantively the same antitrust allegations as before, but with certain new allegations regarding the nature of the alleged conspiracy. On March 30, 2022, the Court granted in part and denied in part defendants’ motion to dismiss, dismissing the newly pled bilateral conspiracy claims but allowing the revised overarching conspiracy claim to proceed against all defendants. On April 8, 2022, Teva and Watson, along with their codefendant Amneal, moved the court to reconsider its partial
motion-to-dismiss
denial or, in the alternative, to certify that denial for immediate appellate review. However, that motion was denied on April 25, 2022. Annual sales of Colcrys
®
in the United States were approximately $187 million at the time of the settlement.
Government Investigations and Litigation Relating to Pricing and Marketing
Teva is involved in government investigations and litigation aris
i
ngarising from the marketing and promotion of its pharmaceutical products in the United States.
In 2015 and 2016, Actavis and Teva USA each respectively received subpoenas from the U.S. Department of Justice (“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. On August 25, 2020, a federal grand jury in the Eastern District of Pennsylvania returned a three count indictment charging Teva USA with criminal felony Sherman Act violations. See No.
No. 20-cr-200
(E.D. Pa.). The indictment alleges Teva USA participated in a conspiracythree separate conspiracies with certain other generic drug manufacturers to maintain and fix prices, allocate customers, and other alleged antitrust offenses concerning the sale of generic drugs. The indictment identified the following generic drugs: Pravastatin, Carbamazepine, Clotrimazole, Etodolac (IR and ER), Fluocinonide (Cream
E-Cream,
Gel, and Ointment), Warfarin, Etodolac (IR), Nadolol, Temozolomide, and Tobramycin. On September 8, 2020, Teva USA pled not guilty to all counts. A tentative trial date is yet to be scheduled. While the Company is unable to estimate a range of loss at this time, a conviction on these criminal charges could have a material adverse impact on the Company’s business, including monetary penalties and debarment from federally funded health care programs.
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. An adverse resolution of this matter may include fines, penalties, financial forfeiture and compliance conditions.
In 2015 and 2016, Actavis and Teva USA each respectively received a subpoena from the Connecticut Attorney General seeking documents and other information relating to potential state antitrust law violations. Subsequently, 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 attorneys general filed another antitrust complaint against Actavis, Teva and other companies and individuals, alleging price-fixing and market allocation with respect to additional generic products. On November 1, 2019, the state attorneys general filed an amended complaint, bringing the total number of plaintiff states and territories to 54. The amended 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. On June 10, 2020, most, but not all, of the same states, with the addition
29

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
of the U.S. Virgin Islands, filed a third complaint in the District of Connecticut naming, among other defendants, Actavis, but not Teva USA, in a similar complaint relating to dermatological generics products. On September 9, 2021, the states’ attorneys general amended their third complaint to, among other things, add California as a plaintiff. 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”). On July 13, 2020, the court overseeing the Pennsylvania MDL chose the attorneys’ general November 1, 2019 amended complaint, referenced above, along with threecertain complaints filed by private plaintiffs, to proceed first in the litigation as bellwether complaints. Teva moved the courtOn February 9, 2021, Teva’s motion to reconsider that ruling. The motionruling was granted, on February 9, 2021 and on May 7, 2021, the Court chose the attorneys’ general third complaint (fromfiled on June 10, 2020)2020 and subsequently amended to serve as a bellwether complaint in the Pennsylvania MDL. In June 2021,MDL, along with certain complaints filed by private plaintiffs. Teva settled with the State of Mississippi for
$925,000 in June 2021 and with the State of Louisiana for $1,450,000 in March 2022. Pursuant to these settlements, both states have dismissed itstheir claims against Actavis and Teva USA, as well as certain former employees of Actavis and Teva USA. On December 9, 2021, the Court entered an order setting the schedule for the proceedings in the bellwether cases. The order did not include trial dates, but provides for the parties to complete briefing on motions for summary judgement in early 2024. On March 30, 2022, the State of Alabama voluntarily dismissed all of its claims in the litigation, including its claims against Actavis and Teva USA, pursuant towithout prejudice. On June 7, 2022, the Court dismissed the attorneys’ general claims for monetary relief under federal law, concluding that settlement.the federal statute under which the attorneys general brought suit authorizes injunctive relief only. However, the attorneys general have pending claims for monetary relief under state law.    
30

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Beginning on March 2, 2016, and continuing through December 2020, 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 USA and Actavis. The plaintiffs generally seek injunctive relief and damages under federal antitrust law, and damages under various state laws. On October 16, 2018, the court denied certain of the defendants’ motions to dismiss as to certain federal claims, pending as of that date, 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, and again on May 6, 2020 and October 8, 2021, certain individual plaintiffs commenced a civil actionactions 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 hascomplaints have been filed in either actionthe actions and botheach of the three of the cases have been placed in deferred status. On November 13, 2019, and again on August 24, 2020, certainCertain counties in New York and Texas have also commenced civil actions against many of the defendants in the Pennsylvania MDL, including Teva and Actavis, and the complaints have been transferred to the Pennsylvania MDL. On December 15, 2020, several additional New York counties filed suit in New York state court raising similar allegations, and the case was removed to federal court on March 26, 2021 and 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 Texas, which has been transferred to the Pennsylvania MDL. There is also one similar complaint brought in Canada, which alleges that the defendants engaged in conspiracies to fix prices and/or allocate market share of generic drug products to the detriment of a class of private payors. The action is in its early stages.
In March 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. Subsequently, in August 2020, the U.S. Attorney’s office in Boston, Massachusetts brought a civil action in the U.S. District Court for the District of Massachusetts alleging violations of the federal Anti-Kickback Statute, and asserting causes of action under the federal False Claims Act and state law. It is alleged that Teva caused the submission of false claims to Medicare through Teva’s donations to bona fide independent charities that provide financial assistance to patients. An adverse judgment may involve damages, civil penalties and injunctive remedies. On October 19, 2020, Teva filed aSeptember 10, 2021, the Court granted Teva’s motion to dismiss the complaint on the grounds that it fails to state aunjust enrichment claim and that motion remains pending.denied the remainder of the motion. On October 15, 2021, Teva filed an answer to the complaint. The proceeding is in early stages. Additionally, on January 8, 2021, Humana, Inc. filed an action against Teva in the United States District Court for the Middle District of Florida based on the allegations raised in the August 2020 complaint filed by the U.S. Attorney’s Office in Boston. On April 2, 2021, Teva filed a motion to dismiss the claims on the grounds that the claims are time-barred and/or insufficiently pled, and that motion remains pending.
In April 2021, a city and county in Washington sued Teva in the United States District Court for the Western District of Washington for alleged violations of the Racketeer Influenced and Corrupt Organizations Act, Washington’s Consumer Protection Act, and unjust enrichment concerning Teva’s sale of COPAXONE. Plaintiffs purport to represent a nationwide class of health plans and a subclass of Washington-based health plans that purchased and/or reimbursed health plan members for COPAXONE. Plaintiffs allege that Teva engaged in several fraudulent schemes that resulted in

30

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
plaintiffs and the putative class members purchasing and/or reimbursing plan members for additional prescriptions of COPAXONE and/or at inflated COPAXONE prices. Plaintiffs seek treble damages for the excess reimbursements and inflated costs, as well as injunctive relief. On July 2,September 28, 2021, plaintiffs filed an amended complaint. On November 17, 2021, Teva moved to dismiss the suit, arguingon the grounds that plaintiffs’ claims are barred by the applicable statutes of limitations plaintiffs cannot recover underand the direct purchaser rule, suffer from jurisdictional defects, and that plaintiffs failedfail to plausibly allege fraud or other elements of their claims. That motion is fully briefed and a decision remains pending.
O
nOn June 29, 2021, Mylan Pharmaceuticals (“Mylan”) sued Teva in the District Court for the District of New Jersey. On March 11, 2022 and March 15, 2022, FWK Holdings, LLC, KPH Healthcare Servs., Inc. d/b/a Kinney Drugs, Inc., Meijer Inc., Meijer Distribution, Inc., Labor-Management Healthcare Fund, the Mayor and City Council of Baltimore, and the New York State Teamsters Council Health and Hospital Fund sued Teva in the District Court for the District of New Jersey on behalf of themselves and others similarly situated direct and indirect purchasers of COPAXONE. The complaints assert claims for alleged violations of the Lanham Act, state and federal unfair competition and monopolization laws, tortious interference, trade libel, and trade libel.a violation of the Racketeer Influenced and Corrupt Organizations Act. Plaintiffs claim Teva was involved in an unlawful scheme to delay and hinder generic competition concerning COPAXONE sales. Plaintiffs seek damages for lost profits and expens
e
s,expenses, disgorgement, restitution, treble damages, attorneys’ fees and costs, and injunctive relief.
Teva has moved to dismiss the complaint filed by Mylan on the grounds, among others, that none of its challenged conduct violates the law. That motion is fully briefed and a decision remains pending. Teva has also moved to dismiss the remaining complaints on similar grounds and the briefing on that motion is ongoing.
31

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Opioids Litigation
Since May 2014, more than
3,500
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. Two cases that were included in the MDL Opioid Proceeding were transferred back to federal district court for additional discovery,
pre-trial
proceedings and trial. Those cases are: City of Chicago v. Purdue Pharma L.P. et al., No.
No. 14-cv-04361
(N.D. Ill.) and City and County of San Francisco v. Purdue Pharma L.P. et al., No.
No. 18-cv-07591-CRB
(N.D. Cal.). Other cases remain pending in various states. In some jurisdictions, such as Illinois, New York, Pennsylvania, South Carolina, Texas, Utah and West Virginia, certain state court cases have been transferred to a single court within their respective state court systems for coordinated pretrial proceedings. 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, over 950 personal injury plaintiffs, including various putative class actions of individuals, have asserted personal injury and wrongful death claims in over 600 complaints, nearly all of which are consolidated in the MDL Opioid Proceeding. Furthermore, approximately 700
non-personal
injury complaints and approximately 100 personal injury 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. The individual personal injury plaintiffs further seek
non-economic
damages. In many of these cases, plaintiffs are seeking joint and several damages among all defendants.
On April 19, 2021, a bench trial in California (The People of the State of California, acting by and through Santa Clara County Counsel James R. Williams, et. al. v. Purdue Pharma L.P., et. al.) commenced withagainst Teva and other defendants focused on the marketing of branded opioids. On December 14, 2021, the court issued its final judgment in favor of the defendants on all claims. Plaintiffs filed a notice of appeal of this judgment in February 2022. On June 29, 2021, a jury trial in New York (
In re Opioid Litigation
, Index No. 400000/2017)) commenced withagainst Teva and other defendants, focused on the marketing and distribution of opioids. Absent resolutions, additional trialsThe case was bifurcated between liability and damages. On December 30, 2021, the jury returned a liability verdict in favor of plaintiffs (the County of Suffolk, the County of Nassau and the State of New York) on the plaintiffs’ public nuisance claim. Teva and the plaintiffs filed post-trial motions with respect to the liability portion of the case, and Teva intends to appeal if its post-trial motions are expecteddenied. The court has not yet set a schedule for damages discovery or a date for the relief phase of the trial. Teva, the State of New York and its subdivisions remain actively engaged in settlement negotiations.
31

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to proceed in several states in 2022.Consolidated Financial Statements
(Unaudited)
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 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.”
Additionally, 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 willagreed to provide the two counties with opioid treatment medication, buprenorphine naloxone (sublingual tablets), known by the brand name Suboxone®Suboxone
®
, with a value
of $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, which has been paid.
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. This nationwide settlement was 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., counties, tribes and other plaintiffs) thereof. Under this nationwide settlement, 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. In addition, Teva would also provide cash payments of up to $250 million over a ten year period.
D
u
ring the passage of time since then, the Company has continued to negotiate the terms and conditions of a nationwide settlement. On July 21, 2021, it was announced that four other defendants (not including Teva) have reached a nationwide settlement,settlements, subject to certain conditions, which includesinclude payment of up to approximately $26 billion spread over up to
18 years. Teva has continued to work toward a nationwide settlement with the working group of States’ Attorneys General, the Multi-District Litigation Plaintiffs’ Executive Committee and counsel for Native American tribes (“Tribes”). In July 2022, the parties reached an agreement in principle on the financial terms of a final nationwide settlement similar in structure to the nationwide settlements of other defendants. The achievementparties continue to work on memorializing the non-financial terms of thisthe proposed nationwide settlement may similarly presentagreement. Under the financial terms of the proposed nationwide settlement agreement, Teva will pay
up to
 $4.25
billion (including the already settled cases) plus approximately $100 million for the Tribes, spread over
13
years. This total includes the supply of up to
$1.2
billion of Teva’s generic version of Narcan® (naloxone hydrochloride nasal spray)
,
valued at wholesale acquisition cost
,
over 
10
years or
cash at 
20% of the wholesale acquisition cost
($240 million) in lieu of product. The nationwide settlement agreement is contingent upon (i) final documentation among the working group and Teva, and reaching the thresholds for participation that will be set forth in the final agreement; and (ii) Teva reaching an opportunity foragreement with Allergan with respect to any indemnification obligations, and Allergan reaching a nationwide opioids settlement. No other trials currently are scheduled against Teva in 2022 in any opioids matter, with the possible exception of the relief phase of the trial in the New York opioids litigation. If the nationwide settlement agreement is not finalized, additional trials are expected to arriveproceed in several states in 2023.
On September 28, 2021, Teva reached an agreement with the Attorney General of Louisiana that settles the state’s opioid-related claims. The agreement was contingent that all political subdivisions of Louisiana will formally release Teva as part of the settlement, which Teva was advised has occurred by the Attorney General of Louisiana. Under the terms of the settlement, Teva will pay Louisiana $15 million over an
18-year
period and will provide buprenorphine naloxone (sublingual tablets) valued at a settlement, although there do remain many complex financial and legal issues still outstanding, including indemnification claims by Allergan against$3 million (wholesale acquisition cost).
On February 4, 2022, the Company arising fromreached an agreement with the acquisitionAttorney General of the Actavis Generics business. The Company cannot predict ifState of Texas that settles Texas’ and its subdivisions’ opioid-related claims. On March 10, 2022, Texas confirmed that at least 96% of the population of subdivisions formally released Teva as part of the settlement. Under the terms of the settlement, Teva will pay Texas $150 million over a
15-year
period and will provide its generic version of Narcan
®
(naloxone hydrochloride nasal spray), valued at $75 million (wholesale acquisition cost) over 10 years.
On March 21, 2022, Teva reached an agreement with the Attorney General of Rhode Island that settles Rhode Island’s and its subdivisions’ opioid-related claims. Under the terms of the settlement, Teva will be finalized.pay Rhode Island $21 million over 13 years, in addition to attorneys’ fees and costs, and will provide its generic version of Narcan
®
(naloxone hydrochloride nasal spray) and a significant amount of buprenorphine naloxone sublingual tablets known by the brand name Suboxone
®
, together valued at $78.5 million (wholesale acquisition cost) over 10 years.
 
32

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
On March 30, 2022, Teva reached an agreement with the Attorney General of Florida that settles Florida’s and its subdivisions’ opioid-related claims. Under the terms of the settlement, Teva will pay Florida $177 million over
The15-years,
in addition to attorneys’ fees and costs, and will provide its generic version of Narcan
®
(naloxone hydrochloride nasal spray) valued at $84 million (wholesale acquisition cost) over 10 years.
On May 24, 2022, Teva reached an agreement in principle with the Attorney General of West Virginia that settles West Virginia’s and its subdivisions’ opioid-related claims. Under the terms of the settlement, Teva will pay West Virginia $75 million over
15-years,
in addition to attorneys’ fees and costs, and will provide its generic version of Narcan
®
(naloxone hydrochloride nasal spray) valued at $27 million (wholesale acquisition cost) over 10 years.
On July 12, 2022, Teva reached an agreement in principle with the City and County of San Francisco and the People of the State of California that settles opioid-related claims asserted on behalf of the City and County of San Francisco. Teva will provide San Francisco $20.3 million over 13 years, in addition to attorneys’ fees and costs, and will provide its generic version of Narcan
®
(naloxone hydrochloride nasal spray), valued at $20 million (wholesale acquisition cost), over 10 years.
In light of the agreement in principle on the nationwide settlement between Teva, and the States’ Attorneys General, their subdivisions and the Tribes, Teva’s potential indemnification obligations arising from Teva’s acquisition of the Actavis Generics business for opioid-related claims, prior settlements with Texas, Florida, Louisiana, Rhode Island, West Virginia and San Francisco, the verdict in New York, decisions in California and Oklahoma, as well as an estimate for a number of items including, but not limited to, costs associated with administering injunctive terms, and most favored nations clauses associated with prior settlements, the Company considered a range ofhas reconsidered the potential settlement outcomes.outcome and revised its provision. The currentrevised provision remainsis a reasonable estimate of the ultimate costs if ain the likely event that the nationwide settlement is finalized based onunder its current proposed terms and conditions, after discounting payments to states to their net present value. However, if the Company’s most recent offer to settle. However, ifnationwide settlement is not finalized for the entirety of the remaining cases, a reasonable upper end of a range of loss cannot be determined. 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.
Separately, on April 27, 2018, Teva received subpoena requests from the United 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. This was followed by a Statement of Charges and Notice of Hearing filed by the NYDFS, although no merits hearing date is currently set. Currently, Teva cannot predict how a
the
nationwide settlement (if finalized) will affect these investigations and administrative actions. In addition, a number of state attorneys general,State Attorneys General, including a coordinated multistate effort, have initiated investigations into sales and marketing practices of Teva and its affiliates with respect to opioids. Other states are conducting their own investigations outside of the multistate group. Teva is cooperating with these ongoing investigations and cannot predict their outcome at this time.
In addition, several jurisdictions and consumers in Canada have initiated litigation regarding opioids alleging similar claims as those in the United States. The cases in Canada may be consolidated and are in their early stages.
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. Those lawsuits were consolidated and transferred to the U.S. District Court for the District of Connecticut (the “Ontario Teachers Securities Litigation”). On December 13, 2019, the lead plaintiff in that action filed an amended complaint, purportedly on behalf of purchasers of Teva’s securities between February 6, 2014 and May 10, 2019. The amended 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. The amended complaint seeks unspecified damages, legal fees, interest, and costs. In July 2017, August 2017, and June 2019, other putative securities class actions were filed in other federal courts based on similar allegations, and those cases have been transferred to the U.S. District Court for the District of Connecticut. Between August 2017 and October 2020, twentyJanuary 2022, twenty-three complaints were filed against Teva and certain of its current and former officers and directors seeking unspecified compensatory damages, legal fees, costs and expenses. The similar claims in these complaints have been brought on behalf of plaintiffs, in various forums across the country, who have indicated that they intend to
“opt-out”
of the Ontario Teachers Securities Litigation. On March 10, 2020, the Court consolidated the Ontario Teachers Securities Litigation with all of the above-referenced putative class actions for all purposes and the
“opt-out”
cases for pretrial purposes. The case is now in discovery. Pursuant to that consolidation order, plaintiffs in several of the
“opt-out”
cases filed amended complaints on May 28, 2020. On January 22, 2021, the Court
33

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
dismissed the
“opt-out”
plaintiffs’ claims arising from statements made prior to the five year statute of repose, but denied Teva’s motion to dismiss their claims under Israeli laws. Those
“opt-out”
plaintiffs moved for reconsideration, which was denied on March 30, 2021. On May 24, 2021, Teva moved to dismiss a majority of the
“opt-out”
complaints on various other grounds. Those motions are still pending. The Ontario Teachers Securities Litigation plaintiffs’ Motion for Class Certification and Appointment of Class Representatives and Class Counsel was granted on March 9, 2021, to which Teva’s appeal was denied. MotionsOn January 18, 2022, Teva entered into a settlement in the Ontario Teachers Securities Litigation for $420 million, which received final approval from the court on June 2, 2022. Pursuant to an agreement between the Company and its insurance carriers, the insurance carriers provided the vast majority of the total settlement amount, with a small portion contributed by Teva. Additionally, as part of the settlement, Teva admitted no liability and denied all allegations of wrongdoing. A number of
“opt-out”
complaints still remain outstanding, and motions to approve securities class actions were also filed in the Tel Aviv District Court in Israel with similar allegations to those made in the Ontario Teachers Securities Litigation.
33
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
On September 23, 2020, a putative securities class action was filed in the U.S. District Court for the Eastern District of Pennsylvania against Teva and certain of its former officers alleging, among other things, violations of Section 10(b) ofofficers. On August 10, 2021, the Securities and Exchange Act of 1934, aslead plaintiff filed a corrected amended and SEC Rule
10b-5.
Theclass action complaint, purportedly filed on behalf of persons who purchased or otherwise acquired Teva securities between October 29, 2015 and August 18, 2020,2020. The corrected amended complaint alleges that Teva and certain of its current and former officers violated federal securities laws by allegedly making false and misleading statements regarding the commercial performance of COPAXONE, namely, by failing to disclose that Teva had allegedly caused the submission of false claims to Medicare through Teva’s donations to bona fide independent charities that provide financial assistance to patients, which allegedly impacted COPAXONE’s commercial success and the sustainability of its revenues and resulted in the above referenced August 2020 False Claims Act complaint filed by the DOJ. On March 26, 2021, the Court appointed lead plaintiff and lead counsel. On May 25, 2021, lead plaintiff filed an amended class action complaint, which names four additional former and current officers as defendants. The corrected amended complaint seeks unspecified damages and legal fees, interest,fees. On March 25, 2022, the court granted in part and costs. Defendants’ responsedenied in part Teva’s and the individual defendants’ motion to dismiss the corrected amended complaint, is currently due by August 13, 2021.(i) holding that the plaintiffs’ complaint failed to plead that certain public statements regarding Teva’s compliance with the law were misleading, (ii) holding that two alleged partial corrective disclosures did not establish loss causation and cannot serve as the basis for plaintiff’s claimed loss, (iii) dismissing all claims against one of the individual defendants, and (iv) otherwise denying the motion to dismiss. A motion to approve a securities class action was also filed in the Central District Court in Israel, which has been stayed pending the U.S. litigation, with similar allegations to those made in the above complaint filed in the U.S. District Court for the Eastern District of Pennsylvania.
Motions to approve derivative actions seeking monetary damages against certain past and present directors and officers have been filed in Israeli Courts alleging negligence and recklessness with respect to the acquisition of the Rimsa business, the acquisition of Actavis Generics and the patent settlement relating to Lidoderm
®
.recklessness. Motions for document disclosure prior to initiating derivative actions were filed with respect to several U.S. and EU settlement agreements, opioids, the U.S. price-fixing investigations and allegations related to the DOJ’s complaint regarding Copaxone patient assistance program in the U.S. as well as allegations related to the European Commission investigation. In June 2021, the Tel Aviv District Court approved the settlement reached with respect to the derivative proceeding with regard to the acquisition of Actavis Generics and two related actions, including the derivative proceedings
related to allegations in connection with the Lidoderm
®
patent settlement agreement.
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
34

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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.
Item 103 of Regulation
S-K
promulgated by the SEC requires disclosure of certain environmental matters when a governmental authority is a party to the proceedings and such proceedings involve potential monetary sanctions, unless the Company reasonably believes that the matter will result in no monetary sanctions, or in monetary sanctions, exclusive of interest and costs, of less than $300,000. The following matter is disclosed in accordance with that requirement. On July 8, 2021, the National Green Tribunal Principal Bench, New Delhi, issued an order against Teva’s subsidiary in India, Teva API India Private Limited, finding
non-compliance
with environmental laws and assessed a penalty of $1.4 million. The Company expects to disputedisputed certain of the findings and the amount of the penalty and filefiled an appeal before the Supreme Court inof India. On August 5, 2021, the Supreme Court of India admitted the appeal for hearing and granted an interim unconditional stay on the National Green Tribunal’s order. The Company does not believe that the eventual outcome of such matter will have a material effect on its business.
34

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
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 di
s
misseddismissed all of plaintiffs’ claims, except for their claim against Cephalon for breach of contract. In November 2021, plaintiffs moved to amend their complaint to, among other things, reassert claims against the Company and Teva USA, but the plaintiffs
later stipulated to filing a new amended complaint that includes claims against Teva USA but not the Company, in exchange for Teva USA’s agreement to guarantee any judgment entered against Cephalon in the litigation. Plaintiffs filed that amended complaint on July 12, 2022. Trial in this matter is currently scheduled for JuneSeptember 2022.
NOTE 11 – Income taxes:
In the second quarter of 2022, Teva recognized a tax benefit of $900 million, on
pre-tax
loss of $1,160 million. In the second quarter of 2021, Teva recognized a tax expense of $98 million, on
pre-tax
income of $308 
million.
In the second quarter of 2020,2022, one of Teva’s U.S. subsidiaries was determined to be insolvent for tax purposes (i.e., its liabilities exceeded the fair market value of its assets), mainly in light of its accumulated operational losses. Consequently, Teva recognizedwill recognize on its 2022 tax return, a worthless stock deduction of approximately $4.2 billion, with related tax benefit of $104 million, onapproximately $850 million.
pre-tax
loss of $51 million.
Teva’s tax rate for the second quarter of 20212022 was mainly affected by the realization of losses related to its investment in one of its U.S. subsidiaries mentioned above, as well as impairments, amortizationlegal settlements, adjustments to valuation allowances on deferred tax assets and interest expense disallowance.disallowances.
In the first six months of 2022, Teva recognized a tax benefit of $899 million, on
pre-tax
loss of $2,131 million. In the first six months of 2021, Teva recognized a tax expense of $159 million, on
pre-tax
income of $451 
million. In the first six months of 2020, Teva recognized a tax benefit of $163 million, on
pre-tax
loss of $84 million.
Teva’s tax rate for the first six months of 20212022 was mainly affected by the realization of losses related to its investment in one of its U.S. subsidiaries mentioned above, as well as impairments, amortization, legal settlements, adjustments to valuation allowances on deferred tax assets and interest expense disallowance.disallowances.
The statutory Israeli corporate tax rate is 23% in 2021.2022. 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, interest expense disallowances, tax benefits in Israel and other countries, as well as infrequent or
non-recurring
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 September 2021.
November 2022. A final and binding decision against Teva in this case may lead to an asset write offimpairment of
$133 million.
139
 million.
35

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
The Israeli tax authorities issued tax assessment decrees for 2008-2012 and 2013-2016, challenging the Company’s positions on several issues. Teva has protested the 2008-2012 and 2013-2016 decrees before the Central District Court in Israel.
In October 2021, the Central District Court in Israel held in favor of the Israeli tax authorities with respect to 2008-2011 decrees. The case with respect to 2012-2016 remains pending with similar legal claims. The October 2021 Central District Court decision found that Teva has a tax liability to the Israeli government for 2008-2011 of approximately $350 million,
 of which a portion is being paid in cash during 2022 and 2023, and the remaining portion is being offset by carried forward losses that Teva would otherwise be entitled to. Teva appealed the decision to the Israeli Supreme Court and expects the appeal hearings to begin in early 2023. 
The Company believes it has adequately provided for theseall of its uncertain tax positions, including those items currently under dispute, however, adverse results could be material.

NOTE 12 – Other assets impairments, restructuring and other
items:

 
   
Three months ended
June 30,
   
Six months ended
June 30,
 
   
2021
   
2020
   
2021
   
2020
 
   
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
  $32   $277   $80   $352 
Contingent consideration
   (19   76    (16   83 
Restructuring
   (13   33    69    73 
Other
   28    (6   33    (5
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $28   $381   $165   $502 
   
 
 
   
 
 
   
 
 
   
 
 
 
   
Three months ended
June 30,
   
Six months ended
June 30,
 
   
2022
   
2021
   
2022
   
2021
 
   
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
  $14   $32   $30   $80 
Contingent consideration
   61    (19   94    (16
Restructuring
   35    (13)   92    69 
Other
   8    28    30    33 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $118   $28   $246   $165 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
(1)
Including impairments related to exit and disposal activities
activities.
35
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Impairments
Impairments of tangible assets for the three months ended June 30, 2022 and 2021 and 2020 were $32$14 million and $277 
$32 million, respectively. The impairment for the three months ended June 30, 2021 was mainly related to certain assets in Europe. The impairment for the three months ended June 30, 2020 was mainly related to the agreement to sell certain assets from Teva’s business venture in Japan, which was completed in February 2021.
Impairments of tangible assets for the six months ended June 30, 2022 and 2021 were $30 million and 2020 were $80 million, and $352 
respectively.
million, respectively. The impairment for the six months ended June 30, 2022 was mainly related to certain assets in North America. The impairment for the six months ended June 30, 2021 was mainly related to certain assets in Europe. The impairment for the six months ended June 30, 2020 was mainly related to the agreement to sell certain assets from Teva’s business venture in Japan, which was completed in February 2021 and plant rationalization. See note 2.
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 network consolidation
activities.
Contingent consideration
In the three months ended June 30, 2021,2022, Teva recorded incomean expense of $19$61 million for contingent consideration, compared to an expenseincome of $76 $19 
million in the three months ended June 30, 2020.2021. The expense in the second quarter of 2022 and the income in the second quarter of 2021 waswere mainly related to a changechanges in the estimated future royalty payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®Revlimid
®
), which was part of the Actavis Generics acquisition. The expense in the second quarter of 2020 was mainly related to a change in the estimated future royalty payments to Eagle Pharmaceuticals, Inc. (“Eagle”) in connection with expected future bendamustine sales.
In the six months ended June 30, 2021,2022, Teva recorded
income an expense of $16$94 million for contingent consideration, compared to an expenseincome of $83 
$16 million in the six months ended June 30, 2020.2021. The expense in the first six months of 2022
, and the income in the first six months of 2021 was were
mainly related to a change
s
in the estimated future royalty payments to Allergan in connection with lenalidomide (generic equivalent of Revlimid®Revlimid
®
), which was part of the Actavis Generics acquisition. The expense in the first six months of 2020 was mainly related
36

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to a change in the estimated future royalty payments to Eagle in connection with expected future bendamustine sales.Consolidated Financial Statements
(Unaudited)
Restructuring
In the three months ended June 30, 2021,2022, Teva recorded $35 million of restructuring expenses, compared to $13 million of restructuring
income compared to $33 
million of restructuring expenses
 in the three months ended June 30, 2020.2021.
The expenses for the three months
ended June 30, 2022 were primarily related to network consolidation activities and residual expenses of the restructuring plan announced in 2017. The income for the three months ended June 30, 2021 was primarily related to reassessment of the estimate of a prior employee termination provision.

In
In
the six months ended June 30, 2021,2022, Teva recorded $69$
92
 million of restructuring expenses, compared to $73$
69
 million in the six months ended June 30, 2020.2021. The expenses for the
six months ended June 30, 2022 and June 30, 2021 were primarily related to network consolidation activities and 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 June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Restructuring
          
Employee termination
  $(19  $3 
Other
   6    30 
   
 
 
   
 
 
 
Total
  $(13  $33 
   
 
 
   
 
 
 
3637


TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
   
Six months ended June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Restructuring
          
Employee termination
  $61   $36 
Other
   8    36 
   
 
 
   
 
 
 
Total
  $69   $73 
   
 
 
   
 
 
 
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, 2021
  $(115  $(7  $(122
Provision
   (61   (8   (69
Utilization and other*
   56    8    64 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2021
  $(120  $(7  $(127
   
 
 
   
 
 
   
 
 
 
   
Employee termination
costs
   
Other
   
Total
 
   
(U.S. $ in millions )
 
Balance as of January 1, 2020
  $(208  $(7  $(215
Provision
   (36   (36   (73
Utilization and other*
   114    36    150 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2020
  $(130  $(7  $(137
   
 
 
   
 
 
   
 
 
 
*
Includes adjustments for foreign currency translation.
Significant regulatory and other 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 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 it that the site continues to be classified as OAI. A subsequent FDA inspection in May 2021 concluded with five observations, which Teva addressed in its response. The response is pending with the FDA. If Teva is unable to remediate the findings to the FDA’s satisfaction, Teva may face additional consequences. These would potentially include continued 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 $46.3 million in revenues from this site during the remainder of 2021, 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.
37
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
The following tables provide the components of restructuring costs:
   
Three months ended June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Restructuring
          
Employee termination
  $11   $(19
Other
   24    6 
   
 
 
   
 
 
 
Total
  $35   $(13
   
 
 
   
 
 
 
   
Six months ended June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Restructuring
          
Employee termination
  $63   $61 
Other
   29    8 
   
 
 
   
 
 
 
Total
  $92   $69 
   
 
 
   
 
 
 
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, 2022
  $(131  $(7  $(138
Provision
   (63   (29   (92
Utilization and other*
   74    29    103 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2022
  $(120  $(7  $(127
   
 
 
   
 
 
   
 
 
 
   
Employee termination
costs
   
Other
   
Total
 
   
(U.S. $ in millions)
 
Balance as of January 1, 2021
  $(115  $(7  $(122
Provision
   (61   (8   (69
Utilization and other*
   56    8    64 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2021
  $(120  $(7  $(127
   
 
 
   
 
 
   
 
 
 
*
Includes adjustments for foreign currency translation.
Significant regulatory and other events
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 by Zhejiang Huahai Pharmaceuticals Co. Ltd. (“Huahai”). Since July 2018, Teva has been actively engaged with global regulatory authorities 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. In December 2019, Teva reached a settlement with Huahai resolving Teva’s claims related to certain sartan API supplied by Huahai. Under the settlement agreement, Huahai agreed to compensate Teva for some of
38

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
its direct losses and provide it with 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.
In the second quarter of 2020, Teva’s operations in its manufacturing facilities in Goa, India were temporarily suspended due to a water supply issue. During the second half of 2020, Teva completed partial remediation of this issue and restarted limited supply from its Goa facilities. The site experienced some additional delays in the first quarter of 2021 due to labor related issues, but the situation stabilized during the second quarter of 2021. The water supply remediation is expected to be completed during the third quarter of 2022, and in the meantime the site is operating under an interim water solution without any material impact expected on compliance and supply capacity. The impact to Teva’s financial results for the three and six months ended June 30, 20212022 was immaterial, however, if the full remediation takes longer than expected there may be further loss of sales, customer penalties or impairments to related assets.immaterial.
In June 2021, the Company temporarily paused manufacturing at its Irvine, California facility in the United States, and suspended release of product from the facility pending completion of an open manufacturing investigation. In July 2021, the FDA initiated an establishment inspection at the facility. During the inspection,On August 18, 2021, the Company opened additional investigations, and considered proactivelyissued field alert reports to suspend distribution of product fromthe FDA for products manufactured at the Irvine facility until completionand put Irvine manufactured products in Teva’s distribution center on hold. On August 20, 2021, the FDA completed its inspection and issued a Form
FDA-483
to the Irvine facility with ten observations and, on December 17, 2021, the FDA notified the Company that the inspection classification of these investigations.this site is “official action indicated” (“OAI”). Teva began working diligently to address the FDA’s concerns in a manner consistent with current good manufacturing practice (“CGMP”) requirements, and was in discussions with the FDA Drug Shortage Staff (DSS) and FDA Office of Manufacturing Quality (OMQ) to recommence distribution, release and manufacture of certain medically necessary products from the site under defined controls and protocols.
On March 22, 2022, the Company announced its decision to permanently cease all manufacturing activities and to close the site, and to transfer certain products to other facilities. Teva will remain in contact with FDA regarding the status of the Irvine, California site to ensure that the Company continues to managecomply with all relevant CGMP requirements, particularly those involved with product transfers to other sites within the ongoing FDA inspection, and will address any concerns raised by FDA. A decision to suspend distribution for an extended period or ifTeva network.
If Teva is unable to address additionalFDA inspection issues satisfactorily, it could be subject Teva to additional consequences.regulatory actions. Teva has considered these developments and, has notduring the six months ended June 30, 2022, recorded an impairment or other loss$73 million costs in theits financial statements.statements related to this matter. Teva will continue to assess potential financial implications, including due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and/or FDA enforcement actions.

NOTE 13 – Earnings (Loss) per share:
Basic earnings and loss per share are computed by dividing net resultsincome (loss) attributable to Teva’s ordinary shareholders by the weighted average number of ordinary shares outstanding, (includingincluding fully vested restricted share units (“RSUs”) and performance share units (“PSUs”) during the period, net of treasury shares.
In computing diluted loss per share for the three months ended June 30, 2022, 0 account was taken of the potential dilution that could occur upon the exercise of options and
non-vested
RSUs and PSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
In computing diluted earnings per share for the three months ended June 30, 2021, and June 30, 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.
NaN
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 six months ended June 30, 2022, 0 account was taken of the potential dilution that could occur upon the exercise of options and
non-vested
RSUs and PSUs granted under employee stock compensation plans, and convertible senior debentures, since they had an anti-dilutive effect on loss per share.
In computing diluted earnings per share for the six months ended June 30, 2021, and June 30, 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.
NaN
account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
Basic and diluted earnings per share were $
0.19
for the three months ended June 30, 2021, compared to basic and diluted earnings per share of $
0.13
for the three months ended June 30, 2020.
Basic and diluted earnings per share were
 
$
0.26
for the
six
months ended June 
30
,
2021
, compared to basic and diluted
earnings
per share of $
0.19
for the
six
months ended June 
30
,
2020
.
NOTE 14 – Accumulated other comprehensive income (loss):
The components of, and changes within, accumulated other com
p
rehensive income (loss) attributable to Teva are presented in the table below:39
   
Net Unrealized Gains (Losses)
  
Benefit Plans
    
   
Foreign
currency
translation
adjustments
  
Derivative
financial
instruments
  
Actuarial gains
(losses) and
prior service
(costs) credits
  
Total
 
   
(U.S. $ in millions)
 
Balance as of December 31, 2020, net of taxes
  
$
(1,919
 
$
(363
 
$
(117
 
$
(2,399
   
 
 
  
 
 
  
 
 
  
 
 
 
Other comprehensive income (loss) before reclassifications
   (77  —     —     (77
Amounts reclassified to the statements of income
   —     18   1   19 
   
 
 
  
 
 
  
 
 
  
 
 
 
Net other comprehensive income (loss) before tax
   (77  18   1   (58
   
 
 
  
 
 
  
 
 
  
 
 
 
Corresponding income tax
   15   (4  —     11 
   
 
 
  
 
 
  
 
 
  
 
 
 
Net other comprehensive income (loss) after tax*
   (62  14   1   (47
   
 
 
  
 
 
  
 
 
  
 
 
 
Balance as of June 30, 2021, net of taxes
  $(1,981 $(349 $(116 $(2,446
   
 
 
  
 
 
  
 
 
  
 
 
 
*
Amounts do not include a $68 million loss from foreign currency translation adjustments attributable to
non-controlling
interests.    
38
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
The weighted average diluted shares outstanding used for the fully diluted share calculations for the three months ended June 30, 2022, and 2021, were 1,110 and 1,109 shares, respectively.
The weighted average diluted shares outstanding used for the fully diluted share calculations for the six months ended June 30, 2022, and 2021, were 1,109 and 1,108 shares, respectively.
Basic and diluted loss per share was $0.21 for the three months ended June 30, 2022, compared to basic and diluted earnings per share of $0.19 for the three months ended June 30, 2021. Basic and diluted loss per share was $1.07 for the six months ended June 30, 2022, compared to basic and diluted earnings per share of $0.26 for the six months ended June 30, 2021.

NOTE 14 – Accumulated other comprehensive income (loss):
The components of, and changes within, accumulated other comprehensive income (loss) attributable to Teva are presented in the table below:
40

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
   
Net Unrealized Gains (Losses)
   
Benefit Plans
     
   
Foreign
currency
translation
adjustments
   
Derivative
financial
instruments
   
Actuarial gains
(losses) and
prior service
(costs) credits
   
Total
 
   
(U.S. $ in millions)
 
Balance as of December 31, 2021, net of taxes
  $(2,274  $(324  $(85  $(2,683
   
 
 
   
 
 
   
 
 
   
 
 
 
Other comprehensive income (loss) before reclassifications
   (127   —      —      (127
Amounts reclassified to the statements of income
   —      14         14 
   
 
 
   
 
 
   
 
 
   
 
 
 
Net other comprehensive income (loss) before tax
   (127   14    —      (113
   
 
 
   
 
 
   
 
 
   
 
 
 
Corresponding income tax
   (5   —      —      (5
   
 
 
   
 
 
   
 
 
   
 
 
 
Net other comprehensive income (loss) after tax*
   (132   14    —      (118
   
 
 
   
 
 
   
 
 
   
 
 
 
Balance as of June 30, 2022, net of taxes
  $(2,406  $(310  $(85  $(2,801
   
 
 
   
 
 
   
 
 
   
 
 
 
*
Amounts do not include a $150 million loss from foreign currency translation adjustments attributable to
non-controlling
interests. 
 
  
Net Unrealized Gains (Losses)
 
Benefit Plans
     
Net Unrealized Gains (Losses)
   
Benefit Plans
     
  
Foreign
currency
translation
adjustments
 
Derivative
financial
instruments
 
Actuarial gains
(losses) and
prior service
(costs) credits
 
Total
   
Foreign
currency
translation
adjustments
   
Derivative
financial
instruments
   
Actuarial gains
(losses) and
prior service
(costs) credits
   
Total
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Balance as of December 31, 2019, net of taxes
  $(1,794 $(420 $(98 $(2,312
Balance as of December 31, 2020, net of taxes
  $(1,919  $(363  $(117  $(2,399
  
 
  
 
  
 
  
 
   
 
   
 
   
 
   
 
 
Other comprehensive income (loss) before reclassifications
   (432 19   —    (413   (77      —      (77
Amounts reclassified to the statements of income
   —    18   —    18    —      18    1    19 
  
 
  
 
  
 
  
 
   
 
   
 
   
 
   
 
 
Net other comprehensive income (loss) before tax
   (432 37   —    (395   (77   18    1    (58
  
 
  
 
  
 
  
 
   
 
   
 
   
 
   
 
 
Corresponding income tax
   4   —     —    4    15    (4   —      11 
  
 
  
 
  
 
  
 
   
 
   
 
   
 
   
 
 
Net other comprehensive income (loss) after tax*
   (428 37   —    (391   (62   14    1    (47
  
 
  
 
  
 
  
 
   
 
   
 
   
 
   
 
 
Balance as of June 30, 2020, net of taxes
  $(2,222 $(383 $(98 $(2,703
Balance as of June 30, 2021, net of taxes
  $(1,981  $(349  $(116  $(2,446
  
 
  
 
  
 
  
 
   
 
   
 
   
 
   
 
 
*
Amounts do not include a $12 
$68 million gain
loss from foreign currency translation adjustments attributable to
non-controlling
interests.
​​​​​​​
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, the United Kingdom and certain other European countries.
 
 (c)
International Markets segment, which includes all countries other than those in the North Amer
i
caAmerica and Europe segments.
In addition to these three segments,3segments, 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.
41

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Segment profit is comprised of gross profit for the segment less R&D expenses, S&M expenses, G&A expenses and other income related to the segment. Segment profit does not include amortization and certain other items.
Teva manages its assets on a company basis, not by segments, as many of its assets are shared or commingled. Teva’s CODM does not regularly review asset information by reportable segment and, therefore, Teva does not report asset information by reportable segment.
Teva’s
 CEO may review its strategy and organizational structure from time to 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 3 and note 6.
3942

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
a. Segment information:
Seg
ment
information:
   
Three months ended June 30,
 
   
2021
 
   
North America
   
Europe
   
International Markets
 
   
(U.S. $ in millions)
 
Revenues
  $1,943   $1,184   $485 
Gross profit
   1,040    661    270 
R&D expenses
   162    63    18 
S&M expenses
   255    209    105 
G&A expenses
   106    47    25 
Other income
   (5       (1
   
 
 
   
 
 
   
 
 
 
Segment profit
  $521   $343   $123 
   
 
 
   
 
 
   
 
 
 
 
   
Three months ended June 30,
 
   
2022
 
   
North America
   
Europe
   
International Markets
 
   
(U.S. $ in millions)
 
Revenues
  $1,904   $1,171   $454 
Gross profit
   1,010    703    242 
R&D expenses
   147    56    19 
S&M expenses
   256    196    99 
G&A expenses
   127    63    30 
Other income
   (1   (1   (1
   
 
 
   
 
 
   
 
 
 
Segment profit
  $481   $389   $95 
   
 
 
   
 
 
   
 
 
 
   
Three months ended June 30,
 
   
2021
 
   
North America
   
Europe
   
International Markets
 
   
(U.S. $ in millions)
 
Revenues
  $1,943   $1,184   $485 
Gross profit
   1,040    661    270 
R&D expenses
   162    63    18 
S&M expenses
   255    209    105 
G&A expenses
   106    47    25 
Other income
   (5   §    (1
   
 
 
   
 
 
   
 
 
 
Segment profit
  $521   $343   $123 
   
 
 
   
 
 
   
 
 
 
§ Represents an amount less than $1$0.5 million.
 
   
Three months ended June 30,
 
   
2020
 
   
North America
   
Europe
   
International Markets
 
   
(U.S. $ in millions)
 
Revenues
  $2,047   $1,001   $488 
Gross profit
   1,090    548    247 
R&D expenses
   154    65    19 
S&M expenses
   254    188    105 
G&A expenses
   110    52    29 
Other income
   (2   (1   (2
   
 
 
   
 
 
   
 
 
 
Segment profit
  $573   $244   $97 
   
 
 
   
 
 
   
 
 
 
43
   
Six months ended June 30,
 
   
2021
 
   
North America
   
Europe
   
International Markets
 
   
(U.S. $ in millions)
 
Revenues
  $3,932   $2,398   $975 
Gross profit
   2,114    1,349    530 
R&D expenses
   322    129    35 
S&M expenses
   483    424    201 
G&A expenses
   218    117    51 
Other income
   (7   (1   (3
  
 
 
   
 
 
   
 
 
 
Segment profit
  $1,098   $680   $245 
  
 
 
   
 
 
   
 
 
 
40

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)

   
Six months ended June 30,
 
   
2022
 
   
North America
   
Europe
   
International Markets
 
   
(U.S. $ in millions)
 
Revenues
  $3,641   $2,327   $946 
Gross profit
   1,899    1,397    528 
R&D expenses
   289    114    39 
S&M expenses
   501    393    196 
G&A expenses
   239    122    60 
Other income
   (12   (1   (41
   
 
 
   
 
 
   
 
 
 
Segment profit
  $883   $769   $274 
   
 
 
   
 
 
   
 
 
 
 
  
Six months ended June 30,
   
Six months ended June 30,
 
  
2020
   
2021
 
  
North America
   
Europe
   
International Markets
   
North America
   
Europe
   
International Markets
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Revenues
  $4,129   $2,404   $1,053   $3,932   $2,398   $975 
Gross profit
   2,152    1,371    552    2,114    1,349    530 
R&D expenses
   300    120    34    322    129    35 
S&M expenses
   505    390    211    483    424    201 
G&A expenses
   228    118    63    218    117    51 
Other income
   (4   (2   (8   (7   (1   (3
  
 
   
 
   
 
   
 
   
 
   
 
 
Segment profit
  $1,123   $746   $253   $1,098   $680   $245 
  
 
   
 
   
 
   
 
   
 
   
 
 
The following table presents a reconciliation of Teva’s segment profits to its consolidated operating income (loss) and to consolidated income (loss) before income taxes for the three and six months ended June 30, 20212022 and 2020:2021:
 
.
  
Three months ended
   
Six months ended
 
   
June 30,
   
June 30,
 
   
2021
   
2020
   
2021
   
2020
 
   
(U.S. $ in millions)
   
(U.S. $ in millions)
 
North America profit
  $521   $573   $1,098   $1,123 
Europe profit
   343    244    680    746 
International Markets profit
   123    97    245    253 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total reportable segments profit
   987    914    2,023    2,121 
Profit of other activities
   47    66    87    102 
   
 
 
   
 
 
   
 
 
   
 
 
 
Total segments profit
   1,034    979    2,111    2,223 
Amounts not allocated to segments:
                    
Amortization
   173    249    414    507 
Other assets impairments, restructuring and other items
   28    381    165    502 
Goodwill impairment
   —      —      —      —   
Intangible asset impairments
   195    120    274    768 
Legal settlements and loss contingencies
   6    13    110    (12
Other unallocated amounts
   50    44    132    93 
   
 
 
   
 
 
   
 
 
   
 
 
 
Consolidated operating income (loss)
   582    173    1,015    364 
   
 
 
   
 
 
   
 
 
   
 
 
 
Financial expenses, net
   274    223    564    448 
   
 
 
   
 
 
   
 
 
   
 
 
 
Consolidated income (loss) before income taxes
  $308   $(51  $451   $(84
   
 
 
   
 
 
   
 
 
   
 
 
 
44

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
 
   
Three months ended

June 30,
   
Six months ended

June 30,
 
   
2022
   
2021
   
2022
   
2021
 
   
(U.S. $ in millions)
   
(U.S. $ in millions)
 
North America profit
 
$
 
481
  $521  $883   $1,098 
Europe profit
  
389
   
343
   769    680 
International Markets profit
  
95
   
123
   274    245 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total reportable segments profit
  
964
   
987
   1,926    2,023 
Profit of other activities
  
55
   
47
   107    87 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Total segments profit
  1,019   
1,034
   2,032    2,111 
Amounts not allocated to segments:
                 
Amortization
  
212
   
173
   412    414 
Other assets impairments, restructuring and other items
  
118
   
28
   246    165 
Goodwill impairment
  
745
      745      
Intangible assets impairments
  
51

   
195
   199    274 
Legal settlements and loss contingencies
  
729

   
6

   1,854    110 
Other unallocated amounts
  
113

   
50
   240    132 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated operating income (loss)
  
(949

)

  
582
   (1,662   1,015 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Financial expenses, net
  
211

   
274
   468    564 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Consolidated income (loss) before income taxes
 
$
(1,160
)
 
 
$
308
  $(2,131  $451 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
41

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
b. Segment revenues by major products and activities:
The following tables present revenues by major products and activities for the th
r
eethree and six months ended June 30, 20212022 and 2020:
North America
  
Three months ended

June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Generic products
  $951   $923 
AJOVY
   46    34 
AUSTEDO
   174    161 
BENDEKA
®
/TREANDA
®
   106    103 
COPAXONE
   152    238 
ProAir
®
*
   55    66 
Anda
   316    374 
Other
   144    147 
   
 
 
   
 
 
 
Total
  $1,943   $2,047 
   
 
 
   
 
 
 
*
Does not include revenues from the ProAir authorized generic, which are included under generic products.
North America
  
Six months ended
June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Generic products
  $2,004   $1,875 
AJOVY
   77    63 
AUSTEDO
   320    283 
BENDEKA/TREANDA
   197    208 
COPAXONE
   315    435 
ProAir*
   109    125 
Anda
   605    800 
Other
   305    338 
   
 
 
   
 
 
 
Total
  $3,932   $4,129 
   
 
 
   
 
 
 
*
Does not include revenues from the ProAir authorized generic, which are included under generic products.
2021:
Europe
  
Three months ended

June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions)
 
Generic products
  $878   $737 
AJOVY
   19    5 
COPAXONE
   100    84 
Respiratory products
   85    80 
Other
   102    95 
   
 
 
   
 
 
 
Total
  $1,184   $1,001 
   
 
 
   
 
 
 
 
4245

Table of Contents
TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(
Unaudited)
North America
  
Three months ended

June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Generic products
  $1,026   $951 
AJOVY
   49    46 
AUSTEDO
   204    174 
BENDEKA®/TREANDA®
   83    106 
COPAXONE
   94    152 
Anda
   308    316 
Other
   139    199 
   
 
 
   
 
 
 
Total
  $1,904   $1,943 
   
 
 
   
 
 
 
North America
  
Six months ended
June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Generic products
  $1,925   $2,004 
AJOVY
   86    77 
AUSTEDO
   358    320 
BENDEKA/TREANDA
   165    197 
COPAXONE
   180    315 
Anda
   650    605 
Other
   278    414 
   
 
 
   
 
 
 
Total
  $3,641   $3,932 
   
 
 
   
 
 
 

Europe
  
Three months ended

June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Generic products
  $873   $878 
AJOVY
   29    19 
COPAXONE
   72    100 
Respiratory products
   65    85 
Other
   131    102 
   
 
 
   
 
 
 
Total
  $1,171   $1,184 
   
 
 
   
 
 
 
46

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
Europe
  
Six months ended
June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Generic products
  $1,749   $1,742 
AJOVY
   60    35 
COPAXONE
   144    201 
Respiratory products
   137    179 
Other
   238    242 
   
 
 
   
 
 
 
Total
  $2,327   $2,398 
   
 
 
   
 
 
 
 
Europe
  
Six months ended
June 30,
 
International markets
  
Three months ended

June 30,
 
  
2021
   
2020
   
2022
   
2021
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Generic products
  $1,742   $1,769   $394   $407 
AJOVY
   35    9    10    5 
COPAXONE
   201    193    9    7 
Respiratory products
   179    186 
Other
   242    246    40    65 
  
 
   
 
   
 
   
 
 
Total
  $2,398   $2,404   $454   $485 
  
 
   
 
   
 
   
 
 
 
International markets
  
Three months ended

June 30,
 
   
2021
   
2020
 
   
(U.S. $ in
 
millions)
 
Generic products
  $407   $426 
COPAXONE
   7    12 
Other
   71    50 
   
 
 
   
 
 
 
Total
  $485   $488 
   
 
 
   
 
 
 
International markets
  
Six months ended
June 30,
 
   
2021
   
2020
 
   
(U.S. $ in
 
millions)
 
Generic products
  $799   $875 
COPAXONE
   19    23 
Other
   157    154 
   
 
 
   
 
 
 
Total
  $975   $1,053 
   
 
 
   
 
 
 
43
International markets
  
Six months ended
June 30,
 
   
2022
   
2021
 
   
(U.S. $ in millions)
 
Generic products
  $782   $799 
AJOVY
   16    7 
COPAXONE
   20    19 
Other
   128    150 
   
 
 
   
 
 
 
Total
  $946   $975 
   
 
 
   
 
 
 

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
NOTE 16 – Fair value measurement:
Financial items carried at fair value on a recurring basis as of June 30, 20212022 and December 31, 20202021 are classified in the tables below in one of the three categories of fair value levels:
 
   
June 30, 2021
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
   
(U.S. $ in millions)
 
Cash and cash equivalents:
                    
Money markets
  $278   $—     $—     $278 
Cash, deposits and other
   2,158    —      —      2,158 
Investment in securities:
                    
Equity securities*
   35    —      —      35 
Other, mainly debt securities
   5    —      1    6 
Derivatives:
                    
Asset derivatives—options and forward contracts
   —      30    —      30 
Liability derivatives—options and forward contracts
   —      (25   —      (25
Contingent consideration**
   —      —      (205   (205
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $2,476   $5   $(204  $2,277 
   
 
 
   
 
 
   
 
 
   
 
 
 
47

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
   
June 30, 2022
 
   
Level 1
   
Level 2
   
Level 3
   
Total
 
   
(U.S. $ in millions)
 
Cash and cash equivalents:
                    
Money markets
  $451   $—     $—     $451 
Cash, deposits and other
   1,607    —      —      1,607 
Investment in securities:
                    
Equity securities
   10    —      —      10 
Other
   5    —      1    6 
Restricted cash
   33    —      —      33 
Derivatives:
                    
Asset derivatives—options and forward contracts
   —      69    —      69 
Liability derivatives:
                    
Options and forward contracts
   —      (37   —      (37
Bifurcated embedded derivatives
   —      —      §    —   
Contingent consideration*
   —      —      (205   (205
   
 
 
   
 
 
   
 
 
   
 
 
 
Total
  $2,106   $32   $(204  $1,934 
   
 
 
   
 
 
   
 
 
   
 
 
 
 
  
December 31, 2020
   
December 31, 2021
 
  
Level 1
   
Level 2
   
Level 3
   
Total
   
Level 1
   
Level 2
   
Level 3
   
Total
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Cash and cash equivalents:
                        
Money markets
  $367   $—     $—     $367   $220   $—     $—     $220 
Cash, deposits and other
   1,810    —      —      1,810    1,945    —      —      1,945 
Investment in securities:
                        
Equity securities*
   25    259    —      284 
Other, mainly debt securities
   5    —      10    15 
Equity securities
   18    —      —      18 
Other
   6    —      1    7 
Restricted cash
   33    —      —      33 
Derivatives:
                        
Asset derivatives—options and forward contracts
   —      24    —      24    —      30    —      30 
Liability derivatives—options and forward contracts
   —      (79   —      (79
Contingent consideration**
   —      —      (268   (268
Liability derivatives:
            
Options and forward contracts
   —      (23   —      (23
Bifurcated embedded derivatives
   —      —      §    —   
Contingent consideration*
  $—      —      (176   (176
  
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
 
Total
  $2,207   $204   $(258  $2,153    2,222   $7   $(175  $2,054 
  
 
   
 
   
 
   
 
   
 
   
 
   
 
   
 
 
 
*§During the first quarter of 2021, Teva’s shares in American Well Corporation (“American Well”) moved from a Level 2 measurement to a Level 1 measurement within the fair value hierarchy, since they are no longer subject to a sale restriction. As of June 30, 2021, Teva sold most of its holdings in American Well, and subsequently sold its remaining holdings.
Represents an amount less than $0.5 million.
**
Contingent consideration represents liabilities recorded at fair value in connection with acquisitions.
Teva determined the fair value of the liabilities 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 90% toof 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 7.5%8.3% to 7.8%11.2%. The weighted average discount rate, calculated based on the relative fair value of Teva’s contingent consideration liabilities, was 7.7%8.8%. The contingent
48

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
consideration is evaluated quarterly, or more frequently, if circumstances dictate. Changes in the fair value of contingent consideration are recorded in consolidated statements of income. Significant changes in unobservable inputs, mainly the probability of success and cash flows projected, could result in material changes to the contingent
consideration liabilities.
44

TEVA PHARMACEUTICAL INDUSTRIES LIMITED
Notes to Consolidated Financial Statements
(Unaudited)
The following table summarizes the activity for those financial assets and liabilities where fair value measurements are estimated utilizing Level 3 inputs:
 
   
Six months ended
June 30, 2021
   
Six months ended
June 30, 2020
 
   
(U.S. $ in millions)
 
Fair value at the beginning of the period
  $(258   (448
Redemption of debt securities
   (9   —   
Revaluation of debt securities
   —      1 
Adjustments to provisions for contingent consideration:
          
Actavis Generics transaction
   22    (15
Eagle transaction
   (7   (67
Settlement of contingent consideration:
          
Eagle transaction
   48    58 
   
 
 
   
 
 
 
Fair value at the end of the period
  $(204  $(471
   
Six months
ended June 30,
2022
   
Six months
ended
June 30,
2021
 
   
(U.S. $ in millions)
 
Fair value at the beginning of the period
  $(175   (258
Redemption of debt securities
   —      (9
Bifurcated embedded derivatives
   §    —   
Adjustments to provisions for contingent consideration:
          
Actavis Generics transaction
   (92   22 
Eagle transaction
   (2   (7
Settlement of contingent consideration:
          
Actavis Generics transaction
   30    —   
Eagle transaction
   46    48 
Additional contingent consideration resulting from Novetide acquisition*
   (11   —   
   
 
 
   
 
 
 
Fair value at the end of the period
  $(204  $(204
   
 
 
   
 
 
 
§
Represents an amount less than $0.5 million.
*
In January 2022, Teva acquired 100% ownership of Novetide Ltd. (“Novetide”), which was previously accounted for as “investment in associated
companies.” This
 transaction was accounted for as a business combination. Total consideration for the transaction included cash and certain contingent royalty payments through 2034. As part of the transaction, Teva recognized a gain under “Share in (profits) losses of associated companies, net”, reflecting the difference between the book value of its investment in Novetide and its fair value as of the date Teva completed its acquisition.
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 (see note 7) and are presented in the table below in terms of fair value (level 1 inputs):
 
  
Estimated fair value*
   
Estimated fair value*
 
  
June 30,
   
December 31,
   
June 30,
   
December 31,
 
  
2021
   
2020
   
2022
   
2021
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
Senior notes included under senior notes and loans
  $21,449   $22,684 
Senior notes and sustainability-linked senior notes included under senior notes and loans
  $17,481   $21,477 
Senior notes and convertible senior debentures included under short-term debt
   3,548    3,207    1,702    1,426 
  
 
   
 
   
 
   
 
 
Total
  $24,997   $25,891   $19,183   $22,903 
  
 
   
 
   
 
   
 
 
 
*
The fair value was estimated based on quoted market prices.
 
4549

Table of Contents
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 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 API to third parties, certain contract manufacturing services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis.
The
COVID-19
Pandemic
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.
During the second quarter of 2021,2022, we have not experienced material delays in development,the production and distribution of medicinesmedicines. The
COVID-19
pandemic has had an effect on our suppliers, which led to minimal delays or disruptions in our supply chains. Thematerials supply. However, the supply chain supporting our key products – specialty, generics and API – remains largely uninterrupted, with adequate product inventory across our network and redundancy plans in place to address potential shortfalls, if any. All ourOur facilities that research, manufacture, order, pack, distribute and provide critical customer and patient services remain largely uninterrupted as well, and are currently functioning to meet demand for essential medicines for patients throughout the world.
We did not have and do not expect to have a material impact on our ongoing clinical research programs and product launches as a result of the
COVID-19
pandemic; however, duringDuring the second quarter of 2021,2022, we have experienced minimal delays in some clinical trials due to cessation or slow-downs of recruitment for patient studies and suspended regulatory inspections, raw material supply issues, delays in regulatory approvals of new products due to reduced capacity or
re-prioritization
of regulatory agencies and delays in
pre-commercial
launch activities. We may experience further delays if the pandemic continues for an extended period of time. Alltime, including as a result of ourthe emergence of new product launches have been risk-assessed based on upcoming manufacturing and regulatory inspections.
COVID-19
variants.
The long-term effects of the pandemic 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. In the first quarter of 2020, we experienced increasing demand for certain medicines, as would be expected during a global crisis of this nature. We saw a compensating effect with lower demand for certain medicines during the second quarter of 2020 and continuing slightly lower demand due to less physician and hospital activity in certain regions and for certain medicines in the second half of 2020. 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 continue to see variable demand during the remainder of 2021. While
COVID-19
continues to impact sales in certain markets and for certain products, wefuture periods. We do not currently anticipate that the ongoing
COVID-19
pandemic will have a material negative impact on our 20212022 financial results due to the ongoing global pandemic.results.
46

Highlights
Significant highlights in the second quarter of 20212022 included:
 
Revenues in the second quarter of 20212022 were $3,910$3,786 million, an increase of 1%, or a decrease of 2% in local currency terms,3% compared to the second quarter of 2020,2021, or an increase of 1% in local currency terms. This increase in local currency terms was mainly due to lower revenues in our North America segment, mainly related to COPAXONE and Anda, partially offset by positive foreign currency impacts as well as higher revenues from generic products OTC, AJOVY and COPAXONE in our Europe segment. Revenues were also affectedand North America segments, partially offset by changeslower revenues from COPAXONE and BENDEKA/TREANDA in demand for certain products resulting from the impact of the
COVID-19our North America segment.
pandemic.
 
50

Our North America segment generated revenues of $1,943$1,904 million and profit of $521$481 million in the second quarter of 2021.2022. Revenues decreased by 5%2% compared to the second quarter of 2020, mainly due to a decrease in revenues from COPAXONE and Anda, partially offset by higher revenues from generic products, AUSTEDO and AJOVY. Our North America segment has experienced some reductions in volume due to less physician and hospital activity during the
COVID-19
pandemic, but has also experienced increase in demand for certain products related to the treatment of
COVID-19
and its symptoms. In addition, the ability to promote certain specialty products has been impacted by less physician visits by patients and less physician interactions by our sales personnel.2021. Profit decreased by 9%8% compared to the second quarter of 2020, mainly due to lower gross profit, as well as higher R&D expenses.2021.
 
Our Europe segment generated revenues of $1,184$1,171 million and profit of $343$389 million in the second quarter of 2021.2022. Revenues decreased by 1% in U.S. dollars, but increased by 18%, or 8% in local currency terms compared to the second quarter of 2020. This increase was mainly due2021. Profit increased by 13% compared to changed buying patterns in the second quarter of 2020 as a result of significant customer stocking due to the
COVID-192021.
pandemic in March 2020, and a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the second quarter of 2020. Profit increased by 41%, mainly due to higher revenues.
 
Our International Markets segment generated revenues of $485$454 million and profit of $123$95 million in the second quarter of 2021.2022. Revenues decreased by 1%, or6% in U.S. dollars, but increased by 3% in local currency terms, compared to the second quarter of 2020, mainly due2021. Profit decreased by 23% compared to lowerthe second quarter of 2021.
Our revenues in Japan resulting from the divestment of the majority of the generic and operational assets of our Japanese business venture, as well as regulatory price reductions and generic competition to
off-patented
products in Japan and a negative impact from hedging activity, partially offset by higher revenues in most other markets as well as lower revenues in certain marketsactivities in the second quarter of 2020 resulting from reduced demand due2022 were $257 million, a decrease of 14% compared to the impact the
COVID-19
pandemic had on purchasing patterns. Profit increasedsecond quarter of 2021. In local currency terms, revenues decreased by 27%, mainly due10% compared to the divestment in Japan mentioned above and a change in product portfolio mix.second quarter of 2021.
Exchange rate movements during the second quarter of 2022, net of hedging effects, negatively impacted revenues by $162 million, compared to the second quarter of 2021. See note 8d to our consolidated financial statements.
 
Impairments of identifiable intangible assets were $51 million in the second quarter of 2022, compared to $195 million in the second quarter of 2021, compared to $120 million in the second quarter of 2020.2021. See note 5 to our consolidated financial statements.
 
NoWe recorded a goodwill impairments were recordedimpairment charge of $745 million in the second quartersquarter of both 20212022, of which $479 million is related to our International Markets reporting unit and 2020.$266 million is related to Teva’s API reporting unit. See note 6 to our consolidated financial statements.
 
We recorded expenses of $118 million for other asset impairments, restructuring and other items in the second quarter of 2022, compared to expenses of $28 million in the second quarter of 2021, compared to expenses of $381 million in the second quarter of 2020.2021. See note 12 to our consolidated financial statements.
 
Legal settlements and loss contingencies expenses were $729 million in the second quarter of 2022, compared to $6 million in the second quarter of 2021, compared to $13 million in the second quarter of 2020.2021. See note 9 to our consolidated financial statements.
 
Operating loss was $949 million in the second quarter of 2022, compared to an operating income wasof $582 million in the second quarter of 2021, compared to $173 million in the second quarter of 2020. This increase was mainly due to lower other assets impairments, restructuring and other items charges and higher profit in our Europe segment, partially offset by higher intangible asset impairment charges.2021.
 
Financial expenses were $211 million in the second quarter of 2022, compared to $274 million in the second quarter of 2021, compared to $223 million in the second quarter of 2020. Financial expenses in the second quarter of 2021 were mainly comprised of interest expenses of $240 million and loss on revaluations of marketable securities of $34 million (see note 16 to our consolidated financial statements). Financial expenses in the second quarter of 2020 were mainly comprised of interest expenses of $241 million.2021.
 
In the second quarter of 2022, we recognized a tax benefit of $900 million, on
pre-tax
loss of $1,160 million. In the second quarter of 2021, we recognized a tax expense of $98 million, on
pre-tax
income of $308 million. In the second quarter of 2020, we recognized a tax benefit of $104 million, on
pre-tax
loss of $51 million. Our tax rate for the second quarter of 2021 was mainly affected by impairments, amortization and interest expense disallowance.
47

Exchange rate movements during the second quarter of 2021, including hedging effects, positively impacted revenues by $135 million and operating income by $26 million, comparedSee note 11 to the second quarter of 2020.
our consolidated financial statements.
 
As of June 30, 2021,2022, our debt was $25,132$22,082 million, compared to $24,986$23,043 million as of MarchDecember 31, 2021. This increasedecrease was mainly due to $680 million from exchange rate fluctuations. In July 2021, we repaid $1,475fluctuations and $296 million of our 2.2% senior notes repaid at maturity. During July 2021, $500 million was drawn down under the RCF.
 
Cash flow generated from operating activities during the second quarter of 20212022 was $218$123 million, compared to $273$218 million in the second quarter of 2020. The2021. This decrease was mainly due to payments related to legal settlements in the second quarter of 2021 was mainly due to favorable collection of payments from customers2022, partially offset by an increase in the second quarter of 2020, which resulted from increased sales in the first quarter of 2020.accounts payables.
 
During the second quarter of 2022, we generated free cash flow of $301 million, which we define as comprising: $123 million in cash flow generated from operating activities, $287 million in beneficial interest collected in exchange for securitized accounts receivables and $18 million in proceeds from divestitures of businesses and other assets, partially offset by $127 million in cash used for capital investment. During the second quarter of 2021, we generated free cash flow of $625 million, which we define as comprising $218 million in cash flow generated from operating activities, $405 million in beneficial interest collected in exchange for securitized accounts receivables and $115 million in proceeds from divestitures of businesses and other assets, partially offset by $113 million in cash used for capital investment. During the second quarter of 2020, we generated free cash flow of $582 million, comprising $273 million in cash flow generated from operating activities, $401 million in beneficial interest collected in exchange for securitized accounts receivables and $39 million in proceeds from sale of property, plant and equipment and intangible assets, partially offset by $131 million in cash used for capital investment.million. The increasedecrease in the second quarter of 2021,2022 resulted mainly from higher proceeds from divestitures of businesses and other assets, partially offset by lower cash flow from operating activities.activities as well as lower proceeds from sales of assets.
51

Results of Operations
Comparison of Three Months Ended June 30, 20212022 to Three Months Ended June 30, 20202021
Segment Information
North America Segment
The following table presents revenues, expenses and profit for our North America segment for the three months ended June 30, 20212022 and 2020:2021:
 
  
Three months ended June 30,
   
Three months ended June 30,
 
  
2021
 
2020
   
2022
 
2021
 
  
(U.S. $ in millions / % of Segment
Revenues)
   
(U.S. $ in millions / % of Segment
Revenues)
 
Revenues
  $1,943    100 $2,047    100  $1,904    100 $1,943    100
Gross profit
   1,040    53.5 1,090    53.3   1,010    53.0  1,040    53.5
R&D expenses
   162    8.4 154    7.5   147    7.7  162    8.4
S&M expenses
   255    13.1 254    12.4   256    13.4  255    13.1
G&A expenses
   106    5.5 110    5.4   127    6.7  106    5.5
Other income
   (5   §  (2   §    (1   §   (5   § 
  
 
   
 
  
 
   
 
   
 
   
 
  
 
   
 
 
Segment profit*
  $521    26.8 $573    28.0  $481    25.3 $521    26.8
  
 
   
 
  
 
   
 
   
 
   
 
  
 
   
 
 
 
*
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 second quarter of 20212022 were $1,943$1,904 million, a decrease of $104$39 million, or 5%2%, compared to the second quarter of 2020,2021, mainly due to a decrease in revenues from COPAXONE and Anda,BENDEKA/TREANDA, partially offset by higher revenues from generic products, AUSTEDO and AJOVY. Our North America segment has experienced some reductions in volume due to less physician and hospital activity during the
COVID-19
pandemic, but has also experienced increase in demand for certain products related to the treatment of
COVID-19
and its symptoms. In addition, the ability to promote certain specialty products has been impacted by less physician visits by patients and less physician interactions by our sales personnel.
products.
48

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 June 30, 20212022 and 2020:2021:
 
  
Three months

ended

June 30,
   
Percentage

Change
   
Three months ended

June 30,
   
Percentage

Change
 
  
2021
   
2020
   
2020-2021
   
2022
   
2021
   
2022-2021
 
  
(U.S. $ in millions)
       
(U.S. $ in millions)
     
Generic products
  $951   $923    3  $1,026   $951    8
AJOVY
   46    34    32   49    46    9
AUSTEDO
   174    161    8   204    174    17
BENDEKA/TREANDA
   106    103    3   83    106    (22%) 
COPAXONE
   152    238    (36%)    94    152    (38%) 
ProAir*
   55    66    (16%) 
Anda
   316    374    (16%)    308    316    (2%) 
Other
   144    147    (2%)    139    199    (30%) 
  
 
   
 
     
 
   
 
   
Total
  $1,943   $2,047    (5%)   $1,904   $1,943    (2%) 
  
 
   
 
     
 
   
 
   
 
*
52

Does not include revenues from the ProAir authorized generic, which are included under generic products.
Generic products
revenues in our North America segment (including biosimilars) in the second quarter of 20212022 were $951$1,026 million, an increase of 3%8% compared to the second quarter of 2020,2021, mainly due to higher revenues from epinephrine injectable solutionlenalidomide capsules (the generic equivalentversion of EpiPen
®
and EpiPen Jr.Revlimid
®
), Truxima (the biosimilar to Rituxan
®
) and ProAir
®
authorized generic, partially offset by lower volumeincreased competition and pricingloss of other generic products.revenues due to the closure of the Irvine, CA site.
Among the most significant generic products we sold in North America in the second quarter of 20212022 were lenalidomide capsules (the generic version of Revlimid
®
), Truxima (the
®
(the biosimilar to Rituxan
®
), epinephrine injectable solution (the generic equivalent of EpiPen
®
and EpiPen Jr.
®
), and albuterol sulfate inhalation aerosol (our ProAir
®
authorized generic) and lidocaine transdermal patch (the generic equivalent of Lidoderm Patch
®
).
In the second quarter of 2021,2022, our total prescriptions were approximately 314302 million (based on trailing twelve months), representing 8.8%8.2% of total U.S. generic prescriptions according to IQVIA data.
On March 7, 2022, we announced the launch of the first generic version of Revlimid
®
 (lenalidomide capsules), in 5mg, 10mg, 15mg, and 25mg strengths, in the United States. These lenalidomide capsules are a prescription medicine used in adults for the treatment of (i) multiple myeloma in combination with the medicine dexamethasone, (ii) certain myelodysplastic syndromes, and (iii) mantle cell lymphoma following specific prior treatment.
AJOVY
revenues in our North America segment in the second quarter of 20212022 increased by 32%9% to $46$49 million, compared to the second quarter of 2020,2021, mainly due to growth in volume. In the second quarter of 2021,2022, AJOVY’s exit market share in the United StatedStates in terms of total number of prescriptions was 21.2%,24.4% compared to 16.1%20.7% in the second quarter of 2020.2021.
AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY was launched in the U.S. in 2018, and was approved in Canada in April 2020. Our auto-injector device for AJOVY became commercially available in the U.S. in April 2020 and in Canada in April 2021. AJOVY is the only anti-CGRP product indicated for quarterly treatment and in January 2021, we launched a new product offering, providing a quarterly dose.
AJOVY is protected by patents expiring in 2026 in Europe and in 2027 in the United States. Applications for patent term extensions have been submitted in various markets around the world, and certain extensions in Europe and other countries have already been granted until 2031. Additional patents relating to the use of AJOVY in the treatment of migraine have also been issued in the United States and will expire inbetween 2035 and 2037.2039. Such patents are also pending in other countries. AJOVY will also be protected by regulatory exclusivity for 12 years from marketing approval in the United States and 10 years from marketing approval in Europe. We 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 then submitted IPR (interinter partes review)review (“IPR”) petitions to the Patent Trial and Appeal Board (“PTAB”), challenging the validity of the nine patents asserted against it in the litigation.
49

The litigation in the district court was stayed pending resolution of the IPR petitions. On February 18, 2020, the Patent Trial and Appeal BoardPTAB issued decisions on the first six IPRs, finding the six composition of matter 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 (“PTAB”)PTAB issued a decision upholding the three method of treatment patents and on June 1, 2020, Lilly filed notices of appeal in connection withpatents. On August 16, 2021 the decisions on these three patents. The Court of Appeals for the Federal Circuit heard oral argument foraffirmed all of the IPR appeals on June 7, 2021 and we await thosePTAB’s decisions. The litigation stay ended followingis proceeding as to the IPR decisions by the PTAB,three method of treatment patents and the parties are proceeding with the litigation.trial is expected in October 2022. We also filed another suit against Lilly on June 8, 2021, asserting two patents which issued that same day and relaterecently granted to Teva, related to the treatment of refractory migraine. The case has been assignedLilly responded to the same judge incomplaint with a motion to dismiss, which Teva opposed. On March 15, 2022, the U.S. District Court for the District of Massachusetts denied Lilly’s motion to dismiss and Lilly’s responseon March 23, 2022, Lilly submitted IPR petitions challenging the patentability of the two refractory migraine patents. On April 11, 2022, Lilly submitted another IPR petition challenging the patentability of a patent related to our complaint is due on August 27, 2021.the two refractory migraine patents. In addition, in 2018 we entered into separate agreements with Alder Biopharmaceuticals, Inc. and Lilly, resolving the European Patent Office oppositions that they filed against our AJOVY patents. The settlement agreement with Lilly also resolved Lilly’s action to revoke the patent protecting AJOVY in the United Kingdom.
AUSTEDO
revenues in our North America segment in the second quarter of 20212022 increased by 8%17%, to $174$204 million, compared to $161$174 million in the second quarter of 2020. This increase was2021, mainly due to growth in volume.
AUSTEDO was launched in the U.S. in 2017. It is indicated for the treatment of chorea associated with Huntington disease and for the treatment of tardive dyskinesia in adults.
AUSTEDO is protected in the United States by sixeight Orange Book patents expiring between 2031 and 20362038 and in Europe by two patents expiring in 2029. We received notice letters from two ANDA filers regarding the filing of their ANDAs with paragraph (IV) certifications for certain of the patents listed in the Orange Book for AUSTEDO. On July 1,
53

2021, we filed a complaint against Aurobindo, asserting all six of the Orange Book patents, and a separate complaint against Lupin, asserting four of the Orange Book patents. The suits were filed in the U.S. District Court for the District of New Jersey. The seventh patent was issued in November 2021, and listed in the Orange Book in December 2021. In addition, Apotex filed a petition for IPR by the PTAB of the patent covering the deutetrabenazine compound that expires in 2031. On March 9, 2022, the U.S. Patent and Trademark Office denied Apotex’s petition and declined to institute a review of the deutetrabenazine patent. On April 29, 2022, we reached an agreement with Lupin to resolve the abovementioned dispute over Lupin’s ANDA for a generic deutetrabenazine product. On June 8, 2022 we reached an agreement with Aurobindo regarding the dispute over Aurobindo’s ANDA for a generic deutetrabenazine product. Under the terms of the settlement agreements, the litigation between the parties in the U.S. District Court for the District of New Jersey have been ended, and Lupin and Aurobindo will have a license to sell its generic product beginning April 2033, or earlier under certain circumstances. There are no further patent litigations pending regarding AUSTEDO.
BENDEKA
and
TREANDA
combined revenues in our North America segment in the second quarter of 2021 increased2022 decreased by 3%22% to $106$83 million, compared to the second quarter of 2020,2021, mainly due to higher sales of oncology products compared to sales in the second quarter of 2020, which were impacted by the
COVID-19
pandemic, partially offset by the availability of alternative therapies and continued competition from Belrapzo
®
(a
ready-to-dilute
bendamustine hydrochloride product from Eagle Pharmaceuticals, Inc. (“Eagle”))Eagle).
In July 2018, Eagle prevailed in its suit against the FDA to obtain seven years of orphan drug exclusivity in the United States for BENDEKA. On March 13, 2020, this decision was upheld in the appellate court. As things currently stand, 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. In April 2019, we signed an amendment to the license agreement with Eagle extending the royalty term applicable to the United States to the full period for which we sell BENDEKA and increased the royalty rate. In consideration, Eagle agreed to assume a portion of BENDEKA-related patent litigation expenses.
There are 1516 patents listed in the U.S. Orange Book for BENDEKA with expiry dates in 2026 and 2031. In September 2019, a patent infringement action against four of six ANDA filers for generic versions of BENDEKA was tried in the United StatesU.S. District Court for the District of Delaware. On April 27, 2020, the District Courtdistrict court upheld the validity of all of the asserted patents and found that all four ANDA filers infringe at least one of the patents. Three of the four ANDA filers have appealed the district court decision, but barring an adverse appellate decision, thesedecision. Teva settled with one of the three ANDA filers, should be enjoined untiland on August 13, 2021, the patents expire in 2031. A litigationFederal Circuit issued a Rule 36 affirmance of the district court decision with respect to the other two filers. On December 14, 2021, Apotex filed a Petition for a Writ of Certiorari with the U.S. Supreme Court, which was denied. Litigation against the fifth ANDA filer was dismissed after the withdrawal of its patent challenge, and the case against a sixth ANDA filer is in the early stages of litigation. Recent suitswas also settled. Suits against two filers of 505(b)(2) NDAs referencing BENDEKA are also in the initial stages of litigation.pending.
Additionally, in July 2018, Teva and Eagle filed suit against Hospira, Inc. (“Hospira”) related to its 505(b)(2) new drug application (“NDA”)NDA referencing BENDEKA in the U.S. District Court for the District of Delaware. On December 16, 2019, the Delaware District Courtdistrict court dismissed the case against Hospira on all but one of the asserted patents, which expires in 2031. Trial againstOn April 18, 2022, Teva and Eagle settled this matter, allowing Hospira to launch its product on that patent is scheduled to begin on November 15, 2021.January 17, 2028 or earlier under certain circumstances.
In addition to the settlement with Eagle regarding its bendamustine 505(b)(2) NDA, between 2015 and 2020, we reached final settlements with 22 ANDA filers for generic versions of the lyophilized form of TREANDA and one 505(b)(2) NDA filer for a generic version of the liquid form of TREANDA, providing for the launch of generic versions of TREANDA prior to patent expiration.
50

COPAXONE
revenues in our North America segment in the second quarter of 20212022 decreased by 36%38% to $152$94 million, compared to the second quarter of 2020,2021, mainly due to generic competition in the United States.States and a decrease in glatiramer acetate market share due to availability of alternative therapies.
The market for MS treatments continues to develop, particularly with the approval of generic versions of COPAXONE. Additionally, oralOral 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
(HFA and RespiClick)
revenues in our North America segment in the second quarter of 2021 were $55 million, a decrease of 16% compared to the second quarter of 2020. In January 2019, we launched our own ProAir authorized generic in the United States, following the launch of a generic version of VentolinKesimpta
®
.
HFA, another albuterol inhaler. Revenues from our ProAir authorized generic are included in “generic products” above. During the second quarter of 2021, the exit market share of our overall albuterol product, including our ProAir authorized generic was 41.4%, making it the second largest in the market, compared to 34.9% in the second quarter of 2020. Other generic versions of ProAir were launched in 2020.
Anda
revenues in our North America segment in the second quarter of 20212022 decreased by 16%2% to $316$308 million, compared to $374$316 million in the second quarter of 2020,2021, mainly due to lower demand by Anda’s customers for generic products.market demand. 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.
54

Product Launches and Pipeline
In the second quarter of 2021,2022, 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))
*
 
Mesalamine Suppositories
   Canasa
®
  April  $66 
Isotretinoin Capsules, USP
   Absorica
®
  April  $156 
Erythromycin Tablets, USP
   n/a  May  $45 
Tiopronin Tablets
   Thiola
®
  May  $81
**
 
Ivermectin Cream, 1%
   Soolantra
®
  June  $111 
Formoterol Fumarate Inhalation Solution
   Perforomist®  June  $300 
Product Name
  
Brand Name
 
Launch
Date
   
Total Annual U.S.
Branded Sales at Time
of Launch
(U.S. $ in millions
(IQVIA))
*
 
Pirfenidone Tablets 267mg & 801mg
  Esbriet
®
 tablets
  May   $569.8 
Vilazodone Hydrochloride Tablets 10mg, 20mg, 40mg
  Viibryd
®
 tablets
  June   $569.1 
Scopolamine Transdermal System 1mg/3 days
  Transderm Scop
®

Transdermal System
  May   $87.9 
Dalfampridine Extended-release Tablets 10mg
  Ampyra
®
 Extended
Release Tablets
  May   $81.3 
Mycophenolate Mofetil for Oral Suspension, USP, 200mg/mL
  CellCept
®
Oral
Suspension
  June   $55.2 
Lanthanum Carbonate Chewable Tablets 500mg, 750mg, 1000mg
  Fosrenol
®
 chewable
tablets
  May   $35.4 
Pemetrexed Injection 100mg/4mL, 500mg/20mL, 1g/40mL**
  N/A  May    N/A 
 
*
The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or
re-launch.
**
Limited data
Teva’s Pemetrexed is available for thisa 505(b)(2) product, in IQVIAwas filed as an NDA and asis not bioequivalent to a result Teva estimated the brand market based on data available in Travere Therapeutic’s
10-Kproduct.
for the year ended December 31, 2020.
Our generic products pipeline in the United States includes, as of June 30, 2021, 2072022, 178 product applications awaiting FDA approval, including 7268 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 March 31, 2021 exceeding $1062022 of approximately $109 billion, according to IQVIA. Approximately 72%73% of pending applications include a paragraph IV patent challenge, and we believe we are first to file with respect to 7769 of these products, or 10397 products including final approvals where launch is pending a settlement agreement or court decision. Collectively, these first to file opportunities represent over $76$82 billion in U.S. brand sales for the twelve months ended March 31, 2021,2022, according to IQVIA.
51

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 second quarter of 2021,2022, we received tentative approvals for generic equivalents of the products listed in the table below, excluding overlapping applications. A “tentative approval” indicates that the FDA has substantially completed its review of an application and final approval is expected once the relevant patent expires, a court decision is reached, a
30-month
regulatory stay lapses or a
180-day
exclusivity period awarded to another manufacturer either expires or is forfeited.
 
Generic Name
  
Brand Name
  
Total Annual U.S.

Branded Market

(U.S. $ in millions

(IQVIA))
*
 
Lenalidomide Capsules, 2.5 mg and 20 mg
   Revlimid®  $179 
Pimavanserin Capsules, 34 mg
   Nuplazid®  $173 
55

Generic Name
  
Brand Name
 
Total Annual U.S.
Branded Sales at Time
of Launch
(U.S. $ in millions
(IQVIA))
*
 
Canagliflozin Tabs
  Invokana
®
 $900 
Linaclotide Capsules, 72 mcg
  Linzess
®
 $457 
Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL)
  Mozobil
®
 $192 
Methylnaltrexone Bromide Tablets, 150 mg
  Relistor
®
 $131 
Methylphenidate Hydrochloride Extended-Release Chewable Tablets, 20 mg, 30 mg and 40 mg
  Quillichew ER
®
 $118 
 
*
The figures presented are for the twelve months ended in the calendar quarter immediately prior to our launch or
re-launch.
For information regarding our specialty and biosimilar products pipeline, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
North America Gross Profit
Gross profit from our North America segment in the second quarter of 2022 was $1,010 million, a decrease of 3%, compared to $1,040 million in the second quarter of 2021.
Gross profit margin for our North America segment in the second quarter of 2022 decreased to 53.0%, compared to 53.5% in the second quarter of 2021. This decrease was mainly due to a change in mix of products.
North America R&D Expenses
R&D expenses relating to our North America segment in the second quarter of 2022 were $147 million, a decrease of 10%, compared to $162 million in the second quarter of 2021.
For a description of our R&D expenses in the second quarter of 2022, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
North America S&M Expenses
S&M expenses relating to our North America segment in the second quarter of 2022 were $256 million, flat compared to the second quarter of 2021.
North America G&A Expenses
G&A expenses relating to our North America segment in the second quarter of 2022 were $127 million, an increase of 19% compared to the second quarter of 2021.
North America Profit
Profit from our North America segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our North America segment in the second quarter of 2022 was $481 million, a decrease of 8% compared to $521 million in the second quarter of 2021, mainly due to lower revenues, as discussed above.
Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the three months ended June 30, 2022 and 2021:
56

   
Three months ended June 30,
 
   
2022
  
2021
 
   
(U.S. $ in millions / % of Segment

Revenues)
 
Revenues
  $1,171    100 $1,184    100
Gross profit
   703    60.0  661    55.8
R&D expenses
   56    4.7  63    5.3
S&M expenses
   196    16.8  209    17.7
G&A expenses
   63    5.4  47    4.0
Other income
   (1   §   §    § 
  
 
 
   
 
 
  
 
 
   
 
 
 
Segment profit*
  $389    33.2 $343    28.9
  
 
 
   
 
 
  
 
 
   
 
 
 
*
Segment profit does not include amortization and certain other items.
§
Represents an amount less than $0.5 million or 0.5%, as applicable.
Europe Revenues
Our Europe segment includes the European Union, the United Kingdom and certain other European countries. Revenues from our Europe segment in the second quarter of 2022 were $1,171 million, a decrease of 1%, or $13 million, compared to the second quarter of 2021. In local currency terms, revenues increased by 8%.
In the second quarter of 2021, our revenues were impacted by the implications of the
COVID-19
pandemic. In the second quarter of 2022, the increase in our revenues in local currency terms was attributed to higher demand for generic and OTC products resulting mainly from the removal of restrictions related to doctor and hospital visits by patients that were previously implemented in response to the
COVID-19
pandemic, together with higher revenues from generic product launches.
In the second quarter of 2022, revenues were negatively impacted by exchange rate fluctuations of $106 million, net of hedging effects, compared to the second quarter of 2021. Revenues in the second quarter of 2022 included $31 million from a positive hedging impact, which is included in “Other” in the table below. See note 8d to our consolidated financial statements.
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 June 30, 2022 and 2021:
   
Three months ended

June 30,
   
Percentage
Change
 
   
2022
   
2021
   
2022-2021
 
   
(U.S. $ in millions)
     
Generic products
  $873   $878    (1%) 
AJOVY
   29    19    52
COPAXONE
   72    100    (28%) 
Respiratory products
   65    85    (23%) 
Other
   131    102    29
  
 
 
   
 
 
   
Total
  $1,171   $1,184    (1%) 
  
 
 
   
 
 
   
Generic products
revenues in our Europe segment in the second quarter of 2022, including OTC products, decreased by 1% to $873 million, compared to the second quarter of 2021. In local currency terms, revenues increased by 12%, mainly due to higher demand for generic and OTC products, resulting mainly from the removal of restrictions related to doctor and hospital visits by patients that were previously implemented in response to the
COVID-19
pandemic, together with higher revenues from generic product launches.
AJOVY
revenues in our Europe segment in the second quarter of 2022 increased to $29 million, compared to $19 million in the second quarter of 2021, mainly due to growth in European countries in which AJOVY had previously been launched, as well as launches and reimbursements in additional European countries.
57

For information about AJOVY patent protection, see “—North America Revenues—Revenues by Major Product” above.
COPAXONE
revenues in our Europe segment in the second quarter of 2022 decreased by 28% to $72 million, compared to the second quarter of 2021. In local currency terms, revenues decreased by 18%, due to price reductions and a decline in volume resulting from competing glatiramer acetate products.
One European patent protecting COPAXONE 40 mg/mL was found invalid by the Board of Appeal of the European Patent Office in September 2020. Two additional patents expiring in 2030 were found invalid at the European Patent Office in December 2021. In certain countries, Teva remains in litigation against generic companies on an additional COPAXONE 40 mg/mL patent that expires in 2030.
Respiratory products
revenues in our Europe segment in the second quarter of 2022 decreased by 23% to $65 million compared to the second quarter of 2021. In local currency terms, revenues decreased by 14%, mainly due to net price reductions and lower volumes.
Product Launches and Pipeline
As of June 30, 2022, our generic products pipeline in Europe included 434 generic approvals relating to 54 compounds in 118 formulations, with no European Medicines Agency (“EMA”) approvals received. In addition, approximately 1,144 marketing authorization applications are pending approval in 37 European countries, relating to 125 compounds in 252 formulations. Two applications are pending with the EMA with one application relating to two strengths in 30 markets and one application relating to three strengths in 30 markets.
For information regarding our specialty and biosimilar products pipeline, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe Gross Profit
Gross profit from our Europe segment in the second quarter of 2022 was $703 million, an increase of 6% compared to $661 million in the second quarter of 2021.
Gross profit margin for our Europe segment in the second quarter of 2022 increased to 60.0%, compared to 55.8% in the second quarter of 2021. This increase was mainly due to higher revenues from the positive impact of hedging activities discussed above as well as lower cost of goods sold, mainly due to better mix of products and decrease in write-offs.
Europe R&D Expenses
R&D expenses relating to our Europe segment in the second quarter of 2022 were $56 million, a decrease of 11% compared to $63 million in the second quarter of 2021.
For a description of our R&D expenses in the second quarter of 2022, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
Europe S&M Expenses
S&M expenses relating to our Europe segment in the second quarter of 2022 were $196 million, a decrease of 6% compared to $209 million in the second quarter of 2021. This decrease was mainly due to exchange rate fluctuations in the second quarter of 2022.
Europe G&A Expenses
G&A expenses relating to our Europe segment in the second quarter of 2022 were $63 million, an increase of 34% compared to $47 million in the second quarter of 2021.
Europe Profit
Profit from 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 second quarter of 2022 was $389 million, an increase of 13%, compared to $343 million in the second quarter of 2021. This increase was mainly due to higher gross profit as discussed above.
58

International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2022 and 2021:
   
Three months ended June 30,
 
   
2022
  
2021
 
   
(U.S. $ in millions /% of Segment Revenues)
 
Revenues
  $454    100 $485    100
Gross profit
   242    53.3  270    55.7
R&D expenses
   19    4.2  18    3.6
S&M expenses
   99    21.7  105    21.7
G&A expenses
   30    6.7  25    5.1
Other income
   (1   §   (1   § 
  
 
 
   
 
 
  
 
 
   
 
 
 
Segment profit*
  $95    20.9 $123    25.5
  
 
 
   
 
 
  
 
 
   
 
 
 
*
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 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 Japan, Russia and Israel. The countries in our International Markets segment include highly regulated, pure generic markets, such as Israel, branded generics oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan.
In February 2022, Russia launched an invasion of Ukraine. As of the date of this Quarterly Report on Form
10-Q,
sustained conflict and disruption in the region is ongoing. Russia and Ukraine markets are included in our International Markets segment results. We have no manufacturing or R&D facilities in these markets. During the three and six months ended June 30, 2022, the impact of this conflict on our International Markets segment’s results of operations and financial condition was immaterial. Consistent with our foreign exchange risk management hedging programs, we entered into hedges to hedge our exposure to currency exchange rate fluctuations with respect to our balance sheet assets, revenues and expenses. However, as of the end of the second quarter of 2022, we were unable to renew certain of our expiring hedging positions due to the liquidity situation in the market for Rubles. Prior to and since the escalation of the conflict, we have been taking measures to reduce our operational cash balances in Russia and Ukraine. We have been monitoring the solvency of our customers in Russia and Ukraine and have taken measures, where practicable, to mitigate our exposure to risks related to the conflict in the region. However, the duration, severity and global implications (including potential inflation and devaluation consequences) of the conflict cannot be predicted at this time and could have an effect on our business, including on our exchange rate exposure, supply chain, operational costs and commercial presence in these markets.
Revenues from our International Markets segment in the second quarter of 2022 were $454 million, a decrease of 6% compared to the second quarter of 2021. In local currency terms, revenues increased by 3% compared to the second quarter of 2021, mainly due to higher revenues in certain markets, partially offset by lower revenues in Japan due to regulatory price reductions and generic competition to
off-patented
products.
In the second quarter of 2022, revenues were negatively impacted by exchange rate fluctuations of $45 million, including hedging effects, compared to the second quarter of 2021. Revenues in the second quarter of 2022 included $17 million from a negative hedging impact, which is included in “Other” in the table below. See note 8d to our consolidated financial statements.
59

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 June 30, 2022 and 2021:
   
Three months ended

June 30,
   
Percentage
Change
 
   
2022
   
2021
   
2022-2021
 
   
(U.S. $ in millions)
     
Generic products
  $394   $407    (3%) 
AJOVY
   10    5    96
COPAXONE
   9    7    27
Other
   40    65    (39%) 
  
 
 
   
 
 
   
Total
  $454   $485    (6%) 
  
 
 
   
 
 
   
Generic products
revenues in our International Markets segment in the second quarter of 2022, which include OTC products, decreased by 3% in U.S. dollars. In local currency terms, revenues increased by 4% to $394 million, compared to the second quarter of 2021. This increase was mainly due to higher revenues in certain markets, partially offset by lower sales in Japan due to regulatory price reductions and generic competition to
off-patented
products in Japan.
AJOVY
was launched in certain markets in our International Markets segment, including in Japan in August 2021. We are moving forward with plans to launch AJOVY in other markets. AJOVY revenues in our International Markets segment in the second quarter of 2022 were $10 million, compared to $5 million in the second quarter of 2021.
COPAXONE
revenues in our International Markets segment in the second quarter of 2022 were $9 million compared to $7 million in the second quarter of 2021.
AUSTEDO
was launched in early 2021 in China for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia, and was also launched in Israel during 2021. In October 2021, we received marketing approval for both indications in Brazil. We continue with additional submissions in various other markets.
International Markets Gross Profit
Gross profit from our International Markets segment in the second quarter of 2022 was $242 million, a decrease of 10% compared to $270 million in the second quarter of 2021.
Gross profit margin for our International Markets segment in the second quarter of 2022 decreased to 53.3%, compared to 55.7% in the second quarter of 2021. This decrease was mainly due to regulatory price reductions and generic competition to
off-patented
products in Japan, as well as a negative impact from hedging activity.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in the second quarter of 2022 were $19 million, an increase of 10% compared to $18 million in the second quarter of 2021.
For a description of our R&D expenses in the second quarter of 2022, see “—Teva Consolidated Results—Research and Development (R&D) Expenses” below.
International Markets S&M Expenses
S&M expenses relating to our International Markets segment in the second quarter of 2022 were $99 million, a decrease of 6% compared to $105 million the second quarter of 2021.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in the second quarter of 2022 were $30 million, an increase of 22% compared to $25 million in the second quarter of 2021.
International Markets Profit
Profit from 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.
60

Profit from our International Markets segment in the second quarter of 2022 was $95 million, a decrease of 23%, compared to $123 million in the second quarter of 2021. This decrease was mainly due to lower gross profit, as discussed above.
Other Activities
We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments described above.
Our revenues from other activities in the second quarter of 2022 were $257 million, a decrease of 14% compared to the second quarter of 2021. In local currency terms, revenues decreased by 10%.
API sales to third parties in the second quarter of 2022 were $177 million, a decrease of 11% in both U.S. dollars and local currency terms compared to the second quarter of 2021.
Teva Consolidated Results
Revenues
Revenues in the second quarter of 2022 were $3,786 million, a decrease of 3% compared to the second quarter of 2021. In local currency terms, revenues increased by 1%, mainly due to higher revenues from generic products in our Europe and North America segments, partially offset by lower revenues from COPAXONE and BENDEKA/TREANDA in our North America segment. See “—North America Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.
Exchange rate movements during the second quarter of 2022, net of hedging effects, negatively impacted revenues by $162 million, compared to the second quarter of 2021. See note 8d to our consolidated financial statements.
Gross Profit
Gross profit in the second quarter of 2022 was $1,794 million, a decrease of 4% compared to the second quarter of 2021.
Gross profit margin was 47.4% in the second quarter of 2022, compared to 47.9% in the second quarter of 2021. This decrease was mainly driven by lower revenues from COPAXONE and a change in the mix of products in our North America segment, partially offset by a favorable mix of products in our Europe segment.
Research and Development (R&D) Expenses
Our R&D activities for generic products in each of our segments include both (i) direct expenses relating to product formulation, analytical method development, stability testing, management of bioequivalence and other clinical studies and regulatory filings; and (ii) indirect expenses, such as costs of internal administration, infrastructure and personnel.
Our R&D activities for specialty and biosimilar products in each of our segments include costs of discovery research, preclinical development, in various stages ofearly- and late-clinical development and drug formulation, clinical trials and regulatory review.product registration costs. These expenditures are reported net of contributions received from collaboration partners. Our spending takes place throughout the development process, including (i) early-stage projects in both discovery and preclinical phases; (ii) middle-stage projects in clinical programs up to phase 3; (iii) late-stage projects in phase 3 programs, including where a new drug application is currently pending approval; (iv) post-approval studies for marketed products; and (v) indirect expenses, such as costs of internal administration, infrastructure and personnel.
R&D expenses in the second quarter of 2022 were $228 million, a decrease of 8% compared to the second quarter of 2021.
In the second quarter of 2022, our R&D expenses related primarily to specialty product candidates in neuroscience (such as migraine, movement disorders/ neurodegeneration and neuropsychiatry, including post-approval commitments), immunology (such as respiratory medicines) and selected other areas, as well as generic products and biosimilars.
61

Our lower R&D expenses in the second quarter of 2022, compared to the second quarter of 2021, were mainly due to a decrease in neuroscience (in the pain and migraine and headache therapeutic areas) and immunology (in the respiratory therapeutic area) as well as various generics projects, partially offset by higher R&D expenses related to our biosimilar products pipeline.
R&D expenses as a percentage of revenues were 6.0% in the second quarter of 2022, compared to 6.3% in the second quarter of 2021.
Specialty Products Pipeline
Below is a description of key products in our specialty pipeline as of June 30, 2021:July 15, 2022:
 
   
Phase 2
  
Phase 3
  
Pre-Submission
Under Regulatory Review
Novel Biologics
  
Fremanezumab
TEV-48574
FibromyalgiaInflammatory Bowel Disease
  
Fasinumab
Osteoarthritic Pain
(March 2016)
(1)
TEV-48574
Respiratory
    
TEV-53275
Respiratory
Small Molecules
    
Deutetrabenazine
Dyskinesia in Cerebral Palsy
(September 2019)
  
Risperidone LAI
Schizophrenia
(2)
Digital Respiratory
      
Digihaler
®
(budesonide and formoterol fumarate dihydrate)
(EU)
      
QVAR
®
Digihaler
®
(beclomethasone dipropionate HFA)
(U.S.)
 
(1)
Developed in collaboration with Regeneron Pharmaceuticals, Inc. (“Regeneron”). Results for two phase 3 clinical trials, FACT OA1 and FACT OA2, were released on August 5, 2020, indicating that the
co-primary
endpoints for fasinumab 1 mg monthly were achieved. Fasinumab 1 mg monthly demonstrated significant improvements in pain and physical function over placebo at week 16 and week 24, respectively. Fasinumab 1 mg monthly also showed nominally significant benefits in physical function in two trials and pain in one trial, when compared to the maximum
FDA-approved
prescription doses of
non-steroidal
anti-inflammatory drugs for osteoarthritis. The FACT OA1 trial included an additional treatment arm, fasinumab 1 mg every two months, which showed numerical benefit over placebo, but did not reach statistical significance. In initial safety analyses from the phase 3 trials, there was an increase in arthropathies reported with fasinumab. In a
sub-group
of patients from one phase 3 long-term safety trial, there was an increase in joint replacement with fasinumab 1 mg monthly treatment during the
off-drug
follow-up
period, although this increase was not seen in the other trials to date.
52

Active treatment of patients with fasinumab, which only involved dosing in an optional second-year extension phase of one trial, has been discontinued following a recommendation from the fasinumab program’s Independent Data Monitoring Committee that the program should be terminated, based on available evidence obtained to date. The core efficacy data has already been obtained to support potential fasinumab regulatory filings. Long-term safety data continues to be gathered, and is expected to be reporteddiscussed with the FDA in 2021. 2022.
Currently, all
non-essential
activities and related expenditures for fasinumab have been put on hold. Next steps will be assessed together with Regeneron, with the intention of discussing data with the FDA.
 
(2)
Developed under a license agreement with MedinCell. In JanuaryAugust 2021, we announced positive resultsthe FDA accepted the NDA for arisperidone LAI, based on phase 3 clinical trial designed to evaluatedata from two pivotal studies. In April 2022, the efficacy ofFDA issued a Complete Response Letter (“CRL”) regarding the NDA for risperidone LAI. No new safety signals were identified thatWe are inconsistentworking to address the issues raised in the CRL with the known safety profile of other risperidone formulations. The second phase 3 study evaluating long-term safety and tolerability is ongoing.
Discontinued Project
During the second quarter of 2021, development of fremanezumab for an additional indication was discontinued.
North America Gross Profit
Gross profit from our North America segment in the second quarter of 2021 was $1,040 million, a decrease of 5%, compared to $1,090 million in the second quarter of 2020. This decrease was mainly due to lower gross profit from Anda and COPAXONE.
Gross profit margin for our North America segment in the second quarter of 2021 increased to 53.5%, compared to 53.3% in the second quarter of 2020. This increase was mainly due to a change in the mix of products.
North America R&D Expenses
R&D expenses relating to our North America segment in the second quarter of 2021 were $162 million, an increase of 5%, compared to $154 million in the second quarter of 2020.
For a description of our R&D expenses in the second quarter of 2021, 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 second quarter of 2021 were $255 million, flat compared to the second quarter of 2020.
North America G&A Expenses
G&A expenses relating to our North America segment in the second quarter of 2021 were $106 million, a decrease of 4%, compared to $110 million in the second quarter of 2020.
North America Profit
Profit from our North America segment consists of gross profit less R&D expenses, S&M expenses, G&A expenses and any other income related to this segment. Segment profit does not include amortization and certain other items.
Profit from our North America segment in the second quarter of 2021 was $521 million, a decrease of 9% compared to $573 million in the second quarter of 2020, mainly due to lower gross profit, as discussed above, as well as higher R&D expenses.
53

Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the three months ended June 30, 2021 and 2020:
   
Three months ended June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions / % of Segment
Revenues)
 
Revenues
  $1,184    100%    $1,001    100% 
Gross profit
   661    55.8%    548    54.7% 
R&D expenses
   63    5.3%    65    6.5% 
S&M expenses
   209    17.7%    188    18.8% 
G&A expenses
   47    4.0%    52    5.2% 
Other income
   §    §    (1)    § 
  
 
 
   
 
 
   
 
 
   
 
 
 
Segment profit*
  $343    28.9%    $244    24.3% 
  
 
 
   
 
 
   
 
 
   
 
 
 
*
Segment profit does not include amortization and certain other items.
§
Represents an amount less than $1 million or 0.5%, as applicable.a view to resubmission.
Europe RevenuesBiosimilar Products Pipeline
OurWe have additional biosimilar products in development internally and with our partners that are in various stages of clinical trials and regulatory review worldwide, including phase 3 clinical trials for biosimilars to Prolia
®
(denosumab), Stelara
®
(ustekinumab), Xolair
®
(omalizumab) and Eylea
®
(afilbercept), a biosimilar to Lucentis
®
(ranibizumab) that is currently under regulatory review in Europe segment includes the European Union and certain other European countries. Revenues from our Europe segmentis in the second quarter of 2021 were $1,184 million, an increase of 18% or $183 million, compared to the second quarter of 2020. In local currency terms, revenues increased by 8%, mainly due to changed buying patterns
pre-submission
in the second quarter of 2020 as a result of significant customer stocking due to the
COVID-19
pandemic in March 2020, and a decline in doctor and hospital visits by patients resulting in fewer prescriptions during the second quarter of 2020.
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 June 30, 2021 and 2020:
   
Three months ended

June 30,
   
Percentage
Change
 
   
2021
   
2020
   
2020-2021
 
   
(U.S. $ in millions)
     
Generic products
  $878   $737    19
AJOVY
   19    5    302
COPAXONE
   100    84    19
Respiratory products
   85    80    7
Other
   102    95    7
  
 
 
   
 
 
   
Total
  $1,184   $1,001    18
  
 
 
   
 
 
   
Generic products
revenues in our Europe segment in the second quarter of 2021, including OTC products, increased by 19% to $878 million, compared to the second quarter of 2020. In local currency terms, revenues increased by 9% compared to the second quarter of 2020, mainly due lower revenues in the second quarter of 2020, as a result of significant changes in buying patterns and customer stocking due to the
COVID-19
pandemic in March 2020. In addition, revenues in the second quarter of 2020 were impacted by lower demand of generic products resulting from a decline in doctor and hospital visits by patients resulting in fewer prescriptions,Canada, as well as lower sales of OTC products resulting from lower demand for cough and cold products, both duea biosimilar to theHumira
COVID-19®
pandemic.
AJOVY
revenues in our Europe segment in the second quarter of 2021 were $19 million, compared to $5 million in the second quarter of 2020, mainly due to launches and reimbursements in additional European countries.(adalimumab) that is currently under U.S. regulatory review.
 
5462

By the end of 2020, we launched AJOVY in most European countries and we are moving forward with plans to launch in other European countries. For information about AJOVY patent protection, see “—North America Revenues—Revenues by Major Product” above.
COPAXONE
revenues in our Europe segment in the second quarter of 2021 increased by 19% to $100 million, compared to the second quarter of 2020. In local currency terms, revenues increased by 9%, mainly due to customer stocking due to the
COVID-19
pandemic in March 2020 resulting in significant changes in buying patterns in the second quarter of 2020.
One European patent protecting COPAXONE 40 mg/mL was found invalid by the Board of Appeal of the European Patent Office in September 2020. Two additional patents expiring in 2030 are currently under opposition at the European Patent Office. In certain countries, Teva remains in litigation against generic companies on an additional COPAXONE 40 mg/mL patent that expires in 2030.
Respiratory products
revenues in our Europe segment in the second quarter of 2021 increased by 7% to $85 million compared to the second quarter of 2020. In local currency terms, revenues decreased by 4%, mainly due to lower sales in the United Kingdom, partially offset by changes in buying patterns in the second quarter of 2020 as a result of significant customer stocking due to the
COVID-19
pandemic in March 2020.
Product Launches and Pipeline
As of June 30, 2021, our generic products pipeline in Europe included 266 generic approvals relating to 50 compounds in100 formulations, with no European Medicines Agency (“EMA”) approvals received. In addition, approximately 1,161 marketing authorization applications are pending approval in 37 European countries, relating to 118 compounds in 252 formulations. No applications are pending with the EMA.
For information regarding our specialty pipeline, see “—North America Segment —Product Launches and Pipeline” above.
Europe Gross Profit
Gross profit from our Europe segment in the second quarter of 2021 was $661 million, an increase of 21% compared to $548 million in the second quarter of 2020.
Gross profit margin for our Europe segment in the second quarter of 2021 increased to 55.8%, compared to 54.7% in the second quarter of 2020. This increase was mainly due to a change in product mix.
Europe R&D Expenses
R&D expenses relating to our Europe segment in the second quarter of 2021 were $63 million, a decrease of 4% compared to $65 million in the second quarter of 2020.
For a description of our R&D expenses in the second quarter of 2021, 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 second quarter of 2021 were $209 million, an increase of 11% compared to $188 million in the second quarter of 2020. This increase was mainly due to exchange rate fluctuations, as well as lower expenses in the second quarter of 2020 attributed to restrictions related to the
COVID-19
pandemic.
Europe G&A Expenses
G&A expenses relating to our Europe segment in the second quarter of 2021 were $47 million, a decrease of 10% compared to $52 million in the second quarter of 2020.
Europe Profit
Profit from 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 second quarter of 2021 was $343 million, an increase of 41%, compared to $244 million in the second quarter of 2020. This increase was mainly due to higher revenues, as discussed above.
55

International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the three months ended June 30, 2021 and 2020:
   
Three months ended June 30,
 
   
2021
   
2020
 
   
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
  $485    100%   $488    100% 
Gross profit
   270    55.7%    247    50.8% 
R&D expenses
   18    3.6%    19    3.9% 
S&M expenses
   105    21.7%    105    21.4% 
G&A expenses
   25    5.1%    29    6.0% 
Other income
   (1   §    (2  § 
  
 
 
   
 
 
   
 
 
   
 
 
 
Segment profit*
  $123    25.5%   $97    19.9% 
  
 
 
   
 
 
   
 
 
   
 
 
 
*
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 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 Japan, Russia and Israel. The countries in our International Markets segment include highly regulated, pure generic markets, such as Israel, branded generics oriented markets, such as Russia and certain Latin America markets and hybrid markets, such as Japan.
On February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.
Revenues from our International Markets segment in the second quarter of 2021 were $485 million, a decrease of $3 million, or 1%, compared to the second quarter of 2020. In local currency terms, revenues decreased by 3% compared to the second quarter of 2020, mainly due to lower revenues in Japan resulting from the divestment mentioned above, as well as regulatory price reductions and generic competition to
off-patented
products in Japan, and a negative impact from hedging activity, partially offset by higher revenues in most other markets as well as lower revenues in certain markets in the second quarter of 2020, resulting from reduced demand due to the impact the
COVID-19
pandemic had on purchasing patterns.
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 June 30, 2021 and 2020:
   
Three months ended

June 30,
   
Percentage
Change
 
   
2021
   
2020
   
2020-2021
 
   
(U.S. $ in millions)
     
Generic products
  $407   $426    (5%) 
COPAXONE
   7    12    (35%) 
Other
   71    50    42
  
 
 
   
 
 
   
Total
  $485   $488    (1%) 
  
 
 
   
 
 
   
Generic products
revenues in our International Markets segment in the second quarter of 2021, which include OTC products, decreased by 5% in both U.S. dollar and local currency terms, to $407 million, compared to the second quarter of 2020. This decrease was mainly due to lower sales in Japan resulting from the divestment mentioned above, as well as regulatory price reductions and generic competition to
off-patented
products in Japan, partially offset by higher revenues in most other markets as well as lower revenues in certain markets in the second quarter of 2020, resulting from reduced demand due to the impact the
COVID-19
pandemic had on purchasing patterns.
56

COPAXONE
revenues in our International Markets segment in the second quarter of 2021 were $7 million, a decrease of 35% compared to the second quarter of 2020. In local currency terms, revenues decreased by 33%.
AJOVY
was launched in certain markets in our International Markets segment and we are moving forward with plans to launch in other markets. On June 23, 2021, AJOVY was approved for the preventive treatment of migraine in adults in Japan.
AUSTEDO
was launched in China for the treatment of chorea associated with Huntington disease and for the treatment of tardive dyskinesia in early 2021. We continue with additional submissions in various other countries.
International Markets Gross Profit
Gross profit from our International Markets segment in the second quarter of 2021 was $270 million, an increase of 9% compared to $247 million in the second quarter of 2020.
Gross profit margin for our International Markets segment in the second quarter of 2021 increased to 55.7%, compared to 50.8% in the second quarter of 2020. This increase was mainly due to the divestment in Japan mentioned above and a change in product portfolio mix.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in the second quarter of 2021 were $18 million, a decrease of 8% compared to $19 million in the second quarter of 2020.
For a description of our R&D expenses in the second quarter of 2021, 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 second quarter of 2021 were $105 million, flat compared to the second quarter of 2020.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in the second quarter of 2021 were $25 million, a decrease of 15% compared to $29 million in the second quarter of 2020.
International Markets Profit
Profit from 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 second quarter of 2021 was $123 million, an increase of 27%, compared to $97 million in the second quarter of 2020. This increase was mainly due to higher gross profit as discussed above.
Other Activities
We have other sources of revenues, primarily the sale of APIs to third parties, certain contract manufacturing services and an
out-licensing
platform offering a portfolio of products to other pharmaceutical companies through our affiliate Medis. Our other activities are not included in our North America, Europe or International Markets segments described above.
Our revenues from other activities in the second quarter of 2021 were $298 million, a decrease of 11% compared to the second quarter of 2020. In local currency terms, revenues decreased by 13% compared to the second quarter of 2020, mainly due to a decrease in volumes from API and Medis resulting from the
COVID-19
pandemic.
API sales to third parties in the second quarter of 2021 were $199 million, a decrease of 6% in both U.S. dollar and local currency terms compared to the second quarter of 2020.
57

Teva Consolidated Results
Revenues
Revenues in the second quarter of 2021 were $3,910 million, an increase of 1%, or a decrease of 2% in local currency terms, compared to the second quarter of 2020. This decrease was mainly due to lower revenues in our North America segment, mainly related to COPAXONE and Anda, partially offset by positive foreign currency impacts as well as higher revenues from generic products, OTC, AJOVY and COPAXONE in our Europe segment. Revenues were also affected by changes in demand for certain products resulting from the impact of the
COVID-19
pandemic. See “—North America Revenues,” “—Europe Revenues,” “—International Markets Revenues” and “—Other Activities” above.
Exchange rate movements during the second quarter of 2021, including hedging effects, positively impacted revenues by $135 million, compared to the second quarter of 2020. See note 8c to our consolidated financial statements.
Gross Profit
Gross profit in the second quarter of 2021 was $1,873 million, an increase of 6% compared to the second quarter of 2020. 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 margin was 47.9% in the second quarter of 2021, compared to 45.5% in the second quarter of 2020.
The increase in gross profit margin was mainly driven by higher profitability in North America resulting from the change in mix of products sold as well as network optimization activities, partially offset by lower sales of COPAXONE.
Research and Development (R&D) Expenses
Our R&D activities for generic products in each of our segments include both (i) direct expenses relating to product formulation, analytical method development, stability testing, management of bioequivalence and other clinical studies and regulatory filings; and (ii) indirect expenses, such as costs of internal administration, infrastructure and personnel.
Our R&D activities for specialty and biosimilar 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) post-approval studies for marketed products; and (v) indirect expenses, such as costs of internal administration, infrastructure and personnel.
R&D expenses in the second quarter of 2021 were $248 million, an increase of 10% compared to the second quarter of 2020.
In the second quarter of 2021, our R&D expenses related primarily to specialty product candidates in the respiratory, migraine and headache therapeutic areas, with additional activities in selected other areas and generic products including biosimilars.
Our higher R&D expenses in the second quarter of 2021, compared to the second quarter of 2020, were mainly due to an increase in respiratory and biosimilar projects as well as various generics projects.
R&D expenses as a percentage of revenues were 6.3% in the second quarter of 2021, compared to 5.8% in the second quarter of 2020.
Selling and Marketing (S&M) Expenses
S&M expenses in the second quarter of 20212022 were $615$594 million, an increasea decrease of 3% compared to the second quarter of 2020. Our S&M expenses were primarily the2021. This decrease was mainly a 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 15.7% in the second quarter of 2021, compared to 15.4% in the second quarter of 2020.both 2022 and 2021.
General and Administrative (G&A) Expenses
G&A expenses in the second quarter of 20212022 were $242$313 million, a decreasean increase of 8%29% compared to the second quarter of 2020.2021. The increase in G&A expenses in the second quarter of 2022 was related to proceeds received from Teva’s insurance carriers pursuant to a settlement reached on a derivative proceeding related to the acquisition of Actavis Generics in the second quarter of 2021, as well as higher litigation fees in the second quarter of 2022.
58

G&A expenses as a percentage of revenues were 8.3% in the second quarter of 2022, compared to 6.2% in the second quarter of 2021, compared to 6.8% in the second quarter of 2020.2021.
Intangible Asset Impairments
We recorded expenses of $195$51 million for identifiable intangible asset impairments in the second quarter of 2021,2022, compared to expenses of $120$195 million in the second quarter of 2020.2021. See note 5 to our consolidated financial statements.
Goodwill Impairment
NoWe recorded a goodwill impairments were recordedimpairment charge of $745 million in the second quartersquarter of both 20212022, of which $479 million is related to our International Markets reporting unit and 2020.$266 million is related to Teva’s API reporting unit. See note 6 to our consolidated financial statements.
Other Asset Impairments, Restructuring and Other Items
We recorded expenses of $28$118 million for other asset impairments, restructuring and other items in the second quarter of 2021,2022, compared to expenses of $381$28 million in the second quarter of 2020.2021. For further details, as well as a description of significant regulatory and other events, see note 12 to our consolidated financial statements.
Legal Settlements and Loss Contingencies
In the second quarter of 2021,2022, we recorded an expenseexpenses of $6$729 million in legal settlements and loss contingencies, compared to incomean expense of $13$6 million in the second quarter of 2020.2021. See note 9 to our consolidated financial statements.
Other Income
Other income in the second quarter of 20212022 was $43$34 million, compared to $9$43 million in the second quarter of 2020. The2021. Other income in the second quarter of 2022 was mainly related to a capital gain related to the sale of an R&D site. Other income in the second quarter of 2021 was mainly due to capital gains related to the sale of certain OTC assets.
Operating Income (Loss)
Operating loss was $949 million in the second quarter of 2022, compared to an operating income wasof $582 million in the second quarter of 2021, compared to $173 million2021.
Operating loss as a percentage of revenues was 25.1% in the second quarter of 2020.
Operating2022, compared to operating income as a percentage of revenues wasof 14.9% in the second quarter of 2021, compared to 4.5%2021. Operating loss in the second quarter of 2020. This increase2022 was mainly due to lower other assets impairments, restructuring and other itemsaffected by goodwill impairment charges and higher profit in our Europe segment, partially offset by higher intangible asset impairment charges.legal settlements and loss contingencies, as discussed above.
Financial Expenses, Net
Financial expenses were $211 million in the second quarter of 2022, compared to $274 million in the second quarter of 2021, compared to $223 million2021. Financial expenses in the second quarter of 2020.2022 were mainly comprised of interest expenses of $225 million, partially offset by a positive exchange rate impact driven mainly from currencies which we were unable to hedge, such as the Russian ruble. Financial expenses in the second quarter of 2021 were mainly comprised of interest expenses of $240 million and loss on revaluations of marketable securities of $34 million (see note 16 to our consolidated financial statements). Financial expenses in the second quarter of 2020 were mainly comprised of interest expenses of $241 million.
63

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 June 30, 20212022 and 2020:2021:
 
.
  
Three months

ended
 
  
June 30,
   
Three months ended June 30,
 
  
2021
   
2020
   
2022
   
2021
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
North America profit
  $521   $573   $481   $521 
Europe profit
   343    244    389    343 
International Markets profit
   123    97    95    123 
  
 
   
 
   
 
   
 
 
Total reportable segments profit
   987    914    964    987 
Profit of other activities
   47    66    55    47 
  
 
   
 
   
 
   
 
 
Total segments profit
   1,034    979    1,019    1,034 
Amounts not allocated to segments:
        
Amortization
   173    249    212    173 
  
 
   
 
 
Other assets impairments, restructuring and other items
   28    381    118    28 
  
 
   
 
 
Goodwill impairment
   —      —      745    —   
  
 
   
 
 
Intangible asset impairments
   195    120 
Intangible assets impairments
   51    195 
Legal settlements and loss contingencies
   6    13    729    6 
Other unallocated amounts
   50    44    113    50 
  
 
   
 
 
Consolidated operating income (loss)
   582    173    (949   582 
  
 
   
 
   
 
   
 
 
Financial expenses, net
   274    223    211    274 
  
 
   
 
   
 
   
 
 
Consolidated income (loss) before income taxes
  $308   $(51  $(1,160  $308 
  
 
   
 
   
 
   
 
 
59

Tax Rate
In the second quarter of 2022, we recognized a tax benefit of $900 million, on
pre-tax
loss of $1,160 million. In the second quarter of 2021, we recognized a tax expense of $98 million, on
pre-tax
income of $308 million. In the second quarter of 2020, we recognized a tax benefit of $104 million, on
pre-tax
loss of $51 million. Our tax rate for the second quarter of 2021 was mainly affected by impairments, amortization and interest expense disallowance.
The statutory Israeli corporate tax rate is 23% in 2021. Our tax rate differs from the Israeli statutory tax rate, mainly dueSee note 11 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.
our consolidated financial statements.
Share In (Profits) Losses of Associated Companies, Net
Share in losses of associated companies, net in the second quarter of 2021 was $11 million. We did not have any share in (profits) losses of associated companies, net in the second quarter of 2020.2022. Share in profits of associated companies, net in the second quarter of 2021 was $11 million.
Net Income (Loss) Attributable to Teva
Net loss was $232 million in the second quarter of 2022, compared to net income wasof $207 million in the second quarter of 2021, compared to $140 million2021. Net loss in the second quarter of 2020. This increase2022 was mainly due to the increase in operating income,affected by goodwill impairment charges and legal settlements and loss contingencies, partially offset by a tax benefit, all as discussed above.
Diluted Shares Outstanding and Earnings (Loss) per Share
The weighted average diluted shares outstanding used for the fully diluted share calculationcalculations for the three months ended June 30, 2022 and 2021 and 2020 were 1,1091,110 million and 1,1001,109 million shares, respectively.
In computing diluted earnings
Diluted loss per share for the three months ended June 30, 2021 and June 30, 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. No account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
Diluted earnings per share were $0.19$0.21 in the second quarter of 2021,2022, compared to diluted earnings per share of $0.13$0.19 in the second quarter of 2020.2021. See note 13 to our consolidated financial statements.
64

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 unitsPSUs and the conversion of our convertible senior debentures, in each case, at period end.
As of June 30, 20212022 and 2020,2021, the fully diluted share count for purposes of calculating our market capitalization was approximately 1,1291,144 million and 1,1191,129 million, respectively.
Impact of Currency Fluctuations on Results of Operations
In the second quarter of 2021,2022, approximately 47% 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, Canadian dollar, Russian ruble, Japanese yen, Swiss franc and new Israeli shekel, Canadian dollar and Russian ruble)shekel) impact our results.
During the second quarter of 2021,2022, 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): Turkish lira by 46%, Argentinian peso by 28%20%, Turkish liraHungarian forint by 18%, Russian ruble by 2% and Japanese yen by 2%15%, Chilean peso by 15%, Swedish krona by 14%, Polish zloty by 14% and euro by 12%. The following main currencies relevant to our operations increased in value against the U.S. dollar: Australian dollarRussian ruble by 17%, Mexican peso by 16%, Swedish krona by 15%, Chilean peso by 15%, British pound by 13%, Canadian dollar by 13%, euro by 9%11% and Israeli shekelBrazilian real by 8%.
60

As a result, exchange rate movements during the second quarter of 2021, including2022, net of hedging effects, positivelynegatively impacted overall revenues by $135$162 million and our operating income by $26$6 million, in comparison withcompared to the second quarter of 2020.2021.
In the second quarter of 2022, a positive hedging impact of $17 million was recognized under revenues, and a positive impact of $3 million was recognized under cost of sales. In the second quarter of 2021, a negative hedging impact of $15 million was recognized under revenues and a minimal negative impact was recognized under cost of sales. In the second quarter of 2020, a negative hedging impact of $20 million was recognized under revenues and a negative impact of $1 million was recognized under cost of sales.
Hedging transactions against future projected revenues and expenses are recognized on the balance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. See note 8c8d 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.
Commencing in the second quarter of 2022, the cumulative inflation in Turkey exceeded 100% or more over a three-year period. Although this triggered highly inflationary accounting treatment, it did not have a material impact on our results of operations.
Comparison of Six Months Ended June 30, 20212022 to Six Months Ended June 30, 20202021
Unless specified otherwise, the factors used to explain quarterly changes on a year-over-year basis are also relevant for the comparison of the results for the six months ended June 30, 20212022 and 2020.2021. Where there are different factors affecting the six months comparison, we have described them below.
Segment Information
North America Segment
The following table presents revenues, expenses and profit for our North America segment for the six months ended June 30, 20212022 and 2020:2021:
 
   
Six months ended June 30,
 
   
2021
  
2020
 
   
(U.S. $ in millions / % of Segment Revenues)
 
Revenues
  $3,932    100 $4,129    100
Gross profit
   2,114    53.8  2,152    52.1
R&D expenses
   322    8.2  300    7.3
S&M expenses
   483    12.3  505    12.2
G&A expenses
   218    5.5  228    5.5
Other income
   (7  §   (4  § 
  
 
 
   
 
 
  
 
 
   
 
 
 
Segment profit*
  $1,098    27.9 $1,123    27.2
  
 
 
   
 
 
  
 
 
   
 
 
 
*
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 six months of 2021 were $3,932 million, a decrease of 4.8% compared to $4,129 million in the first six months of 2020.
Revenues by Major Products and Activities
The following table presents revenues for our North America segment by major products and activities for the six months ended June 30, 2021 and 2020:
   
Six months ended June 30,
   
Percentage
Change
 
   
2021
   
2020
   
2020-2021
 
   
(U.S. $ in millions)
     
Generic products
  $2,004   $1,875    7
AJOVY
   77    63    21
AUSTEDO
   320    283    13
BENDEKA/TREANDA
   197    208    (6%) 
COPAXONE
   315    435    (28%) 
ProAir*
   109    125    (13%) 
Anda
   605    800    (24%) 
Other
   305    338    (10%) 
  
 
 
   
 
 
   
 
 
 
Total
  $3,932   $4,129    (5%) 
  
 
 
   
 
 
   
 
 
 
*
Does not include revenues from the ProAir authorized generic, which are included under generic products.
61

North America Gross Profit
Gross profit from our North America segment in the first six months of 2021 was $2,114 million, a decrease of 2%, compared to $2,152 million in the first six months of 2020.
Gross profit margin for our North America segment in the first six months of 2021 increased to 53.8% compared to 52.1% in the first six months of 2020.
North America R&D Expenses
R&D expenses relating to our North America segment in the first six months of 2021 were $322 million, an increase of 7%, compared to $300 million in the first six months of 2020.
North America S&M Expenses
S&M expenses relating to our North America segment in the first six months of 2021 were $483 million, a decrease of 4% compared to $505 million in the first six months of 2020. This decrease was mainly due to lower S&M expenses related to Anda and additional efficiency measures.
North America G&A Expenses
G&A expenses relating to our North America segment in the first six months of 2021 were $218 million, a decrease of 4%, compared to $228 million in the first six months of 2020.
North America Profit
Profit from our North America segment in the first six months of 2021 was $1,098 million, a decrease of 2%, compared to $1,123 million in the first six months of 2020.
Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the six months ended June 30, 2021 and 2020:
  
Six months ended June 30,
   
Six months ended June 30,
 
  
2021
 
2020
   
2022
 
2021
 
  
(U.S. $ in millions / % of Segment Revenues)
   
(U.S. $ in millions / % of Segment
Revenues)
 
Revenues
  $2,398    100 $2,404    100  $3,641    100 $3,932    100
Gross profit
   1,349    56.2 1,371    57.0   1,899    52.2  2,114    53.8
R&D expenses
   129    5.4 120    5.0   289    7.9  322    8.2
S&M expenses
   424    17.7 390    16.2   501    13.7  483    12.3
G&A expenses
   117    4.9 118    4.9   239    6.6  218    5.5
Other (income) expense
   (1  §  (2  § 
Other income
   (12  §   (7  § 
  
 
   
 
  
 
   
 
   
 
   
 
  
 
   
 
 
Segment profit*
  $680    28.4 $746    31.0  $883    24.2 $1,098    27.9
  
 
   
 
  
 
   
 
   
 
   
 
  
 
   
 
 
 
*
Segment profit does not include amortization and certain other items.
§
Represents an amount less than 0.5%.
 
6265

Table
North America Revenues
Our North America segment includes the United States and Canada. Revenues from our North America segment in the first six months of Contents2022 were $3,641 million, a decrease of 7% compared to $3,932 million in the first six months of 2021.
Revenues by Major Products and Activities
The following table presents revenues for our North America segment by major products and activities for the six months ended June 30, 2022 and 2021:
   
Six months ended
June 30,
   
Percentage

Change
 
   
2022
   
2021
   
2022-2021
 
   
(U.S. $ in millions)
     
Generic products
  $1,925   $2,004    (4%) 
AJOVY
   86    77    12
AUSTEDO
   358    320    12
BENDEKA/TREANDA
   165    197    (16%) 
COPAXONE
   180    315    (43%) 
Anda
   650    605    7
Other
   278    414    (33%) 
  
 
 
   
 
 
   
Total
  $3,641   $3,932    (7%) 
  
 
 
   
 
 
   
Generic products
revenues in our North America segment (including biosimilars) in the first six months of 2022 were $1,925 million, a decrease of 4% compared to the first six months of 2021, mainly due to increased competition and loss of revenues due to the closure of the Irvine, CA site, partially offset by revenues from lenalidomide capsules (the generic version of Revlimid
®
).
Anda
revenues in our North America segment in the first six months of 2022 increased by 7% to $650 million, compared to $605 million in the first six months of 2021, mainly due to higher demand for COVID-related products.
North America Gross Profit
Gross profit from our North America segment in the first six months of 2022 was $1,899 million, a decrease of 10%, compared to $2,114 million in the first six months of 2021.
Gross profit margin for our North America segment in the first six months of 2022 decreased to 52.2% compared to 53.8% in the first six months of 2021.
North America R&D Expenses
R&D expenses relating to our North America segment in the first six months of 2022 were $289 million, a decrease of 10%, compared to $322 million in the first six months of 2021.
66

North America S&M Expenses
S&M expenses relating to our North America segment in the first six months of 2022 were $501 million, an increase of 3.5% compared to $483 million in the first six months of 2021. This increase was mainly due to promotional activities related to AUSTEDO.
North America G&A Expenses
G&A expenses relating to our North America segment in the first six months of 2022 were $239 million, an increase of 10%, compared to $218 million in the first six months of 2021.
North America Profit
Profit from our North America segment in the first six months of 2022 was $883 million, a decrease of 20%, compared to $1,098 million in the first six months of 2021.
Europe Segment
The following table presents revenues, expenses and profit for our Europe segment for the six months ended June 30, 2022 and 2021:
   
Six months ended June 30,
 
   
2022
  
2021
 
   
(U.S. $ in millions / % of Segment
Revenues)
 
Revenues
  $2,327    100 $2,398    100
Gross profit
   1,397    60.0  1,349    56.2
R&D expenses
   114    4.9  129    5.4
S&M expenses
   393    16.9  424    17.7
G&A expenses
   122    5.2  117    4.9
Other (income) expense
   (1  §   (1  § 
  
 
 
   
 
 
  
 
 
   
 
 
 
Segment profit*
  $769    33.1 $680    28.4
  
 
 
   
 
 
  
 
 
   
 
 
 
*
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 six months of 20212022 were $2,398$2,327 million, flata decrease of 3% or $71 million, compared to the first six months of 2020.2021. In local currency terms, revenues decreasedincreased by 8%3%, compared to the first six months of 2020, as a result2021, which increase was attributed to higher demand for generic and OTC products resulting mainly from the removal of significant customer stocking duerestrictions related to doctor and hospital visits by patients that were previously implemented in response to the
COVID-19
pandemic, in March 2020, partially offsettogether with higher revenues from generic product launches.
In the first six months of 2022, revenues were negatively impacted by changes in buying patternsexchange rate fluctuations of $196 million, net of hedging effects, compared to the first six months of 2021. Revenues in the second quarterfirst six months of 2020.2022 included $39 million from a positive hedging impact, which are included in “Other” in the table below. See note 8d to our consolidated financial statements.
67

Revenues by Major Products and Activities
The following table presents revenues for our Europe segment by major products and activities for the six months ended June 30, 20212022 and 2020:2021:
 
  
Six months ended June 30,
   
Six months ended
June 30,
   
Percentage

Change
 
  
2021
   
2020
   
2022
   
2021
   
2022-2021
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
     
Generic products
  $1,742   $1,769   $1,749   $1,742   § 
AJOVY
   35    9    60    35    71
COPAXONE
   201    193    144    201    (28%) 
Respiratory products
   179    186    137    179    (24%) 
Other
   242    246    238    242    (2%) 
  
 
   
 
   
 
   
 
   
 
 
Total
  $2,398   $2,404   $2,327   $2,398    (3%) 
  
 
   
 
   
 
   
 
   
 
 
§
Represents an amount less than 0.5%.
Europe Gross Profit
Gross profit from our Europe segment in the first six months of 20212022 was $1,349$1,397 million, a decreasean increase of 2%4% compared to $1,371$1,349 million in the first six months of 2020.2021.
Gross profit margin for our Europe segment in the first six months of 2021 decreased2022 increased to 56.2%60.0% compared to 57.0%56.2% in the first six months of 2020, mainly due to a change in the mix of products.2021.
Europe R&D Expenses
R&D expenses relating to our Europe segment in the first six months of 20212022 were $129$114 million, an increasea decrease of 8%12% compared to $120$129 million in the first six months of 2020.2021.
Europe S&M Expenses
S&M expenses relating to our Europe segment in the first six months of 20212022 were $424$393 million, an increasea decrease of 9%7% compared to $390$424 million in the first six months of 2020.2021.
Europe G&A Expenses
G&A expenses relating to our Europe segment in the first six months of 20212022 were $117$122 million, a decreasean increase of 1%4% compared to $118$117 million in the first six months of 2020.2021.
Europe Profit
Profit from our Europe segment in the first six months of 20212022 was $680$769 million, a decreasean increase of 9%13% compared to the first six months of 2020, mainly due to lower revenues, as discussed above.2021.
International Markets Segment
The following table presents revenues, expenses and profit for our International Markets segment for the six months ended June 30, 20212022 and 2020:2021:
 
  
2021
 
2020
   
2022
 
2021
 
  
(U.S. $ in millions / % of Segment Revenues)
   
(U.S. $ in millions /% of Segment Revenues)
 
Revenues
  $975    100 $1,053  100  $946    100 $975    100
Gross profit
   530    54.4 552  52.5   528    55.8  530    54.4
R&D expenses
   35    3.6 34  3.3   39    4.1  35    3.6
S&M expenses
   201    20.7 211  20.0   196    20.7  201    20.7
G&A expenses
   51    5.2 63  6.0   60    6.3  51    5.2
Other (income) expense
   (3  §  (8 (0.8%)    (41   (4.3%)   (3  § 
  
 
   
 
  
 
  
 
   
 
   
 
  
 
   
 
 
Segment profit*
  $245    25.2 $253  24.0  $274    29.0 $245    25.2
  
 
   
 
  
 
  
 
   
 
   
 
  
 
   
 
 
 
*
Segment profit does not include amortization and certain other items.
§
Represents an amount less than 0.5%.
 
6368

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 six months of 20212022 were $975$946 million, a decrease of $78$29 million, or 7%3%, compared to the first six months of 2020.2021. In local currency terms, revenues decreasedincreased by 5%.
In the first six months of 2022, revenues were negatively impacted by exchange rate fluctuations of $81 million, including hedging effects, compared to the first six months of 2020.2021. Revenues in the first six months of 20202022 included $20$5 million from a positivenegative hedging impact, which areis included in “Other” in the table below. The hedging impact in the first six months of 2021 was immaterial. See note 8c8d to our consolidated financial statements.
On February 1, 2021, we completed the sale of the majority of the generic and operational assets of our business venture in Japan.
Revenues by Major Products and Activities
The following table presents revenues for our International Markets segment by major products and activities for the six months ended June 30, 20212022 and 2020:2021:
 
  
Six months ended June 30,
   
Percentage
Change
   
Six months ended
June 30,
   
Percentage
Change
 
  
2021
   
2020
   
2020-2021
   
2022
   
2021
   
2022-2021
 
  
(U.S. $ in millions)
       
(U.S. $ in millions)
     
Generic products
  $799   $875    (9%)   $782   $799    (2%) 
AJOVY
   16    7    143
COPAXONE
   19    23    (18%)    20    19    4
Other
   157    154    2   128    150    (15%) 
  
 
   
 
     
 
   
 
   
 
 
Total
  $975   $1,053    (7%)   $946   $975    (3%) 
  
 
   
 
     
 
   
 
   
 
 
International Markets Gross Profit
Gross profit from our International Markets segment in the first six months of 20212022 was $530$528 million, a decrease of 4% compared to $552$530 million in the first six months of 2020, mainly due to a negative impact from hedging activity as well as regulatory price reductions and generic competition to off-patented products in Japan.2021.
Gross profit margin for our International Markets segment in the first six months of 20212022 increased to 54.4%55.8%, compared to 52.5%54.4% in the first six months of 2020.2021. This increase was mainly due to price increases largely as a result of rising costs due to inflationary pressure.
International Markets R&D Expenses
R&D expenses relating to our International Markets segment in the first six months of 20212022 were $35$39 million, an increase of 3%11% compared to $34$35 million in the first six months of 2020.2021.
International Markets S&M Expenses
S&M expenses relating to our International Markets segment in the first six months of 20212022 were $201$196 million, a decrease of 4%3% compared to $211$201 million in the first six months of 2020.2021.
International Markets G&A Expenses
G&A expenses relating to our International Markets segment in the first six months of 20212022 were $51$60 million, a decreasean increase of 19%17% compared to $63$51 million in the first six months of 2020.2021.
International Markets Other Income
Other income in the first six months of 2022 was $41 million, compared to $3 million in the first six months of 2021. Other income in the first six months of 2022 was mainly the result of settlement proceeds.
International Markets Profit
Profit from our International Markets segment in the first six months of 20212022 was $245$274 million, a decreasean increase of 3%12%, compared to $253$245 million in the first six months of 2020.2021. This decreaseincrease was mainly due to lower gross profit, partially offset by lower S&M and G&A expenses.the higher other income discussed above.
 
6469

Other Activities
Our revenues from other activities in the first six months of 20212022 decreased by 9% to $587$532 million, compared to the first six months of 2020.2021. In local currency terms, revenues decreased by 11%7%.
API sales to third parties in the first six months of 20212022 were $376$357 million, a decrease of 3%5% in both U.S dollarU.S. dollars and local currency terms, compared to the first six months of 2020.2021.
Teva Consolidated Results
Revenues
Revenues in the first six months of 20212022 were $7,892$7,447 million, a decrease of 4%6%, or 7%2% in local currency terms, compared to the first six months of 2020.2021. The decrease in the first six months of 2022 was mainly due to lower revenues from COPAXONE in our North America and Europe segments, and from generic products and BENDEKA/TREANDA in our North America segment, partially offset by higher revenues from generic products in our Europe segment.
Exchange rate movements during the first six months of 2021, including2022, net of hedging effects, negatively impacted revenues by $209$295 million, compared to the first six months of 2020.2021. See note 8c8d to our consolidated financial statements.
Gross Profit
Gross profit in the first six months of 20212022 was $3,750$3,534 million, a decrease of 2%6% compared to the first six months of 2020. This decrease was mainly due to lower gross profit from COPAXONE and Anda in our North America segment as well as lower gross profit from generic products in our Europe segment, partially offset by higher gross profit from generic products in our North America segment.2021.
Gross profit margin was 47.5% in the first six months of 2021,2022, flat compared to 46.5% in the first six months of 2020.2021.
Research and Development (R&D) Expenses
R&D expenses in the first six months of 20212022 were $501$453 million, an increasea decrease of 12%10% compared to the first six months of 2020.2021.    
R&D expenses as a percentage of revenues were 6.1% in the first six months of 2022, compared to 6.4% in the first six months of 2021, compared to 5.4% in the first six months of 2020.2021.
Selling and Marketing (S&M) Expenses
S&M expenses in the first six months of 20212022 were $1,200$1,178 million, a decrease of 1%2% compared to the first six months of 2020. 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.”2021.
S&M expenses as a percentage of revenues were 15.8% in the first six months of 2022, compared to 15.2% in the first six months of 2021, compared to 14.7% in the first six months of 2020.2021.
General and Administrative (G&A) Expenses
G&A expenses in the first six months of 20212022 were $532$609 million, a decreasean increase of 6%15% compared to the first six months of 2020.2021.
G&A expenses as a percentage of revenues were 8.2% in the first six months of 2022, compared to 6.7% in the first six months of 2021, compared to 6.9% in the first six months of 2020.2021.
Intangible Asset Impairments
We recorded expenses of $274$199 million for identifiable intangible asset impairments, in the first six months of 2021,2022, compared to expenses of $768$274 million in the first six months of 2020.2021. See note 5 to our consolidated financial statements.
Goodwill Impairment
NoWe recorded a goodwill impairments were recordedimpairment charge of $745 million in the first six months of both 20212022, of which $479 million is related to our International Markets reporting unit and 2020.$266 million is related to Teva’s API reporting unit. See note 6 to our consolidated financial statements.
70

Other Asset Impairments, Restructuring and Other Items
We recorded expenses of $165$246 million for other asset impairments, restructuring and other items in the first six months of 2021,2022, compared to expenses of $502$165 million in the first six months of 2020.2021. See note 12 to our consolidated financial statements.
65

Legal Settlements and Loss Contingencies
In the first six months of 2021,2022, we recorded expenses of $110$1,854 million in legal settlements and loss contingencies, compared to incomean expense of $12$110 million in the first six months of 2020.2021. See note 9 to our consolidated financial statements.
Other Income
Other income in the first six months of 20212022 was $48$87 million, compared to $22$48 million in the first six months of 2020. The2021. Other income in the second quarterfirst six months of 2022 was mainly the result of settlement proceeds in our International Markets segment as well as a capital gain related to the sale of an R&D site. Other income in the first six months of 2021 was mainly due to capital gains related to the sale of certain OTC assets.
Operating Income (Loss)
Operating loss was $1,662 million in the first six months of 2022, compared to operating income wasof $1,015 million in the first six months of 2021, compared to $364 million2021.
Operating loss as a percentage of revenues was 22.3% in the first six months of 2020.
Operating2022, compared to operating income as a percentage of revenues wasof 12.9% in the first sixth months of 2021, compared to 4.4% in the first six months of 2020.2021.
Financial Expenses, Net
Financial expenses were $468 million in the first six months of 2022, compared to $564 million in the first six months of 2021, compared to $448 million2021. Financial expenses in the first six months of 2020.2022 were mainly comprised of interest expenses of $463 million. Financial expenses in the first six months of 2021 were mainly comprised of interest expenses of $479 million and loss on revaluations of marketable securities of $98 million (see note 16 to our consolidated financial statements). Financial expenses in the first six months of 2020 were mainly comprised of interest expenses of $482 million, partially offset by a gain of $29 million resulting from our hedging and derivatives activities.million.
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 six months ended June 30, 20212022 and 2020:2021:
 
.
  
Six months ended
June 30,
 
  
Six months ended
 
  
June 30,
 
  
2021
   
2020
   
2022
   
2021
 
  
(U.S. $ in millions)
   
(U.S. $ in millions)
 
North America profit
  $1,098   $1,123   $883   $1,098 
Europe profit
   680    746    769    680 
International Markets profit
   245    253    274    245 
  
 
   
 
   
 
   
 
 
Total reportable segments profit
   2,023    2,121    1,926    2,023 
Profit of other activities
   87    102    107    87 
  
 
   
 
   
 
   
 
 
Total segments profit
   2,111    2,223    2,033    2,111 
Amounts not allocated to segments:
        
Amortization
   414    507    412    414 
Other assets impairments, restructuring and other items
   165    502    246    165 
Goodwill impairment
   —      —      745    —   
Intangible asset impairments
   274    768    199    274 
Legal settlements and loss contingencies
   110    (12   1,854    110 
Other unallocated amounts
   132    93    240    132 
  
 
   
 
   
 
   
 
 
Consolidated operating income (loss)
   1,015    364    (1,662   1,015 
  
 
   
 
   
 
   
 
 
Financial expenses, net
   564    448    468    564 
  
 
   
 
   
 
   
 
 
Consolidated income (loss) before income taxes
  $451   $(84  $(2,131  $451 
  
 
   
 
   
 
   
 
 
71

Tax Rate
In the first six months of 2022, we recognized a tax benefit of $899 million, on
pre-tax
loss of $2,131 million. In the first six months of 2021, we recognized a tax expense of $159 million, on
pre-tax
income of $451 million. In the first six months of 2020, we recognized a tax benefit of $163 million, on
pre-taxSee note 11 to our consolidated financial statements.
loss of $84 million. Our tax rate in the first six months of 2021 was mainly affected by impairments, amortization, legal settlements and interest expense disallowance.
66

Share in (Profits) Losses of Associated Companies, Net
Share in lossprofits of associated companies, net in the first six months of 20212022 was $14 million. We did not have any$21 million, compared to share in (profits) lossesprofits of $14 million in the first six months of 2021. The share in profits of associated companies, net in the first six months of 2020.2022 was mainly related to the difference between the book value of our investment in Novetide and its fair value as of the date we completed its acquisition in January 2022.
Net Income (Loss) Attributable to Teva
Net loss was $1,187 million in the first six months of 2022, compared to net income wasof $284 million in the first six months of 2021, compared to $209 million in the first six months of 2020.2021.
Diluted Shares Outstanding and Earnings (Loss) per Share
The weighted average diluted shares outstanding used for the fully diluted share calculation for the six months ended June 30, 2022 and 2021 were 1,109 million and 2020 was 1,108 million and 1,098 million shares, respectively.shares.
In computing
Diluted loss per share was $1.07 in the first six months of 2022, compared to diluted earnings per share for the six months ended June 30, 2021 and June 30, 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. No account was taken of the potential dilution by the convertible senior debentures, since they had an anti-dilutive effect on earnings per share.
Diluted earnings per share were $0.26 in the first six months of 2021, compared2021. See note 13 to diluted earnings per share of $0.19 in the first six months of 2020.our consolidated financial statements.
Impact of Currency Fluctuations on Results of Operations
In the first six months of 2021,2022, approximately 47%48% 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 markets in which we operate (primarily the euro, British pound, Canadian dollar, Russian ruble, Japanese yen, Swiss franc and new Israeli shekel, Canadian dollar and Russian ruble)shekel) impact our results.
During the first six months of 2021,2022, the following main currencies relevant to our operations decreased in value against the U.S. dollar: Turkish lira by 47%, Argentinian peso by 29%, Turkish lira by 18%, Brazilian realHungarian forint by 10%13%, Russian rubleChilean peso by 7%13%, Japanese yen by 12%, Swedish krona by 12%, Polish zloty by 11% and Ukrainian hryvniaeuro by 7%9% (all compared on a
six-month
average basis). The following main currenciescurrency relevant to our operations increased in value against the U.S. dollar: Australian dollarBrazilian real by 17%, Swedish krona by 15%, Chilean peso by 13%, British pound by 10%, euro by 9%, Canadian dollar by 9% and new Israeli shekel by 7%6%.
As a result, exchange rate movements during the first six months of 2021 positively2022 negatively impacted overall revenues by $209$295 million and our operating income by $12$63 million, in comparison to the first six months of 2020.2021.
In the first six months of 2022, a positive hedging impact of $35 million was recognized under revenues, and a positive hedging impact of $4 million was recognized under cost of sales. In the first six months of 2021, a positive hedging impact of $13 million was recognized under revenues and a minimal negative impact was recognized under cost of sales. In the first six months of 2020, a positive hedging impact of $40 million was recognized under revenues and a positive impact of $4 million was recognized under cost of sales.
Hedging transactions against future projected revenues and expenses are recognized on the balance sheet at their fair value on a quarterly basis, while the foreign exchange impact on the underlying revenues and expenses may occur in subsequent quarters. See note 8c8d to our consolidated financial statements.
Liquidity and Capital Resources
Total balance sheet assets were $49,195$45,932 million as of June 30, 2021,2022, compared to $49,004$47,666 million as of MarchDecember 31, 2021.
72

Our working capital balance, which includes accounts receivables net of SR&A, inventories, prepaid expenses and other current assets, accounts payables, employee-related obligations, accrued expenses and other current liabilities, was $1,196$814 million as of June 30, 2021,2022, compared to $1,179$787 million as of MarchDecember 31, 2021. This increase was mainly due to an increase in inventory levels and accounts receivables, net of SR&A, partially offset by an update to the estimated settlement provision recorded in connection with the remaining opioid cases and an increase in accounts payables.
Employee-related obligations, as of June 30, 2022 were $467 million, compared to $563 million as of December 31, 2021. The decrease in the first six months of 2022 was mainly due to performance incentive payments to employees for 2021.
Cash investment in property, plant and equipment in the second quarter of 20212022 was $113$127 million, compared to $150$113 million in the firstsecond quarter of 2021. Depreciation in both the second and first quartersquarter of 20212022 was $146 million, compared to $134 million.million in the second quarter of 2021.
Cash and cash equivalents and short-term and long-term investments as of June 30, 20212022 were $2,479$2,108 million, compared to $1,933$2,191 million as of MarchDecember 31, 2021. The increase in the second quarter of 2021 was mainly due to cash flow 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.
67

OurTeva’s principal sources of short-term liquidity are ourits cash on hand, existing cash investments, liquid securities and available credit facilities, primarily, our $2.3as of June 30, 2022, its $1.8 billion unsecured syndicated sustainability-linked revolving credit facility, entered into in April 20192022 (“RCF”).
The RCF agreement provides for two separate tranches, a $1.15 billion tranche A and a $1.15 billion tranche B. Tranche A has a maturity date of April 8, 2022, of which an amount of $1.065 billion was extended twice, initially See note 7 to April 8, 2023 and then to April 8, 2024. Tranche B has a maturity date of April 8, 2024. Loans and letters of credit will be available from time to time under each tranche for Teva’s general corporate purposes.
The RCF contains certain covenants, including certain limitations on incurring liens and indebtedness and maintenance of certainour consolidated 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 was 5.50x through June 30, 2021, gradually declines to 5.00x in the third and fourth quarters of 2021, 4.50x in the first and second quarters of 2022, and continues to gradually decline over the remaining term of the RCF to 3.50x in the first quarter of 2023.
The RCF can be used for general corporate purposes, including repaying existing debt. As of June 30, 2021, no amounts were outstanding under the RCF. During July 2021, $500 million was drawn down 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.statements.
Debt Balance and Movements
As of June 30, 2021,2022, our debt was $25,132$22,082 million, compared to $24,986$23,043 million as of MarchDecember 31, 2021. This increasedecrease was mainly due to $680 million from exchange rate fluctuations.
In July 2021, we repaid $1,475fluctuations and $296 million of our 2.2% senior notes repaid at maturity.
Our debt as of June 30, 20212022 was effectively denominated in the following currencies: 65%63% in U.S. dollars, 32%34% in euros and 3% in Swiss francs.
The portion of total debt classified as short-term as of June 30, 20212022 was 14%8%, compared to 11%6% as of MarchDecember 31, 2021.
Our financial leverage was 69% as of June 30, 2021 and2022, compared to 67% as of MarchDecember 31, 2021.
Our average debt maturity was approximately 5.36.1 years as of June 30, 2021,2022, compared to 5.66.4 years as of MarchDecember 31, 2021.
Total Equity
Total equity was $11,311$9,828 million as of June 30, 2021,2022, compared to $10,975$11,244 million as of MarchDecember 31, 2021. This increasedecrease was mainly due to a net incomeloss of $221$1,211 million and a positivenegative impact of $79$282 million from exchange rate fluctuations.
Exchange rate fluctuations affected our balance sheet, as approximately 56%58% of our net assets in the second quarteras of 2021June 30, 2022 (including both
non-monetary
and monetary assets) were in currencies other than the U.S. dollar. When compared to MarchDecember 31, 2021, changes in currency rates had a positivenegative impact of $79$282 million on our equity as of June 30, 2021, mainly due to the changes2022. The following main currencies decreased in value against the U.S. dollar of:dollar: the Turkish lira by 27%, the Japanese yen by 7%19%, the Swiss francBritish pound by 4%11%, the euroPolish zloty by 3%10%, the Chilean peso by 9%, the Croatian kuna by 3%9%, the Polish zlotyBulgarian lev by 2%8%, the euro by 8% and the Chilean pesoIndian rupee by 2%6 %. The following main currency increased in value against the U.S. dollar: the Russian ruble by 30%. All comparisons are on a
quarter-end
year to
quarter-end
date basis.
Cash Flow
We seek to continually improve the efficiency of our working capital management. From time to time, as part of our cash and commercial relationship management activities, we may make decisions in our commercial and supply chain activities which may drive an acceleration of receivable payments from customers or deceleration of payments to vendors, having the effect of increasing or decreasing cash from operations in an individual period. Such decisions had no materialmay have an impact on our
year-to-date
annual operating cash flow measurement, but may impact
quarter-to-quarteras well as on our quarterly results.
results.
 
6873

Cash flow generated from operating activities during the second quarter of 20212022 was $218$123 million, compared to $273$218 million in the second quarter of 2020. The2021. This decrease was mainly due to payments related to legal settlements in the second quarter of 2021 was mainly due to favorable collection of payments from customers2022, partially offset by an increase in accounts payables.
During the second quarter of 2020,2022, we generated free cash flow of $301 million, which resultedwe define as comprising $123 million in cash flow generated from increased salesoperating activities, $287 million in the first quarterbeneficial interest collected in exchange for securitized accounts receivables and $18 million in proceeds from divestitures of 2020.
businesses and other assets, partially offset by $127 million in cash used for capital investment. During the second quarter of 2021, we generated free cash flow of $625 million, which we define as comprising $218 million in cash flow generated from operating activities, $405 million in beneficial interest collected in exchange for securitized accounts receivables and $115 million in proceeds from divestitures of businesses and other assets, partially offset by $113 million in cash used for capital investment. During the second quarter of 2020, we generated free cash flow of $582 million, comprising $273 million in cash flow generated from operating activities, $401 million in beneficial interest collected in exchange for securitized accounts receivables and $39 million in proceeds from sale of property, plant and equipment and intangible assets, partially offset by $131 million in cash used for capital investment. The increasedecrease in the second quarter of 20212022 resulted mainly from higher proceeds from divestitures of businesses and other assets, partially offset by lower cash flow from operating activities.activities as well as lower proceeds from sales of assets.
Dividends
We have not paid dividends on our ordinary shares or ADSs since December 2017.
Commitments
In addition to financing obligations under short-term debt and long-term senior notes and loans, debentures and convertible debentures, our major contractual obligations and commercial commitments include leases, royalty payments, contingent payments pursuant to acquisition agreements and participation in joint ventures associated with R&D activities.
In October 2021, Teva announced a license agreement with MODAG GmbH (“Modag”) that will provide Teva an exclusive global license to develop, manufacture and commercialize Modag’s lead compound
(TEV-56286)
and a related compound
(TEV-56287).
TEV-56286
was initially developed for the treatment of Multiple System Atrophy (“MSA”) and Parkinson’s disease, and has the potential to be applied to other treatments for neurodegenerative disorders, such as Alzheimer’s disease. A phase 1b clinical trial is currently being completed for
TEV-56286.
In the fourth quarter of 2021, Teva made an upfront payment of $10 million to Modag that was recorded as an R&D expense. Modag may be eligible for future development milestone payments, totaling an aggregate amount of up to $70 million, as well as future commercial milestones and royalties.
In August 2020, weTeva entered into a partnershipan agreement with biopharmaceutical company Alvotech for the exclusive commercialization in the U.S. of five biosimilar product candidates. The initial pipeline for this partnershipcollaboration contains biosimilar candidates addressing multiple therapeutic areas, including a proposed biosimilar to Humira
®
. Under this agreement, Alvotech is responsible for the development, registration and supply of the biosimilar product candidates and Teva will exclusively commercialize the products in the United States. WeTeva paid an upfront payment in the third quarter of 2020 and additional upfront and milestone payments in the second quarter of 2021 that were recorded as R&D expenses. Additional development and commercial milestone payments of up to $450$455 million, as well as royalty payments, may be payable by Teva over the next few years. Teva and Alvotech will share profit from the commercialization of these biosimilars. In March 2021,Alvotech was previously involved in litigation involving certain IP and trade secrets claims filed by Abbvie sued Alvotech for allegedly misappropriating confidential information relatingin relation to Alvotech’s proposed biosimilar to Humira
®
., all of which were settled on March 8, 2022. Pursuant to that settlement, Alvotech has disputed these claims. In addition, thereand Teva may sell Alvotech’s proposed biosimilar to Humira
®
in the United States beginning on July 1, 2023, provided that U.S. regulatory approval is pending patent litigation between Abbvie and Alvotech.obtained by that date.
In September 2016, weTeva and Regeneron entered into a collaborative agreement with Regeneron to develop and commercialize Regeneron’s pain medication product, fasinumab. WeTeva and Regeneron share in the global commercial rights to this product with Regeneron (excluding Japan, Korea and nine other Asian countries), as well as ongoing associated R&D costs of approximately $1 billion. WeTeva made an upfront payment of $250 million to Regeneron in the third quarter of 2016 and additional payments for achievement of development milestones in an aggregate amount of $120 million were paid during 2017 and 2018. The agreement stipulates additional development and commercial milestone payments of up to $2,230 million, as well as future royalties. For information regardingCurrently, all
non-essential
activities and related expenditures for fasinumab see “—North America Segment —Product Launches and Pipeline” above.have been put on hold. Next steps will be assessed together with Regeneron, with the intention of discussing data with the FDA.
74

In October 2016, weNovember 2013, Teva entered into a collaborativean agreement with Celltrion to commercialize Truxima
®
and Herzuma
®
, two biosimilar productsMedinCell for the U.S.development and Canadian markets. We paid Celltrion $160 million, of which we received an aggregate credit of $60 million as of March 31, 2021. We share the profit from the commercialization of these products with Celltrion. These two products, Truxima and Herzuma, were approved bymultiple long-acting injectable products. The lead product candidate selected was risperidone LAI
(TV-46000)
suspension for subcutaneous use for the treatment of schizophrenia. In August 2021, the FDA accepted the new drug application (“NDA”) for risperidone LAI, based on phase 3 data from two pivotal studies. Teva leads the clinical development and regulatory process and is responsible for commercialization of this product candidate. MedinCell may be eligible for development milestones, and future commercial milestones of up to $112 million in November and December 2018, respectively and were launchedrespect of risperidone LAI. Teva will also pay MedinCell royalties on net sales. In April 2022, the FDA issued a Complete Response Letter (“CRL”) regarding the NDA for risperidone LAI. Teva is working to address the issues raised in the United States in November 2019 and March 2020, respectively. No additional milestone payments are expected.
CRL with a view to resubmission.
We are committed to paypaying 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.
69

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.
20212022 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, 2020.2021.
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:
 
amortization of purchased intangible assets;
 
legal settlements and material litigation fees and/or loss contingencies, due to the difficulty in predicting their timing and scope;
 
impairments of long-lived assets, including intangibles, property, plant and equipment and goodwill;
 
75

restructuring expenses, including severance, retention costs, contract cancellation costs and certain accelerated depreciation expenses primarily related to the rationalization of our plants or to certain other strategic activities, such as the realignment of R&D focus or other similar activities;
 
acquisition- or divestment- related items, including changes in contingent consideration, integration costs, banker and other professional fees and inventory
step-upstep-up;
and
in-process
R&D acquired in development arrangements;
 
expenses related to our equity compensation;
 
significant
one-time
financing costs, amortization of issuance costs and terminated derivative instruments, and marketable securities investment valuation gains/losses;
 
unusual tax items;
 
70

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.
71

TableCommencing the first quarter of Contents2022, we no longer exclude IPR&D acquired in development arrangements from our
non-GAAP
financial measures. No IPR&D acquired in development arrangements was recorded in our comparable non-GAAP financial measures for the second quarter of 2021. In our comparable
non-GAAP
financial measures for the six months ended June 30, 2021, we excluded $5 million IPR&D acquired in development. We are not recasting the
non-GAAP
presentation for the six months ended June 30, 2021 since the adjustment is not significant. We are making this change to our presentation of
non-GAAP
financial measures to improve the comparability of our
non-GAAP
presentation to those of other companies in the pharmaceutical industry that are making a similar change to their presentations beginning in the first quarter of 2022.
The following tables present supplemental
non-GAAP
data, in U.S. dollar,dollars, which we believe facilitates an understanding of the factors affecting our business. In these tables, we exclude the following amounts:
76

The following table presents the GAAP measures, related
non-GAAP
adjustments and the corresponding
non-GAAP
amounts for the applicable periods:
 
 
Three Months Ended June 30, 2021
  
Three Months Ended June 30, 2022
 
 
U.S. $ and shares in millions (except per share amounts)
  
U.S. $ and shares in millions (except per share amounts)
 
 GAAP Excluded for non-GAAP measurement Non-GAAP  GAAP Excluded for
non-GAAP
measurement
 Non-GAAP 
   
Amortization
of purchased
intangible
assets
 
Legal
settlements
and loss
contingencies
 
Impairment
of long
lived
assets
 
Restructuring
costs
 
Costs
related to
regulatory
actions
taken in
facilities
 
Equity
compensation
 Contingent
consideration
 
Other
non-GAAP
items*
 
Other
items
      Amortization
of purchased
intangible
assets
 Legal
settlements
and loss
contingencies
 Goodwill
impairment
 
Impairment
of long
lived
assets
 Restructuring
costs
 Costs
related to
regulatory
actions
taken in
facilities
 Equity
compensation
 Contingent
consideration
 Other
non-GAAP

items*
 Accelerated
Depreciation
 Other
items
   
Net revenues
 3,910           3,910   3,786              3,786 
Cost of sales
 2,037  148     8  6   50   1,826   1,992   191       3   6    34   32    1,726 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Gross profit
 1,873  148     8  6   50   2,084   1,794   191       3   6    34   32    2,059 
Gross profit margin
 47.9          53.3  47.4             54.4
R&D expenses
 248       5     243   228         5       222 
S&M expenses
 615  25      8     582   594   21        9    0     563 
G&A expenses
 242       11     231   313         18    37     258 
Other income
 (43        (37  (6  (34          (31    (3
Legal settlements and loss contingencies
 6   6          —     729    729            —   
Other assets impairments, restructuring and other items
 28    32  (13   (19 28    —     118      14   35     61   8     —   
Intangible assets impairments
 195    195         —     51      51          —   
Goodwill Impairment
  745     745          
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Operating income (loss)
 582  173  6  226  (13 8  29  (19 42   1,034   (949  212   729   745   65   35   3   39   61   48   32    1,019 
Financial expenses, net
 274          34  240   211             23   188 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Income (loss) before income taxes
 308  173  6  226  (13 8  29  (19 42  34  794   (1,160  212   729   745   65   35   3   39   61   48   32   23   831 
Income taxes
 98          (36 133   (900            **(965  64 
Share in (profits) losses of associated companies – net
 (11         (3 (8
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss)
 221  173  6  226  (13 8  29  (19 42  (5 669   (259  212   729   745   65   35   3   39   61   48   32   (942  767 
Net income (loss) attributable to
non-controlling
interests
 14          (3 18   (27            (39  13 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss) attributable to Teva
 207  173  6  226  (13 8  29  (19 42  (8 651   (232  212   729   745   65   35   3   39   61   48   32   (981  754 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
EPS - Basic
 0.19          0.40  0.59   (0.21            0.89   0.68 
EPS - Diluted
 0.19          0.40  0.59   (0.21            0.89   0.68 
The
non-GAAP
diluted weighted average number of shares was 1,114 million for the three months ended June 30, 2022.
Non-GAAP
income taxes for the three months ended June 30, 2022 were 8% on
pre-tax
non-GAAP
income.
*
Other
non-GAAP
items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
**
Includes a portion of the realization of losses related to an investment in one of our U.S. subsidiaries as well as corresponding tax effects on non-GAAP items.
77

  
Three Months Ended June 30, 2021
 
  
U.S. $ and shares in millions (except per share amounts)
 
  GAAP  Excluded for
non-GAAP
measurement
  Non-GAAP 
     Amortization
of purchased
intangible
assets
  Legal
settlements
and loss
contingencies
  
Impairment
of long
lived
assets
  Restructuring
costs
  Costs
related to
regulatory
actions
taken in
facilities
  Equity
compensation
  Contingent
consideration
  Other
non-GAAP

items*
  Other
items
    
Net revenues
  3,910            3,910 
Cost of sales
  2,037   148      8   6    50    1,826 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Gross profit
  1,873   148      8   6    50    2,084 
Gross profit margin
  47.9           53.3
R&D expenses
  248        5      243 
S&M expenses
  615   25       8      582 
G&A expenses
  242        11    —      231 
Other income
  (43         (37   (6
Legal settlements and loss contingencies
  6    6          —   
Other assets impairments, restructuring and other items
  28     32   (13    (19  28    —   
Intangible assets impairments
  195     195         —   
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Operating income (loss)
  582   173   6   226   (13  8   29   (19  42    1,034 
Financial expenses, net
  274           34   240 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Income (loss) before income taxes
  308   173   6   226   (13  8   29   (19  42   34   794 
Income taxes
  98           (36  133 
Share in (profit) losses of associated companies – net
  (11          (3  (8
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss)
  221   173   6   226   (13  8   29   (19  42   (5  669 
Net income (loss) attributable to
non-controlling
interests
  14           (3  18 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss) attributable to Teva
  207   173   6   226   (13  8   29   (19  42   (8  651 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
EPS - Basic
  0.19           0.40   0.59 
EPS - Diluted
  0.19           0.40   0.59 
The
non-GAAP
diluted weighted average number of shares was 1,109 million for the three months ended June 30, 2021.
Non-GAAP
income taxes for the three months ended June 30, 2021 were 17% on
pre-tax
non-GAAP
income.
*
Other
non-GAAP
items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
 
7278

 
Three Months Ended June 30, 2020
  
Six Months Ended June 30, 2022
 
 
U.S. $ and shares in millions (except per share amounts)
  
U.S. $ and shares in millions (except per share amounts)
 
 GAAP Excluded for non-GAAP measurement Non-GAAP  GAAP Excluded for
non-GAAP
measurement
 Non-GAAP 
   
Amortization
of purchased
intangible
assets
 
Legal
settlements
and loss
contingencies
 
Impairment
of long
lived
assets
 
Other
R&D
expenses
 
Restructuring
costs
 
Costs
related to
regulatory
actions
taken in
facilities
 
Equity
compensation
 
Contingent
consideration
 
Other
non-GAAP
items*
 
Other
items
      Amortization
of purchased
intangible
assets
 Legal
settlements
and loss
contingencies
 Goodwill
impairment
 
Impairment
of long-
lived
assets
 Restructuring
costs
 Costs
related to
regulatory
actions
taken in
facilities
 Equity
compensation
 Contingent
consideration
 Accelerated
depreciation
 Other
non-GAAP

items*
 Other
items
   
Net revenues
 3,870                      3,870 
Net revenue
  7,447              7,447 
Cost of sales
 2,107  219          6  6    16    1,859   3,913   368       4   11    33   95    3,401 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Gross profit
 1,763  219          6  6    16    2,011   3,534   368       4   11    33   95    4,045 
Gross profit margin
 45.5                     52.0  47.5             54.3
R&D expenses
 225        (13     5        233   453         10       443 
S&M expenses
 597  30            8        559   1,178   43        16     3    1,115 
G&A expenses
 264              11    8    245   609         26     73    510 
Other income
 (9                 (4   (6
Other (income) expense
  (87           (31   (55
Legal settlements and loss contingencies
 13    13                   —     1,854    1,854             
Other assets impairments, restructuring and other items
 381      277    33      76  (6    —     246      30   92     94    30     
Intangible assets impairments
 120      120                 —   
Intangible assets impairment
  199      199           
Goodwill impairment
  745     745          
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Operating income (loss)
 173  249  13  396  (13 33  6  30  76  14    979   (1,662  412   1,854   745   230   92   4   63   94   33   170    2,033 
Financial expenses, net
 223                    (5 229   468             33   435 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Income (loss) before income taxes
 (51 249  13  396  (13 33  6  30  76  14  (5 751   (2,131  412   1,854   745   230   92   4   63   94   33   170   33   1,597 
Income taxes
 (104                   (231 128   (899            **(1,105  206 
Share in (profits) losses of associated companies – net
  (21            (22  1 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss)
 53  249  13  396  (13 33  6  30  76  14  (237 623   (1,211  412   1,854   745   230   92   4   63   94   33   170   (1,094  1,390 
Net income (loss) attributable to
non-controlling
interests
 (87                   (105 19   (24            (50  26 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss) attributable to Teva
 140  249  13  396  (13 33  6  30  76  14  (342 605   (1,187  412   1,854   745   230   92   4   63   94   33   170   (1,144  1,363 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
EPS - Basic
 0.13                    0.42  0.55   (1.07            2.30   1.23 
EPS - Diluted
 0.13                    0.42  0.55   (1.07            2.29   1.22 
The
non-GAAP
diluted weighted average number of shares was 1,1001,116 million for the threesix months ended June 30, 2020.    2022.
Non-GAAP
income taxes for the threesix months ended June 30, 20202022 were 17%13% on
pre-tax
non-GAAP
income.
*
Other
non-GAAP
items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
**
Includes a portion of the realization of losses related to an investment in one of our U.S. subsidiaries as well as corresponding tax effects on non-GAAP items.
 
7379

 
Six Months Ended June 30, 2021
  
Six months ended June 30, 2021
 
 
U.S. $ and shares in millions (except per share amounts)
  
U.S. $ and shares in millions (except per share amounts)
 
 GAAP Excluded for non-GAAP measurement Non-GAAP  GAAP Excluded for
non-GAAP
measurement
 Non-GAAP 
   
Amortization
of purchased
intangible
assets
 
Legal
settlements
and loss
contingencies
 
Impairment
of long
-lived
assets
 
Restructuring
costs
 
Costs
related to
regulatory
actions
taken in
facilities
 
Equity
compensation
 
Contingent
consideration
 
Other
non-GAAP
items*
 
Other
items
      Amortization
of purchased
intangible
assets
 Legal
settlements
and loss
contingencies
 
Impairment
of long-
lived
assets
 Restructuring
costs
 Costs
related to
regulatory
actions
taken in
facilities
 Equity
compensation
 Contingent
consideration
 Other
non-GAAP

items*
 Other
items
   
Net revenue
 7,892           7,892   7,892                     7,892 
Cost of sales
 4,141  363     13  12   91   3,663   4,141   363         13   12     91     3,663 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Gross profit
 3,750  363     13  12   91   4,228   3,750   363         13   12     91     4,228 
Gross profit margin
 47.5          53.6  47.5                    53.6
R&D expenses
 501       10   5   487   501             10     5     487 
S&M expenses
 1,200  52      18       1,131   1,200   52           18         1,131 
G&A expenses
 532       21   0   510   532             21     —       510 
Other (income) expense
 (48        (37  (11  (48                (37    (11
Legal settlements and loss contingencies
 110   110             110     110                 —   
Other assets impairments, restructuring and other items
 165    80  69    (16 33       165       80   69       (16  33     —   
Intangible assets impairment
 274    274            274       274               —   
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Operating income (loss)
 1,015  414  110  354  69  13  60  (16 92   2,111   1,015   414   110   354   69   13   60   (16  92   —     2,111 
Financial expenses, net
 564          98  467   564                   98   467 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Income (loss) before income taxes
 451  414  110  354  69  13  60  (16 92  98  1,644   451   414   110   354   69   13   60   (16  92   98   1,644 
Income taxes
 159          (120 280   159                   (120  280 
Share in (profits) losses of associated companies – net
 (14         (1 (13
Share in losses of associated companies – net
  (14                  (1  (13
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss) attributable to Teva
  306   414   110   354   69   13   60   (16  92   (24  1,377 
Net income (loss) attributable to
non-controlling
interests
  21                   (6  28 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss)
 306  414  110  354  69  13  60  (16 92  (24 1,377   284   414   110   354   69   13   60   (16  92   (30  1,350 
Net income (loss) attributable to
non-controlling
interests
 21          (6 28 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
Net income (loss) attributable to Teva
 284  414  110  354  69  13  60  (16 92  (30 1,350 
 
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
  
 
 
EPS - Basic
 0.26          0.97  1.23   0.26                   0.97   1.23 
EPS - Diluted
 0.26          0.96  1.22   0.26                   0.96   1.22 
The
non-GAAP
diluted weighted average number of shares was 1,108 million for the six months ended June 30, 2021.
Non-GAAP
income taxes for the six months ended June 30, 2021 were 17% on
pre-tax
non-GAAP
income.
*
Other
non-GAAP
items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
 
7480

  
Six months ended June 30, 2020
 
  
U.S. $ and shares in millions (except per share amounts)
 
  GAAP  Excluded for non-GAAP measurement  Non-GAAP 
     
Amortization
of purchased
intangible
assets
  
Legal
settlements
and loss
contingencies
  
Impairment
of long-
lived
assets
  Restructuring
costs
  
Costs
related to
regulatory
actions
taken in
facilities
  Equity
compensation
  Contingent
consideration
  
Other
non-GAAP
items*
  Other
items
    
Net revenue
  8,227            8,227 
Cost of sales
  4,402   443      11   12    32    3,905 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Gross profit
  3,826   443      11   12    32    4,322 
Gross profit margin
  46.5           52.5
R&D expenses
  446        9    (17   454 
S&M expenses
  1,210   64       17      1,129 
G&A expenses
  567        21    12    535 
Other (income) expense
  (22         (3   (19
Legal settlements and loss contingencies
  (12   (12         —   
Other assets impairments, restructuring and other items
  502     352   73     83   (5   —   
Intangible assets impairment
  768     768         —   
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Operating income (loss)
  364   507   (12  1,121   73   11   60   83   18      2,223 
Financial expenses, net
  448           6   442 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Income (loss) before income taxes
  (84  507   (12  1,121   73   11   60   83   18   6   1,781 
Income taxes
  (163          (465  303 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss) attributtible to Teva
  78   507   (12  1,121   73   11   60   83   18   (460  1,478 
Net income (loss) attributable to
non-controlling
interests
  (131          (169  38 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
Net income (loss)
  209   507   (12  1,121   73   11   60   83   18   (629  1,440 
 
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
  
 
 
 
EPS - Basic
  0.19            1.32 
EPS - Diluted
  0.19            1.31 
The
non-GAAP
diluted weighted average number of shares was 1,098 million for the six months ended June 30, 2020.
Non-GAAP
income taxes for the six months ended June 30, 2021 were 17% on
pre-tax
non-GAAP
income.
*
Other
non-GAAP
items include other exceptional items that we believe are sufficiently large that their exclusion is important to facilitate an understanding of trends in our financial results, such as certain accelerated depreciation expenses and inventory write offs, primarily related to the rationalization of our plants and other unusual events.
75

Non-GAAP
Tax Rate
Non-GAAP
income taxes in the second quarter of 2022 were $64 million, or 7.7%, on
pre-tax
non-GAAP
income of $831 million.
Non-GAAP
income taxes in the second quarter of 2021 were $133 million, or 17%, on
pre-tax
non-GAAP
income of $794 million.
Non-GAAP
income taxes in the second quarter of 2020 were $128 million, or 17%, on
pre-tax
non-GAAP
income of $751 million. Our
non-GAAP
tax rate in the second quarter of 20212022 was mainly affected by a portion of the realization of losses related to an investment in one of our U.S. subsidiaries, as mentioned in note 11 to our consolidated financial statements, as well as the mix of products we sold and interest expense disallowance.
disallowances.
Non-GAAP
income taxes in the first six months of 2022 were $206 million, or 12.9%, on
pre-tax
non-GAAP
income of $1,597 million.
Non-GAAP
income taxes in the first six months of 2021 were $280 million, or 17%, on
pre-tax
non-GAAP
income of $1,644 million.
Non-GAAP
income taxes in the first six months of 2020 were $303 million, or 17%, on
pre-tax
non-GAAP
income of $1,781 million.
We expect our annual
non-GAAP
tax rate for 20212022 to be between 17%13% to 18%14%, similar tolower than our
non-GAAP
tax rate for 2020,2021, which was 17%.16.4%, mainly due to the effect of a portion of the realization of losses related to an investment in one of our U.S. subsidiaries, as mentioned in note 11 to our consolidated financial statements.
Off-Balance
Sheet Arrangements
Except for securitization transactions, which are disclosed in note 10(f) to our consolidated financial statements included in our Annual Report on Form
10-K
for the year ended December 31, 2020,2021, 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, 2020.2021.
Recently Issued Accounting Pronouncements
See note 1 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, 2020.2021.
 
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 June 30, 2021,2022, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, Teva’s disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
During the quarter ended June 30, 2021,2022, there were no changes in internal control over financial reporting that materially affected or are reasonably likely to materially affect Teva’s internal control over financial reporting.
 
7681

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 10 to the consolidated financial statements included in Part I, Item 1 of this Quarterly Report on Form
10-Q.
 
ITEM 1A.
RISK FACTORS
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, 2020.2021.
 
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 June 30, 2021.2022.
Repurchase of Shares
We did not repurchase any of our shares during the three months ended June 30, 20212022 and currently cannot conduct share repurchases or pay dividends due to our accumulated deficit.
 
ITEM 3.
DEFAULTS UPON SENIOR SECURITIES
Not applicable.
 
ITEM 4.
MINE SAFETY DISCLOSURES
Not applicable.
 
ITEM 5.
OTHER INFORMATION
None.
 
7782

ITEM 6.
EXHIBITS
 
3.1Articles of Association (1)
31.1  Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
31.2  Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 *
32  Certification of the Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 *
101.INS  Inline XBRL Taxonomy Instance Document
101.SCH  Inline XBRL Taxonomy Extension Schema Document
101.CAL  Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF  Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB  Inline XBRL Taxonomy Extension Labels Linkbase Document
101.PRE  Inline XBRL Taxonomy Extension Presentation Linkbase Document
104  Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)
 
*
Filed herewith.
1.
Incorporated by reference to Exhibit 3.1 to Current Report on Form
8-K
filed on June 23, 2022.
 
78
83

Table of Contents
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: July 28, 202127, 2022  By: 
/s/ Eli Kalif
  Name: 
Eli Kalif
  Title: 
Executive Vice President,
Chief Financial Officer
(Duly Authorized Officer)
 
7984