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Other assets impairments, restructuring and other items
6 Months Ended
Jun. 30, 2020
Other assets impairments, restructuring and other items
NOTE 12 – Other assets impairments, restructuring and other items:
 
    
Three months ended
    
Six months ended
 
    
June 30,
    
June 30,
 
    
2020
    
2019
    
2020
    
2019
 
    
(U.S. $ in millions)
    
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
   $ 277      $ 48      $ 352      $ 68  
Contingent consideration      76        24        83        (47
Restructuring      33        47        73        79  
Other      (6      (18      (5      3  
  
 
 
    
 
 
    
 
 
    
 
 
 
Total
   $ 381      $ 101      $ 502      $ 103  
  
 
 
    
 
 
    
 
 
    
 
 
 
 
(1)
Including impairments related to exit and disposal activities
Impairments
Impairments of tangible assets for the three months ended June 30, 2020 and 2019
 
were $
277
 million and $
48
 
million, respectively. The impairment for the three months ended June 30, 2020 was mainly related to an agreement to sell certain assets from Teva’s business venture in Japan. See note 2.
Impairments of tangible assets for the six months ended June 30, 2020 and 2019
 
were $352 million and $68 
million, respectively. The impairment for the six months ended June 30, 2020 was mainly related to an agreement to sell certain assets from Teva’s business venture in Japan and plant rationalization. See note 2.
Teva may record additional impair
m
ents in the future, to the extent it changes its plans on any given asset and/or the assumptions underlying such plans, as a result of its plant rationalization plan.
Contingent consideration
In the three months ended June 30, 2020, Teva recorded an expense of $76 million for contingent consideration, compared to an expense of $24 million
in the three months ended June 30, 2019. 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 and the expected royalty payments in connection with lenalidomide (generic equivalent of Revlimid
®
) which was part of the Actavis acquisition.
In the six months ended June 30, 2020, Teva recorded an expense of $83 million for contingent consideration, compared to an income of $47 million in the six months ended June 30, 2019.
The expense in the first six months of 2020 was mainly related to a change in the estimated future royalty payments to Eagle in connection with expected future bendamustine sales and the expected royalty payments in connection with lenalidomide (generic equivalent of Revlimid
®
), which was part of the Actavis acquisition.
Restructuring
In the three months ended June 30, 2020, Teva recorded $33 million of restructuring expenses, compared to $47 million in the three months ended June 30, 2019. 
In the six months ended June 30, 2020, Teva recorded $73 million of restructuring expenses, compared to $79 million in the six months ended June 30, 2019.
The expenses for the three and six months ended June 30, 2020 were primarily related to residual expenses of the restructuring plan announced in 2017 and other network consolidation impacts.
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,
 
    
2020
    
2019
 
    
(U.S. $ in millions)
 
Restructuring
   
Employee termination
  $ 3     $ 36  
Other
    30       11  
 
 
 
   
 
 
 
Total
  $ 33     $ 47  
 
 
 
   
 
 
 
 
    
Six months ended June 30,
 
    
2020
    
2019
 
    
(U.S. $ in millions)
 
Restructuring
   
Employee termination
  $ 36     $ 56  
Other
    36       23  
 
 
 
   
 
 
 
Total
  $ 73     $ 79  
 
 
 
   
 
 
 
The following table provides the components of and changes in the Company’s restructuring accruals:
 
 
 
 
 
 
 
 
 
 
    
Employee termination
costs
    
Other
    
Total
 
    
(U.S. $ in millions )
 
Balance as of January 1, 2020
   $ (208    $ (7    $ (215
Provision
     (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, and to address those concerns as quickly and as thoroughly as possible. An FDA follow up inspection occurred in January 2020, resulting in some follow up findings, and Teva received a letter from the FDA dated April 24, 2020 notifying that the site continues to be classified as OAI. If Teva is unable to remediate the findings to the FDA’s satisfaction, it may face additional consequences. These would potentially include delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. Teva expects to generate approximately $161 million in revenues from this site in 2020, assuming remediation or enforcement does not cause any unscheduled slowdown or stoppage at the facility, however delays in FDA approvals of future products from the site may occur.
In July 2018, Teva announced the voluntary recall of valsartan and certain combination valsartan medicines in various countries due to the detection of trace amounts of a previously unknown nitrosamine impurity called NDMA found in valsartan API supplied 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 its claims related to certain sartan API supplied by Huahai. Under the settlement agreement, Huahai agreed to compensate Teva for some of 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. Teva expects remediation of this issue to be completed in the third quarter of 2020. The impact to Teva’s financial results in the second quarter of 2020 was immaterial, however, if the remediation takes longer than expected there may be further loss of sales, customer penalties or impairments to related assets.