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Other assets impairments, restructuring and other items
3 Months Ended
Mar. 31, 2021
Other assets impairments, restructuring and other items
NOTE 12 – Other assets impairments, restructuring and other items:
 
    
Three months ended
 
    
March 31,
 
    
2021
    
2020
 
    
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
   $ 48      $ 75  
Contingent consideration
     3        6  
Restructuring
     81        39  
Other
     4        —    
    
 
 
    
 
 
 
Total
   $ 137      $ 121  
    
 
 
    
 
 
 
 
(1)
Including impairments related to exit and disposal activities
 
Impairments
Impairments of tangible assets for the three months ended March 31, 2021 and 2020 were $48 million and $75 
million, respectively. The impairment for the three months ended March 31, 2021 was mainly related to certain assets in Europe.
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 March 31, 2021, Teva recorded an expense of $3 million for contingent consideration, compared to an expense of $6 million in the three months ended March 31, 2020.
Restructuring
In the three months ended March 31, 2021, Teva recorded $81 million of restructuring expenses, compared to $39 million in the three months ended March 31, 2020.
The expenses for the three months ended March 31, 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 March 31,
 
    
2021
    
2020
 
    
(U.S. $ in millions)
 
Restructuring
                 
Employee termination
   $ 79      $ 33  
Other
     2        6  
    
 
 
    
 
 
 
Total
   $ 81      $ 39  
    
 
 
    
 
 
 
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
     (79      (2      (81
Utilization and other*
     33        2        35  
    
 
 
    
 
 
    
 
 
 
Balance as of March 31, 2021
   $ (161    $ (7    $ (168
    
 
 
    
 
 
    
 
 
 
 
 
  
Employee termination
costs
 
  
Other
 
  
Total
 
 
  
(U.S. $ in millions )
 
Balance as of January 1, 2020
  
$
(208
  
$
(7
  
$
(215
Provision
  
 
(33
  
 
(6
  
 
(39
Utilization and other*
  
 
69
 
  
 
6
 
  
 
75
 
 
  
 
 
 
  
 
 
 
  
 
 
 
Balance as of March 31, 2020
  
$
(172
  
$
(7
  
$
(179
 
  
 
 
 
  
 
 
 
  
 
 
 
 
 
*
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. 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 $125 
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
.
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 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 has completed partial remediation of this issue and has restarted limited supply from its Goa facilities. The site experienced some additional delays in first quarter of 2021 due to labor related issues. The impact to Teva’s financial results for the three months ended March 31, 2021 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.