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Other assets impairments, restructuring and other items
6 Months Ended
Jun. 30, 2019
Other assets impairments, restructuring and other items
NOTE 14 – Other assets impairments, restructuring and other items:
 
Three months ended
June 30,
   
Six months ended
June 30,
 
 
2019
   
2018
   
2019
   
2018
 
 
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
  $
48
    $
27
    $
68
    $
253
 
Contingent consideration
   
24
     
47
     
(47
)    
55
 
Restructuring
   
47
     
107
     
79
     
354
 
Other
   
(18
)    
13
     
3
     
33
 
                                 
Total
  $
101
    $
194
    $
103
    $
695
 
 
(1) Including impairments related to exit and disposal activities
Impairments
Impairments of property, plant and equipment for the three months ended on June 30, 2019 and 2018 were 
$
48
 
million and $27 million, respectively.
Impairments of property, plant and equipment for the six months ended on June 30, 2019 and 2018 were $68 million and $253 million, respectively.
As a result of Teva’s plant rationalization acceleration in connection with the two-year restructuring plan announced in December 2017, to the extent the Company changes its plans on any given asset and/or the assumptions underlying such plans, there may be additional impairments in the future.
Contingent consideration
In the three months ended June 30, 2019, Teva recorded
an expense of 
$24 million for contingent consideration, compared to an expense of $47 
million in the three months ended June 30, 2018. The expenses in the second quarter of 2019 mainly related to an increase in the expected future royalty payments to Eagle Pharmaceuticals, Inc. due to the orphan drug status granted to BENDEKA 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, 2019, Teva recorded $47 million of contingent consideration income, compared to $55 million expense in the six months ended June 30, 2018. The income in the first six months of 2019 mainly related to the decrease in 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, 2019, Teva recorded $47 million of restructuring expenses, compared to $107 million in the three months ended June 30, 2018.
In the six months ended June 30, 2019, Teva recorded $79 million of restructuring expenses, compared to $354 million in the six months ended June 30, 2018.
Since the announcement of its restructuring plan, Teva reduced its global headcount by approximately 11,145 full-time-equivalent employees.
 
During the three months ended June 
30
,
2019
and
2018
, Teva recorded impairments of property, plant and equipment related to restructuring costs of $21 million and $8 million, respectively.
During the six months ended June 
30
,
2019
and
2018
, Teva recorded
impairments
of property, plant and equipment related to restructuring costs of $21 million and $155 million, respectively.
The following tables provide the components of costs associated with Teva’s restructuring​​​​​​​ plan, including other costs associated with Teva’s restructuring plan and recorded under different items:
 
Three months ended June 30,
 
 
2019
   
2018
 
 
(U.S. $ in millions)
 
Restructuring
   
     
 
Employee termination
  $
36
    $
90
 
Other
   
11
     
17
 
                 
Total
  $
47
    $
107
 
                 
       
 
Six months ended June 30,
 
 
2019
   
2018
 
 
(U.S. $ in millions)
 
Restructuring
   
     
 
Employee termination
  $
56
    $
318
 
Other
   
23
     
36
 
                 
Total
  $
79
    $
354
 
                 
The following table provides the components of and changes in the Company’s restructuring accruals:
 
Employee
termination costs
   
Other
   
Total
 
 
(U.S. $ in millions )
 
Balance as of January 1, 2019
  $
(204
)   $
(29
)   $
(233
)
Provision
   
(56
)    
(23
)    
(79
)
Utilization and other*
   
67
     
45
     
112
 
                         
Balance as of June 30, 2019
  $
(193
)   $
(7
)   $
(200
)
                         
 
* Includes adjustments for foreign currency translation.
Significant regulatory events
In July 2018, the FDA completed an inspection of Teva’s manufacturing plant in Davie, Florida in the United States, and issued a Form
FDA-483
to the site. In October 2018, the FDA notified Teva that the inspection of the site is classified as “official action indicated” (OAI). On February 5, 2019, Teva received a warning letter from the FDA that contains four enumerated concerns related to production, quality control, and investigations at this site. Teva is working diligently to remediate the FDA’s concerns in a manner consistent with current good manufacturing practice (CGMP) requirements, and to address those concerns as quickly and as thoroughly as possible. If Teva is unable to remediate the warning letter findings to the FDA’s satisfaction, it may face additional consequences, including delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. Teva expects to generate approximately $142 million in revenues from this site for the remainder of 2019, assuming remediation or enforcement does not cause any unscheduled slowdown or stoppage at the facility.
In July 2018, Teva announced the voluntary recall of valsartan and certain combination valsartan medicines in various countries due to the detection of trace amounts of a previously unknown impurity called NDMA found in valsartan API supplied to Teva by Zhejiang Huahai Pharmaceutical. Since July 2018, Teva has been actively engaged with regulatory agencies around the world in reviewing its valsartan and other sartan products for NDMA and other related impurities and, where necessary, has initiated additional voluntary recalls. The impact of this recall
as of June 30, 2019
on Teva’s financial statements was $55 million, primarily related to inventory reserves
 and returns
. Teva expects to continue to experience loss of revenues and profits in connection with this matter. In addition, multiple lawsuits have been filed in connection with this matter, for which litigation costs are currently being incurred. Teva may also incur additional customer penalties, impairments and litigation costs going forward.