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Other assets impairments, restructuring and other items
3 Months Ended
Mar. 31, 2020
Other assets impairments, restructuring and other items
NOTE 12 – Other assets impairments, restructuring and other items:
 
Three months ended
 
 
March 31,
 
 
2020
 
 
2019
 
 
(U.S. $ in millions)
 
Impairments of long-lived tangible assets (1)
 
$
75
 
 
$
20
 
Contingent consideration
 
 
6
 
 
 
(71
)
Restructuring
 
 
39
 
 
 
32
 
Other
 
 
—  
 
 
 
20
 
 
 
 
 
 
 
 
 
 
Total
 
$
121
 
 
$
1
 
 
 
 
 
 
 
 
 
 
 
(1)
Including impairments related to exit and disposal activities.
Impairme
nts
Impairments of tangible assets for the first three months of 2020
and 2019
were
$75 million and $20 million, respectively.
 
The impairments in the first three months of 2020
are mainly related to plant rationalization.
Teva may record additional impairments in the future, to the extent it changes its plans on any given asset and/or the assumptions underlying such plans, as a result of its plant rationalization plan.
Contingent consideration
In the three months ended March 31, 2020, Teva recorded an expense
of
$6 
million for contingent consideration, compared to an income of
 
$71 
million 
 
in the three months ended March 31, 2019. The income in the first quarter of 2019 was mainly related to a decrease in royalty payments expected in connection with lenalidomide (generic equivalent of Revlimid
®
) which was part of the Actavis Generics acquisition.
Restructuring
In the three months ended March 31, 2020, Teva
 
recorded $
39
 
million of restructuring expenses, compared
 
to $
32
 million
in the three months ended March 31, 2019. The expenses in the first quarter of 2020 were primarily related to residual expenses of the restructuring plan announced in 2017.
The following tables provide the components of costs associated with Teva’s restructuring plan, including other costs associated with Teva’s restructuring plan and recorded under different items:
 
   
Three months ended
 
March 31,
 
 
2020
 
 
2019
 
 
(U.S. $ in millions)
 
Restructuring
   
     
 
Employee termination
  $
33
    $
20
 
Other
   
6
     
12
 
                 
Total
  $
39
    $
32
 
                 
The following table provides the components of and changes in the Company’s restructuring accruals:
 
Employee termination
costs
   
Other
   
Total
 
 
(U.S. $ in millions )
 
Balance as of January 1, 2020
  $
(208
)   $
(7
)   $
(215
)
Provision
   
(33
)    
(6
)    
(39
)
Utilization and other*
   
69
     
6
     
75
 
Balance as of March 3
1
, 2020
  $
(172
)   $
(7
)   $
(179
)
                         
 
* Includes adjustments for foreign currency translation.
Significant regulatory events
In July 2018, the FDA completed an inspection of Teva’s manufacturing plant in Davie, Florida in the United States, and issued a Form
FDA-483
to the site. In October 2018, the FDA notified Teva that the inspection of the site is classified as “official action indicated” (OAI). On February 5, 2019, Teva received a warning letter from the FDA that contained four additional enumerated concerns related to production, quality control, and investigations at this site. Teva has been working diligently to address the FDA’s concerns in a manner consistent with current good manufacturing practice (cGMP) requirements, and to address those concerns as quickly and as thoroughly as possible.
An FDA follow up inspection occurred in January 2020, resulting in some follow up findings, and Teva received a letter from the FDA dated April 24, 2020 notifying that the site continues to be classified as OAI
. If Teva is unable to remediate the findings to the FDA’s satisfaction, it may face additional consequences. These would potentially include delays in FDA approval for future products from the site, financial implications due to loss of revenues, impairments, inventory write offs, customer penalties, idle capacity charges, costs of additional remediation and possible FDA enforcement action. Teva expects to generate
approximately
$230 
million in revenues
from this site in 2020, assuming remediation or enforcement does not cause any unscheduled slowdown or stoppage at the facility, however delays in FDA approvals of future products from the site may occur.
In July 2018, Teva announced the voluntary recall of valsartan and certain combination valsartan medicines in various countries due to the detection of trace amounts of a previously unknown nitrosamine impurity called NDMA found in valsartan API supplied to Teva by Zhejiang Huahai Pharmaceuticals Co. Ltd. (“Huahai”). Since July 2018, Teva has been actively engaged with regulatory agency requests around the world in reviewing its sartan and other products to determine whether NDMA and/or other related nitrosamine impurities are present in specific products. Where necessary, Teva has initiated additional voluntary recalls. The aggregate direct impact of the sartan recalls on Teva’s 2018 and 2019 financial statements was
$54 million,
primarily related to inventory write-downs and returns. As a result of this loss, Teva initiated negotiations with Huahai and in December 2019, Teva reached a settlement with Huahai resolving its claims related to certain sartan API supplied by Huahai to Teva. Under the settlement agreement, Huahai agreed to compensate Teva for some of the direct losses suffered by Teva and provide Teva prospective cost reductions for API. The settlement does not release Huahai from liability for any losses Teva may incur as a result of third party personal injury or product liability claims relating to the sartan API at issue. In addition, multiple lawsuits have been filed in connection with this matter, which may lead to additional customer penalties, impairments and litigation costs. Teva expects additional expenses and loss of revenues and profits in connection with this matter going forward.