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Other assets impairments, restructuring and other items
9 Months Ended
Sep. 30, 2019
Other assets impairments, restructuring and other items
NOTE 14 – Other assets impairments, restructuring and other items:
 
Three months ended
   
Nine months ended
 
 
September 30,
   
September 30,
 
 
2019
   
2018
   
2019
   
2018
 
 
(U.S. $ in millions)
 
Impairments of long-lived tangible assets
(1)
 
$
28
 
 
$
2
 
 
$
96
 
 
$
255
 
Contingent consideration
   
51
     
29
     
4
     
84
 
Restructuring
   
61
     
88
     
140
     
442
 
Other
   
21
     
20
     
24
     
53
 
                                 
Total
 
$
160
 
 
$
139
 
 
$
263
 
 
$
834
 
                                 
 
(1)
Including impairments related to exit and disposal activities
Impairments
Impairments of long-lived tangible assets for the three months ended September 30, 2019 and 2018 were $
28
 million and $
2
 million, respectively.
Impairments of long-lived tangible assets for the nine months ended September 30, 2019 and 2018 were $
96
 million and $
255
 million, respectively.
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 September 30, 2019, Teva recorded an expense of $51 million for contingent consideration, compared to an expense of $29 million in the three months ended September 30, 2018. The expenses in the third quarter of 2019 were mainly related to a change in the estimated future royalty payments from Eagle Pharmaceuticals, Inc. (“Eagle”) in connection with bendamustine sales.
In the nine months ended September 30, 2019, Teva recorded an expense of $4 million for contingent consideration, compared to an expense of $84 million in the nine months ended September 30, 2018. The expense in the first nine months of 2019 were mainly related to a change in the estimated future royalty payments from Eagle in connection with bendamustine sales and an increase in the expected future royalty payments to Eagle due to the orphan drug status granted to BENDEKA
®
, offset by the change in the future royalty payments in connection with lenalidomide (generic equivalent of Revlimid
®
), which was part of the Actavis Generics acquisition.
 
Restructuring
In the three months ended September 30, 2019, Teva recorded $61 million of restructuring expenses, compared to $88 million in the three months ended September 30, 2018.
In the nine months ended September 30, 2019, Teva recorded $140 million of restructuring expenses, compared to $442 million in the nine months ended September 30, 2018.
Since the announcement of its restructuring plan, Teva reduced its global headcount by 11,554 full-time-equivalent employees.
During the three months ended September 30, 2019 and 2018, Teva recorded impairments of property, plant and equipment related to restructuring costs of $8 million and $2 million, respectively.
During the nine months ended September 30, 2019 and 2018, Teva recorded impairments of property, plant and equipment related to restructuring costs of $29 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
 
September 30,
 
 
2019
   
2018
 
 
(U.S. $ in millions)
 
Restructuring
   
     
 
Employee termination
  $
49
    $
62
 
Other
   
11
     
26
 
                 
Total
  $
 
 
61
   
$
 
88
 
                 
       
 
Nine months ended
 
September 30,
 
 
2019
   
2018
 
 
(U.S. $ in millions)
 
Restructuring
 
 
 
 
 
 
 
 
Employee termination
  $
105
    $
380
 
Other
   
34
     
62
 
                 
Total
  $
140
    $
442
 
                 
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
   
(105
)
 
 
(34
)
 
 
(140
)
Utilization and other*
   
108
 
 
 
56
 
 
 
164
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Balance as of September 30, 2019
  $
(201
)
 
$
(7
)
 
$
(208
)
                         
 
*
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 $63
 
million in revenues from this site in the remainder of 2019 and approximately $
230
 
million
 
in
 
2020
, 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.
As of September 30, 2019, the accumulated impact of this recall 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.