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Intangible Assets
9 Months Ended
Jun. 30, 2018
Goodwill and Intangible Assets Disclosure [Abstract]  
Intangible Assets
5.

Intangible Assets

A summary of our acquired intangible assets subject to amortization, as of June 30, 2018 and September 30, 2017, is as follows:

 

     June 30, 2018      September 30, 2017  
     Gross
Carrying
Value
     Accumulated
Amortization
     Gross
Carrying
Value
     Accumulated
Amortization
 

Manufacturing technologies, core products and

cell lines

   $ 22,314    $ 13,693    $ 22,332    $ 12,807

Trade names, licenses and patents

     8,668      5,058      8,689      4,398

Customer lists, customer relationships and

supply agreements

     24,516      12,772      24,562      11,854

Non-compete agreements

     720      720      720      540
  

 

 

    

 

 

    

 

 

    

 

 

 
   $ 56,218    $ 32,243    $ 56,303    $ 29,599
  

 

 

    

 

 

    

 

 

    

 

 

 

The actual aggregate amortization expense for these intangible assets was $849 and $939 for the three months ended June 30, 2018 and 2017, respectively, and $2,732 and $2,843 for the nine months ended June 30, 2018 and 2017, respectively. The estimated aggregate amortization expense for these intangible assets for each of the fiscal years through fiscal 2023 is as follows: remainder of fiscal 2018 – $844, fiscal 2019 – $3,333, fiscal 2020 – $3,170, fiscal 2021 – $2,561, fiscal 2022 – $2,182, and fiscal 2023 – $2,170.

In light of the factors discussed below and their impacts, during our fiscal 2017 third quarter, it was determined that a potential impairment of goodwill recorded in connection with the acquisition of Magellan had occurred (i.e., a “triggering event”). With the assistance of an independent valuation firm, Magellan’s fair value was calculated via both market (comparable company) and income (discounted cash flows) approaches. Based upon these approaches, it was determined that the carrying value of the Magellan reporting unit did, in fact, exceed its fair value. As a result, an impairment charge of $6,628, on both a pre-tax and after-tax basis, was recorded during the fiscal 2017 third quarter. Given all of the factors considered, we do not anticipate, at this time, any further goodwill impairment charge from the Magellan acquisition.

On May 17, 2017, the FDA issued a field safety notice advising customers to discontinue use of Magellan’s lead testing systems with venous blood samples. This field safety notice was followed by product recall notices on May 25th and June 5th. Magellan’s lead testing systems are capable of processing both capillary and venous blood samples. Magellan’s LeadCare Plus and LeadCare Ultra systems, which accounted for approximately 10% of Magellan’s annual revenues, are used predominantly with venous blood samples. Magellan’s LeadCare and LeadCare II systems are predominantly used with capillary blood samples.

Subsequent to the issuances of these field safety and product recall notices, the FDA completed an inspection of Magellan’s Quality System, and issued its Form 483, Inspectional Observations, on June 29, 2017, which was expectedly followed by a Warning Letter issued on October 23, 2017. The Warning Letter requires periodic reporting on our remediation progress. To date, we have satisfied our post-Warning Letter reporting requirements with the FDA. During the three and nine months ended June 30, 2018, we incurred approximately $100 and $900, respectively, in Quality System remediation costs, primarily related to regulatory consultants and studies required to reinstate our venous blood sample claim.

As a result of these matters, we expect to experience delays in reinstating venous blood sample testing on our LeadCare products, as well as in obtaining 510(k) clearance for new Magellan products. We also expect delays in obtaining export certifications for Magellan products during the remediation period.