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Intangible Assets
12 Months Ended
Dec. 31, 2021
Goodwill And Intangible Assets Disclosure [Abstract]  
Intangible Assets

(4) Intangible Assets

Intangible Assets

Inbrija and ARCUS Technology

In connection with the acquisition of Civitas in October 2014, the Company acquired global rights to Inbrija, a Phase 3 treatment candidate for Parkinson’s disease OFF periods, also known as OFF episodes. The acquisition of Civitas also included rights to Civitas’ proprietary ARCUS drug delivery technology, which the Company believes has potential to be used in the development of a variety of inhaled medicines. In December 2018, the FDA approved Inbrija for intermittent treatment of OFF episodes in people with Parkinson’s disease treated with carbidopa/levodopa.

In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the transaction to the underlying assets acquired and liabilities assumed by the Company, based upon the estimated fair values of those assets and liabilities at the date of acquisition and classified the fair value of the acquired IPR&D as an indefinite-lived intangible asset until the successful completion of the associated research and development efforts. The value allocated to the indefinite lived intangible asset was $423 million. In December 2018, the Company received FDA approval for Inbrija and accordingly reclassified the indefinite lived intangible asset to a definite lived intangible asset with amortization commencing upon launch in February 2019.

 BTT1023 IPR&D

In connection with the acquisition of Biotie, the Company acquired global rights to BTT1023 (timolumab). BTT1023 is a product candidate for the orphan disease Primary Sclerosing Cholangitis, or PSC, a chronic and progressive liver disease.

In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the transaction to the underlying assets acquired and liabilities assumed, based upon the estimated fair values of those assets and liabilities at the date of acquisition. The Company classified the fair value of the acquired IPR&D as indefinite lived intangible assets until the successful completion or abandonment of the associated research and development efforts.     

In the three-month period ended March 31, 2020, the Company determined that there were relevant changes to the key assumptions that would negatively affect the value of the IPR&D asset for BTT-1023. The Company noted that it received a final read-out of the results of the BUTEO study on March 31, 2020 and noted that the study did not meet its primary or secondary endpoints. Based on conclusions drawn from these results, management determined that the Company would not continue further development of the asset on March 31, 2020. Management also conferred with its independent consultant in March 2020 to review and opine on the results of the BUTEO study to assess whether the asset was a candidate for potential out-licensing since the Company would no longer continue to develop the asset. Based on the assessment and review of the BUTEO study results with the consultant, management determined that the results of the clinical trial did not meet the primary or secondary end-points, and the clinical trial was not large enough or expansive enough to be persuasive to generate interest by third parties for a possible licensing arrangement. Management determined that this assessment was the triggering event that indicated that the asset was fully impaired as there was no potential value with an out-licensing arrangement. Based on the qualitative assessment, management determined that the fair value of the IPR&D asset was $0 and the carrying value of the asset which was approximately $4.1 million at March 31, 2020 exceeded the fair value of the asset. As a result, the Company fully impaired the asset and recorded an impairment charge of $4.1 million for the year ended December 31, 2020. Management determined that additional quantitative procedures were not relevant in this circumstance given the overwhelming qualitative evidence that indicated the asset was fully impaired.

Websites

Intangible assets also include certain website development costs which have been capitalized. The Company has developed several websites, each with its own purpose, including the general corporate website, product information websites and various other websites.

The Company continually evaluates whether events or circumstances have occurred that indicate that the carrying value of the intangible assets may be impaired or that the estimated remaining useful lives of these assets may warrant revision. As of December 31, 2021, the Company determined that the intangible assets were not impaired and that there are no facts or circumstances that would indicate a need for changing the estimated remaining useful lives of these assets.

Intangible assets consisted of the following:

 

 

 

 

 

 

December 31, 2021

 

 

December 31, 2020

 

(Dollars In thousands)

 

Estimated

Remaining

Useful Lives

(Years)

 

 

Cost

 

 

Additions

 

 

Accumulated

Amortization

 

 

Net

Carrying

Amount

 

 

Cost

 

 

Impairment

 

 

Accumulated

Amortization

 

 

Foreign

Currency

Translation

 

 

Net

Carrying

Amount

 

In-process research

   & development (1)

 

Indefinite-lived

 

 

$

 

 

$

 

 

$

 

 

$

 

 

$

4,212

 

 

$

(4,131

)

 

$

 

 

$

(81

)

 

$

 

Inbrija (2)

 

 

11

 

 

 

423,000

 

 

 

 

 

 

(87,164

)

 

 

335,836

 

 

 

423,000

 

 

 

 

 

 

(56,400

)

 

 

 

 

 

366,600

 

Website

   development costs

 

1-3

 

 

 

14,559

 

 

 

26

 

 

 

(14,441

)

 

 

144

 

 

 

14,559

 

 

 

 

 

 

(14,178

)

 

 

 

 

 

381

 

 

 

 

 

 

 

$

437,559

 

 

$

26

 

 

$

(101,605

)

 

$

335,980

 

 

$

441,771

 

 

$

(4,131

)

 

$

(70,578

)

 

$

(81

)

 

$

366,981

 

 

 

 

(1)

Includes the fair value of BTT1023.

 

(2)

In December 2018, the Company received FDA approval for Inbrija and accordingly reclassified the indefinite lived intangible assets to definite lived intangible assets and began amortizating the assets upon launch in February 2019.

The Company recorded amortization expense of $31.0 million of which $30.7 million pertained to the intangible asset related to Inbrija and $0.3 million related to the amortization of website development costs for the year ended December 31, 2021. The Company recorded amortization expense of $31.1 million of which $30.7 million pertained to the intangible asset related to Inbrija and $0.4 million related to the amortization of website development costs related to these intangible assets for the year ended December 31, 2020.

Estimated future amortization expense for intangible assets subsequent to December 31, 2021 is as follows:

(In thousands)

 

 

 

 

2022

 

$

30,894

 

2023

 

 

30,772

 

2024

 

 

30,768

 

2025

 

 

30,764

 

2026

 

 

30,764

 

Thereafter

 

 

182,018

 

 

 

$

335,980

 

The weighted-average remaining useful lives of all amortizable assets is approximately 11.0 years.