Intangible Assets and Goodwill

3 Months Ended

Mar. 31, 2021

Goodwill and Intangible Assets Disclosure [Abstract]

Intangible Assets

Intangible assets, net of accumulated amortization, impairment charges and adjustments are summarized as follows:


		As of March 31, 2021						As of December 31, 2020
(In millions)	Estimated Life	Cost		Accumulated Amortization		Net		Cost		Accumulated Amortization		Net
Completed technology	4-28 years	$	7,394.3	$	(5,190.3)	$	2,204.0	$	7,394.3	$	(5,136.5)	$	2,257.8
In-process research and development	Indefinite until commercialization	720.1		—		720.1		762.5		—		762.5
Trademarks and trade names	Indefinite	64.0		—		64.0		64.0		—		64.0
Total intangible assets		$	8,178.4	$	(5,190.3)	$	2,988.1	$	8,220.8	$	(5,136.5)	$	3,084.3

For the three months ended March 31, 2021, amortization and impairment of acquired intangible assets totaled $98.1 million, compared to $71.5 million in the prior year comparative period. For the three months ended March 31, 2021, amortization and impairment of acquired intangible assets reflects a $44.3 million impairment charge related to vixotrigine (BIIB074) for the potential treatment of trigeminal neuralgia (TGN). For the three months ended March 31, 2020, we had no impairment charges.

Completed Technology

Completed technology primarily relates to our acquisition of all remaining rights to TYSABRI as well as other amounts related to our other marketed products and programs acquired through business combinations.

IPR&D Related to Business Combinations

IPR&D represents the fair value assigned to research and development assets that we acquired as part of a business combination and had not yet reached technological feasibility at the date of acquisition. Included in IPR&D balances are adjustments related to foreign currency exchange rate fluctuations. We review amounts capitalized as acquired IPR&D for impairment annually, as of October 31, and whenever events or changes in circumstances indicate to us that the carrying value of the assets might not be recoverable. The carrying value associated with our IPR&D assets as of March 31, 2021, relates to the various IPR&D programs we acquired in connection with our acquisitions of Nightstar Therapeutics plc (NST) and Convergence Pharmaceuticals Holdings Ltd. (Convergence). The majority of the balance relates to our acquisition of NST in June 2019. For additional information on our acquisition of NST, please read Note 2, Acquisitions, to our consolidated financial statements included in our 2020 Form 10-K.

Vixotrigine

In the periods since we acquired vixotrigine, there have been numerous delays in the initiation of Phase 3 studies for the potential treatment of TGN and for the potential treatment of diabetic painful neuropathy (DPN), another form of neuropathic pain. We have engaged with the U.S. Food and Drug Administration (FDA) regarding the design of the Phase 3 studies of vixotrigine for TGN and DPN and now plan to perform an additional clinical trial of vixotrigine before initiating a Phase 3 study of DPN.

The performance of this additional clinical trial has delayed the initiation of the Phase 3 studies of vixotrigine for the potential treatment of TGN, and, as a result, we recognized an impairment charge of $44.3 million related to vixotrigine for the potential treatment of TGN during the first quarter of 2021. As of March 31, 2021, the carrying value associated with our remaining vixotrigine IPR&D assets was $135.1 million, all of which is related to DPN.

BIIB111 and BIIB112

During the fourth quarter of 2020 we recognized an impairment charge of $115.0 million related to BIIB111 (timrepigene emparvovec) for the potential treatment of choroideremia, a rare, degenerative, X-linked inherited retinal disorder that leads to blindness and currently has no approved treatments, as a result of third-party manufacturing delays that may impact our timeline for a potential filing of a Biologics License Application (BLA) for regulatory approval by up to one year, and increase the costs associated with advancing BIIB111 through Phase 3 development.

We are continuing to monitor the manufacturing issues encountered with BIIB111 and their potential impact on that program's timing. As of March 31, 2021, we have no indication that BIIB111 or BIIB112 (cotoretigene toliparvovec) for the potential treatment of X-linked retinitis pigmentosa, which is a rare inherited retinal disease with no currently approved treatments, were impaired; however, we will continue to monitor the capabilities of our manufacturing partners and how any additional new manufacturing issues might affect the planned timing of such gene therapy programs.

Estimated Future Amortization of Intangible Assets

The estimated future amortization of finite-lived intangible assets for the next five years is expected to be as follows:


(In millions)	As of March 31, 2021
2021 (remaining nine months)	$	165.0
2022	215.0
2023	215.0
2024	225.0
2025	220.0
2026	200.0

Goodwill

The following table provides a roll forward of the changes in our goodwill balance:


(In millions)	As of March 31, 2021
Goodwill, beginning of period	$	5,762.1

Other	1.0
Goodwill, end of period	$	5,763.1

As of March 31, 2021, we had no accumulated impairment losses related to goodwill. Other includes adjustments related to foreign currency exchange rate fluctuations.