Goodwill and Intangible Assets

3 Months Ended

Mar. 26, 2021

Goodwill and Intangible Assets Disclosure [Abstract]

Goodwill and Intangible Assets

8. Intangible Assets

The gross carrying amount and accumulated amortization of intangible assets were comprised of the following at the end of each period:

	March 26, 2021				December 25, 2020
	Gross Carrying Amount		Accumulated Amortization		Gross Carrying Amount		Accumulated Amortization
Amortizable:
Completed technology	$	10,394.6	$	4,730.0	$	10,394.6	$	4,586.6
License agreements	120.1		79.1		120.1		78.1
Trademarks	77.7		24.4		77.7		23.5
Total	$	10,592.4	$	4,833.5	$	10,592.4	$	4,688.2
Non-Amortizable:
Trademarks	$	35.0			$	35.0
In-process research and development	180.8				245.3
Total	$	215.8			$	280.3

Terlipressin

During September 2020, the U.S. Food and Drug Administration ("FDA") issued a Complete Response Letter ("CRL") regarding the Company's New Drug Application ("NDA") seeking approval for the investigational agent terlipressin to treat adults with hepatorenal syndrome type 1 ("HRS-1"). The CRL stated that, based on the available data, the agency cannot approve the terlipressin

NDA in its current form and requires more information to support a positive risk-benefit profile for terlipressin for patients with HRS-1.

In response to receipt of the CRL, the Company had an End of Review Meeting on October 26, 2020 and a Type A Meeting on January 29, 2021 with the FDA where both parties engaged in constructive dialogue in an effort to clarify a viable path to U.S. approval. As the Company continues to engage with the FDA over the coming months, it will continue to assess the impact of any changes to planned revenue or earnings on the fair value of the associated in-process research and development asset of $81.0 million included within intangible assets, net on the unaudited condensed consolidated balance sheets as of March 26, 2021 and December 25, 2020.

The Company annually tests the indefinite-lived intangible assets for impairment, or whenever events or changes in circumstances indicate that the carrying value may not be recoverable by either a qualitative or income approach. Management relies on a number of qualitative factors when considering a potential impairment such as changes to planned revenue or earnings that could affect significant inputs used to determine the fair value of the indefinite-lived intangible asset.

MNK-6105 and MNK-6106

During the three months ended March 26, 2021, the Company recognized a full impairment on its Specialty Brands in-process research and development ("IPR&D") asset related to MNK-6105 and MNK-6106 of $64.5 million. The Company has decided it will no longer pursue further development of this asset.

Intangible asset amortization expense

Intangible asset amortization expense was as follows:

	Three Months Ended
	March 26, 2021		March 27, 2020
Amortization expense	$	145.3	$	197.6

The estimated aggregate amortization expense on intangible assets owned by the Company is expected to be as follows:

Remainder of Fiscal 2021	$	435.8
Fiscal 2022	581.1
Fiscal 2023	581.1
Fiscal 2024	581.1
Fiscal 2025	579.6