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Goodwill and Intangible Assets
9 Months Ended
Sep. 24, 2021
Goodwill and Intangible Assets Disclosure [Abstract]  
Goodwill and Intangible Assets
9.Intangible Assets
The gross carrying amount and accumulated amortization of intangible assets were comprised of the following at the end of each period:
September 24, 2021December 25, 2020
Gross Carrying AmountAccumulated AmortizationGross Carrying AmountAccumulated Amortization
Amortizable:
Completed technology$10,494.4 $5,016.9 $10,394.6 $4,586.6 
License agreements120.181.1 120.178.1
Trademarks77.726.1 77.723.5
Total$10,692.2 $5,124.1 $10,592.4 $4,688.2 
Non-Amortizable:
Trademarks$35.0 $35.0 
In-process research and development81.0 245.3 
Total$116.0 $280.3 

StrataGraft®
On June 15, 2021, the Company announced that the U.S. Food and Drug Administration ("FDA") had approved the StrataGraft biologics license application ("BLA") for the treatment of adults with deep partial-thickness burns. Upon FDA approval, the Company transferred the total $99.8 million of asset value from non-amortized, indefinite-lived acquired in-process research and development ("IPR&D") product rights to amortizable, finite-lived completed technology and will begin amortization of the asset in tandem with commercial launch of the product, which is expected during the fourth quarter of fiscal 2021.
Terlipressin
During September 2020, the 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. On August 18, 2021, the Company resubmitted its NDA for terlipressin to the FDA. The Prescription Drug User Fee Act (PDUFA) date for this development product is February 18, 2022. The Company will continue to assess the impact of any changes to planned revenue or earnings on the fair value of the associated IPR&D asset of $81.0 million included within intangible assets, net on the unaudited condensed consolidated balance sheets as of September 24, 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 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 EndedNine Months Ended
September 24,
2021
September 25,
2020
September 24,
2021
September 25,
2020
Amortization expense$145.3 $210.6 $435.8 $599.8 

The estimated aggregate amortization expense on intangible assets owned by the Company and being amortized as of September 24, 2021, is expected to be as follows:
Remainder of Fiscal 2021$145.3
Fiscal 2022581.1
Fiscal 2023581.1
Fiscal 2024581.1
Fiscal 2025579.6