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Goodwill and Intangible Assets
 12 Months Ended
Dec. 31, 2021
Goodwill and Intangible Assets Disclosure [Abstract]  
Goodwill and Intangible Assets
13.Intangible Assets
Intangible Assets
The gross carrying amount and accumulated amortization of intangible assets were comprised of the following at the end of each period:
December 31, 2021December 25, 2020
Gross
Carrying
Amount
Accumulated
Amortization
Gross
Carrying
Amount
Accumulated
Amortization
Amortizable:
Completed technology$10,404.0 $5,160.4 $10,394.6 $4,586.6 
License agreements120.182.1 120.178.1 
Trademarks77.726.9 77.723.5
Total
$10,601.8 $5,269.4 $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 

The Company recorded impairment charges related to its Specialty Brands segment totaling $154.9 million, $63.5 million and $388.0 million during fiscal 2021, 2020 and 2019, respectively. The valuation method used to approximate fair value in each of these periods was based on the estimated discounted cash flows for the respective asset. The fiscal 2021 impairment charge included a partial impairment of $90.4 million related to Amitiza, as discussed further below, and a full impairment of $64.5 million related to MNK-6105 and MNK-6106 as the Company decided it would no longer pursue further development of this IPR&D asset. The fiscal 2020 impairment charge related to Ofirmev® (acetaminophen) injection ("Ofirmev") and was primarily driven by a change in the estimate of the asset's useful life resulting in its undiscounted cash flow being less than its net book value. The fiscal 2019 impairment charge included $274.5 million related to VTS-270, primarily driven by continued regulatory challenges, and $113.5 million related to stannsoporfin as a result of the Company ending the development program.
Amitiza
During the three months ended December 31, 2021, due to lower anticipated cash flows expected from Amitiza, the Company identified a triggering event with respect to the associated intangible asset within the Specialty Brands segment and assessed the recoverability of the definite-lived asset. The Company determined that the undiscounted cash flows related to the Amitiza intangible asset were less than its net book value, which required the Company to record an impairment charge for the difference between the fair value of the Amitiza intangible asset and its net book value. In connection with this analysis, the Company concluded that the sum of the years digits method, an accelerated method of amortization, on a prospective basis (beginning with the first quarter of fiscal 2022) would more accurately reflect the consumption of the economic benefits over the remaining useful life of the asset.
The Company determined the fair value of the Amitiza intangible asset using the income approach, a level three measurement technique. For purposes of determining fair value, the Company made various assumptions regarding estimated future cash flows, the discount rate and other factors in determining the fair value of the intangible asset. The Company's projections in relation to the Amitiza intangible asset included long-term net sales and operating income at lower than historical levels. These changes in assumptions resulted in a fair value of the Amitiza intangible asset that was less than its net book value. Therefore, the Company recorded an impairment charge of $90.4 million.
StrataGraft®
On June 15, 2021, the Company announced that the 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 IPR&D product rights to amortizable, finite-lived completed technology and will begin amortization of the asset in tandem with the first commercial shipment of the product during the first quarter of fiscal 2022. Concurrent with the approval of StrataGraft, the FDA granted the Company a Priority Review Voucher ("PRV"). A PRV is a voucher that may be used to obtain an accelerated FDA review of one of the Company's future products or sold to a third party to obtain accelerated review of one of its future products.
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 approval. On August 18, 2021, the Company resubmitted its NDA for terlipressin to the FDA and on February 18, 2022 (the Prescription Drug User Fee Act, or "PDUFA date"), the FDA issued a CRL. In the weeks leading up to the PDUFA date, it became necessary for the Company to identify a new packaging and labeling manufacturing facility, which meant that an inspection by the FDA could not be completed by the PDUFA date. A satisfactory inspection is required before the NDA can be approved. This is the only outstanding issue noted in the CRL, and it is important to note that there were no safety or efficacy issues cited. The Company remains committed to this critically ill patient population, who currently have no approved treatment option in the U.S for HRS-1 and believes that there is a path to approval in 2022. The Company 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 consolidated balance sheets as of December 31, 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.
Intangible asset amortization expense
Intangible asset amortization expense was as follows:
Fiscal Year
202120202019
Amortization expense$581.1 $771.2 $853.4 

The estimated aggregate amortization expense on intangible assets owned by the Company and being amortized as of December 31, 2021, is expected to be as follows:
Fiscal 2022$605.3 
Fiscal 2023585.1
Fiscal 2024564.8
Fiscal 2025543.1
Fiscal 2026517.2