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Intangible assets and goodwill

12 Months Ended

Dec. 31, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

17. Intangible assets and goodwill

Definite-lived intangibles

Definite lived intangible assets consisted of the following at December 31, 2024 and 2023:


		Ending Balance at				Reclass from		Foreign		Ending Balance at
Definite-lived		December 31,				Indefinite Lived to		currency		December 31,
intangibles assets, gross		2023		Additions		Definite Lived		translation		2024
Emflaza	$	527,417	$	—	$	—	$	—	$	527,417
Waylivra		10,218		2,874		—		(695)		12,397
Tegsedi		13,322		5,936		—		(1,009)		18,249
Kebilidi		—		—		10,731		—		10,731
Upstaza		89,550		—		17,387		—		106,937
Total definite-lived intangibles, gross	$	640,507	$	8,810	$	28,118	$	(1,704)	$	675,731


		Ending Balance at				Foreign		Ending Balance at
Definite-lived		December 31,				currency		December 31,
intangibles assets, accumulated amortization		2023		Amortization		translation		2024
Emflaza	$	(478,618)	$	(48,799)	$	—	$	(527,417)
Waylivra		(3,965)		(1,602)		294		(5,273)
Tegsedi		(3,311)		(2,581)		283		(5,609)
Kebilidi		—		(112)		—		(112)
Upstaza		(10,882)		(7,644)		—		(18,526)
Total definite-lived intangibles, accumulated amortization	$	(496,776)	$	(60,738)	$	577	$	(556,937)

Total definite-lived intangibles, net							$	118,794

Marathon was entitled to receive contingent payments from the Company based on annual net sales of Emflaza beginning in 2018, up to a specified aggregate maximum amount over the expected commercial life of the asset, which expired February 2024. In accordance with the guidance for an asset acquisition, the Company recorded the milestone payments when they became payable to Marathon and increased the cost basis for the Emflaza rights intangible asset. As of December 31, 2024, the Emflaza rights intangible asset was fully amortized, therefore, milestones are recorded on the consolidated statement of operations within cost of product sales, excluding amortization of acquired intangible assets from February 2024 onward.

Akcea is also entitled to receive royalty payments subject to certain terms set forth in the Tegsedi-Waylivra Agreement related to sales of Waylivra and Tegsedi. In accordance with the guidance for an asset acquisition, the Company records royalty payments when they become payable to Akcea and increase the cost basis for the Waylivra and Tegsedi intangible assets, respectively. For the year ended December 31, 2024, royalty payments of $5.9 million and $2.9 million were recorded for Tegsedi and Waylivra, respectively. As of December 31, 2024, the royalties payable for Tegsedi and Waylivra were immaterial.

The Company received multiple approvals during the fourth quarter of 2024 related to PTC-AADC. In October 2024, the Company received regulatory approval for Upstaza in Brazil. In November 2024, the Company’s BLA for its gene therapy treatment of AADC deficiency was approved by the FDA, and is marketed under the brand name Kebilidi. With these approvals, $10.7 million and $17.4 million for Kebilidi and Upstaza, respectively, was reclassified from the PTC-AADC indefinite lived intangible asset to definite lived intangible assets. The Company will amortize these allocated balances of $10.7 million and $17.4 million over its expected useful life of 12 years on a straight-line basis.

For the years ended December 31, 2024, 2023 and 2022, the Company recognized amortization expense of $60.7 million, $222.6 million, and $116.6 million respectively, related to the Emflaza rights, Waylivra, Tegsedi, and Upstaza/Kebilidi intangible assets.

The estimated future amortization of the Emflaza rights, Waylivra, Tegsedi, and Upstaza/Kebilidi intangible assets is expected to be as follows:


	As of December 31, 2024
2025	$	14,374
2026		14,364
2027		14,364
2028		14,364
2029 and thereafter		61,328
Total	$	118,794

The weighted average remaining amortization period of the definite-lived intangibles as of December 31, 2024 is 9.3 years.

Indefinite-lived intangibles

Indefinite lived intangible assets consisted of the following at December 31, 2024 and 2023:


		Ending Balance at				Reclass from		Priority Review				Ending Balance at
Indefinite-lived		December 31,				Indefinite Lived to		Voucher Book Value				December 31,
intangibles assets		2023		Additions		Definite Lived		Derecognized Upon Sale		Impairment		2024
PTC AADC (Upstaza and Kebilidi)	$	235,766	$	—	$	(28,118)	$	(48,100)	$	(159,548)	$	—
Total indefinite-lived intangibles	$	235,766	$	—	$	(28,118)	$	(48,100)	$	(159,548)	$	—

Total intangible assets, net											$	118,794

In connection with the acquisition of the Company’s gene therapy platform from Agilis, the Company acquired rights to Upstaza, for the treatment of AADC deficiency. AADC deficiency is a rare CNS disorder arising from reductions in the enzyme AADC that result from mutations in the dopa decarboxylase gene. In accordance with the acquisition method of accounting, the Company allocated the acquisition cost for the Agilis Merger 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.

The Company performed an annual test for its PTC-AADC indefinite-lived intangible asset as of October 1, 2024 and recorded a partial impairment on the PTC-AADC indefinite lived intangible asset of $159.5 million, which is recorded as intangible asset impairment in the statement of operations. The impairment was related to a decrease in projected cash flows due to refinements in current market assumptions and the timing of patient treatments. To calculate the impairment amount, the Company utilized a discounted cash flow model under the income method, which primarily utilized Level 3 fair value inputs. The discount rate utilized in the discounted cash flow model was 15%, and the probability of success was 100% as the Company received regulatory approval in Brazil and the United States.

In connection with the Company’s FDA approval of Kebilidi, the Company received a PRV. The Company sold the PRV for aggregate net proceeds of $150.0 million, excluding $2.0 million in broker fees which were recorded in accounts payable and accrued expenses on the consolidated balance sheet as of December 31, 2024. The Company had previously recorded an indefinite lived intangible asset for the PRV of $48.1 million in connection with its acquisition of Agilis in 2018, which was included as part of the book balance of the Company’s PTC-AADC indefinite lived intangible asset. Accordingly, the Company derecognized the book value of the PRV and recorded a gain of $99.9 million upon the sale, which is recorded as gain on sale of priority review voucher on the consolidated statement of operations.

The Company reclassified the remaining $28.1 million from the PTC-AADC indefinite lived intangible asset to definite lived intangible assets as denoted above. As such, there is no remaining indefinite lived intangible asset balance as of December 31, 2024.

Goodwill

As a result of the Agilis Merger on August 23, 2018, the Company recorded $82.3 million of goodwill. There have been no changes to the balance of goodwill since the date of the Agilis Merger. Accordingly, the goodwill balance as of December 31, 2024 and 2023 was $82.3 million. The Company performed an annual impairment test for goodwill as of October 1, 2024. The Company’s single reporting unit had a negative carrying value and thus the Company determined there was no impairment of goodwill.