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Intangible assets and goodwill

9 Months Ended

Sep. 30, 2024

Goodwill and Intangible Assets Disclosure [Abstract]

12. Intangible assets and goodwill

Definite-lived intangibles

Definite-lived intangible assets consisted of the following at September 30, 2024 and December 31, 2023:


		Ending Balance at				Foreign		Ending Balance at
Definite-lived		December 31,				currency		September 30,
intangibles assets, gross		2023		Additions		translation		2024
Emflaza	$	527,417	$	—	$	—	$	527,417
Waylivra		10,218		2,732		183		13,133
Tegsedi		13,322		5,269		253		18,844
Upstaza		89,550		—		—		89,550
Total definite-lived intangibles, gross	$	640,507	$	8,001	$	436	$	648,944


		Ending Balance at				Foreign		Ending Balance at
Definite-lived		December 31,				currency		September 30,
intangibles assets, accumulated amortization		2023		Amortization		translation		2024
Emflaza	$	(478,618)	$	(48,799)	$	—	$	(527,417)
Waylivra		(3,965)		(1,187)		(63)		(5,215)
Tegsedi		(3,311)		(1,847)		(72)		(5,230)
Upstaza		(10,882)		(5,598)		—		(16,480)
Total definite-lived intangibles, accumulated amortization	$	(496,776)	$	(57,431)	$	(135)	$	(554,342)

Total definite-lived intangibles, net							$	94,602

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 September 30, 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 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. For the nine months ended September 30, 2024, royalty payments of $5.3 million and $2.7 million were recorded for Tegsedi and Waylivra, respectively. As of September 30, 2024, a royalty payable of $1.9 million and $0.5 million for Tegsedi and Waylivra, respectively, was recorded on the consolidated balance sheet within accounts payable and accrued expenses.

For the three months ended September 30, 2024 and 2023, the Company recognized amortization expense of $3.0 million and $58.6 million, respectively, related to the Emflaza rights, Upstaza, Waylivra, and Tegsedi intangible assets. For the nine months ended September 30, 2024 and 2023, the Company recognized amortization expense of $57.4 million and $145.5 million, respectively, related to the Emflaza rights, Upstaza, Waylivra, and Tegsedi intangible assets. The estimated future amortization of the Upstaza, Waylivra, and Tegsedi intangible assets is expected to be as follows:


	As of September 30, 2024
2024	$	3,043
2025		12,160
2026		12,160
2027		12,160
2028 and thereafter		55,079
Total	$	94,602

The weighted average remaining amortization period of the definite-lived intangibles as of September 30, 2024 is 8.7 years.

Indefinite-lived intangibles

Indefinite-lived intangible assets consisted of the following at September 30, 2024 and December 31, 2023:


		Ending Balance at						Ending Balance at
Indefinite-lived		December 31,						September 30,
intangibles assets		2023		Additions		Impairment		2024
Upstaza	$	235,766	$	—	$	—	$	235,766
Total indefinite-lived intangibles	$	235,766	$	—	$	—	$	235,766

Total intangible assets, net							$	330,368

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. There have been no changes to the indefinite lived intangible assets balance since the year ended December 31, 2023. Accordingly, the indefinite lived intangible asset balance as of September 30, 2024 is $235.8 million.

Goodwill

As a result of the Agilis Merger on August 23, 2018, the Company recorded $82.3 million of goodwill. As of September 30, 2024, there have been no changes to the balance of goodwill since the date of the Agilis Merger. Accordingly, the goodwill balance as of September 30, 2024 is $82.3 million.