Income Taxes

12 Months Ended

Dec. 31, 2023

Income Tax Disclosure [Abstract]

Income Taxes

18. Income Taxes

Loss from continuing operations before provision for income taxes for the Company’s domestic and international operations was as follows (in thousands):

	Year Ended December 31,
	2023			2022			2021
United States	$	(10,377	)	$	(87,400	)	$	(80,926	)
Foreign		—			—			—
Loss before provision for income taxes	$	(10,377	)	$	(87,400	)	$	(80,926	)

As of December 31, 2023, the Company has concluded that it is more likely than not that the Company may not realize the benefit of its deferred tax assets due to its history of losses. The Company has incurred operating losses since inception. Accordingly, the net deferred tax assets have been fully reserved. The provision for income taxes consists of the following (in thousands):

	Year Ended December 31,
	2023			2022			2021
Current
U.S. federal	$	—		$	—		$	—
U.S. state		1,555			—			—
Non-U.S.		—			—			—
Total current		1,555			—			—
Deferred
U.S. federal		(190	)		(5,606	)		(5,170	)
U.S. state		7,002			(4,334	)		(14,461	)
Non-U.S.		—			—			—
Total deferred		6,812			(9,940	)		(19,631	)
Valuation allowance		(6,806	)		9,940			19,631
Net deferred		6			—			—
Total	$	1,561		$	—		$	—

Deferred income taxes reflect the tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting and income tax purposes. A valuation allowance is established when uncertainty exists as to whether all or a portion of the net deferred tax assets will be realized. Components of the net deferred tax assets are approximately as follows (in thousands):

	December 31,
	2023			2022
Deferred tax assets:
Net operating loss carryforwards	$	506,641		$	542,537
Research and development credits		77,007			78,804
Capitalized research costs		14,225			4,369
Milestone Rights		1,006			1,331
Accrued expenses		3,760			2,675
Loss on purchase commitment		22,806			23,117
Non-qualified stock option expense		3,559			7,686
Capitalized patent costs		6,720			8,058
Other		3,405			3,204
Lease liability		1,280			1,624
Interest expense limitation		2,782			10,991
Depreciation		21,134			22,157
Deferred product revenue and costs		346			370
Sale of future royalties		34,848			-
Total deferred tax assets		699,519			706,923
Valuation allowance		(698,228	)		(705,034	)
Net deferred tax assets	$	1,291		$	1,889
Deferred tax liabilities:
Right of use asset	$	(1,121	)	$	(1,640	)
Other prepaids		(176	)		(249	)
Total deferred tax liabilities		(1,297	)		(1,889	)
Net deferred tax assets	$	(6	)	$	—

The Company’s effective tax rate differs from the statutory federal income tax rate as follows:

	Year Ended December 31,
	2023			2022			2021
Federal tax benefit rate		21.0	%		21.0	%		21.0	%
State tax expense (net of federal benefit)		-11.8	%		0.0	%		0.0	%
Permanent items		-2.8	%		-0.1	%		-4.4	%
Officers compensation		-35.3	%		-1.1	%		0.0	%
Stock based compensation		-5.6	%		0.4	%		0.3	%
Tax attribute expirations		0.4	%		-13.2	%		-5.9	%
Valuation allowance		9.1	%		-7.2	%		-11.2	%
Other deferred adjustments		10.0	%		0.2	%		0.2	%
Effective income tax rate		-15.0	%		0.0	%		0.0	%

As of December 31, 2023 and 2022, management assessed the realizability of deferred tax assets. Management evaluated the need for an amount of any valuation allowance for deferred tax assets on a jurisdictional basis. This evaluation utilizes the framework contained in ASC 740, Income Taxes, wherein management analyzes all positive and negative evidence available at the balance sheet date to determine whether all or some portion of our deferred tax assets will not be realized. Under this guidance, a valuation allowance must be established for deferred tax assets when it is more likely than not (a probability level of more than 50 percent) that they will not be realized. In assessing the realization of the Company's deferred tax assets, the Company considers all available evidence, both positive and negative.

In concluding on the evaluation, management placed significant emphasis on guidance in ASC 740, which states that “a cumulative loss in recent years is a significant piece of negative evidence that is difficult to overcome.” Based upon available evidence as of December 31, 2023, it was concluded on a more-likely-than-not basis that all deferred tax assets were not realizable. Accordingly, a valuation allowance of $698.2 million has been recorded to offset these deferred tax assets. During the years ended December 31, 2023 and 2022, the change in valuation allowance was $6.8 million and $9.9 million, respectively.

As of December 31, 2023, the Company had federal and state net operating loss carryforwards of approximately $2.0 billion and $1.3 billion available, respectively, to reduce future taxable income. $494.0 million of the federal losses do not expire and the remaining federal losses have started expiring, beginning in the current year through various future dates.

Pursuant to IRC Sections 382 and 383, annual use of the Company’s federal and California net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50% occurs within a three-year period. As a result of the Company's initial public offering, an ownership change within the meaning of IRC Section 382 occurred in August 2004. As a result, federal net operating loss and credit carryforwards of approximately $105.8 million are subject to an annual use limitation of approximately $13.0 million. The annual limitation is cumulative and therefore, if not fully utilized in a year can be utilized in future years in addition to the Section 382 limitation for those years. We have completed a Section 382 analysis beginning from the date of our initial public offering through December 31, 2023, to determine whether additional limitations may be placed on the net operating loss carryforwards and other tax attributes, and no additional changes in ownership that met Section 382 study ownership change threshold has been identified through December 31, 2023. There is a risk that changes in ownership may occur in tax years after December 31, 2023. If a change in ownership were to occur, our net operating loss carryforwards and other tax attributes could be further limited or restricted. If limited, the related asset would be removed from the deferred tax asset schedule with a corresponding reduction in the valuation allowance. Due to the existence of the valuation allowance, limitations created by future ownership changes, if any, related to the Company’s operations in the U.S. will not impact the Company’s effective tax rate.

As of December 31, 2023, the Company had $54.2 million of U.S. federal research and development credits which expire beginning in 2024, and $22.8 million of state research and development credits. The Company also had two types of credits in Connecticut of which $19.8 million do not expire and the $1.1 million of the R&D credit expired at the end of 2023.

The Company files U.S. federal and state income tax returns in jurisdictions with varying statutes of limitations. In the normal course of business the Company is subject to examination by taxing authorities throughout the country. These audits could include examining the timing and amount of deductions, the allocation of income among various tax jurisdictions and compliance with federal, state, and local tax laws. The Company's tax years since 2018 remain subject to examination by federal, state and foreign tax authorities.

A reconciliation of beginning and ending amounts of unrecognized tax benefits was as follows (in thousands):

	Year Ended December 31,
	2023		2022		2021
Unrecognized Tax Benefit
Beginning of Year	$	268,902	$	268,902	$	268,902
Gross increases for tax positions of prior years		—		—		—
Gross decreases for tax positions of current year		—		—		—
Settlements		—		—		—
Lapse of statute of limitations		—		—		—
End of Year	$	268,902	$	268,902	$	268,902

As of December 31, 2023, 2022 and 2021, the Company has not recognized a liability for unrecognized tax benefits. If any were recognized, it would affect the Company’s effective tax rate. The Company does not expect its unrecognized tax benefits to change significantly over the next 12 months. The Company recognizes interest and penalties accrued related to unrecognized tax benefits in income tax expense. During the years ended December 31, 2023, 2022 and 2021, the Company did not recognize any interest and/or penalties.