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Restatement of Previously Issued Financial Statements
 12 Months Ended
Dec. 31, 2023
Accounting Changes and Error Corrections [Abstract]  
Restatement of Previously Issued Financial Statements Restatement of Previously Issued Financial Statements
The Company has restated its previously issued consolidated financial statements as of and for the year ended December 31, 2022, and its previously issued unaudited condensed consolidated financial information for each of the first three quarters of the years ended December 31, 2023 and 2022 in this Form 10-K. The restated unaudited condensed consolidated financial information is disclosed in Note 21, Quarterly Financial Information (Unaudited). The Company has also restated impacted amounts within the notes to the consolidated financial statements, as applicable.

Leases
The Company identified errors pertaining to 1) the application of its accounting policy for the treatment of combining lease and non-lease components in arrangements that contain a lease, 2) the missed identification of embedded leases and improper accounting for its lease arrangements, including embedded leases and lease modifications, and 3) the misclassification of such embedded leases. The Company’s accounting policy is to combine lease and non-lease components in all agreements. The Company determined that it did not consistently combine such components in its arrangements with contract manufacturing organizations ("CMOs") and a contract testing organization ("CTO") and certain office and laboratory space agreements that contain a lease. Correctly combining lease and non-lease components on a consistent basis, correctly identifying embedded leases and lease modifications associated with a change in scope of lease or non-lease components, and correcting other accounting errors for all lease arrangements resulted in the following adjustments as of and for the year ended December 31, 2022:
•Three embedded leases with CMOs that were incorrectly classified as operating leases were determined to be finance leases. As a result, property, plant and equipment (right-of-use finance lease assets), finance lease liabilities, and interest expense were understated and operating lease right-of-use assets, accounts payable and accrued expenses, operating lease liabilities and research and development expense were overstated. The impact to prepaid expenses, other non-current assets, and other income varied from period to period.
•Two additional embedded finance leases were identified in existing CMO agreements and one additional embedded finance lease was identified in an existing CTO agreement. As a result, property, plant and equipment (right-of-use finance lease assets), finance lease liabilities, and interest expense were understated, accounts payable and accrued
expenses were overstated, and on a net basis, research and development expense was understated. The impact to prepaid expenses and other income varied from period to period.
•Minimum fixed payments for certain operating leases related to office and laboratory space were understated and sublease income was improperly classified within selling, general and administrative expense, which resulted in an understatement of operating lease right-of-use assets, operating lease liabilities, selling, general and administrative expense and other income. The impact to other current assets varied from period to period.
•Right-of-use assets associated with finance leases used in performing research and development activities without alternative future use at lease commencement or upon lease modification were immediately expensed to research and development expense which is the primary driver of the $95.6 million adjusted to accumulated deficit as of December 31, 2021. Subsequent finance lease amortization costs are expensed as research and development until achievement of regulatory approval and a subsequent modification to the embedded lease occurs.
•Reclassification of the principal portion of embedded finance lease payments as financing activities as well as other reclassifications of cash and non-cash activity within operating activities on the consolidated statement of cash flows.
Other Adjustments
In addition to the misstatements identified above, the Company has corrected other immaterial errors. These other errors are quantitatively and qualitatively immaterial, individually and in the aggregate. However, the Company has corrected these other errors as part of the correction for the material errors related to embedded leases.
Impact of Restatement
The following tables represent the as-restated consolidated balance sheet as of December 31, 2022, and the related consolidated statements of operations and comprehensive loss, stockholders’ equity and cash flows for the year ended December 31, 2022. These tables also present a reconciliation from the prior period as previously reported to the as-restated amounts. The amounts as previously reported for fiscal year 2022 were derived from the Annual Report on Form 10-K for the fiscal year ended December 31, 2022, filed on March 29, 2023.
Consolidated Balance Sheet:
As of December 31, 2022
(in thousands)
As Previously Reported
Adjustments to Leases
Other AdjustmentsAs Restated
Assets
Current assets:
Cash and cash equivalents$113,006 $— $— $113,006 
Marketable securities67,321 — — 67,321 
Prepaid expenses8,374 244 — 8,618 
Receivables and other current assets10,787 3,840 — 14,627 
Total current assets199,488 4,084 — 203,572 
Marketable securities1,414 — — 1,414 
Property, plant and equipment, net9,362 58,585 (311)67,636 
Goodwill5,646 — — 5,646 
Intangible assets, net
4,868 — — 4,868 
Operating lease right-of-use assets281,996 (51,111)230,885 
Restricted cash and other non-current assets52,128 3,665 — 55,793 
Total assets$554,902 $15,223 $(311)$569,814 
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable$25,092 $(10,225)$— $14,867 
Accrued expenses and other current liabilities51,985 (520)1,999 53,464 
Operating lease liability, current portion51,160 (23,566)— 27,594 
Finance lease liability, current portion
— 60,654 — 60,654 
Total current liabilities128,237 26,343 1,999 156,579 
Operating lease liability, net of current portion230,230 (21,102)— 209,128 
Financing lease liability, net of current portion
— 69,682 — 69,682 
Other non-current liabilities92 — — 92 
Total liabilities358,559 74,923 1,999 435,481 
Commitments and contingencies (Note 12)
Stockholders’ Equity:
Preferred stock, $0.01 par value, 5,000 shares
authorized; 0 shares issued and outstanding at December 31, 2022
$— $— $— $— 
Common stock, $0.01 par value, 125,000 shares
authorized; 82,923 shares issued and outstanding at December 31, 2022
830 — — 830 
Additional paid-in capital4,186,086 — (98)4,185,988 
Accumulated other comprehensive loss(4,070)— — (4,070)
Accumulated deficit(3,986,503)(59,700)(2,212)(4,048,415)
Total stockholders’ equity196,343 (59,700)(2,310)134,333 
Total liabilities and stockholders’ equity$554,902 $15,223 $(311)$569,814 
Consolidated Statement of Operations and Comprehensive Loss
Year ended December 31, 2022
(in thousands, except per share amounts)
As Previously Reported
Adjustments to Leases
Other AdjustmentsAs Restated
Revenue:
Product revenue, net
$2,739 $— $— $2,739 
Other revenue858 — — 858 
Total revenues3,597 — — 3,597 
Cost of product revenue10,077 — — 10,077 
Gross margin(6,480)— — (6,480)
Operating expenses:
Research and development240,764 (40,121)(204)200,439 
Selling, general and administrative136,908 3,516 (98)140,326 
Restructuring expenses4,940 — — 4,940 
Total operating expenses382,612 (36,605)(302)345,705 
Gain from sale of priority review voucher, net102,000 — — 102,000 
 (Loss) Income from operations
(287,092)36,605 302 (250,185)
Interest income
1,032 — — 1,032 
Interest expense
— (6,322)— (6,322)
Other (expense) income, net
19,599 5,651 — 25,250 
(Loss) income before income taxes
(266,461)35,934 302 (230,225)
Income tax (expense) benefit(117)— — (117)
Net (loss) income
(266,578)35,934 302 (230,342)
Net (loss) income per share - basic
$(3.39)$0.46 $— $(2.93)
Net (loss) income per share - diluted
$(3.39)$0.46 $— $(2.93)
Weighted-average number of common shares used
in computing net (loss) income per share - basic:
78,585 — — 78,585 
Weighted-average number of common shares used
in computing net (loss) income per share - diluted:
78,585 — — 78,585 
Other comprehensive (loss) income:
Other comprehensive (loss) income, net of tax
(benefit) expense of $0.0 million for the
year ended December 31, 2022
(1,159)— — (1,159)
Total other comprehensive (loss) income
(1,159)— — (1,159)
Comprehensive (loss) income
$(267,737)$35,934 $302 $(231,501)
Consolidated Statement of Changes in Stockholders' Equity:
Common stockAdditional
paid-in
capital		Accumulated
other
comprehensive
loss		Accumulated
deficit		Total
stockholders'
equity
(in thousands)
SharesAmount
As Previously Reported
Balances at December 31, 202171,115 $711 $4,096,402 $(2,911)$(3,719,925)$374,277 
Vesting of restricted stock979 10 (10)— — — 
Exercise of stock options7 — 16 — — 16 
Purchase of shares under ESPP68 1 238 — — 239 
Issuance of common stock
10,742 107 53,960 — — 54,067 
Issuance of unrestricted stock awards to
settle accrued employee compensation
12 1 — — — 1 
Stock-based compensation expense
— — 35,480 — — 35,480 
Other comprehensive loss— — — (1,159)— (1,159)
Net (loss) income
— — — — (266,578)(266,578)
Balances at December 31, 202282,923 $830 $4,186,086 $(4,070)$(3,986,503)$196,343 
Adjustments to Leases
Balances at December 31, 2021— $— $— $— $(95,634)$(95,634)
Vesting of restricted stock— — — — — — 
Exercise of stock options— — — — — — 
Purchase of shares under ESPP— — — — — — 
Issuance of common stock
— — — — — — 
Issuance of unrestricted stock awards to
settle accrued employee compensation
— — — — — — 
Stock-based compensation expense
— — — — — — 
Other comprehensive loss— — — — — — 
Net (loss) income
— — — — 35,934 35,934 
Balances at December 31, 2022— $— $— $— $(59,700)$(59,700)
Other Adjustments
Balances at December 31, 2021— — — — (2,514)(2,514)
Vesting of restricted stock— — — — — — 
Exercise of stock options— — — — — — 
Purchase of shares under ESPP— — — — — — 
Issuance of common stock
— — — — — — 
Issuance of unrestricted stock awards to
settle accrued employee compensation
— — — — — — 
Stock-based compensation expense
— — (98)— — (98)
Other comprehensive loss— — — — — — 
Net (loss) income
— — — — 302 302 
Balances at December 31, 2022— $— $(98)$— $(2,212)$(2,310)
As Restated
Balances at December 31, 202171,115 711 4,096,402 (2,911)(3,818,073)276,129 
Vesting of restricted stock979 10 (10)— — — 
Exercise of stock options7 — 16 — — 16 
Purchase of shares under ESPP68 1 238 — — 239 
Issuance of common stock
10,742 107 53,960 — — 54,067 
Issuance of unrestricted stock awards to
settle accrued employee compensation
12 1 — — — 1 
Stock-based compensation expense
— — 35,382 — — 35,382 
Other comprehensive loss— — — (1,159)— (1,159)
Net (loss) income
— — — — (230,342)(230,342)
Balances at December 31, 202282,923 $830 $4,185,988 $(4,070)$(4,048,415)$134,333