Restatement of Previously Issued Financial Statements (Tables)

6 Months Ended

Jun. 30, 2024

Accounting Changes and Error Corrections [Abstract]

Schedule of Corrections to Impacted Financial Statements

The following tables present the restated unaudited Condensed Consolidated Financial Information for the three and six months ended June 30, 2023.

Consolidated Statements of Operations and Comprehensive Loss

	For the three months ended June 30, 2023
	As Previously Reported		Adjustments to Embedded Leases		Other Adjustments		As Restated
Revenue:
Product revenue, net	$	6,837	$	—	$	—	$	6,837
Other revenue	53		—		—		53
Total revenues	6,890		—		—		6,890
Cost of product revenue	9,564		(2,867)		—		6,697
Gross margin	(2,674)		2,867		—		193
Operating expenses:
Research and development	42,274		(10,189)		(637)		31,448
Selling, general and administrative	40,349		113		—		40,462
Total operating expenses	82,623		(10,076)		(637)		71,910
Loss from operations	(85,297)		12,943		637		(71,717)
Interest income	2,679		—		—		2,679
Interest expense	—		(3,750)		—		(3,750)
Other income, net	9,630		289		—		9,919
Loss before income taxes	(72,988)		9,482		637		(62,869)
Income tax (expense) benefit	80		—		—		80
Net loss	(72,908)		9,482		637		(62,789)
Net loss per share - basic (1)	$	(0.67)	$	0.09	$	0.01	$	(0.58)
Net loss per share - diluted (1)	$	(0.67)	$	0.09	$	0.01	$	(0.58)
Weighted-average number of common shares used in computing net loss per share - basic:	108,685		108,685		108,685		108,685
Weighted-average number of common shares used in computing net loss per share - diluted:	108,685		108,685		108,685		108,685
Other comprehensive income (loss):
Other comprehensive income (loss), net of tax (benefit) expense of $0.0 million for the three months ended June 30, 2023	722		—		—		722
Total other comprehensive income (loss)	722		—		—		722
Comprehensive loss	$	(72,186)	$	9,482	$	637	$	(62,067)

(1) Due to differences in rounding to the nearest cent per basic or diluted share, totals may not equal the sum of the line items.

	For the six months ended June 30, 2023
	As Previously Reported		Adjustments to Embedded Leases		Other Adjustments		As Restated
Revenue:
Product revenue, net	$	9,133	$	—	$	—	$	9,133
Other revenue	138		—		—		138
Total revenues	9,271		—		—		9,271
Cost of product revenue	12,940		(731)		—		12,209
Gross margin	(3,669)		731		—		(2,938)
Operating expenses:
Research and development	88,418		(14,705)		(678)		73,035
Selling, general and administrative	77,703		226		—		77,929
Total operating expenses	166,121		(14,479)		(678)		150,964
Gain from sale of priority review voucher, net	92,930		—		—		92,930
Loss from operations	(76,860)		15,210		678		(60,972)
Interest income	5,507		—		—		5,507
Interest expense	(3)		(8,017)		—		(8,020)
Other income, net	19,608		(62)		—		19,546
Loss before income taxes	(51,748)		7,131		678		(43,939)
Income tax (expense) benefit	80		—		—		80
Net loss	(51,668)		7,131		678		(43,859)
Net loss per share - basic	$	(0.49)	$	0.07	$	0.01	$	(0.41)
Net loss per share - diluted	$	(0.49)	$	0.07	$	0.01	$	(0.41)
Weighted-average number of common shares used in computing net loss per share - basic:	105,819		105,819		105,819		105,819
Weighted-average number of common shares used in computing net loss per share - diluted:	105,819		105,819		105,819		105,819
Other comprehensive income (loss):
Other comprehensive income (loss), net of tax (benefit) expense of $0.0 million for the six months ended June 30, 2023	1,706		—		—		1,706
Total other comprehensive income (loss)	1,706		—		—		1,706
Comprehensive loss	$	(49,962)	$	7,131	$	678	$	(42,153)

Statements of Changes in Stockholders' Equity:

	Common stock				Additional paid-in capital		Accumulated other comprehensive income (loss)		Accumulated deficit		Total stockholders' equity
	Shares		Amount
As Previously Reported
Balances at December 31, 2022	82,923		$	830	$	4,186,086	$	(4,070)	$	(3,986,503)	$	196,343
Vesting of restricted stock	382		3		(198)		—		—		(195)
Exercise of stock options	3		—		7		—		—		7
Purchase of shares under ESPP	62		1		226		—		—		227
Issuance of common stock for private equity placement	23,000		230		130,061		—		—		130,291
Stock-based compensation	—		—		5,843		—		—		5,843
Other comprehensive income (loss)	—		—		—		984		—		984
Net income (loss)	—		—		—		—		21,240		21,240
Balances at March 31, 2023	106,370		$	1,064	$	4,322,025	$	(3,086)	$	(3,965,263)	$	354,740
Adjustments to Embedded Leases
Balances at December 31, 2022	$	—	$	—	$	—	$	—	$	(59,700)	$	(59,700)
Vesting of restricted stock	—		—		—		—		—		—
Exercise of stock options	—		—		—		—		—		—
Purchase of shares under ESPP	—		—		—		—		—		—
Issuance of common stock for private equity placement	—		—		—		—		—		—
Stock-based compensation	—		—		—		—		—		—
Other comprehensive income (loss)	—		—		—		—		—		—
Net income (loss)	—		—		—		—		(2,351)		(2,351)
Balances at March 31, 2023	—		$	—	$	—	$	—	$	(62,051)	$	(62,051)
Other Adjustments
Balances at December 31, 2022	—		—		(98)		—		(2,212)		(2,310)
Vesting of restricted stock	—		—		—		—		—		—
Exercise of stock options	—		—		—		—		—		—
Purchase of shares under ESPP	—		—		—		—		—		—
Issuance of common stock for private equity placement	—		—		—		—		—		—
Stock-based compensation	—		—		—		—		—		—
Other comprehensive income (loss)	—		—		—		—		—		—
Net income (loss)	—		—		—		—		41		41
Balances at March 31, 2023	—		$	—	$	(98)	$	—	$	(2,171)	$	(2,269)
As Restated
Balances at December 31, 2022	82,923		830		4,185,988		(4,070)		(4,048,415)		134,333
Vesting of restricted stock	382		3		(198)		—		—		(195)
Exercise of stock options	3		—		7		—		—		7
Purchase of shares under ESPP	62		1		226		—		—		227
Issuance of common stock for private equity placement	23,000		230		130,061		—		—		130,291
Stock-based compensation	—		—		5,843		—		—		5,843
Other comprehensive income (loss)	—		—		—		984		—		984
Net income (loss)	—		—		—		—		18,930		18,930
Balances at March 31, 2023	106,370		$	1,064	$	4,321,927	$	(3,086)	$	(4,029,485)	$	290,420

	Common stock				Additional paid-in capital		Accumulated other comprehensive loss		Accumulated deficit		Total stockholders' equity
	Shares		Amount
As Previously Reported
Balances at March 31, 2023	106,370		$	1,064	$	4,322,025	$	(3,086)	$	(3,965,263)	$	354,740
Vesting of restricted stock	65		1		(1)		—		—		—
Exercise of stock options	19		—		77		—		—		77
Purchase of shares under ESPP	—		—		—		—		—		—
Issuance of common stock for private equity placement	—		—		—		—		—		—
Stock-based compensation	—		—		6,388		—		—		6,388
Other comprehensive income (loss)	—		—		—		722		—		722
Net income (loss)	—		—		—		—		(72,908)		(72,908)
Balances at June 30, 2023	106,454		$	1,065	$	4,328,489	$	(2,364)	$	(4,038,171)	$	289,019
Adjustments to Embedded Leases
Balances at March 31, 2023	$	—	$	—	$	—	$	—	$	(62,051)	$	(62,051)
Vesting of restricted stock	—		—		—		—		—		—
Exercise of stock options	—		—		—		—		—		—
Purchase of shares under ESPP	—		—		—		—		—		—
Issuance of common stock for private equity placement	—		—		—		—		—		—
Stock-based compensation	—		—		—		—		—		—
Other comprehensive income (loss)	—		—		—		—		—		—
Net income (loss)	—		—		—		—		9,482		9,482
Balances at June 30, 2023	—		$	—	$	—	$	—	$	(52,569)	$	(52,569)
Other Adjustments
Balances at March 31, 2023	—		—		(98)		—		(2,171)		(2,269)
Vesting of restricted stock	—		—		—		—		—		—
Exercise of stock options	—		—		—		—		—		—
Purchase of shares under ESPP	—		—		—		—		—		—
Issuance of common stock for private equity placement	—		—		—		—		—		—
Stock-based compensation	—		—		—		—		—		—
Other comprehensive income (loss)	—		—		—		—		—		—
Net income (loss)	—		—		—		—		637		637
Balances at June 30, 2023	—		$	—	$	(98)	$	—	$	(1,534)	$	(1,632)
As Restated
Balances at March 31, 2023	106,370		1,064		4,321,927		(3,086)		(4,029,485)		290,420
Vesting of restricted stock	65		1		(1)		—		—		—
Exercise of stock options	19		—		77		—		—		77
Purchase of shares under ESPP	—		—		—		—		—		—
Issuance of common stock for private equity placement	—		—		—		—		—		—
Stock-based compensation	—		—		6,388		—		—		6,388
Other comprehensive income (loss)	—		—		—		722		—		722
Net income (loss)	—		—		—		—		(62,789)		(62,789)
Balances at June 30, 2023	106,454		$	1,065	$	4,328,391	$	(2,364)	$	(4,092,274)	$	234,818

Consolidated Statement of Cash Flows

	For the six months ended June 30,
	2023
	As Previously Reported		Adjustments to Embedded Leases		Other Adjustments		As Restated
Cash flows from operating activities:
Net loss	$	(51,668)	$	7,131	$	678	$	(43,859)
Adjustments to reconcile net loss to net cash used in operating    activities:
Depreciation and amortization	2,052		10,274		(76)		12,250
Stock-based compensation expense	11,145		—		—		11,145
Noncash research and development expense (finance lease)	—		434		—		434
Noncash operating lease expense	—		14,966		—		14,966
Gain from sale of priority review voucher	(92,930)		—		—		(92,930)
Excess inventory reserve	3,939		—		2,339		6,278
Other non-cash items	343		—		—		343
Gain on foreign currency exchange rates	—		(281)		—		(281)
Changes in operating assets and liabilities:
Prepaid expenses and other assets	(9,082)		2,642		—		(6,440)
Inventory	(16,496)		1,838		(2,941)		(17,599)
Operating right of use assets	24,102		(24,102)		—		—
Accounts payable	(14,767)		9,144		—		(5,623)
Accrued expenses and other liabilities	3,625		(573)		—		3,052
Accrued interest payable under finance lease	—		819		—		819
Operating lease liabilities	(19,488)		6,212		—		(13,276)
Deferred revenue	(138)		—		—		(138)
Net cash (used in) provided by operating activities	(159,363)		28,504		—		(130,859)
Cash flows from investing activities:
Purchase of property, plant and equipment	(937)		—		—		(937)
Purchases of marketable securities	(34,418)		—		—		(34,418)
Proceeds from maturities of marketable securities	26,521		—		—		26,521
Proceeds from sales of marketable securities	5,853		—		—		5,853
Purchase of intangible assets	(868)		—		—		(868)
Proceeds from sale of priority review voucher	92,930		—		—		92,930
Net cash provided by investing activities	89,081		—		—		89,081
Cash flows from financing activities:
Proceeds from exercise of stock options and ESPP contributions	85		—		—		85
Proceeds from vesting of restricted stock	(196)		—		—		(196)
Principal payments on finance lease	—		(28,504)		—		(28,504)
Proceeds from the secondary public offering, net of issuance costs	130,122		—		—		130,122
Net cash (used in) provided by financing activities	130,011		(28,504)		—		101,507
Increase in cash, cash equivalents and restricted cash	59,729		—		—		59,729
Cash, cash equivalents and restricted cash at beginning of year	158,445		—		—		158,445
Cash, cash equivalents and restricted cash at end of year	$	218,174	$	—	$	—	$	218,174
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	172,872	$	—	$	—	$	172,872
Restricted cash included in receivables and other current assets	1,364		—		—		1,364
Restricted cash included in restricted cash and other non-current assets	43,938		—		—		43,938
Total cash, cash equivalents and restricted cash	$	218,174	$	—	$	—	$	218,174
Supplemental cash flow disclosures:
Right-of-use assets obtained in exchange for operating lease liabilities	44,968		(44,968)		—		—
Increase (Reduction) of right of use asset and associated operating lease liability due to lease reassessment	(14)		14		—		—
Purchases of property, plant and equipment included in accounts    payable and accrued expenses	2,290		—		—		2,290
Right-of-use assets obtained in exchange for finance lease liabilities	—		3,436		—		3,436
Cash paid during the period for income taxes	7		—		—		7