Restatement of Previously Issued Financial Statements (Tables)

9 Months Ended

Sep. 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 nine months ended September 30, 2023.

Consolidated Statements of Operations and Comprehensive Loss

	For the three months ended September 30, 2023
	As Previously Reported		Adjustments to Embedded Leases		Other Adjustments		As Restated
Revenue:
Product revenue, net	$	12,281	$	—	$	—	$	12,281
Other revenue	111		—		—		111
Total revenues	12,392		—		—		12,392
Cost of product revenue	10,955		(1,829)		—		9,126
Gross margin	1,437		1,829		—		3,266
Operating expenses:
Selling, general and administrative	40,703		68		—		40,771
Research and development	45,463		14,757		(1,719)		58,501
Total operating expenses	86,166		14,825		(1,719)		99,272
Loss from operations	(84,729)		(12,996)		1,719		(96,006)
Interest income	2,454		—		—		2,454
Interest expense	—		(4,311)		—		(4,311)
Other income, net	10,544		168		(81)		10,631
Loss before income taxes	(71,731)		(17,139)		1,638		(87,232)
Income tax (expense) benefit	—		—		—		—
Net loss	(71,731)		(17,139)		1,638		(87,232)
Net loss per share - basic (1)	$	(0.66)	$	(0.16)	$	0.02	$	(0.80)
Net loss per share - diluted (1)	$	(0.66)	$	(0.16)	$	0.02	$	(0.80)
Weighted-average number of common shares used in computing net loss per share - basic:	109,098		—		—		109,098
Weighted-average number of common shares used in computing net loss per share - diluted:	109,098		—		—		109,098
Other comprehensive income (loss):
Other comprehensive income (loss), net of tax (benefit) expense of $0.0 million for the three months ended September 30, 2023	137		—		—		137
Total other comprehensive income (loss)	137		—		—		137
Comprehensive loss	$	(71,594)	$	(17,139)	$	1,638	$	(87,095)

(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 nine months ended September 30, 2023
	As Previously Reported		Adjustments to Embedded Leases		Other Adjustments		As Restated
Revenue:
Product revenue, net	$	21,414	$	—	$	—	$	21,414
Other revenue	249		—		—		249
Total revenues	21,663		—		—		21,663
Cost of product revenue	23,895		(2,560)		—		21,335
Gross margin	(2,232)		2,560		—		328
Operating expenses:
Selling, general and administrative	118,406		294		—		118,700
Research and development	133,881		52		(2,397)		131,536
Total operating expenses	252,287		346		(2,397)		250,236
Gain from sale of priority review voucher, net	92,930		—		—		92,930
Loss from operations	(161,589)		2,214		2,397		(156,978)
Interest income	7,961		—		—		7,961
Interest expense	(3)		(12,328)		—		(12,331)
Other income, net	30,152		106		(81)		30,177
Loss before income taxes	(123,479)		(10,008)		2,316		(131,171)
Income tax (expense) benefit	80		—		—		80
Net loss	(123,399)		(10,008)		2,316		(131,091)
Net loss per share - basic	$	(1.15)	$	(0.09)	$	0.02	$	(1.23)
Net loss per share - diluted	$	(1.15)	$	(0.09)	$	0.02	$	(1.23)
Weighted-average number of common shares used in computing net loss per share - basic:	106,924		—		—		106,924
Weighted-average number of common shares used in computing net loss per share - diluted:	106,924		—		—		106,924
Other comprehensive income (loss):
Other comprehensive income (loss), net of tax (benefit) expense of $0.0 million for the nine months ended September 30, 2023	1,843		—		—		1,843
Total other comprehensive income (loss)	1,843		—		—		1,843
Comprehensive loss	$	(121,556)	$	(10,008)	$	2,316	$	(129,248)

(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.

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

	Common stock				Additional paid-in capital		Accumulated other comprehensive loss		Accumulated deficit		Total stockholders' equity
	Shares		Amount
As previously reported
Balances at June 30, 2023	106,454		$	1,065	$	4,328,489	$	(2,364)	$	(4,038,171)	$	289,019
Vesting of restricted stock	566		6		(6)		—		—		—
Exercise of stock options	2		—		8		—		—		8
Issuance of common stock	—		—		(50)		—		—		(50)
Stock-based compensation expense	—		—		5,153		—		—		5,153
Other comprehensive income (loss)	—		—		—		137		—		137
Net income (loss)	—		—		—		—		(71,731)		(71,731)
Balances at September 30, 2023	107,022	107,022	$	1,071	$	4,333,594	$	(2,227)	$	(4,109,902)	$	222,536
Balances at
Adjustments to Leases
Balances at June 30, 2023	—		—		—		—		(52,569)		(52,569)
Vesting of restricted stock	—		—		—		—		—		—
Exercise of stock options	—		—		—		—		—		—
Issuance of common stock	—		—		—		—		—		—
Stock-based compensation expense	—		—		—		—		—		—
Other comprehensive income (loss)	—		—		—		—		—		—
Net income (loss)	—		—		—		—		(17,139)		(17,139)
Balances at September 30, 2023	—		$	—	$	—	$	—	$	(69,708)	$	(69,708)
Balances at
Other Adjustments
Balances at June 30, 2023	—		—		(98)		—		(1,534)		(1,632)
Vesting of restricted stock	—		—		—		—		—		—
Exercise of stock options	—		—		—		—		—		—
Issuance of common stock	—		—		—		—		—		—
Stock-based compensation expense	—		—		—		—		—		—
Other comprehensive income (loss)	—		—		—		—		—		—
Net income (loss)	—		—		—		—		1,638		1,638
Balances at September 30, 2023	—		$	—	$	(98)	$	—	$	104	$	6
Balances at
As Restated
Balances at June 30, 2023	106,454		1,065		4,328,391		(2,364)		(4,092,274)		234,818
Vesting of restricted stock	566		6		(6)		—		—		—
Exercise of stock options	2		—		8		—		—		8
Issuance of common stock	—		—		(50)		—		—		(50)
Stock-based compensation expense	—		—		5,153		—		—		5,153
Other comprehensive income (loss)	—		—		—		137		—		137
Net income (loss)	—		—		—		—		(87,232)		(87,232)
Balances at September 30, 2023	107,022		$	1,071	$	4,333,496	$	(2,227)	$	(4,179,506)	$	152,834

Consolidated Statement of Cash Flows

	For the nine months ended September 30,
	2023
	As Previously Reported		Adjustments to Leases		Other Adjustments		As Restated
Cash flows from operating activities:
Net loss	$	(123,399)	$	(10,008)	$	2,316	$	(131,091)
Adjustments to reconcile net loss to net cash used in operating    activities:
Depreciation and amortization	3,124		16,648		(112)		19,660
Stock-based compensation expense	16,013		—		—		16,013
Noncash research and development expense (finance lease)	—		22,223		—		22,223
Noncash operating lease expense	—		23,965		—		23,965
Gain from sale of priority review voucher	(92,930)		—		—		(92,930)
Excess inventory reserve	5,333		1,554		2,315		9,202
Other non-cash items	19		—		81		100
(Gain) loss on foreign currency exchange rates	—		(1,062)		—		(1,062)
Changes in operating assets and liabilities:
Accounts receivable	(23,000)		—		8,400		(14,600)
Prepaid expenses and other assets	(523)		2,640		—		2,117
Inventory	(24,931)		1,651		(2,917)		(26,197)
Operating right of use assets	40,101		(40,101)		—		—
Accounts payable	(5,787)		7,183		316		1,712
Accrued expenses and other liabilities	7,125		583		(1,999)		5,709
Accrued interest payable under finance lease	—		3,203		—		3,203
Operating lease liabilities	(30,506)		11,820		—		(18,686)
Deferred revenue	8,152		—		(8,400)		(248)
Net cash (used in) provided by operating activities	(221,209)		40,299		—		(180,910)
Cash flows from investing activities:
Purchase of property, plant and equipment	(2,975)		—		—		(2,975)
Purchases of marketable securities	(43,297)		—		—		(43,297)
Proceeds from maturities of marketable securities	99,521		—		—		99,521
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	151,164		—		—		151,164
Cash flows from financing activities:
Proceeds from exercise of stock options and ESPP contributions	93		—		—		93
Proceeds from vesting of restricted stock	(196)		—		—		(196)
Principal payments on finance lease	—		(40,299)		—		(40,299)
Proceeds from the secondary public offering, net of issuance costs	130,072		—		—		130,072
Net cash (used in) provided by financing activities	129,969		(40,299)		—		89,670
Increase in cash, cash equivalents and restricted cash	59,924		—		—		59,924
Cash, cash equivalents and restricted cash at beginning of year	158,445		—		—		158,445
Cash, cash equivalents and restricted cash at end of year	$	218,369	$	—	$	—	$	218,369
Reconciliation of cash, cash equivalents and restricted cash:
Cash and cash equivalents	$	165,347	$	—	$	—	$	165,347
Restricted cash included in receivables and other current assets	8,885		—		—		8,885
Restricted cash included in restricted cash and other non-current assets	44,137		—		—		44,137
Total cash, cash equivalents and restricted cash	$	218,369	$	—	$	—	$	218,369
Supplemental cash flow disclosures:
Right-of-use assets obtained in exchange for operating lease liabilities	44,819		(45,527)		—		(708)
Purchases of property, plant and equipment included in accounts    payable and accrued expenses	941		—		—		941
Offering expenses included in accounts payable and accrued expenses	248		—		—		248
Right-of-use assets obtained in exchange for finance lease liabilities	—		21,508		—		21,508
Increase (reduction) of right of use asset and associated operating lease liability due to lease reassessment	8,003		(8,003)		—		—

Cash paid during the period for income taxes 5  —  —  5