Restatement of Previously Issued Financial Statements | Restatement of Previously Issued Financial Statements As further described below, as well as in Note 2 - Basis of Presentation, the Company identified several prior period misstatements that impacted its unaudited quarterly condensed consolidated financial statements for the three and six months ended June 30, 2023. Such restated and unaudited quarterly financial data and the related impacted amounts were presented in the Company's Annual Report on Form 10-K for the year ended December 31, 2023. As part of the restatement, the Company recorded adjustments to correct the material misstatements related to accounting for embedded leases and other immaterial errors. 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 Accumulated other comprehensive income (loss) Accumulated Total 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 Accumulated Accumulated Total 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 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 |