Cover Page
Cover Page - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 01, 2023 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2023 | |
Document Transition Report | false | |
Entity File Number | 001-38205 | |
Entity Registrant Name | ZAI LAB LIMITED | |
Entity Incorporation, State or Country Code | E9 | |
Entity Tax Identification Number | 98-1144595 | |
Entity Address, Address Line One | 4560 Jinke Road | |
Entity Address, Address Line Two | Bldg. 1, Fourth Floor, Pudong | |
Entity Address, City or Town | Shanghai | |
Entity Address, Country | CN | |
Entity Address, Postal Zip Code | 201210 | |
City Area Code | 86 21 | |
Local Phone Number | 6163 2588 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Small Business | false | |
Entity Shell Company | false | |
Entity Central Index Key | 0001704292 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
American Depositary Shares | ||
Document Information [Line Items] | ||
Title of 12(b) Security | American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per share | |
Trading Symbol | ZLAB | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 754,401,320 | |
Ordinary Shares | ||
Document Information [Line Items] | ||
Title of 12(b) Security | Ordinary Shares, par value $0.000006 per share | |
Trading Symbol | 9688 | |
Entity Common Stock, Shares Outstanding | 988,387,430 |
Unaudited Condensed Consolidate
Unaudited Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 788,806 | $ 1,008,470 |
Short-term investments | 31,600 | 0 |
Accounts receivable (net of allowance for credit loss of $12 and $11 as of September 30, 2023 and December 31, 2022, respectively) | 41,596 | 39,963 |
Notes receivable | 23,679 | 8,608 |
Inventories, net | 44,229 | 31,621 |
Prepayments and other current assets | 29,821 | 35,674 |
Total current assets | 959,731 | 1,124,336 |
Restricted cash, non-current | 1,792 | 803 |
Long term investments | 4,466 | 6,431 |
Prepayments for equipment | 144 | 1,396 |
Property and equipment, net | 55,282 | 57,863 |
Operating lease right-of-use assets | 16,398 | 19,512 |
Land use rights, net | 3,057 | 6,892 |
Intangible assets, net | 1,568 | 1,511 |
Long-term deposits | 1,256 | 1,396 |
Total assets | 1,043,694 | 1,220,140 |
Current liabilities: | ||
Accounts payable | 55,020 | 65,974 |
Current operating lease liabilities | 6,886 | 7,050 |
Other current liabilities | 62,990 | 66,818 |
Total current liabilities | 124,896 | 139,842 |
Deferred income | 27,686 | 21,360 |
Non-current operating lease liabilities | 9,808 | 13,343 |
Other non-current liabilities | 325 | 0 |
Total liabilities | 162,715 | 174,545 |
Commitments and contingencies (Note 15) | ||
Shareholders’ equity | ||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 973,930,280 and 962,455,850 shares issued as of September 30, 2023 and December 31, 2022, respectively; 969,037,150 and 960,219,570 shares outstanding as of September 30, 2023 and December 31, 2022, respectively) | 6 | 6 |
Additional paid-in capital | 2,954,362 | 2,893,120 |
Accumulated deficit | (2,100,551) | (1,861,360) |
Accumulated other comprehensive income | 47,952 | 25,685 |
Treasury Stock (at cost, 4,893,130 and 2,236,280 shares as of September 30, 2023 and December 31, 2022, respectively) | (20,790) | (11,856) |
Total shareholders’ equity | 880,979 | 1,045,595 |
Total liabilities and shareholders’ equity | $ 1,043,694 | $ 1,220,140 |
Unaudited Condensed Consolida_2
Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Accounts receivable, allowance for credit loss | $ 12 | $ 11 |
Ordinary shares, par value (in dollars per share) | $ 0.000006 | $ 0.000006 |
Ordinary shares, shares authorized (in shares) | 5,000,000,000 | 5,000,000,000 |
Ordinary shares, shares issued (in shares) | 973,930,280 | 962,455,850 |
Ordinary shares, shares outstanding (in shares) | 969,037,150 | 960,219,570 |
Treasury Stock (in shares) | 4,893,130 | 2,236,280 |
Unaudited Condensed Consolida_3
Unaudited Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenues: | ||||
Product revenue, net | $ 69,228,000 | $ 56,963,000 | $ 200,889,000 | $ 150,633,000 |
Collaboration revenue | 0 | 577,000 | 0 | 1,806,000 |
Total revenues | 69,228,000 | 57,540,000 | 200,889,000 | 152,439,000 |
Expenses: | ||||
Cost of sales | (25,479,000) | (20,044,000) | (70,579,000) | (53,094,000) |
Research and development | (58,767,000) | (99,524,000) | (183,920,000) | (219,462,000) |
Selling, general, and administrative | (68,552,000) | (66,555,000) | (198,982,000) | (186,947,000) |
Gain on sale of intellectual property | 0 | 0 | 10,000,000 | 0 |
Loss from operations | (83,570,000) | (128,583,000) | (242,592,000) | (307,064,000) |
Interest income | 9,172,000 | 3,872,000 | 29,493,000 | 5,235,000 |
Foreign currency gain (loss) | 4,852,000 | (40,442,000) | (26,315,000) | (73,052,000) |
Other income (expense), net | 394,000 | 3,963,000 | 223,000 | (6,415,000) |
Loss before income tax and share of loss from equity method investment | (69,152,000) | (161,190,000) | (239,191,000) | (381,296,000) |
Income tax expense | 0 | 0 | 0 | 0 |
Share of loss from equity method investment | 0 | 0 | 0 | (221,000) |
Net loss | (69,152,000) | (161,190,000) | (239,191,000) | (381,517,000) |
Net loss attributable to ordinary shareholders - basic | (69,152,000) | (161,190,000) | (239,191,000) | (381,517,000) |
Net loss attributable to ordinary shareholders - diluted | $ (69,152,000) | $ (161,190,000) | $ (239,191,000) | $ (381,517,000) |
Loss per share/ADS - basic (in dollars per share) | $ (0.07) | $ (0.17) | $ (0.25) | $ (0.40) |
Loss per share/ADS - diluted (in dollars per share) | $ (0.07) | $ (0.17) | $ (0.25) | $ (0.40) |
Weighted-average shares/ADSs used in calculating net loss per ordinary share/ADS - basic (in shares) | 968,767,730 | 959,085,960 | 965,060,570 | 957,439,910 |
Weighted-average shares/ADSs used in calculating net loss per ordinary share/ADS - diluted (in shares) | 968,767,730 | 959,085,960 | 965,060,570 | 957,439,910 |
American Depositary Shares | ||||
Expenses: | ||||
Loss per share/ADS - basic (in dollars per share) | $ (0.71) | $ (1.68) | $ (2.48) | $ (3.98) |
Loss per share/ADS - diluted (in dollars per share) | $ (0.71) | $ (1.68) | $ (2.48) | $ (3.98) |
Weighted-average shares/ADSs used in calculating net loss per ordinary share/ADS - basic (in shares) | 96,876,773 | 95,908,596 | 96,506,057 | 95,743,991 |
Weighted-average shares/ADSs used in calculating net loss per ordinary share/ADS - diluted (in shares) | 96,876,773 | 95,908,596 | 96,506,057 | 95,743,991 |
Unaudited Condensed Consolida_4
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (69,152) | $ (161,190) | $ (239,191) | $ (381,517) |
Other comprehensive income, net of tax of nil: | ||||
Foreign currency translation adjustments | (4,228) | 35,062 | 22,267 | 63,194 |
Comprehensive loss | $ (73,380) | $ (126,128) | $ (216,924) | $ (318,323) |
Unaudited Condensed Consolida_5
Unaudited Condensed Consolidated Statements of Comprehensive Loss (Parenthetical) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Statement of Comprehensive Income [Abstract] | ||||
Other comprehensive (loss) income, tax | $ 0 | $ 0 | $ 0 | $ 0 |
Unaudited Condensed Consolida_6
Unaudited Condensed Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Ordinary Shares | Additional paid in capital | Accumulated deficit | Accumulated other comprehensive income (loss) | Treasury Stock |
Beginning balance (in shares) at Dec. 31, 2021 | 955,363,980 | |||||
Beginning balance at Dec. 31, 2021 | $ 1,379,956 | $ 6 | $ 2,825,948 | $ (1,418,074) | $ (23,645) | $ (4,279) |
Beginning balance (in shares) at Dec. 31, 2021 | (382,930) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of ordinary shares upon vesting of restricted shares (in shares) | 514,800 | |||||
Issuance of ordinary shares upon vesting of restricted shares | 0 | $ 0 | 0 | |||
Exercise of share options (in shares) | 1,156,660 | |||||
Exercise of share options | 297 | $ 0 | 297 | |||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation (in shares) | (15,150) | |||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | (68) | $ (68) | ||||
Share-based compensation | 12,410 | 12,410 | ||||
Net loss | (82,394) | (82,394) | ||||
Foreign currency translation | (2,193) | (2,193) | ||||
Ending balance (in shares) at Mar. 31, 2022 | 957,035,440 | |||||
Ending balance at Mar. 31, 2022 | 1,308,008 | $ 6 | 2,838,655 | (1,500,468) | (25,838) | $ (4,347) |
Ending balance (in shares) at Mar. 31, 2022 | (398,080) | |||||
Beginning balance (in shares) at Dec. 31, 2021 | 955,363,980 | |||||
Beginning balance at Dec. 31, 2021 | 1,379,956 | $ 6 | 2,825,948 | (1,418,074) | (23,645) | $ (4,279) |
Beginning balance (in shares) at Dec. 31, 2021 | (382,930) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | (381,517) | |||||
Foreign currency translation | 63,194 | |||||
Ending balance (in shares) at Sep. 30, 2022 | 961,829,720 | |||||
Ending balance at Sep. 30, 2022 | 1,105,869 | $ 6 | 2,877,361 | (1,799,591) | 39,549 | $ (11,456) |
Ending balance (in shares) at Sep. 30, 2022 | (2,104,780) | |||||
Beginning balance (in shares) at Mar. 31, 2022 | 957,035,440 | |||||
Beginning balance at Mar. 31, 2022 | 1,308,008 | $ 6 | 2,838,655 | (1,500,468) | (25,838) | $ (4,347) |
Beginning balance (in shares) at Mar. 31, 2022 | (398,080) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of ordinary shares upon vesting of restricted shares (in shares) | 683,700 | |||||
Issuance of ordinary shares upon vesting of restricted shares | 0 | $ 0 | 0 | |||
Exercise of share options (in shares) | 2,801,000 | |||||
Exercise of share options | 4,322 | $ 0 | 4,322 | |||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation (in shares) | (1,627,230) | |||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | (6,782) | $ (6,782) | ||||
Share-based compensation | 14,225 | 14,225 | ||||
Net loss | (137,933) | (137,933) | ||||
Foreign currency translation | 30,325 | 30,325 | ||||
Ending balance (in shares) at Jun. 30, 2022 | 960,520,140 | |||||
Ending balance at Jun. 30, 2022 | 1,212,165 | $ 6 | 2,857,202 | (1,638,401) | 4,487 | $ (11,129) |
Ending balance (in shares) at Jun. 30, 2022 | (2,025,310) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of ordinary shares upon vesting of restricted shares (in shares) | 230,250 | |||||
Issuance of ordinary shares upon vesting of restricted shares | 0 | $ 0 | 0 | |||
Exercise of share options (in shares) | 1,079,330 | |||||
Exercise of share options | 1,052 | $ 0 | 1,052 | |||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation (in shares) | (79,470) | |||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | (327) | $ (327) | ||||
Share-based compensation | 19,107 | 19,107 | ||||
Net loss | (161,190) | (161,190) | ||||
Foreign currency translation | 35,062 | 35,062 | ||||
Ending balance (in shares) at Sep. 30, 2022 | 961,829,720 | |||||
Ending balance at Sep. 30, 2022 | $ 1,105,869 | $ 6 | 2,877,361 | (1,799,591) | 39,549 | $ (11,456) |
Ending balance (in shares) at Sep. 30, 2022 | (2,104,780) | |||||
Beginning balance (in shares) at Dec. 31, 2022 | 960,219,570 | 962,455,850 | ||||
Beginning balance at Dec. 31, 2022 | $ 1,045,595 | $ 6 | 2,893,120 | (1,861,360) | 25,685 | $ (11,856) |
Beginning balance (in shares) at Dec. 31, 2022 | (2,236,280) | (2,236,280) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of ordinary shares upon vesting of restricted shares (in shares) | 732,040 | |||||
Issuance of ordinary shares upon vesting of restricted shares | $ 0 | $ 0 | 0 | |||
Exercise of share options (in shares) | 4,009,460 | |||||
Exercise of share options | 1,673 | $ 0 | 1,673 | |||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation (in shares) | (1,272,330) | |||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | (5,130) | $ (5,130) | ||||
Share-based compensation | 16,661 | 16,661 | ||||
Net loss | (49,144) | (49,144) | ||||
Foreign currency translation | (8,413) | (8,413) | ||||
Ending balance (in shares) at Mar. 31, 2023 | 967,197,350 | |||||
Ending balance at Mar. 31, 2023 | $ 1,001,242 | $ 6 | 2,911,454 | (1,910,504) | 17,272 | $ (16,986) |
Ending balance (in shares) at Mar. 31, 2023 | (3,508,610) | |||||
Beginning balance (in shares) at Dec. 31, 2022 | 960,219,570 | 962,455,850 | ||||
Beginning balance at Dec. 31, 2022 | $ 1,045,595 | $ 6 | 2,893,120 | (1,861,360) | 25,685 | $ (11,856) |
Beginning balance (in shares) at Dec. 31, 2022 | (2,236,280) | (2,236,280) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Net loss | $ (239,191) | |||||
Foreign currency translation | $ 22,267 | |||||
Ending balance (in shares) at Sep. 30, 2023 | 969,037,150 | 973,930,280 | ||||
Ending balance at Sep. 30, 2023 | $ 880,979 | $ 6 | 2,954,362 | (2,100,551) | 47,952 | $ (20,790) |
Ending balance (in shares) at Sep. 30, 2023 | (4,893,130) | (4,893,130) | ||||
Beginning balance (in shares) at Mar. 31, 2023 | 967,197,350 | |||||
Beginning balance at Mar. 31, 2023 | $ 1,001,242 | $ 6 | 2,911,454 | (1,910,504) | 17,272 | $ (16,986) |
Beginning balance (in shares) at Mar. 31, 2023 | (3,508,610) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of ordinary shares upon vesting of restricted shares (in shares) | 6,117,040 | |||||
Issuance of ordinary shares upon vesting of restricted shares | 0 | $ 0 | 0 | |||
Exercise of share options (in shares) | 41,000 | |||||
Exercise of share options | 88 | $ 0 | 88 | |||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation (in shares) | (1,280,500) | |||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | (3,540) | $ (3,540) | ||||
Share-based compensation | 20,511 | 20,511 | ||||
Net loss | (120,895) | (120,895) | ||||
Foreign currency translation | 34,908 | 34,908 | ||||
Ending balance (in shares) at Jun. 30, 2023 | 973,355,390 | |||||
Ending balance at Jun. 30, 2023 | 932,314 | $ 6 | 2,932,053 | (2,031,399) | 52,180 | $ (20,526) |
Ending balance (in shares) at Jun. 30, 2023 | (4,789,110) | |||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||
Issuance of ordinary shares upon vesting of restricted shares (in shares) | 394,890 | |||||
Issuance of ordinary shares upon vesting of restricted shares | 0 | $ 0 | 0 | |||
Exercise of share options (in shares) | 180,000 | |||||
Exercise of share options | 317 | $ 0 | 317 | |||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation (in shares) | (104,020) | |||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | (264) | $ (264) | ||||
Share-based compensation | 21,992 | 21,992 | ||||
Net loss | (69,152) | (69,152) | ||||
Foreign currency translation | $ (4,228) | (4,228) | ||||
Ending balance (in shares) at Sep. 30, 2023 | 969,037,150 | 973,930,280 | ||||
Ending balance at Sep. 30, 2023 | $ 880,979 | $ 6 | $ 2,954,362 | $ (2,100,551) | $ 47,952 | $ (20,790) |
Ending balance (in shares) at Sep. 30, 2023 | (4,893,130) | (4,893,130) |
Unaudited Condensed Consolida_7
Unaudited Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (239,191) | $ (381,517) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Allowance for credit loss (gain) | 1 | (3) |
Inventory write-down | 746 | 480 |
Depreciation and amortization expenses | 6,570 | 6,100 |
Amortization of deferred income | (2,547) | (2,041) |
Share-based compensation | 59,164 | 45,742 |
Share of loss from equity method investment | 0 | 221 |
Loss from fair value changes of equity investment with readily determinable fair value | 1,965 | 12,067 |
Loss (gain) on disposal of property and equipment | 139 | (11) |
Gain on disposal of land use right | (408) | 0 |
Noncash lease expenses | 6,630 | 5,820 |
Gain from sale of intellectual property | (10,000) | 0 |
Foreign currency remeasurement loss | 26,315 | 73,052 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,823) | 16,483 |
Notes receivable | (15,563) | (3,861) |
Inventories | (14,408) | (13,235) |
Prepayments and other current assets | 5,126 | (5,860) |
Long-term deposits | 140 | (459) |
Value added tax recoverable | 0 | 21,432 |
Accounts payable | (9,494) | (28,850) |
Other current liabilities | 227 | 1,628 |
Operating lease liabilities | (5,794) | (6,008) |
Deferred income | 9,619 | 470 |
Other non-current liabilities | 325 | 0 |
Net cash used in operating activities | (183,261) | (258,350) |
Cash flows from investing activities | ||
Purchases of short-term investments | (134,000) | (260,274) |
Proceeds from maturity of short-term investment | 102,400 | 705,274 |
Purchase of property and equipment | (6,990) | (20,172) |
Proceeds from the sale of property and equipment | 122 | 0 |
Purchase of intangible assets | (658) | (439) |
Proceeds from sale of intellectual property | 10,000 | 0 |
Proceeds from disposal of land use right | 3,893 | 0 |
Net cash (used in) provided by investing activities | (25,233) | 424,389 |
Cash flows from financing activities | ||
Proceeds from exercises of stock options | 1,899 | 5,640 |
Taxes paid related to settlement of equity awards | (8,725) | (7,171) |
Net cash used in financing activities | (6,826) | (1,531) |
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (3,355) | (9,132) |
Net (decrease) increase in cash, cash equivalents and restricted cash | (218,675) | 155,376 |
Cash, cash equivalents and restricted cash - beginning of period | 1,009,273 | 964,903 |
Cash, cash equivalents and restricted cash - end of period | 790,598 | 1,120,279 |
Supplemental disclosure on non-cash investing and financing activities | ||
Payables for purchase of property and equipment | 2,625 | 3,234 |
Payables for intangible assets | 98 | 32 |
Payables for treasury stock | 31 | 32 |
Receivables for stock option exercise under equity incentive plans | 0 | 31 |
Right-of-use asset acquired under operating leases | 3,296 | 12,861 |
Supplemental disclosure of cash flow information | ||
Cash and cash equivalents | 788,806 | 1,119,476 |
Restricted cash, non-current | 1,792 | 803 |
Total cash and cash equivalents and restricted cash | $ 790,598 | $ 1,120,279 |
Organization and Principal Acti
Organization and Principal Activities | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Principal Activities | Organization and Principal Activities Zai Lab Limited was incorporated on March 28, 2013 in the Cayman Islands as an exempted company with limited liability under the Companies Act of the Cayman Islands (as amended). Zai Lab Limited and its subsidiaries (collectively referred to as the “Company”) are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs, including in the areas of oncology, autoimmune disorders, infectious disease, and neuroscience. The Company’s principal operations and geographic markets are in Greater China. The Company has a substantial presence in Greater China and the United States. The accompanying unaudited condensed consolidated financial statements are the financial statements of the Company. |
Basis of Presentation and Conso
Basis of Presentation and Consolidation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Consolidation and Significant Accounting Policies | Basis of Presentation and Consolidation and Significant Accounting Policies (a) Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”), regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”). The December 31, 2022 condensed consolidated balance sheet data included in this report were derived from the audited financial statements in the 2022 Annual Report. In the third quarter of 2022, the Company began to separately present the amount of foreign currency remeasurement gain (loss) on our statements of cash flows. This amount was previously included in changes in other current liabilities. This change did not have any impact on net cash used in operating activities. Corresponding amounts in the prior periods of the condensed consolidated financial statement have been presented to conform to the current period presentation. The accompanying condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the year ending December 31, 2023. (b) Principles of Consolidation The unaudited condensed consolidated financial statements include the financial statements of the Company. All intercompany transactions and balances are eliminated upon consolidation. (c) Use of Estimates The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, accrual of rebates, recognition of research and development expenses to the appropriate financial reporting period based on the progress of the research and development projects, fair value of share-based compensation expenses, and recoverability of deferred tax assets. These estimates, judgments, and assumptions can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented. Actual results could differ from these estimates. (d) Fair Value Measurements Equity investments with readily determinable fair value are measured using level 1 inputs and were $4.5 million and $6.4 million as of September 30, 2023 and December 31, 2022, respectively. The unrealized gains and losses from fair value changes are recognized in other income (expenses), net in the condensed consolidated statements of operations. Financial instruments of the Company primarily include cash, cash equivalents and restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable, and other current liabilities. As of September 30, 2023 and December 31, 2022, the carrying values of cash and cash equivalents, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable, and other current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of restricted cash approximated its fair value based on the nature of the assessment of the ability to recover these amounts. (e) Recent Accounting Pronouncements |
Cash and Cash Equivalents
Cash and Cash Equivalents | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Cash and Cash Equivalents | Cash and Cash Equivalents The following table presents the Company’s cash and cash equivalents ($ in thousands): September 30, 2023 December 31, 2022 Cash 787,725 1,007,423 Cash equivalents (i) 1,081 1,047 788,806 1,008,470 Denominated in: US$ 764,765 957,824 RMB (ii) 21,056 45,486 Hong Kong dollar (“HK$”) 2,352 4,378 Australian dollar (“A$”) 553 598 Taiwan dollar (“TW$”) 80 184 788,806 1,008,470 (i) Cash equivalents represent short-term and highly liquid investments in a money market fund. |
Inventories, Net
Inventories, Net | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventories, Net | Inventories, Net The following table presents the Company’s inventories, net ($ in thousands): September 30, 2023 December 31, 2022 Finished goods 21,417 12,156 Raw materials 22,812 19,029 Work in progress — 436 Inventories, net 44,229 31,621 |
Property and Equipment, Net
Property and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, Net The following table presents the components of the Company’s property and equipment, net ($ in thousands): September 30, 2023 December 31, 2022 Office equipment 1,024 977 Electronic equipment 8,757 7,416 Vehicle 196 202 Laboratory equipment 19,858 18,726 Manufacturing equipment 16,865 17,055 Leasehold improvements 11,153 11,300 Construction in progress 25,019 24,251 82,872 79,927 Less: accumulated depreciation (27,590) (22,064) Property and equipment, net 55,282 57,863 Depreciation expense was $1.8 million and $6.1 million for the three and nine months ended September 30, 2023, respectively, and $2.1 million and $5.7 million for the three and nine months ended September 30, 2022, respectively. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue Product Revenue The Company’s product revenue is primarily derived from the sales of ZEJULA, Optune, QINLOCK, NUZYRA, and VYVGART in mainland China and Hong Kong. The table below presents the Company’s product revenue ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Product revenue - gross 74,018 60,446 220,240 168,095 Less: Rebates and sales returns (4,790) (3,483) (19,351) (17,462) Product revenue - net 69,228 56,963 200,889 150,633 Sales rebates are offered to distributors in mainland China, and the amounts are recorded as a reduction of revenue. Estimated rebates are determined based on contracted rates, sales volumes, and level of distributor inventories. The following table presents the Company’s net revenue by product ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 ZEJULA 41,593 39,214 127,230 102,863 Optune 11,562 10,662 38,596 35,051 QINLOCK 5,702 5,541 14,535 9,123 NUZYRA 5,483 1,546 15,588 3,596 VYVGART 4,888 — 4,940 — Product revenue - net 69,228 56,963 200,889 150,633 |
Income Tax
Income Tax | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Tax | Income Tax No provision for income taxes has been required to be accrued because the Company is in a cumulative loss position for the periods presented. The Company recorded a full valuation allowance against deferred tax assets of all its consolidated entities because all entities were in a cumulative loss position as of September 30, 2023 and December 31, 2022. No unrecognized tax benefits and related interest and penalties were recorded in the periods presented. |
Other Current Liabilities
Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Other Current Liabilities | Other Current Liabilities The following table presents the Company’s other current liabilities ($ in thousands): September 30, 2023 December 31, 2022 Payroll 26,046 31,689 Accrued professional service fee 9,578 4,080 Payables for purchase of property and equipment 2,625 5,269 Accrued rebate to distributors 8,121 8,443 Tax payables 13,792 13,283 Others (i) 2,828 4,054 Total 62,990 66,818 (i) Others mainly include accrued travel and business-related expenses. |
Loss Per Share
Loss Per Share | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Loss Per Share | Loss Per Share The following table presents the computation of the basic and diluted net loss per share ($ in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to ordinary shareholders (69,152) (161,190) (239,191) (381,517) Denominator: Weighted average number of ordinary shares - basic and diluted 968,767,730 959,085,960 965,060,570 957,439,910 Net loss per share - basic and diluted (0.07) (0.17) (0.25) (0.40) As a result of the Company’s net loss for the three and nine months ended September 30, 2023 and 2022, share options and non-vested restricted shares outstanding in the respective periods were excluded from the calculation of diluted loss per share as their inclusion would have been anti-dilutive. September 30, 2023 2022 Share options 107,249,960 90,511,530 Non-vested restricted shares 32,359,260 34,103,830 |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | Related Party Transactions The Company incurred research and development expenses for product research and development services provided by MEDx (Suzhou) Translational Medicine Co., Ltd (“MEDx”), over which an immediate family member of our Chief Executive Officer and Chairperson of the Board held significant influence. The Company incurred development expenses with MEDx of nil and an insignificant amount during the three and nine months ended September 30, 2023 and an insignificant amount and $0.3 million during the three and nine months ended September 30, 2022, respectively. |
Share-Based Compensation
Share-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Share-Based Compensation During the nine months ended September 30, 2023, the Company granted share options to purchase up to 23,768,090 ordinary shares and restricted shares representing 8,836,580 ordinary shares under the 2022 Plan. The share options granted have a contractual term of ten years. Share options granted since April 2023 generally vest ratably over a four-year period, and share options granted prior to April 2023 generally vest ratably over a five-year period, with 25% or 20% of the awards vesting on each anniversary of the grant date, respectively, subject to continued employment with the Company on the vesting date. The restricted shares granted generally vest ratably over a specified period on the anniversary of the grant date, subject to continued employment/service with the Company on the vesting date. For a description of the Company’s equity incentive plans and more details on the terms of the share-based awards, see Note 15 to our 2022 Annual Report. The following table presents the share-based compensation expense that has been reported in the Company’s condensed consolidated statements of operations and comprehensive loss as follows ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Selling, general and administrative 14,041 11,298 35,880 27,221 Research and development 7,951 7,809 23,284 18,521 Total 21,992 19,107 59,164 45,742 |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements The Company has entered into various license and collaboration agreements with third parties to develop and commercialize product candidates. Significant License and Collaboration Arrangements For a description of the material terms of the Company’s significant license and collaboration agreements, see Note 16 to our 2022 Annual Report. During the nine months ended September 30, 2023, the Company did not enter into any new significant license or collaboration agreements. The following includes a description of payments or accruals related to upfront or milestone fees under our significant license and collaboration agreements during the nine months ended September 30, 2023. License and Collaboration Agreement with Entasis Therapeutics Holdings Inc.(“Entasis”) (SUL-DUR) Under the terms of our license and collaboration agreement with Entasis for SUL-DUR, the Company paid a $3.0 million development milestone in the third quarter of 2023, which was accrued in the second quarter of 2023. As of September 30, 2023, the Company may be required to pay an additional aggregate amount of up to $88.6 million in development, regulatory, and sales-based milestones. License Agreement with BMS (Formerly Turning Point Therapeutics Inc (“Turning Point”)) (Repotrectinib) Under the terms of our license agreement with BMS for reprotrectinib, the Company paid a $5.0 million development milestone in the third quarter of 2023, which was accrued in the second quarter of 2023. As of September 30, 2023, the Company may be required to pay an additional aggregate amount of up to $141.0 million in development, regulatory, and sales-based milestones. Other License and Collaboration Arrangements That Are Not Individually Significant The Company made an upfront payment of $10.0 million in the second quarter of 2023 for a new strategic partnership and global license agreement with MediLink Therapeutics (Suzhou) Co., Ltd. for an early-stage next generation DLL3 ADC program, ZL-1310. |
Other Income (Expenses), Net
Other Income (Expenses), Net | 9 Months Ended |
Sep. 30, 2023 | |
Other Income and Expenses [Abstract] | |
Other Income (Expenses), Net | Other Income (Expenses), Net The following table presents the Company’s other income (expenses), net ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Government grants 671 3,422 754 5,048 Loss on equity investments with readily determinable fair value (661) 489 (1,965) (12,067) Others miscellaneous gain 384 52 1,434 604 Total 394 3,963 223 (6,415) |
Restricted Net Assets
Restricted Net Assets | 9 Months Ended |
Sep. 30, 2023 | |
Restricted net assets | |
Restricted Net Assets | Restricted Net Assets The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its Chinese subsidiaries. Relevant Chinese laws and regulations permit payments of dividends by the Company’s Chinese subsidiaries only out of its retained earnings, if any, as determined in accordance with Chinese accounting standards and regulations. The results of operations reflected in the unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP differ from those reflected in the statutory financial statements of the Company’s Chinese subsidiaries. In accordance with the Company Law of the People’s Republic of China, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual after-tax profit until such reserve has reached 50% of its respective registered capital based on the enterprise’s Chinese statutory accounts. A domestic enterprise may provide discretionary surplus reserve, at the discretion of the Board of Directors, from the profits determined in accordance with the enterprise’s Chinese statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s Chinese subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits. No appropriation to statutory reserves was made during the three and nine months ended September 30, 2023 and 2022 because the Chinese subsidiaries had substantial losses during such periods. As a result of these Chinese laws and regulations, subject to the limits discussed above that require annual appropriations of 10% of after-tax profit to be set aside, prior to payment of dividends, as a general reserve fund, the Company’s Chinese subsidiaries are restricted in their ability to transfer out a portion of their net assets. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies (a) Purchase Commitments The Company’s commitments related to purchase of property and equipment contracted but not yet reflected in the unaudited condensed consolidated financial statements were $2.5 million as of September 30, 2023 and were expected to be incurred within one year. (b) Legal Proceedings The Company is not currently a party to any material legal proceedings. (c) Indemnifications |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2023 | Jun. 30, 2023 | Mar. 31, 2023 | Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Pay vs Performance Disclosure | ||||||||
Net loss | $ (69,152) | $ (120,895) | $ (49,144) | $ (161,190) | $ (137,933) | $ (82,394) | $ (239,191) | $ (381,517) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended | 9 Months Ended |
Sep. 30, 2023 shares | Sep. 30, 2023 shares | |
Trading Arrangements, by Individual | ||
Non-Rule 10b5-1 Arrangement Adopted | false | |
Rule 10b5-1 Arrangement Terminated | false | |
Non-Rule 10b5-1 Arrangement Terminated | false | |
Joshua Smiley [Member] | ||
Trading Arrangements, by Individual | ||
Material Terms of Trading Arrangement | On August 12, 2023, Joshua Smiley, the Company’s President and Chief Operating Officer, adopted a new written Rule 10b5-1 trading arrangement (as defined in Item 408 of Regulation S-K), for the purchase of up to 15,000 of the Company’s ADSs, each representing ten of the Company’s ordinary shares. This Rule 10b5-1 trading arrangement is scheduled to terminate no later than May 13, 2024. | |
Name | Joshua Smiley | |
Title | President and Chief Operating Officer | |
Rule 10b5-1 Arrangement Adopted | true | |
Adoption Date | August 12, 2023 | |
Termination Date | May 13, 2024 | |
Arrangement Duration | 275 days | |
Aggregate Available | 15,000 | 15,000 |
Basis of Presentation and Con_2
Basis of Presentation and Consolidation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States (“U.S. GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”), regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2022 (the “2022 Annual Report”). The December 31, 2022 condensed consolidated balance sheet data included in this report were derived from the audited financial statements in the 2022 Annual Report. In the third quarter of 2022, the Company began to separately present the amount of foreign currency remeasurement gain (loss) on our statements of cash flows. This amount was previously included in changes in other current liabilities. This change did not have any impact on net cash used in operating activities. Corresponding amounts in the prior periods of the condensed consolidated financial statement have been presented to conform to the current period presentation. The accompanying condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the year ending December 31, 2023. |
Principles of Consolidation | The unaudited condensed consolidated financial statements include the financial statements of the Company. All intercompany transactions and balances are eliminated upon consolidation. |
Use of Estimates | The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, accrual of rebates, recognition of research and development expenses to the appropriate financial reporting period based on the progress of the research and development projects, fair value of share-based compensation expenses, and recoverability of deferred tax assets. These estimates, judgments, and assumptions can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented. Actual results could differ from these estimates. |
Fair Value Measurements | The unrealized gains and losses from fair value changes are recognized in other income (expenses), net in the condensed consolidated statements of operations. Financial instruments of the Company primarily include cash, cash equivalents and restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable, and other current liabilities. As of September 30, 2023 and December 31, 2022, the carrying values of cash and cash equivalents, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable, and other current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of restricted cash approximated its fair value based on the nature of the assessment of the ability to recover these amounts. |
Recent Accounting Pronouncements | The Company has not adopted any new accounting standards since December 31, 2022. For a discussion of the Company’s significant accounting policies, see the discussion in Note 2 above and the notes to the consolidated financial statements in the 2022 Annual Report. |
Cash and Cash Equivalents (Tabl
Cash and Cash Equivalents (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Cash and Cash Equivalents | The following table presents the Company’s cash and cash equivalents ($ in thousands): September 30, 2023 December 31, 2022 Cash 787,725 1,007,423 Cash equivalents (i) 1,081 1,047 788,806 1,008,470 Denominated in: US$ 764,765 957,824 RMB (ii) 21,056 45,486 Hong Kong dollar (“HK$”) 2,352 4,378 Australian dollar (“A$”) 553 598 Taiwan dollar (“TW$”) 80 184 788,806 1,008,470 (i) Cash equivalents represent short-term and highly liquid investments in a money market fund. |
Inventories, Net (Tables)
Inventories, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventories, Net | The following table presents the Company’s inventories, net ($ in thousands): September 30, 2023 December 31, 2022 Finished goods 21,417 12,156 Raw materials 22,812 19,029 Work in progress — 436 Inventories, net 44,229 31,621 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | The following table presents the components of the Company’s property and equipment, net ($ in thousands): September 30, 2023 December 31, 2022 Office equipment 1,024 977 Electronic equipment 8,757 7,416 Vehicle 196 202 Laboratory equipment 19,858 18,726 Manufacturing equipment 16,865 17,055 Leasehold improvements 11,153 11,300 Construction in progress 25,019 24,251 82,872 79,927 Less: accumulated depreciation (27,590) (22,064) Property and equipment, net 55,282 57,863 |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Product Revenue | The table below presents the Company’s product revenue ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Product revenue - gross 74,018 60,446 220,240 168,095 Less: Rebates and sales returns (4,790) (3,483) (19,351) (17,462) Product revenue - net 69,228 56,963 200,889 150,633 |
Schedule of Disaggregation of Net Revenue | The following table presents the Company’s net revenue by product ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 ZEJULA 41,593 39,214 127,230 102,863 Optune 11,562 10,662 38,596 35,051 QINLOCK 5,702 5,541 14,535 9,123 NUZYRA 5,483 1,546 15,588 3,596 VYVGART 4,888 — 4,940 — Product revenue - net 69,228 56,963 200,889 150,633 |
Other Current Liabilities (Tabl
Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Schedule of other Current Liabilities | The following table presents the Company’s other current liabilities ($ in thousands): September 30, 2023 December 31, 2022 Payroll 26,046 31,689 Accrued professional service fee 9,578 4,080 Payables for purchase of property and equipment 2,625 5,269 Accrued rebate to distributors 8,121 8,443 Tax payables 13,792 13,283 Others (i) 2,828 4,054 Total 62,990 66,818 (i) Others mainly include accrued travel and business-related expenses. |
Loss Per Share (Tables)
Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Earnings Per Share [Abstract] | |
Summary of Basic and Diluted Net Loss Per Share | The following table presents the computation of the basic and diluted net loss per share ($ in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Numerator: Net loss attributable to ordinary shareholders (69,152) (161,190) (239,191) (381,517) Denominator: Weighted average number of ordinary shares - basic and diluted 968,767,730 959,085,960 965,060,570 957,439,910 Net loss per share - basic and diluted (0.07) (0.17) (0.25) (0.40) |
Summary of Anti-Dilutive Shares Excluded from Calculation of Diluted Loss Per Share | As a result of the Company’s net loss for the three and nine months ended September 30, 2023 and 2022, share options and non-vested restricted shares outstanding in the respective periods were excluded from the calculation of diluted loss per share as their inclusion would have been anti-dilutive. September 30, 2023 2022 Share options 107,249,960 90,511,530 Non-vested restricted shares 32,359,260 34,103,830 |
Share-Based Compensation (Table
Share-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Share-Based Compensation expense | The following table presents the share-based compensation expense that has been reported in the Company’s condensed consolidated statements of operations and comprehensive loss as follows ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Selling, general and administrative 14,041 11,298 35,880 27,221 Research and development 7,951 7,809 23,284 18,521 Total 21,992 19,107 59,164 45,742 |
Other Income (Expenses), Net (T
Other Income (Expenses), Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Other Income and Expenses [Abstract] | |
Schedule of Other Expense, Net | The following table presents the Company’s other income (expenses), net ($ in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Government grants 671 3,422 754 5,048 Loss on equity investments with readily determinable fair value (661) 489 (1,965) (12,067) Others miscellaneous gain 384 52 1,434 604 Total 394 3,963 223 (6,415) |
Basis of Presentation and Con_3
Basis of Presentation and Consolidation and Significant Accounting Policies (Details) - USD ($) $ in Millions | Sep. 30, 2023 | Dec. 31, 2022 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity investments with readily determinable fair value | $ 4.5 | $ 6.4 |
Cash and Cash Equivalents (Deta
Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | Sep. 30, 2022 |
Cash And Cash Equivalents [Line Items] | |||
Cash | $ 787,725 | $ 1,007,423 | |
Cash equivalents | 1,081 | 1,047 | |
Cash and cash equivalents | 788,806 | 1,008,470 | $ 1,119,476 |
US$ | |||
Cash And Cash Equivalents [Line Items] | |||
Cash and cash equivalents | 764,765 | 957,824 | |
RMB | |||
Cash And Cash Equivalents [Line Items] | |||
Cash and cash equivalents | 21,056 | 45,486 | |
Hong Kong dollar (“HK$”) | |||
Cash And Cash Equivalents [Line Items] | |||
Cash and cash equivalents | 2,352 | 4,378 | |
Australian dollar (“A$”) | |||
Cash And Cash Equivalents [Line Items] | |||
Cash and cash equivalents | 553 | 598 | |
Taiwan dollar (“TW$”) | |||
Cash And Cash Equivalents [Line Items] | |||
Cash and cash equivalents | $ 80 | $ 184 |
Inventories, Net - Summary of I
Inventories, Net - Summary of Inventories, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 21,417 | $ 12,156 |
Raw materials | 22,812 | 19,029 |
Work in progress | 0 | 436 |
Inventories, net | $ 44,229 | $ 31,621 |
Inventories, Net - Additional I
Inventories, Net - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | ||||
Inventory write-down | $ 0.1 | $ 0.3 | $ 0.7 | $ 0.5 |
Property and Equipment, Net - S
Property and Equipment, Net - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property Plant And Equipment | ||
Property and equipment, gross | $ 82,872 | $ 79,927 |
Less: accumulated depreciation | (27,590) | (22,064) |
Property and equipment, net | 55,282 | 57,863 |
Office equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 1,024 | 977 |
Electronic equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 8,757 | 7,416 |
Vehicle | ||
Property Plant And Equipment | ||
Property and equipment, gross | 196 | 202 |
Laboratory equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 19,858 | 18,726 |
Manufacturing equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 16,865 | 17,055 |
Leasehold improvements | ||
Property Plant And Equipment | ||
Property and equipment, gross | 11,153 | 11,300 |
Construction in progress | ||
Property Plant And Equipment | ||
Property and equipment, gross | $ 25,019 | $ 24,251 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 1.8 | $ 2.1 | $ 6.1 | $ 5.7 |
Revenue - Summary of Product Re
Revenue - Summary of Product Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | ||||
Product revenue - gross | $ 74,018 | $ 60,446 | $ 220,240 | $ 168,095 |
Less: Rebates and sales returns | (4,790) | (3,483) | (19,351) | (17,462) |
Product revenue - net | $ 69,228 | $ 56,963 | $ 200,889 | $ 150,633 |
Revenue - Disaggregation of Net
Revenue - Disaggregation of Net Revenue by Product (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | $ 69,228 | $ 56,963 | $ 200,889 | $ 150,633 |
ZEJULA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 41,593 | 39,214 | 127,230 | 102,863 |
Optune | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 11,562 | 10,662 | 38,596 | 35,051 |
QINLOCK | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 5,702 | 5,541 | 14,535 | 9,123 |
NUZYRA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 5,483 | 1,546 | 15,588 | 3,596 |
VYVGART | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | $ 4,888 | $ 0 | $ 4,940 | $ 0 |
Income Tax (Details)
Income Tax (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 0 | $ 0 | $ 0 | $ 0 | |
Unrecognized tax benefits | 0 | 0 | $ 0 | ||
Unrecognized tax benefits, interest and penalties | $ 0 | $ 0 | $ 0 | $ 0 |
Other Current Liabilities (Deta
Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Other Liabilities Disclosure [Abstract] | ||
Payroll | $ 26,046 | $ 31,689 |
Accrued professional service fee | 9,578 | 4,080 |
Payables for purchase of property and equipment | 2,625 | 5,269 |
Accrued rebate to distributors | 8,121 | 8,443 |
Tax payables | 13,792 | 13,283 |
Other | 2,828 | 4,054 |
Total | $ 62,990 | $ 66,818 |
Loss Per Share - Computation of
Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Numerator: | ||||
Net loss attributable to ordinary shareholders - basic | $ (69,152) | $ (161,190) | $ (239,191) | $ (381,517) |
Net loss attributable to ordinary shareholders - diluted | $ (69,152) | $ (161,190) | $ (239,191) | $ (381,517) |
Denominator: | ||||
Weighted average number of ordinary shares - basic (in shares) | 968,767,730 | 959,085,960 | 965,060,570 | 957,439,910 |
Weighted average number of ordinary shares - diluted (in shares) | 968,767,730 | 959,085,960 | 965,060,570 | 957,439,910 |
Net loss per share - basic (in dollars per share) | $ (0.07) | $ (0.17) | $ (0.25) | $ (0.40) |
Net loss per share - diluted (in dollars per share) | $ (0.07) | $ (0.17) | $ (0.25) | $ (0.40) |
Loss Per Share - Summary of Ant
Loss Per Share - Summary of Anti-Dilutive Shares Excluded from Calculation of Diluted Loss Per Share (Details) - shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares excluded from calculation of diluted loss per share | 107,249,960 | 90,511,530 |
Non-vested restricted shares | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares excluded from calculation of diluted loss per share | 32,359,260 | 34,103,830 |
Related Party Transactions (Det
Related Party Transactions (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Related Party Transaction [Line Items] | ||||
Research and development expense | $ 58,767,000 | $ 99,524,000 | $ 183,920,000 | $ 219,462,000 |
Limited Liability Company | ||||
Related Party Transaction [Line Items] | ||||
Research and development expense | $ 0 | $ 0 | $ 0 | $ 300,000 |
Share-Based Compensation - Addi
Share-Based Compensation - Additional Information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2023 USD ($) shares | |
Share options | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Contractual term | 10 years |
Unrecognized share-based compensation expense related to unvested share options granted | $ | $ 114.6 |
Recognized over a weighted-average period | 3 years 2 months 26 days |
Share options | Since April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 4 years |
Share options | Prior to April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting period | 5 years |
Share options | Tranche one | Since April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 25% |
Share options | Tranche one | Prior to April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 20% |
Share options | Tranche two | Since April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 25% |
Share options | Tranche two | Prior to April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 20% |
Share options | Tranche three | Since April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 25% |
Share options | Tranche three | Prior to April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 20% |
Share options | Tranche four | Since April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 25% |
Share options | Tranche four | Prior to April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 20% |
Share options | Tranche five | Prior to April 2023 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Vesting percentage | 20% |
Non-vested restricted shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unrecognized share-based compensation expense related to unvested restricted shares | $ | $ 115.4 |
Recognized over a weighted-average period | 2 years 11 months 23 days |
2022 Plan | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Options granted (in shares) | shares | 23,768,090 |
2022 Plan | Non-vested restricted shares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Non-option awards granted (in shares) | shares | 8,836,580 |
Share-Based Compensation - Summ
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 21,992 | $ 19,107 | $ 59,164 | $ 45,742 |
Selling, general and administrative | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | 14,041 | 11,298 | 35,880 | 27,221 |
Research and development | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 7,951 | $ 7,809 | $ 23,284 | $ 18,521 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) $ in Millions | 3 Months Ended | |
Sep. 30, 2023 | Jun. 30, 2023 | |
Entasis | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payment made | $ 3 | |
Maximum additional milestone payments | 88.6 | |
Turning Point | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payment made | 5 | |
Maximum additional milestone payments | $ 141 | |
MediLink | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Upfront payments made | $ 10 |
Other Income (Expenses), Net (D
Other Income (Expenses), Net (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Other Income and Expenses [Abstract] | ||||
Government grants | $ 671 | $ 3,422 | $ 754 | $ 5,048 |
Loss on equity investments with readily determinable fair value | (661) | 489 | (1,965) | (12,067) |
Others miscellaneous gain | 384 | 52 | 1,434 | 604 |
Total | $ 394 | $ 3,963 | $ 223 | $ (6,415) |
Restricted Net Assets (Details)
Restricted Net Assets (Details) - PRC - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Restricted net assets | |||||
Statutory reserves | $ 0 | $ 0 | $ 0 | $ 0 | |
Restricted amount by subsidiaries | $ 506,000,000 | $ 506,000,000 | $ 456,000,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | Sep. 30, 2023 USD ($) |
Property and Equipment | |
Loss Contingencies [Line Items] | |
Purchase obligation to be incurred within on year | $ 2.5 |