QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | ||||
314 Main Street 4th Floor, Suite 100 Cambridge, MA, USA | 02142 | ||||
(Address of Principal Executive Offices) | (Zip Code) | ||||
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
The Stock Exchange of Hong Kong Limited |
x | Accelerated filer | o | ||||||||||||
Non-accelerated filer | o | Smaller reporting company | ||||||||||||
Emerging growth company |
Page | ||||||||
Notes | September 30, 2024 | December 31, 2023 | |||||||||||||||
Assets | |||||||||||||||||
Current assets | |||||||||||||||||
Cash and cash equivalents | 3 | ||||||||||||||||
Restricted cash, current | |||||||||||||||||
Short-term investments | |||||||||||||||||
Accounts receivable (net of allowance for credit losses of $ | |||||||||||||||||
Notes receivable | |||||||||||||||||
Inventories, net | 4 | ||||||||||||||||
Prepayments and other current assets | |||||||||||||||||
Total current assets | |||||||||||||||||
Restricted cash, non-current | |||||||||||||||||
Long term investments | |||||||||||||||||
Prepayments for equipment | |||||||||||||||||
Property and equipment, net | 5 | ||||||||||||||||
Operating lease right-of-use assets | |||||||||||||||||
Land use rights, net | |||||||||||||||||
Intangible assets, net | 6 | ||||||||||||||||
Long-term deposits | |||||||||||||||||
Value added tax recoverable | |||||||||||||||||
Total assets | |||||||||||||||||
Liabilities and shareholders’ equity | |||||||||||||||||
Current liabilities | |||||||||||||||||
Accounts payable | |||||||||||||||||
Current operating lease liabilities | |||||||||||||||||
Short-term debt | 10 | ||||||||||||||||
Other current liabilities | 11 | ||||||||||||||||
Total current liabilities | |||||||||||||||||
Deferred income | |||||||||||||||||
Non-current operating lease liabilities | |||||||||||||||||
Other non-current liabilities | |||||||||||||||||
Total liabilities | |||||||||||||||||
Commitments and contingencies (Note 16) | |||||||||||||||||
Shareholders’ equity | |||||||||||||||||
Ordinary shares (par value of $ | |||||||||||||||||
Additional paid-in capital | |||||||||||||||||
Accumulated deficit | ( | ( | |||||||||||||||
Accumulated other comprehensive income | |||||||||||||||||
Treasury Stock (at cost, | ( | ( | |||||||||||||||
Total shareholders’ equity | |||||||||||||||||
Total liabilities and shareholders’ equity |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
Notes | 2024 | 2023 | 2024 | 2023 | |||||||||||||||||||||||||
Revenues | |||||||||||||||||||||||||||||
Product revenue, net | 7 | ||||||||||||||||||||||||||||
Collaboration revenue | 7 | ||||||||||||||||||||||||||||
Total revenues | |||||||||||||||||||||||||||||
Expenses | |||||||||||||||||||||||||||||
Cost of product revenue | ( | ( | ( | ( | |||||||||||||||||||||||||
Cost of collaboration revenue | ( | ( | |||||||||||||||||||||||||||
Research and development | ( | ( | ( | ( | |||||||||||||||||||||||||
Selling, general, and administrative | ( | ( | ( | ( | |||||||||||||||||||||||||
Gain on sale of intellectual property | |||||||||||||||||||||||||||||
Loss from operations | ( | ( | ( | ( | |||||||||||||||||||||||||
Interest income | |||||||||||||||||||||||||||||
Interest expense | ( | ( | |||||||||||||||||||||||||||
Foreign currency gains (losses) | ( | ||||||||||||||||||||||||||||
Other income, net | 14 | ||||||||||||||||||||||||||||
Loss before income tax | ( | ( | ( | ( | |||||||||||||||||||||||||
Income tax expense | 8 | ||||||||||||||||||||||||||||
Net loss | ( | ( | ( | ( | |||||||||||||||||||||||||
Loss per share - basic and diluted | 9 | ( | ( | ( | ( | ||||||||||||||||||||||||
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||||||
Net loss | ( | ( | ( | ( | |||||||||||||||||||||||||
Other comprehensive income, net of tax of | |||||||||||||||||||||||||||||
Foreign currency translation adjustments | ( | ( | ( | ||||||||||||||||||||||||||
Comprehensive loss | ( | ( | ( | ( |
Ordinary Shares | Additional paid in capital | Accumulated deficit | Accumulated other comprehensive income | Treasury Stock | Total | ||||||||||||||||||||||||||||||||||||||||||
Number of Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2023 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2024 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Exercise of share options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2024 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Exercise of share options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2024 | ( | ( | ( |
Ordinary Shares | Additional paid in capital | Accumulated deficit | Accumulated other comprehensive income (loss) | Treasury Stock | Total | ||||||||||||||||||||||||||||||||||||||||||
Number of Shares | Amount | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||||||
Balance at December 31, 2022 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Exercise of share options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2023 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Exercise of share options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2023 | ( | ( | ( | ||||||||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Exercise of share options | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||||
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | ( | — | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | ( | — | — | ( | |||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2023 | ( | ( | ( |
Nine Months Ended September 30, | |||||||||||
2024 | 2023 | ||||||||||
Cash flows from operating activities | |||||||||||
Net loss | ( | ( | |||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Allowance for credit losses | ( | ||||||||||
Inventory write-down | |||||||||||
Depreciation and amortization expenses | |||||||||||
Amortization of deferred income | ( | ( | |||||||||
Share-based compensation | |||||||||||
Loss from fair value changes of equity investment with readily determinable fair value | |||||||||||
Losses on disposal of property and equipment | |||||||||||
Gain on disposal of land use right | ( | ||||||||||
Noncash lease expenses | |||||||||||
Gain from sale of intellectual property | ( | ||||||||||
Debt issuance costs | |||||||||||
Foreign currency remeasurement impact | ( | ||||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | ( | ||||||||||
Notes receivable | ( | ( | |||||||||
Inventories | ( | ||||||||||
Prepayments and other current assets | ( | ||||||||||
Long-term deposits | |||||||||||
Value added tax recoverable | ( | ||||||||||
Accounts payable | ( | ||||||||||
Other current liabilities | ( | ||||||||||
Operating lease liabilities | ( | ( | |||||||||
Deferred income | ( | ||||||||||
Other non-current liabilities | |||||||||||
Net cash used in operating activities | ( | ( | |||||||||
Cash flows from investing activities | |||||||||||
Purchases of short-term investments | ( | ||||||||||
Proceeds from maturity of short-term investment | |||||||||||
Purchases of property and equipment | ( | ( | |||||||||
Proceeds from the sale of property and equipment | |||||||||||
Acquisition of intangible assets | ( | ( | |||||||||
Proceeds from sale of intellectual property | |||||||||||
Proceeds from disposal of land use right | |||||||||||
Net cash used in investing activities | ( | ( | |||||||||
Cash flows from financing activities | |||||||||||
Proceeds from short-term debt | |||||||||||
Repayment of short-term bank borrowings | ( | ||||||||||
Payments of debt issuance costs | ( | ||||||||||
Proceeds from exercises of stock options | |||||||||||
Taxes paid related to settlement of equity awards | ( | ||||||||||
Net cash provided by (used in) financing activities | ( | ||||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | ( | ||||||||||
Net decrease in cash, cash equivalents and restricted cash | ( | ( | |||||||||
Cash, cash equivalents and restricted cash - beginning of period | |||||||||||
Cash, cash equivalents and restricted cash - end of period | |||||||||||
Supplemental disclosure on non-cash investing and financing activities | |||||||||||
Payables for purchase of property and equipment | |||||||||||
Payables for acquisition of intangible assets | |||||||||||
Payables for treasury stock | |||||||||||
Right-of-use asset acquired under operating leases | |||||||||||
Receivables for stock option exercise under equity incentive plans | |||||||||||
Supplemental disclosure of cash flow information | |||||||||||
Cash paid for interest | |||||||||||
September 30, 2024 | December 31, 2023 | ||||||||||
Cash | |||||||||||
Cash equivalents (i) | |||||||||||
Denominated in: | |||||||||||
US$ | |||||||||||
Renminbi (“RMB”) (ii) | |||||||||||
Hong Kong dollar (“HK$”) | |||||||||||
Australian dollar (“A$”) | |||||||||||
Taiwan dollar (“TW$”) | |||||||||||
September 30, 2024 | December 31, 2023 | ||||||||||
Finished goods | |||||||||||
Raw materials | |||||||||||
Work in progress | |||||||||||
Inventories, net |
September 30, 2024 | December 31, 2023 | ||||||||||
Office equipment | |||||||||||
Electronic equipment | |||||||||||
Vehicle | |||||||||||
Laboratory equipment | |||||||||||
Manufacturing equipment | |||||||||||
Leasehold improvements | |||||||||||
Construction in progress | |||||||||||
Less: accumulated depreciation | ( | ( | |||||||||
Property and equipment, net |
September 30, 2024 | December 31, 2023 | ||||||||||||||||||||||
Gross Carrying Amount | Accumulated Amortization | Net Carrying Value | Gross Carrying Amount | Accumulated Amortization | Net Carrying Value | ||||||||||||||||||
Finite-lived intangible assets | |||||||||||||||||||||||
Commercial products (i) | ( | ( | |||||||||||||||||||||
Software | ( | ( | |||||||||||||||||||||
Total | ( | ( |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
Product revenue - gross | |||||||||||||||||||||||
Less: Rebates and sales returns | ( | ( | ( | ( | |||||||||||||||||||
Product revenue - net |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
ZEJULA | |||||||||||||||||||||||
OPTUNE | |||||||||||||||||||||||
QINLOCK | |||||||||||||||||||||||
NUZYRA | |||||||||||||||||||||||
VYVGART | |||||||||||||||||||||||
Product revenue - net |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net loss | ( | ( | ( | ( | |||||||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted average number of ordinary shares - basic and diluted | |||||||||||||||||||||||
Net loss per share - basic and diluted | ( | ( | ( | ( |
September 30, | |||||||||||
2024 | 2023 | ||||||||||
Share options | |||||||||||
Non-vested restricted shares |
Weighted average interest rate per annum | September 30, 2024 | ||||||||||
Bank of China Working Capital Loans | % | ||||||||||
SPD Bank Working Capital Loans | % | ||||||||||
China Merchant Bank Working Capital Loans | % | ||||||||||
Total short-term debt | % |
September 30, 2024 | December 31, 2023 | ||||||||||
Accrued payroll | |||||||||||
Accrued professional service fee | |||||||||||
Payables for purchase of property and equipment | |||||||||||
Accrued rebate to distributors | |||||||||||
Tax payables | |||||||||||
Other (i) | |||||||||||
Total |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
Selling, general and administrative | |||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Total |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||
Government grants | |||||||||||||||||||||||
Loss on equity investments with readily determinable fair value | ( | ( | ( | ( | |||||||||||||||||||
Others miscellaneous gain | |||||||||||||||||||||||
Total |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Revenues | ||||||||||||||||||||||||||||||||||||||||||||||||||
Product revenue, net | 101,847 | 69,228 | 32,619 | 47 | % | 289,102 | 200,889 | 88,213 | 44 | % | ||||||||||||||||||||||||||||||||||||||||
Collaboration revenue | 418 | — | 418 | NM | 816 | — | 816 | NM | ||||||||||||||||||||||||||||||||||||||||||
Total revenues | 102,265 | 69,228 | 33,037 | 48 | % | 289,918 | 200,889 | 89,029 | 44 | % | ||||||||||||||||||||||||||||||||||||||||
Expenses | ||||||||||||||||||||||||||||||||||||||||||||||||||
Cost of product revenue | (36,569) | (25,479) | (11,090) | 44 | % | (105,336) | (70,579) | (34,757) | 49 | % | ||||||||||||||||||||||||||||||||||||||||
Cost of collaboration revenue | (348) | — | (348) | NM | (433) | — | (433) | NM | ||||||||||||||||||||||||||||||||||||||||||
Research and development | (65,982) | (58,767) | (7,215) | 12 | % | (182,252) | (183,920) | 1,668 | (1) | % | ||||||||||||||||||||||||||||||||||||||||
Selling, general, and administrative | (67,219) | (68,552) | 1,333 | (2) | % | (216,123) | (198,982) | (17,141) | 9 | % | ||||||||||||||||||||||||||||||||||||||||
Gain on sale of intellectual property | — | — | — | NM | — | 10,000 | (10,000) | (100) | % | |||||||||||||||||||||||||||||||||||||||||
Loss from operations | (67,853) | (83,570) | 15,717 | (19) | % | (214,226) | (242,592) | 28,366 | (12) | % | ||||||||||||||||||||||||||||||||||||||||
Interest income | 9,029 | 9,172 | (143) | (2) | % | 28,017 | 29,493 | (1,476) | (5) | % | ||||||||||||||||||||||||||||||||||||||||
Interest expense | (745) | — | (745) | NM | (1,350) | — | (1,350) | NM | ||||||||||||||||||||||||||||||||||||||||||
Foreign currency gains (losses) | 14,457 | 4,852 | 9,605 | 198 | % | 8,281 | (26,315) | 34,596 | (131) | % | ||||||||||||||||||||||||||||||||||||||||
Other income, net | 3,441 | 394 | 3,047 | 773 | % | 3,859 | 223 | 3,636 | 1630 | % | ||||||||||||||||||||||||||||||||||||||||
Loss before income tax | (41,671) | (69,152) | 27,481 | (40) | % | (175,419) | (239,191) | 63,772 | (27) | % | ||||||||||||||||||||||||||||||||||||||||
Income tax expense | — | — | — | — | % | — | — | — | — | % | ||||||||||||||||||||||||||||||||||||||||
Net loss | (41,671) | (69,152) | 27,481 | (40) | % | (175,419) | (239,191) | 63,772 | (27) | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Product revenue - gross | 107,678 | 74,018 | 33,660 | 45 | % | 307,401 | 220,240 | 87,161 | 40 | % | ||||||||||||||||||||||||||||||||||||||||
Less: Rebates and sales returns | (5,831) | (4,790) | (1,041) | 22 | % | (18,299) | (19,351) | 1,052 | (5) | % | ||||||||||||||||||||||||||||||||||||||||
Product revenue - net | 101,847 | 69,228 | 32,619 | 47 | % | 289,102 | 200,889 | 88,213 | 44 | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
ZEJULA | 48,227 | 41,593 | 6,634 | 16 | % | 138,727 | 127,230 | 11,497 | 9 | % | ||||||||||||||||||||||||||||||||||||||||
OPTUNE | 7,715 | 11,562 | (3,847) | (33) | % | 32,779 | 38,596 | (5,817) | (15) | % | ||||||||||||||||||||||||||||||||||||||||
QINLOCK | 8,643 | 5,702 | 2,941 | 52 | % | 21,774 | 14,535 | 7,239 | 50 | % | ||||||||||||||||||||||||||||||||||||||||
NUZYRA | 9,997 | 5,483 | 4,514 | 82 | % | 32,205 | 15,588 | 16,617 | 107 | % | ||||||||||||||||||||||||||||||||||||||||
VYVGART | 27,265 | 4,888 | 22,377 | 458 | % | 63,617 | 4,940 | 58,677 | 1188 | % | ||||||||||||||||||||||||||||||||||||||||
Total product revenue, net | 101,847 | 69,228 | 32,619 | 47 | % | 289,102 | 200,889 | 88,213 | 44 | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Personnel compensation and related costs | 23,405 | 27,933 | (4,528) | (16) | % | 82,622 | 85,967 | (3,345) | (4) | % | ||||||||||||||||||||||||||||||||||||||||
Licensing fees | 22,634 | 9 | 22,625 | NM | 22,634 | 19,291 | 3,343 | 17 | % | |||||||||||||||||||||||||||||||||||||||||
CROs/CMOs/Investigators expenses | 13,004 | 23,136 | (10,132) | (44) | % | 57,213 | 59,201 | (1,988) | (3) | % | ||||||||||||||||||||||||||||||||||||||||
Other costs | 6,939 | 7,689 | (750) | (10) | % | 19,783 | 19,461 | 322 | 2 | % | ||||||||||||||||||||||||||||||||||||||||
Total | 65,982 | 58,767 | 7,215 | 12 | % | 182,252 | 183,920 | (1,668) | (1) | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Clinical programs | 23,060 | 23,243 | (183) | (1) | % | 63,196 | 68,232 | (5,036) | (7) | % | ||||||||||||||||||||||||||||||||||||||||
Pre-clinical programs | 14,461 | 2,013 | 12,448 | 618 | % | 19,649 | 15,252 | 4,397 | 29 | % | ||||||||||||||||||||||||||||||||||||||||
Unallocated research and development expenses | 28,461 | 33,511 | (5,050) | (15) | % | 99,407 | 100,436 | (1,029) | (1) | % | ||||||||||||||||||||||||||||||||||||||||
Total | 65,982 | 58,767 | 7,215 | 12 | % | 182,252 | 183,920 | (1,668) | (1) | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2024 | 2023 | $ | % | 2024 | 2023 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Personnel compensation and related costs | 39,984 | 45,410 | (5,426) | (12) | % | 134,157 | 129,198 | 4,959 | 4 | % | ||||||||||||||||||||||||||||||||||||||||
Professional service fees | 5,863 | 4,404 | 1,459 | 33 | % | 14,917 | 18,752 | (3,835) | (20) | % | ||||||||||||||||||||||||||||||||||||||||
Other costs | 21,372 | 18,738 | 2,634 | 14 | % | 67,049 | 51,032 | 16,017 | 31 | % | ||||||||||||||||||||||||||||||||||||||||
Total | 67,219 | 68,552 | (1,333) | (2) | % | 216,123 | 198,982 | 17,141 | 9 | % |
Nine Months Ended September 30, | Change | |||||||||||||||||||
2024 | 2023 | $ | ||||||||||||||||||
Net cash used in operating activities | (159,100) | (183,261) | 24,161 | |||||||||||||||||
Net cash used in investing activities | (27,439) | (25,233) | (2,206) | |||||||||||||||||
Net cash provided by (used in) financing activities | 112,077 | (6,826) | 118,903 | |||||||||||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | 402 | (3,355) | 3,757 | |||||||||||||||||
Net decrease in cash, cash equivalents and restricted cash | (74,060) | (218,675) | 144,615 |
Exhibit Number | Exhibit Title | |||||||
10.1+ | ||||||||
10.2+ | ||||||||
31.1 | ||||||||
31.2 | ||||||||
32.1 | ||||||||
32.2 | ||||||||
101.INS* | Inline XBRL Instance Document-the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document | |||||||
101.SCH* | Inline XBRL Taxonomy Extension Schema Document | |||||||
101.CAL* | Inline XBRL Taxonomy Extension Calculation Linkbase Document | |||||||
101.LAB* | Inline XBRL Taxonomy Extension Label Linkbase Document | |||||||
101.PRE* | Inline XBRL Taxonomy Extension Presentation Linkbase Document | |||||||
101.DEF* | Inline XBRL Taxonomy Extension Definitions Linkbase Document | |||||||
104* | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
ZAI LAB LIMITED | ||||||||
Dated: November 12, 2024 | By: | /s/ Yajing Chen | ||||||
Name: | Yajing Chen | |||||||
Title: | Chief Financial Officer | |||||||
(Principal Financial and Accounting Officer) |
Date: November 12, 2024 | /s/ Samantha (Ying) Du | ||||
Samantha (Ying) Du | |||||
Chief Executive Officer | |||||
(Principal Executive Officer) |
Date: November 12, 2024 | /s/ Yajing Chen | ||||
Yajing Chen | |||||
Chief Financial Officer | |||||
(Principal Financial and Accounting Officer) |
Date: November 12, 2024 | /s/ Samantha (Ying) Du | ||||
Samantha (Ying) Du | |||||
Chief Executive Officer | |||||
(Principal Executive Officer) |
Date: November 12, 2024 | /s/ Yajing Chen | ||||
Yajing Chen | |||||
Chief Financial Officer | |||||
(Principal Financial and Accounting Officer) |
Unaudited Condensed Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Statement of Financial Position [Abstract] | ||
Accounts receivable, allowance for credit losses | $ 14 | $ 17 |
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) | 989,268,370 | 977,151,270 |
Ordinary shares, shares outstanding (in shares) | 984,356,170 | 972,239,070 |
Treasury Stock (in shares) | 4,912,200 | 4,912,200 |
Unaudited Condensed Consolidated Statements of Operations - USD ($) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Revenues | ||||
Product revenue, net | $ 101,847,000 | $ 69,228,000 | $ 289,102,000 | $ 200,889,000 |
Collaboration revenue | 418,000 | 0 | 816,000 | 0 |
Total revenues | 102,265,000 | 69,228,000 | 289,918,000 | 200,889,000 |
Expenses | ||||
Cost of product revenue | (36,569,000) | (25,479,000) | (105,336,000) | (70,579,000) |
Cost of collaboration revenue | (348,000) | 0 | (433,000) | 0 |
Research and development | (65,982,000) | (58,767,000) | (182,252,000) | (183,920,000) |
Selling, general, and administrative | (67,219,000) | (68,552,000) | (216,123,000) | (198,982,000) |
Gain on sale of intellectual property | 0 | 0 | 0 | 10,000,000 |
Loss from operations | (67,853,000) | (83,570,000) | (214,226,000) | (242,592,000) |
Interest income | 9,029,000 | 9,172,000 | 28,017,000 | 29,493,000 |
Interest expense | (745,000) | 0 | (1,350,000) | 0 |
Foreign currency gains (losses) | 14,457,000 | 4,852,000 | 8,281,000 | (26,315,000) |
Other income, net | 3,441,000 | 394,000 | 3,859,000 | 223,000 |
Loss before income tax | (41,671,000) | (69,152,000) | (175,419,000) | (239,191,000) |
Income tax expense | 0 | 0 | 0 | 0 |
Net loss | $ (41,671,000) | $ (69,152,000) | $ (175,419,000) | $ (239,191,000) |
Loss per share - basic (in dollars per share) | $ (0.04) | $ (0.07) | $ (0.18) | $ (0.25) |
Loss per share - diluted (in dollars per share) | $ (0.04) | $ (0.07) | $ (0.18) | $ (0.25) |
Weighted-average shares used in calculating net loss per ordinary share - basic (in shares) | 981,687,390 | 968,767,730 | 976,941,030 | 965,060,570 |
Weighted-average shares used in calculating net loss per ordinary share - diluted (in shares) | 981,687,390 | 968,767,730 | 976,941,030 | 965,060,570 |
Unaudited Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (41,671) | $ (69,152) | $ (175,419) | $ (239,191) |
Other comprehensive income, net of tax of nil: | ||||
Foreign currency translation adjustments | (14,503) | (4,228) | (9,356) | 22,267 |
Comprehensive loss | $ (56,174) | $ (73,380) | $ (184,775) | $ (216,924) |
Unaudited Condensed Consolidated Statements of Comprehensive Loss (Parenthetical) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Statement of Comprehensive Income [Abstract] | ||||
Other comprehensive income, tax | $ 0 | $ 0 | $ 0 | $ 0 |
Organization and Principal Activities |
9 Months Ended |
---|---|
Sep. 30, 2024 | |
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 in the areas of oncology, immunology, neuroscience, and infectious disease. 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.
|
Basis of Presentation and Consolidation and Significant Accounting Policies |
9 Months Ended |
---|---|
Sep. 30, 2024 | |
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 U.S. generally accepted accounting principles (“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, 2023 (the “2023 Annual Report”). The December 31, 2023 condensed consolidated balance sheet data included in this report were derived from the audited financial statements in the 2023 Annual Report. The accompanying unaudited 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, 2024. (b) Principles of Consolidation The unaudited condensed consolidated financial statements include the accounts of Zai Lab Limited and its subsidiaries, which are wholly owned. 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, 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 $3.2 million and $9.2 million as of September 30, 2024 and December 31, 2023, respectively. The unrealized losses from fair value changes are recognized in other income, net in the unaudited condensed consolidated statements of operations. Financial instruments of the Company primarily include cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, non-current restricted cash, accounts payable, short-term debt, and other current liabilities. As of September 30, 2024 and December 31, 2023, the carrying values of cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, prepayments and other current assets, accounts payable, short-term debt, and other current liabilities approximated their fair value due to the short-term maturity of these instruments, and the carrying value of notes receivable and non-current restricted cash approximated their fair value based on the assessment of the ability to recover these amounts. (e) Recent Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU requires all public entities, including public entities with a single reportable segment, to disclose the title and position of the Chief Operating Decision Maker (“CODM”) and the significant segment expenses and any additional measures of a segment’s profit or loss used by the CODM to allocate resources and assess performance. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023 and for interim periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of this ASU and expects to adopt it for the year ending December 31, 2024. In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). This ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. This ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is permitted. This ASU will result in additional disclosure in the consolidated financial statements, once adopted. The Company is currently evaluating the impact of this ASU and expects to adopt it for the year ending December 31, 2025. The Company did not adopt any new accounting standards in the nine months ended September 30, 2024 that had a material impact on the consolidated financial statements. For additional information on the Company’s significant accounting policies, refer to the notes to the consolidated financial statements in the 2023 Annual Report.
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Cash and Cash Equivalents |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
(i)Cash equivalents represent short-term and highly liquid investments in a money market fund. (ii)Certain cash and bank balances denominated in RMB were deposited with banks in mainland China. The conversion of these RMB-denominated balances into foreign currencies is subject to the rules and regulations of foreign exchange control promulgated by the Chinese government.
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Inventories, Net |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories, Net | Inventories, Net The following table presents the Company’s inventories, net ($ in thousands):
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Property and Equipment, Net |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
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Intangible Assets, Net |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Intangible Assets, Net | Intangible Assets, Net The following table presents the components of the Company’s intangible assets, net ($ in thousands):
(i) The increase in the net carrying value is primarily driven by $33.0 million of regulatory milestone fees for repotrectinib and SUL-DUR (see Note 13) and $6.0 million of commercial development costs. Intangible assets for commercial products include capitalized post-approval milestone fees and commercial manufacturing development costs. The Company is amortizing commercial products as cost of product revenue over the estimated remaining useful life of the related products. Externally purchased software is amortized over to five years on a straight-line basis. Amortization expense was $0.7 million and $2.3 million in the three and nine months ended September 30, 2024, respectively, and $0.2 million and $0.5 million in the three and nine months ended September 30, 2023, respectively.
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Revenues |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Revenues | Revenues Product Revenue, Net The Company’s product revenue is derived from the sales of its commercial products primarily in mainland China. The table below presents the Company’s gross and net product revenue ($ in thousands):
Sales rebates are offered to distributors in mainland China, and the amounts are recorded as a reduction of product 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):
Collaboration Revenue Collaboration revenue was $0.4 million and $0.8 million in the three and nine months ended September 30, 2024, respectively, and related to promotional activities in mainland China. We had no such collaboration revenue in the prior year periods.
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Income Tax |
9 Months Ended |
---|---|
Sep. 30, 2024 | |
Income Tax Disclosure [Abstract] | |
Income Tax | Income Tax No provision for income taxes has been required to be accrued because the Company is in a cumulative loss position for the periods presented. The Company recorded a full valuation allowance against deferred tax assets of all its consolidated entities because all entities were in a cumulative loss position as of September 30, 2024 and December 31, 2023. No unrecognized tax benefits and related interest and penalties were recorded in the periods presented.
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Loss Per Share |
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Earnings Per Share [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Loss Per Share | Loss Per Share The following table presents the computation of the basic and diluted net loss per share ($ in thousands, except share and per share data):
As a result of the Company’s net loss in the three and nine months ended September 30, 2024 and 2023, 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.
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Borrowings |
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Borrowings | Borrowings The Company has debt arrangements with the Bank of China, SPD Bank, CMB, and Ningbo Bank to support its working capital needs in mainland China. The following table presents the Company’s short-term debt as of September 30, 2024 ($ in thousands):
Bank of China Working Capital Loan Facility On February 5, 2024, the Company entered into an uncommitted facility letter with the Bank of China (Hong Kong) Limited (the “BOC HK”) pursuant to which the BOC HK will provide standby letters of credit for loans of up to $100.0 million for a term of one year. In connection with this agreement, the Company paid a one-time, non-refundable fee of $0.7 million in the first quarter of 2024. In accordance with this agreement, the Company also maintained restricted deposits of $100.0 million, which are presented as restricted cash-current on the unaudited condensed consolidated balance sheet, to secure the standby letters of credit. On February 6, 2024 and June 20, 2024, upon the Company’s application, the BOC HK provided standby letters of credit in favor of the Bank of China Pudong Development Zone Branch (the “BOC Pudong Branch”) for $50.0 million and $23.0 million, respectively, which are or may become payable by the Company’s wholly-owned subsidiary, Zai Lab (Shanghai) Co., Ltd. (“Zai Lab Shanghai”). Zai Lab Shanghai entered into working capital loans with the BOC Pudong Branch under this facility in the first half of 2024, and the aggregate principal amount outstanding was RMB497.0 million (approximately $70.9 million) as of September 30, 2024. Each working capital loan has a one-year term and is subject to a floating interest rate, which is subject to adjustment every six months. SPD Bank Working Capital Loan Facility On February 6, 2024, the Company entered into a maximum-amount guarantee contract with the Shanghai Pudong Development Bank Co., Ltd. Zhangjiang Hi-Tech Park Sub-branch (the “SPD Bank”) pursuant to which the Company will guarantee working capital loans of up to RMB300.0 million (approximately $42.0 million) from SPD Bank to Zai Lab Shanghai over a three-year period. Zai Lab Shanghai entered into working capital loan contracts with SPD Bank under this debt facility in the first quarter of 2024, and the aggregate principal amount outstanding was RMB100.0 million (approximately $14.3 million) as of September 30, 2024. Each working capital loan has a one-year term and is subject to a fixed interest rate. Ningbo Bank Working Capital Loan Facility On February 6, 2024, the Company’s wholly-owned subsidiary, Zai Lab (Suzhou) Co., Ltd. (“Zai Lab Suzhou”), entered into a maximum credit contract with Bank of Ningbo Co., Ltd. Suzhou Sub-branch (“Ningbo Bank”) as well as an Electronic Commercial Draft Discounting Master Agreement and Online Working Capital Loan Master Agreement (collectively, the “Ningbo Bank Agreements”). The Ningbo Bank Agreements permit Zai Lab Suzhou to utilize, including through discounting or working capital loan agreements and subject to the terms and conditions in related master agreements, up to RMB230.3 million (approximately $32.4 million), of which the Company is authorized to utilize up to RMB160.0 million (approximately $22.5 million). In connection with the arrangements described in the Ningbo Bank Agreements, Zai Lab Suzhou agreed to pledge interests in certain real property it owns in Suzhou. As of September 30, 2024, Zai Lab Suzhou has not entered into any discounting arrangements or working capital loans under this Ningbo Bank working capital loan facility. China Merchants Bank Working Capital Loan Facility On July 5, 2024, the Company issued a maximum-amount irrevocable letter of guarantee to China Merchants Bank Co., Ltd., Shanghai Branch (“CMB”) pursuant to which the Company will guarantee working capital loans of up to RMB250.0 million (approximately $34.4 million) from CMB to the Company’s wholly-owned subsidiary, Zai Lab Shanghai, and Zai Lab Shanghai entered into a Credit Agreement with CMB with respect to the RMB250.0 million facility. The credit facility will be available for one year. As of September 30, 2024, Zai Lab Shanghai has an aggregate principal amount outstanding of RMB194.8 million (approximately $27.8 million) under this debt facility. Each working capital loan has a one-year term and is subject to a floating interest rate, which is subject to adjustment every three months.
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Other Current Liabilities |
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Current Liabilities | Other Current Liabilities The following table presents the Company’s other current liabilities ($ in thousands):
(i)Other primarily includes accrued travel and business-related expenses.
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Share-Based Compensation |
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Share-Based Compensation | Share-Based Compensation During the nine months ended September 30, 2024, the Company granted share options to purchase up to 20,747,480 ordinary shares and restricted shares representing 17,293,410 ordinary shares under its equity incentive plans. 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/service 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 of the 2023 Annual Report. The following table presents the share-based compensation expense that has been reported in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss as follows ($ in thousands):
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License and Collaboration Agreements |
9 Months Ended |
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Sep. 30, 2024 | |
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 of the 2023 Annual Report. During the nine months ended September 30, 2024, the Company did not enter into any new significant license or collaboration agreements. The following includes a description of milestone fees incurred in the nine months ended September 30, 2024 under the Company’s significant license and collaboration agreements. License and Collaboration Agreement with Innoviva (SUL-DUR) Under the terms of the Company’s license and collaboration agreement with Entasis Therapeutics Holdings Inc., a wholly owned subsidiary of Innoviva, Inc. (“Innoviva”), the Company recorded an $8.0 million regulatory milestone in the second quarter of 2024, which was capitalized as an intangible asset. As of September 30, 2024, the Company may be required to pay an additional aggregate amount of up to $80.6 million in development, regulatory, and sales-based milestones as well as certain royalties at tiered percentage rates ranging from high single digits to low-teens on annual net sales of the licensed products in the licensed territory. License Agreement with BMS (Repotrectinib) Under the terms of the Company’s license agreement with Turning Point Therapeutics, Inc., a company later acquired by Bristol Myers Squibb (“BMS”), the Company recorded $25.0 million for regulatory milestones in the second quarter of 2024, which was capitalized as an intangible asset. As of September 30, 2024, the Company may be required to pay an additional aggregate amount of up to $116.0 million in development, regulatory, and sales-based milestones as well as certain royalties at tiered percentage rates ranging from mid- to high-teens on annual net sales of the licensed products in the licensed territory. License Agreement with BMS (Xanomeline and Trospium Chloride) Under the terms of the Company’s license agreement with Karuna Therapeutics, Inc. (a company later acquired by BMS), the Company recorded a $10.0 million development milestone into research and development expenses in the third quarter of 2024. As of September 30, 2024, the Company may be required to pay an additional aggregate amount of up to $132.0 million in development, regulatory, and sales-based milestones as well as certain royalties at tiered percentage rates ranging from low- to high-teens on annual net sales of the licensed products in Greater China. Other License and Collaboration Arrangements That Are Not Individually Significant The Company recorded an upfront payment of $12.0 million into research and development expenses in the third quarter of 2024 for a license and collaboration agreement that is not individually significant.
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Other Income, Net |
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income, Net | Other Income, Net The following table presents the Company’s other income, net ($ in thousands):
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Restricted Net Assets |
9 Months Ended |
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Sep. 30, 2024 | |
Equity [Abstract] | |
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 in the three and nine months ended September 30, 2024 and 2023 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. Foreign exchange and other regulation in mainland China may further restrict the Company’s subsidiaries in mainland China from transferring out funds in the form of dividends, loans, and advances. As of September 30, 2024 and December 31, 2023, amounts restricted included the paid-in capital of the Company’s subsidiaries in mainland China and were $506.0 million.
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Commitments and Contingencies |
9 Months Ended |
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Sep. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies (a) Purchase Commitments As of September 30, 2024, the Company’s commitments related to purchase of property and equipment and the commercial manufacturing development activities that are contracted but not yet reflected in the unaudited condensed consolidated financial statements were $8.6 million and were expected to be incurred within one year. (b) Legal Proceedings The Company is not currently a party to any material legal proceedings. (c) Indemnifications In the normal course of business, the Company enters into agreements that indemnify others for certain liabilities that may arise in connection with a transaction or certain events and activities. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations.
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Pay vs Performance Disclosure - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||||||
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Sep. 30, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
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Pay vs Performance Disclosure | ||||||||
Net loss | $ (41,671) | $ (80,277) | $ (53,471) | $ (69,152) | $ (120,895) | $ (49,144) | $ (175,419) | $ (239,191) |
Insider Trading Arrangements |
3 Months Ended |
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Sep. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Basis of Presentation and Consolidation and Significant Accounting Policies (Policies) |
9 Months Ended |
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Sep. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“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, 2023 (the “2023 Annual Report”). The December 31, 2023 condensed consolidated balance sheet data included in this report were derived from the audited financial statements in the 2023 Annual Report. The accompanying unaudited 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, 2024.
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Principles of Consolidation | Principles of Consolidation The unaudited condensed consolidated financial statements include the accounts of Zai Lab Limited and its subsidiaries, which are wholly owned. All intercompany transactions and balances are eliminated upon consolidation. |
Use of Estimates | 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, 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 | Fair Value Measurements Equity investments with readily determinable fair value are measured using level 1 inputs and were $3.2 million and $9.2 million as of September 30, 2024 and December 31, 2023, respectively. The unrealized losses from fair value changes are recognized in other income, net in the unaudited condensed consolidated statements of operations. Financial instruments of the Company primarily include cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, non-current restricted cash, accounts payable, short-term debt, and other current liabilities. As of September 30, 2024 and December 31, 2023, the carrying values of cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, prepayments and other current assets, accounts payable, short-term debt, and other current liabilities approximated their fair value due to the short-term maturity of these instruments, and the carrying value of notes receivable and non-current restricted cash approximated their fair value based on the assessment of the ability to recover these amounts.
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Recent Accounting Pronouncements | Recent Accounting Pronouncements In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU requires all public entities, including public entities with a single reportable segment, to disclose the title and position of the Chief Operating Decision Maker (“CODM”) and the significant segment expenses and any additional measures of a segment’s profit or loss used by the CODM to allocate resources and assess performance. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023 and for interim periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of this ASU and expects to adopt it for the year ending December 31, 2024. In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). This ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. This ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is permitted. This ASU will result in additional disclosure in the consolidated financial statements, once adopted. The Company is currently evaluating the impact of this ASU and expects to adopt it for the year ending December 31, 2025. The Company did not adopt any new accounting standards in the nine months ended September 30, 2024 that had a material impact on the consolidated financial statements. For additional information on the Company’s significant accounting policies, refer to the notes to the consolidated financial statements in the 2023 Annual Report.
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Cash and Cash Equivalents (Tables) |
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Cash and Cash Equivalents [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Cash and Cash Equivalents | The following table presents the Company’s cash and cash equivalents ($ in thousands):
(i)Cash equivalents represent short-term and highly liquid investments in a money market fund. (ii)Certain cash and bank balances denominated in RMB were deposited with banks in mainland China. The conversion of these RMB-denominated balances into foreign currencies is subject to the rules and regulations of foreign exchange control promulgated by the Chinese government.
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Inventories, Net (Tables) |
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Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Inventories, Net | The following table presents the Company’s inventories, net ($ in thousands):
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Property and Equipment, Net (Tables) |
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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):
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Intangible Assets, Net (Tables) |
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Goodwill and Intangible Assets Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Components of Intangible Assets | The following table presents the components of the Company’s intangible assets, net ($ in thousands):
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Revenues (Tables) |
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Revenue from Contract with Customer [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Product Revenue | The table below presents the Company’s gross and net product revenue ($ in thousands):
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Schedule of Disaggregation of Net Revenue | The following table presents the Company’s net revenue by product ($ in thousands):
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Loss Per Share (Tables) |
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of Anti-Dilutive Shares Excluded from Calculation of Diluted Loss Per Share | As a result of the Company’s net loss in the three and nine months ended September 30, 2024 and 2023, 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.
|
Borrowings (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Debt Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Short-Term Debt | The following table presents the Company’s short-term debt as of September 30, 2024 ($ in thousands):
|
Other Current Liabilities (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Liabilities Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Current Liabilities | The following table presents the Company’s other current liabilities ($ in thousands):
(i)Other primarily includes accrued travel and business-related expenses.
|
Share-Based Compensation (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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 unaudited condensed consolidated statements of operations and comprehensive loss as follows ($ in thousands):
|
Other Income, Net (Tables) |
9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2024 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other Income and Expenses [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of Other Income, Net | The following table presents the Company’s other income, net ($ in thousands):
|
Basis of Presentation and Consolidation and Significant Accounting Policies (Details) - USD ($) $ in Millions |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity investments with readily determinable fair value | $ 3.2 | $ 9.2 |
Cash and Cash Equivalents (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Cash And Cash Equivalents [Line Items] | ||
Cash | $ 614,937 | $ 789,051 |
Cash equivalents | 1,149 | 1,100 |
Cash and cash equivalents | 616,086 | 790,151 |
US$ | ||
Cash And Cash Equivalents [Line Items] | ||
Cash and cash equivalents | 575,116 | 762,436 |
Renminbi (“RMB”) | ||
Cash And Cash Equivalents [Line Items] | ||
Cash and cash equivalents | 40,092 | 25,093 |
Hong Kong dollar (“HK$”) | ||
Cash And Cash Equivalents [Line Items] | ||
Cash and cash equivalents | 53 | 1,974 |
Australian dollar (“A$”) | ||
Cash And Cash Equivalents [Line Items] | ||
Cash and cash equivalents | 580 | 587 |
Taiwan dollar (“TW$”) | ||
Cash And Cash Equivalents [Line Items] | ||
Cash and cash equivalents | $ 245 | $ 61 |
Inventories, Net - Summary of Inventories, Net (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Inventory Disclosure [Abstract] | ||
Finished goods | $ 22,460 | $ 22,702 |
Raw materials | 15,397 | 17,655 |
Work in progress | 1,691 | 4,470 |
Inventories, net | $ 39,548 | $ 44,827 |
Inventories, Net - Additional Information (Details) - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Inventory Disclosure [Abstract] | ||||
Inventory write-down | $ 0.0 | $ 0.1 | $ 0.8 | $ 0.7 |
Property and Equipment, Net - Additional Information (Details) - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 2.1 | $ 1.8 | $ 6.6 | $ 6.1 |
Intangible Assets, Net - Components of Intangible Assets (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | $ 56,265 | $ 15,691 |
Accumulated Amortization | (4,596) | (2,302) |
Net Carrying Value | 51,669 | 13,389 |
Commercial products | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 52,050 | 11,351 |
Accumulated Amortization | (1,881) | (186) |
Net Carrying Value | 50,169 | 11,165 |
Regulatory milestone fees | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Value | 33,000 | |
Commercial development costs | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Value | 6,000 | |
Software | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross Carrying Amount | 4,215 | 4,340 |
Accumulated Amortization | (2,715) | (2,116) |
Net Carrying Value | $ 1,500 | $ 2,224 |
Intangible Assets, Net - Additional Information (Details) - USD ($) $ in Millions |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization expense | $ 0.7 | $ 0.2 | $ 2.3 | $ 0.5 |
Software | Minimum | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization period | 3 years | 3 years | ||
Software | Maximum | ||||
Finite-Lived Intangible Assets [Line Items] | ||||
Amortization period | 5 years | 5 years |
Revenues - Summary of Product Revenue (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Revenue from Contract with Customer [Abstract] | ||||
Product revenue - gross | $ 107,678 | $ 74,018 | $ 307,401 | $ 220,240 |
Less: Rebates and sales returns | (5,831) | (4,790) | (18,299) | (19,351) |
Product revenue - net | $ 101,847 | $ 69,228 | $ 289,102 | $ 200,889 |
Revenues - Disaggregation of Net Revenue by Product (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | $ 101,847 | $ 69,228 | $ 289,102 | $ 200,889 |
ZEJULA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 48,227 | 41,593 | 138,727 | 127,230 |
OPTUNE | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 7,715 | 11,562 | 32,779 | 38,596 |
QINLOCK | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 8,643 | 5,702 | 21,774 | 14,535 |
NUZYRA | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | 9,997 | 5,483 | 32,205 | 15,588 |
VYVGART | ||||
Disaggregation of Revenue [Line Items] | ||||
Product revenue - net | $ 27,265 | $ 4,888 | $ 63,617 | $ 4,940 |
Revenues - Additional Information (Details) - USD ($) |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Revenue from Contract with Customer [Abstract] | ||||
Collaboration revenue | $ 418,000 | $ 0 | $ 816,000 | $ 0 |
Income Tax (Details) - USD ($) |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
|
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 0 | $ 0 | $ 0 | $ 0 | |
Unrecognized tax benefits | 0 | 0 | $ 0 | ||
Interest and penalties on unrecognized tax benefits | $ 0 | $ 0 | $ 0 | $ 0 |
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, 2024 |
Jun. 30, 2024 |
Mar. 31, 2024 |
Sep. 30, 2023 |
Jun. 30, 2023 |
Mar. 31, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Numerator: | ||||||||
Net loss | $ (41,671) | $ (80,277) | $ (53,471) | $ (69,152) | $ (120,895) | $ (49,144) | $ (175,419) | $ (239,191) |
Denominator: | ||||||||
Weighted average number of ordinary shares - basic (in shares) | 981,687,390 | 968,767,730 | 976,941,030 | 965,060,570 | ||||
Weighted average number of ordinary shares - diluted (in shares) | 981,687,390 | 968,767,730 | 976,941,030 | 965,060,570 | ||||
Net loss per share - basic (in dollars per share) | $ (0.04) | $ (0.07) | $ (0.18) | $ (0.25) | ||||
Net loss per share - diluted (in dollars per share) | $ (0.04) | $ (0.07) | $ (0.18) | $ (0.25) |
Loss Per Share - Summary of Anti-Dilutive Shares Excluded from Calculation of Diluted Loss Per Share (Details) - shares |
9 Months Ended | |
---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Share options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares excluded from calculation of diluted loss per share | 105,188,950 | 107,249,960 |
Restricted shares | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares excluded from calculation of diluted loss per share | 32,875,090 | 32,359,260 |
Borrowings - Summary of Short-Term Debt (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Short-Term Debt [Line Items] | ||
Weighted average interest rate per annum | 3.01% | |
Total short-term debt | $ 112,994 | $ 0 |
Loans Payable | Bank of China Working Capital Loans | ||
Short-Term Debt [Line Items] | ||
Weighted average interest rate per annum | 2.86% | |
Total short-term debt | $ 70,925 | |
Loans Payable | SPD Bank Working Capital Loans | ||
Short-Term Debt [Line Items] | ||
Weighted average interest rate per annum | 3.45% | |
Total short-term debt | $ 14,271 | |
Loans Payable | China Merchant Bank Working Capital Loans | ||
Short-Term Debt [Line Items] | ||
Weighted average interest rate per annum | 3.15% | |
Total short-term debt | $ 27,798 |
Other Current Liabilities (Details) - USD ($) $ in Thousands |
Sep. 30, 2024 |
Dec. 31, 2023 |
---|---|---|
Other Liabilities Disclosure [Abstract] | ||
Accrued payroll | $ 24,077 | $ 33,711 |
Accrued professional service fee | 3,986 | 7,520 |
Payables for purchase of property and equipment | 2,612 | 2,474 |
Accrued rebate to distributors | 8,800 | 16,926 |
Tax payables | 3,756 | 16,988 |
Other | 2,853 | 5,353 |
Total | $ 46,084 | $ 82,972 |
Share-Based Compensation - Summary of Share-based Compensation Expense (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 16,795 | $ 21,992 | $ 53,413 | $ 59,164 |
Selling, general and administrative | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | 10,404 | 14,041 | 31,861 | 35,880 |
Research and development | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Share-based compensation expense | $ 6,391 | $ 7,951 | $ 21,552 | $ 23,284 |
License and Collaboration Agreements (Details) - USD ($) $ in Millions |
3 Months Ended | |
---|---|---|
Sep. 30, 2024 |
Jun. 30, 2024 |
|
Innoviva Inc. | SUL-DUR | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payment made | $ 8.0 | |
Maximum additional milestone payments | $ 80.6 | |
BMS | Repotrectinib | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payment made | $ 25.0 | |
Maximum additional milestone payments | 116.0 | |
BMS | Xanomeline-Trospium Chloride | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Milestone payment made | 10.0 | |
Maximum additional milestone payments | 132.0 | |
Other Counterparties | ||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||
Payment of upfront fees for license agreement | $ 12.0 |
Other Income, Net (Details) - USD ($) $ in Thousands |
3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
|
Other Income and Expenses [Abstract] | ||||
Government grants | $ 3,861 | $ 671 | $ 7,186 | $ 754 |
Loss on equity investments with readily determinable fair value | (920) | (661) | (6,067) | (1,965) |
Others miscellaneous gain | 500 | 384 | 2,740 | 1,434 |
Total | $ 3,441 | $ 394 | $ 3,859 | $ 223 |
Restricted Net Assets (Details) - PRC - USD ($) |
3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2024 |
Sep. 30, 2023 |
Sep. 30, 2024 |
Sep. 30, 2023 |
Dec. 31, 2023 |
|
Restricted Net Assets [Line Items] | |||||
Statutory reserves | $ 0 | $ 0 | $ 0 | $ 0 | |
Restricted amount by subsidiaries | $ 506,000,000.0 | $ 506,000,000.0 | $ 506,000,000.0 |
Commitments and Contingencies (Details) $ in Millions |
Sep. 30, 2024
USD ($)
|
---|---|
Property and Equipment and Commercial Manufacturing Development Activities | |
Unrecorded Unconditional Purchase Obligation [Line Items] | |
Purchase obligation to be incurred within one year | $ 8.6 |
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