x | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
o | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
Cayman Islands | 98-1144595 | |||||
(State or Incorporation or | (I.R.S. Employer Identification No.) | |||||
4560 Jinke Road Bldg. 1, Fourth Floor, Shanghai | 201210 | |||||
314 Main Street 4th Floor, Suite 100 Cambridge, MA, USA | 02142 | |||||
(Address of | (Zip Code) | |||||
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||||
American Depositary Shares, each representing 10 Ordinary | ZLAB | The Nasdaq Global Market | ||||||||||||||
Ordinary Shares, par value $0.000006 per share* | 9688 | The Stock Exchange of Hong Kong Limited |
Large accelerated filer | x | Accelerated filer | ||||||||||||||
Non-accelerated filer | o | |||||||||||||||
Smaller reporting company | ||||||||||||||||
Emerging growth company | o |
Page | ||||||||||||
Notes | March 31, 2023 | December 31, 2022 | |||||||||||||||
Assets | |||||||||||||||||
Current assets: | |||||||||||||||||
Cash and cash equivalents | 3 | 879,844 | 1,008,470 | ||||||||||||||
Short-term investments | 50,550 | — | |||||||||||||||
Accounts receivable (net of allowance for credit loss of $13 and $11 as of March 31, 2023 and December 31, 2022, respectively) | 43,346 | 39,963 | |||||||||||||||
Notes receivable | 17,381 | 8,608 | |||||||||||||||
Inventories, net | 4 | 38,405 | 31,621 | ||||||||||||||
Prepayments and other current assets | 42,772 | 35,674 | |||||||||||||||
Total current assets | 1,072,298 | 1,124,336 | |||||||||||||||
Restricted cash, non-current | 1,003 | 803 | |||||||||||||||
Long term investments (including the fair value measured investment of $6,872 and $6,431 as of March 31, 2023 and December 31, 2022, respectively) | 6,872 | 6,431 | |||||||||||||||
Prepayments for equipment | 1,721 | 1,396 | |||||||||||||||
Property and equipment, net | 5 | 58,309 | 57,863 | ||||||||||||||
Operating lease right-of-use assets | 20,148 | 19,512 | |||||||||||||||
Land use rights, net | 6,920 | 6,892 | |||||||||||||||
Intangible assets, net | 1,479 | 1,511 | |||||||||||||||
Long-term deposits | 1,324 | 1,396 | |||||||||||||||
Total assets | 1,170,074 | 1,220,140 | |||||||||||||||
Liabilities and shareholders’ equity | |||||||||||||||||
Current liabilities: | |||||||||||||||||
Accounts payable | 66,361 | 65,974 | |||||||||||||||
Current operating lease liabilities | 7,318 | 7,050 | |||||||||||||||
Other current liabilities | 8 | 50,881 | 66,818 | ||||||||||||||
Total current liabilities | 124,560 | 139,842 | |||||||||||||||
Deferred income | 30,968 | 21,360 | |||||||||||||||
Non-current operating lease liabilities | 12,979 | 13,343 | |||||||||||||||
Other non-current liabilities | 325 | — | |||||||||||||||
Total liabilities | 168,832 | 174,545 | |||||||||||||||
Commitments and contingencies (Note 15) | |||||||||||||||||
Shareholders’ equity | |||||||||||||||||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 967,197,350 and 962,455,850 shares issued as of March 31, 2023 and December 31, 2022, respectively; 963,688,740 and 960,219,570 shares outstanding as of March 31, 2023 and December 31, 2022, respectively) | 6 | 6 | |||||||||||||||
Additional paid-in capital | 2,911,454 | 2,893,120 | |||||||||||||||
Accumulated deficit | (1,910,504) | (1,861,360) | |||||||||||||||
Accumulated other comprehensive income | 17,272 | 25,685 | |||||||||||||||
Treasury Stock (at cost, 3,508,610 and 2,236,280 shares as of March 31, 2023 and December 31, 2022, respectively) | (16,986) | (11,856) | |||||||||||||||
Total shareholders’ equity | 1,001,242 | 1,045,595 | |||||||||||||||
Total liabilities and shareholders’ equity | 1,170,074 | 1,220,140 |
As of | ||||||||||||
Notes | March 31, 2022 | December 31, 2021 | ||||||||||
$ | $ | |||||||||||
Assets | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | 3 | 846,957 | 964,100 | |||||||||
Short-term investments | 465,274 | 445,000 | ||||||||||
Accounts receivable (net of allowance for credit loss of $10 and $11 as of March 31, 2022 and December 31, 2021, respectively) | 33,394 | 47,474 | ||||||||||
Notes receivable | 10,848 | 7,335 | ||||||||||
Inventories | 4 | 20,288 | 18,951 | |||||||||
Prepayments and other current assets | 16,490 | 18,021 | ||||||||||
Total current assets | 1,393,251 | 1,500,881 | ||||||||||
Restricted cash, non-current | 803 | 803 | ||||||||||
Long term investments (including the fair value measured investment of $8,444 and $15,383 as of March 31, 2022 and December 31, 2021, respectively) | 8,444 | 15,605 | ||||||||||
Prepayments for equipment | 4,978 | 989 | ||||||||||
Property and equipment, net | 5 | 45,227 | 43,102 | |||||||||
Operating lease right-of-use assets | 16,986 | 14,189 | ||||||||||
Land use rights, net | 7,774 | 7,811 | ||||||||||
Intangible assets, net | 1,745 | 1,848 | ||||||||||
Long-term deposits | 941 | 870 | ||||||||||
Value added tax recoverable | 20,766 | 23,858 | ||||||||||
Total assets | 1,500,915 | 1,609,956 | ||||||||||
Liabilities and shareholders’ equity | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable | 98,161 | 126,163 | ||||||||||
Current operating lease liabilities | 6,795 | 5,927 | ||||||||||
Other current liabilities | 8 | 49,956 | 60,811 | |||||||||
Total current liabilities | 154,912 | 192,901 | ||||||||||
Deferred income | 26,896 | 27,486 | ||||||||||
Non-current operating lease liabilities | 11,099 | 9,613 | ||||||||||
Total liabilities | 192,907 | 230,000 | ||||||||||
Commitments and contingencies (Note 1 4 ) | 0 | 0 | ||||||||||
Shareholders’ equity | ||||||||||||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 957,035,440 and 955,363,980shares issued as of March 31, 2022 and December 31, 2021, respectively; 956,637,360 and 954,981,050 shares outstanding as of March 31, 2022 and December 31, 2021, respectively) | 6 | 6 | ||||||||||
Additional paid-in capital | 2,838,655 | 2,825,948 | ||||||||||
Accumulated deficit | (1,500,468 | ) | (1,418,074 | ) | ||||||||
Accumulated other comprehensive loss | (25,838 | ) | (23,645 | ) | ||||||||
Treasury Stock (at cost, 398,080 and 382,930 shares as of March 31, 2022 and December 31, 2021, respectively) | (4,347 | ) | (4,279 | ) | ||||||||
Total shareholders’ equity | 1,308,008 | 1,379,956 | ||||||||||
Total liabilities and shareholders’ equity | 1,500,915 | 1,609,956 | ||||||||||
Three Months Ended March 31, | |||||||||||||||||
Notes | 2023 | 2022 | |||||||||||||||
Revenues: | |||||||||||||||||
Product revenue, net | 6 | 62,797 | 46,095 | ||||||||||||||
Collaboration revenue | — | 629 | |||||||||||||||
Total revenues | 62,797 | 46,724 | |||||||||||||||
Expenses: | |||||||||||||||||
Cost of sales | (21,337) | (15,643) | |||||||||||||||
Research and development | (48,472) | (53,854) | |||||||||||||||
Selling, general, and administrative | (62,510) | (56,991) | |||||||||||||||
Loss from operations | (69,522) | (79,764) | |||||||||||||||
Interest income | 10,232 | 188 | |||||||||||||||
Foreign currency gain | 8,912 | 2,285 | |||||||||||||||
Other income (expenses), net | 13 | 1,234 | (4,882) | ||||||||||||||
Loss before income tax and share of loss from equity method investment | (49,144) | (82,173) | |||||||||||||||
Income tax expense | 7 | — | — | ||||||||||||||
Share of loss from equity method investment | — | (221) | |||||||||||||||
Net loss | (49,144) | (82,394) | |||||||||||||||
Net loss attributable to ordinary shareholders | (49,144) | (82,394) | |||||||||||||||
Loss per share - basic and diluted | 9 | (0.05) | (0.09) | ||||||||||||||
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 961,444,780 | 955,499,030 | |||||||||||||||
Loss per American Depositary Shares (“ADS”) - basic and diluted | (0.51) | (0.86) | |||||||||||||||
Weighted-average ADSs used in calculating net loss per ADS - basic and diluted | 96,144,478 | 95,549,903 |
Three Months Ended March 31, | ||||||||||||
Notes | 2022 | 2021 | ||||||||||
$ | $ | |||||||||||
Revenues: | ||||||||||||
Product revenue , net | 6 | 46,095 | 20,103 | |||||||||
Collaboration revenue | 6 | 629 | — | |||||||||
Total revenues | 46,724 | 20,103 | ||||||||||
Expenses: | ||||||||||||
Cost of sales | (15,643 | ) | (7,505 | ) | ||||||||
Research and development | (53,854 | ) | (203,852 | ) | ||||||||
Selling, general and administrative | (56,991 | ) | (35,838 | ) | ||||||||
Loss from operations | (79,764 | ) | (227,092 | ) | ||||||||
Interest income | 188 | 214 | ||||||||||
Other expenses, net | (2,597 | ) | (6,227 | ) | ||||||||
Loss before income tax and share of income (loss) from equity method investment | (82,173 | ) | (233,105 | ) | ||||||||
Income tax expense | 7 | 0— | 0 | |||||||||
Share of income (loss) from equity method investment | (221 | ) | 195 | |||||||||
Net loss | (82,394 | ) | (232,910 | ) | ||||||||
Net loss attributable to ordinary shareholders | (82,394 | ) | (232,910 | ) | ||||||||
Loss per share - basic and diluted | 9 | (0.09 | ) | (0.26 | ) | |||||||
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 955,499,030 | 883,749,280 | ||||||||||
Loss per American Depositary Shares (“ADS“)- basic and diluted | (0.86 | ) | (2.64 | ) | ||||||||
Weighted-average ADS s used in calculating net loss perADS - basic and diluted | 95,549,903 | 88,374,928 |
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
Net loss | (82,394 | ) | (232,910 | ) | ||||
Other comprehensive (loss) income, net of tax of NaN: | ||||||||
Foreign currency translation adjustments | (2,193 | ) | 2,900 | |||||
Comprehensive loss | (84,587 | ) | (230,010 | ) | ||||
Three Months Ended March 31, | |||||||||||||||||
2023 | 2022 | ||||||||||||||||
Net loss | (49,144) | (82,394) | |||||||||||||||
Other comprehensive income (loss), net of tax of nil: | |||||||||||||||||
Foreign currency translation adjustments | (8,413) | (2,193) | |||||||||||||||
Comprehensive loss | (57,557) | (84,587) |
Ordinary Shares | Additional paid in capital | Accumulated deficit | Accumulated other comprehensive (loss) income | Treasury Stock | Total | |||||||||||||||||||||||||||
Number of Shares | Amount | Shares | Amount | |||||||||||||||||||||||||||||
$ | $ | $ | $ | $ | $ | |||||||||||||||||||||||||||
Balance at December 31, 2020 | 878,110,260 | 5 | 1,897,467 | (713,603 | ) | (14,524 | ) | — | — | 1,169,345 | ||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 816,000 | 0 | 0 | — | — | — | — | 0 | ||||||||||||||||||||||||
Exercise of shares option s | 583,640 | 0 | 702 | — | — | — | — | 702 | ||||||||||||||||||||||||
Issuance of ordinary shares in connection with collaboration and license arrangement (Note 1 2 ) | 5,681,820 | 0 | 62,250 | — | — | — | — | 62,250 | ||||||||||||||||||||||||
Issuance cost adjustment for secondary listing | — | — | 65 | — | — | — | — | 65 | ||||||||||||||||||||||||
Share-based compensation | — | — | 7,318 | — | — | — | — | 7,318 | ||||||||||||||||||||||||
Net loss | — | — | — | (232,910 | ) | — | — | — | (232,910 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | 2,900 | — | — | 2,900 | ||||||||||||||||||||||||
Balance at March 31, 2021 | 885,191,720 | 5 | 1,967,802 | (946,513 | ) | (11,624 | ) | — | — | 1,009,670 | ||||||||||||||||||||||
Balance at December 31, 2021 | 955,363,980 | 6 | 2,825,948 | | (1,418,074 | ) | (23,645 | ) | (382,930 | ) | (4,279 | ) | 1,379,956 | |||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 514,800 | 0 | 0 | — | — | — | — | — | ||||||||||||||||||||||||
Exercise of shares options | 1,156,660 | 0 | 297 | — | — | — | — | 297 | ||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (15,150 | ) | (68 | ) | (68 | ) | |||||||||||||||||||||
Share-based compensation | — | — | 12,410 | — | — | — | — | 12,410 | ||||||||||||||||||||||||
Net loss | — | — | — | (82,394 | ) | — | — | — | (82,394 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (2,193 | ) | — | — | (2,193 | ) | ||||||||||||||||||||||
Balance at March 31, 2022 | 957,035,440 | 6 | 2,838,655 | (1,500,468 | ) | (25,838 | ) | (398,080 | ) | (4,347 | ) | 1,308,008 | ||||||||||||||||||||
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 | 962,455,850 | 6 | 2,893,120 | (1,861,360) | 25,685 | (2,236,280) | (11,856) | 1,045,595 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 732,040 | 0 | 0 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares options | 4,009,460 | 0 | 1,673 | — | — | — | — | 1,673 | |||||||||||||||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (1,272,330) | (5,130) | (5,130) | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | 16,661 | — | — | — | — | 16,661 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | (49,144) | — | — | — | (49,144) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (8,413) | — | — | (8,413) | |||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2023 | 967,197,350 | 6 | 2,911,454 | (1,910,504) | 17,272 | (3,508,610) | (16,986) | 1,001,242 |
Balance at December 31, 2021 | 955,363,980 | 6 | 2,825,948 | (1,418,074) | (23,645) | (382,930) | (4,279) | 1,379,956 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 514,800 | 0 | 0 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares options | 1,156,660 | 0 | 297 | — | — | — | — | 297 | |||||||||||||||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (15,150) | (68) | (68) | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | 12,410 | — | — | — | — | 12,410 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | (82,394) | — | — | — | (82,394) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (2,193) | — | — | (2,193) | |||||||||||||||||||||||||||||||||||||||
Balance at March 31, 2022 | 957,035,440 | 6 | 2,838,655 | (1,500,468) | (25,838) | (398,080) | (4,347) | 1,308,008 |
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Cash flows from operating activities | |||||||||||
Net loss | (49,144) | (82,394) | |||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Allowance for credit loss (gain) | 1 | (1) | |||||||||
Inventory write-down | 377 | 138 | |||||||||
Depreciation and amortization expenses | 2,657 | 2,013 | |||||||||
Amortization of deferred income | (582) | (708) | |||||||||
Share-based compensation | 16,661 | 12,410 | |||||||||
Share of loss from equity method investment | — | 221 | |||||||||
(Gain) Loss from fair value changes of equity investment with readily determinable fair value | (441) | 6,939 | |||||||||
Loss (gain) on disposal of property and equipment | 64 | (11) | |||||||||
Non-cash lease expenses | 2,464 | 2,017 | |||||||||
Foreign currency remeasurement gain | (8,912) | (2,285) | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | (2,852) | 14,080 | |||||||||
Notes receivable | (8,599) | (3,513) | |||||||||
Inventories | (6,686) | (1,475) | |||||||||
Prepayments and other current assets | (6,470) | 1,531 | |||||||||
Long-term deposits | 72 | (71) | |||||||||
Value added tax recoverable | — | 3,092 | |||||||||
Accounts payable | (327) | (28,002) | |||||||||
Other current liabilities | (15,593) | (8,837) | |||||||||
Operating lease liabilities | (2,141) | (2,389) | |||||||||
Deferred income | 9,839 | 118 | |||||||||
Other non-current liabilities | 325 | — | |||||||||
Net cash used in operating activities | (69,287) | (87,127) | |||||||||
Cash flows from investing activities | |||||||||||
Purchases of short-term investments | (100,000) | (120,274) | |||||||||
Proceeds from maturity of short-term investment | 49,450 | 100,000 | |||||||||
Disposal of property and equipment | 112 | 25 | |||||||||
Purchases of property and equipment | (3,513) | (9,743) | |||||||||
Purchases of intangible assets | (3) | (152) | |||||||||
Net cash used in investing activities | (53,954) | (30,144) | |||||||||
Cash flows from financing activities | |||||||||||
Proceeds from exercises of stock options | 1,197 | 297 | |||||||||
Employee taxes paid related to settlement of equity awards | (5,083) | (39) | |||||||||
Net cash (used in) provided by financing activities | (3,886) | 258 | |||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (1,299) | (130) | |||||||||
Net decrease in cash, cash equivalents and restricted cash | (128,426) | (117,143) | |||||||||
Cash, cash equivalents and restricted cash - beginning of period | 1,009,273 | 964,903 | |||||||||
Cash, cash equivalents and restricted cash - end of period | 880,847 | 847,760 | |||||||||
Supplemental disclosure on non-cash investing and financing activities | |||||||||||
Payables for purchase of property and equipment | 4,232 | 668 | |||||||||
Payables for intangible assets | 268 | 73 | |||||||||
Payables for treasury stock | — | 55 | |||||||||
Receivables for stock option exercise under equity incentive plans | 476 | — | |||||||||
Right-of-use asset acquired under operating leases | 2,662 | 4,596 | |||||||||
Receivables for dispose of property and equipment | 10 | — | |||||||||
Supplemental disclosure of cash flow information | |||||||||||
Cash and cash equivalents | 879,844 | 846,957 | |||||||||
Restricted cash, non-current | 1,003 | 803 | |||||||||
Total cash and cash equivalents and restricted cash | 880,847 | 847,760 |
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
Operating activities | ||||||||
Net loss | (82,394 | ) | (232,910 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Allowance for credit loss | (1 | ) | 1 | |||||
Inventory write-down | 138 | 14 | ||||||
Depreciation and amortization expenses | 2,013 | 1,448 | ||||||
Amortization of deferred income | (708 | ) | (78 | ) | ||||
Share-based compensation | 12,410 | 7,318 | ||||||
Noncash research and development expenses | 0 | 62,250 | ||||||
Share of (income) loss from equity method investment | 221 | (195 | ) | |||||
Loss from fair value changes of equity investment with readily determinable fair value | 6,939 | 0 | ||||||
(Gain) loss on disposal of property and equipment | (11 | ) | 4 | |||||
Noncash lease expenses | 2,017 | 1,322 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | 14,080 | (3,651 | ) | |||||
Notes receivable | (3,513 | ) | 0 | |||||
Inventories | (1,475 | ) | 502 | |||||
Prepayments and other current assets | 1,531 | (3,386 | ) | |||||
Long - term deposits | (71 | ) | (47 | ) | ||||
Value added tax recoverable | 3,092 | (1,558 | ) | |||||
Accounts payable | (28,002 | ) | (21,226 | ) | ||||
Other current liabilities | (11,122 | ) | 21,707 | |||||
Operating lease liabilities | (2,389 | ) | (893 | ) | ||||
Deferred income | 118 | (122 | ) | |||||
Net cash used in operating activities | (87,127 | ) | (169,500 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of short-term investments | (120,274 | ) | 0 | |||||
Proceeds from maturity of short-term investment | 100,000 | 743,902 | ||||||
Disposal of property and equipment | 25 | — | ||||||
Purchase of property and equipment | (9,743 | ) | (1,683 | ) | ||||
Purchase of intangible assets | (152 | ) | (214 | ) | ||||
Net cash (used in) provided by investing activities | (30,144 | ) | 742,005 | |||||
Cash flows from financing activities: | ||||||||
Proceeds from exercises of stock options | 297 | 702 | ||||||
Payment of public offering costs | 0 | (973 | ) | |||||
Employee taxes paid related to net share settlement of equity awards | (39 | ) | — | |||||
Net cash provided by (used in) financing activities | 258 | (271 | ) | |||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (130 | ) | (930 | ) | ||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (117,143 | ) | 571,304 | |||||
Cash, cash equivalents and restricted cash - beginning of period | 964,903 | 442,859 | ||||||
Cash, cash equivalents and restricted cash - end of period | 847,760 | 1,014,163 | ||||||
Supplemental disclosure on non-cash investing and financing activities: | ||||||||
Payables for purchase of property and equipment | 668 | 439 | ||||||
Payables for intangible assets | 73 | 26 | ||||||
Payables for public offering costs | 0 | 26 | ||||||
Payables for treasury stock | 55 | — | ||||||
Supplemental disclosure of cash flow information: | ||||||||
Cash and cash equivalents | 846,957 | 1,013,420 | ||||||
Restricted cash, non-current | 803 | 743 | ||||||
Total cash and cash equivalents and restricted cash | 847,760 | 1,014,163 | ||||||
Description | Fair Value as of March 31, 2022 US$ | Fair Value Measurement at Reporting Date Using Quoted Prices in Active Markets for Identical Assets (Level 1) US$ | ||||||
Equity Investments with Readily Determinable Fair Value | 8,444 | 8,444 | ||||||
Description | Fair Value as of December 31, 202 1 US$ | Fair Value Measurement at Reporting Date Using Quoted Prices in Active Markets for Identical Assets (Level 1) US$ | ||||||
Equity Investments with Readily Determinable Fair Value | 15,383 | 15,383 |
As of | ||||||||
March 31, 2022 | December 31, 2021 | |||||||
$ | $ | |||||||
Cash at bank and in hand | 547,259 | 663,472 | ||||||
Cash equivalents (i) | 299,698 | 300,628 | ||||||
846,957 | 964,100 | |||||||
Denominated in: | ||||||||
US$ | 782,295 | 932,888 | ||||||
RMB (ii) | 58,569 | 23,791 | ||||||
Hong Kong dollar (“HK$”) | 5,551 | 6,674 | ||||||
Australian dollar (“A$”) | 495 | 475 | ||||||
Taiwan dollar (“TW$”) | 47 | 272 | ||||||
846,957 | 964,100 | |||||||
March 31, 2023 | December 31, 2022 | ||||||||||
Cash at bank and in hand | 878,786 | 1,007,423 | |||||||||
Cash equivalents (i) | 1,058 | 1,047 | |||||||||
879,844 | 1,008,470 | ||||||||||
Denominated in: | |||||||||||
US$ | 836,981 | 957,824 | |||||||||
RMB (ii) | 38,278 | 45,486 | |||||||||
Hong Kong dollar (“HK$”) | 3,864 | 4,378 | |||||||||
Australian dollar (“A$”) | 588 | 598 | |||||||||
Taiwan dollar (“TW$”) | 133 | 184 | |||||||||
879,844 | 1,008,470 |
As of | ||||||||
March 31, 2022 | December 31, 2021 | |||||||
$ | $ | |||||||
Finished goods | 4,733 | 5,632 | ||||||
Raw materials | 15,555 | 13,231 | ||||||
Work in Progress | 0 | 88 | ||||||
Inventories | 20,288 | 18,951 | ||||||
March 31, 2023 | December 31, 2022 | ||||||||||
Finished goods | 17,832 | 12,156 | |||||||||
Raw materials | 20,521 | 19,029 | |||||||||
Work in Progress | 52 | 436 | |||||||||
Inventories, net | 38,405 | 31,621 |
March 31, 2023 | December 31, 2022 | ||||||||||
Office equipment | 998 | 977 | |||||||||
Electronic equipment | 8,315 | 7,416 | |||||||||
Vehicle | 205 | 202 | |||||||||
Laboratory equipment | 19,491 | 18,726 | |||||||||
Manufacturing equipment | 16,763 | 17,055 | |||||||||
Leasehold improvements | 11,470 | 11,300 | |||||||||
Construction in progress | 25,546 | 24,251 | |||||||||
82,788 | 79,927 | ||||||||||
Less: accumulated depreciation | (24,479) | (22,064) | |||||||||
Property and equipment, net | 58,309 | 57,863 |
As of | ||||||||
March 31, 2022 | December 31, 2021 | |||||||
$ | $ | |||||||
Office equipment | 838 | 836 | ||||||
Electronic equipment | 5,932 | 5,036 | ||||||
Vehicle | 222 | 220 | ||||||
Laboratory equipment | 18,130 | 17,069 | ||||||
Manufacturing equipment | 14,721 | 14,600 | ||||||
Leasehold improvements | 10,506 | 10,432 | ||||||
Construction in progress | 13,126 | 11,334 | ||||||
63,475 | 59,527 | |||||||
Less: accumulated depreciation | (18,248 | ) | (16,425 | ) | ||||
Property and equipment, net | 45,227 | 43,102 | ||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Product revenue - gross | 71,212 | 53,310 | |||||||||
Less: Rebates and sales returns | (8,415) | (7,215) | |||||||||
Product revenue - net | 62,797 | 46,095 |
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
Product revenue - gross | 53,310 | 46,555 | ||||||
Less: Rebate and sales return | (7,215 | ) | (26,452 | ) | ||||
Product revenue - net | 46,095 | 20,103 | ||||||
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
ZEJULA | 29,597 | 12,606 | ||||||
Optune | 12,797 | 7,130 | ||||||
QINLOCK | 2,959 | 367 | ||||||
NUZYRA | 742 | 0 | ||||||
Product revenue - net | 46,095 | 20,103 | ||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
ZEJULA | 42,680 | 29,597 | |||||||||
Optune | 13,342 | 12,797 | |||||||||
QINLOCK | 1,306 | 2,959 | |||||||||
NUZYRA | 5,469 | 742 | |||||||||
Product revenue - net | 62,797 | 46,095 |
March 31, 2023 | December 31, 2022 | ||||||||||
Payroll | 11,472 | 31,689 | |||||||||
Accrued professional service fee | 7,148 | 4,080 | |||||||||
Payables for purchase of property and equipment | 4,232 | 5,269 | |||||||||
Accrued rebate to distributors | 11,536 | 8,443 | |||||||||
Tax payables | 13,001 | 13,283 | |||||||||
Others (i) | 3,492 | 4,054 | |||||||||
Total | 50,881 | 66,818 |
As of | ||||||||
March 31, 2022 | December 31, 2021 | |||||||
$ | $ | |||||||
Payroll | 16,318 | 25,685 | ||||||
Accrued professional service fee | 5,170 | 4,319 | ||||||
Payables for purchase of property and equipment | 668 | 2,568 | ||||||
Accrued rebate to distributors | 14,625 | 15,001 | ||||||
Tax payables | 9,931 | 8,817 | ||||||
Others (note (i)) | 3,244 | 4,421 | ||||||
Total | 49,956 | 60,811 | ||||||
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
Numerator: | ||||||||
Net loss attributable to ordinary shareholders | (82,394 | ) | (232,910 | ) | ||||
Denominator: | ||||||||
Weighted average number of ordinary shares- basic and diluted | 955,499,030 | 883,749,280 | ||||||
Net loss per share - basic and diluted | (0.09 | ) | (0.26 | ) | ||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Numerator: | |||||||||||
Net loss attributable to ordinary shareholders | (49,144) | (82,394) | |||||||||
Denominator: | |||||||||||
Weighted average number of ordinary shares - basic and diluted | 961,444,780 | 955,499,030 | |||||||||
Net loss per share - basic and diluted | (0.05) | (0.09) |
March 31 | |||||||||||
2023 | 2022 | ||||||||||
Share options | 86,242,060 | 80,514,330 | |||||||||
Non-vested restricted shares | 32,154,670 | 9,846,360 |
As of | ||||||||
March 31, 2022 | March 31, 2021 | |||||||
Share options | 80,514,330 | 86,932,740 | ||||||
Non-vested restricted shares | 9,846,360 | 4,800,100 |
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
Selling, general and administrative | 4,069 | 3,259 | ||||||
Research and development | 3,138 | 2,290 | ||||||
Total | 7,207 | 5,549 | ||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Selling, general and administrative | 10,063 | 6,992 | |||||||||
Research and development | 6,598 | 5,418 | |||||||||
Total | 16,661 | 12,410 |
Three Months Ended March 31, | ||||||||
2022 | 2021 | |||||||
$ | $ | |||||||
Selling, general and administrative | 2,923 | 1,211 | ||||||
Research and development | 2,280 | 558 | ||||||
Total | 5,203 | 1,769 | ||||||
Three Months Ended March 31, | |||||||||||
2023 | 2022 | ||||||||||
Government grants | — | 1,576 | |||||||||
Gain (loss) on equity investments with readily determinable fair value | 441 | (6,939) | |||||||||
Others miscellaneous gain | 793 | 481 | |||||||||
Total | 1,234 | (4,882) |
Three Months Ended March 31, | Change | |||||||||||||||||||||||||
2023 | 2022 | $ | % | |||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||
Product revenue, net | 62,797 | 46,095 | 16,702 | 36 | % | |||||||||||||||||||||
Collaboration revenue | — | 629 | (629) | (100) | % | |||||||||||||||||||||
Total revenues | 62,797 | 46,724 | 16,073 | 34 | % | |||||||||||||||||||||
Expenses: | ||||||||||||||||||||||||||
Cost of sales | (21,337) | (15,643) | (5,694) | 36 | % | |||||||||||||||||||||
Research and development | (48,472) | (53,854) | 5,382 | (10) | % | |||||||||||||||||||||
Selling, general, and administrative | (62,510) | (56,991) | (5,519) | 10 | % | |||||||||||||||||||||
Loss from operations | (69,522) | (79,764) | 10,242 | (13) | % | |||||||||||||||||||||
Interest income | 10,232 | 188 | 10,044 | 5343 | % | |||||||||||||||||||||
Foreign currency gain | 8,912 | 2,285 | 6,627 | 290 | % | |||||||||||||||||||||
Other income (expenses), net | 1,234 | (4,882) | 6,116 | (125) | % | |||||||||||||||||||||
Loss before income tax and share of loss from equity method investment | (49,144) | (82,173) | 33,029 | (40) | % | |||||||||||||||||||||
Income tax expense | — | — | — | — | % | |||||||||||||||||||||
Share of loss from equity method investment | — | (221) | 221 | (100) | % | |||||||||||||||||||||
Net loss | (49,144) | (82,394) | 33,250 | (40) | % | |||||||||||||||||||||
Net loss attributable to ordinary shareholders | (49,144) | (82,394) | 33,250 | (40) | % |
Three Months Ended March 31, | Change | |||||||||||||||||||||||||
2023 | 2022 | $ | % | |||||||||||||||||||||||
Product revenue - gross | $ | 71,212 | $ | 53,310 | $ | 17,902 | 34 | % | ||||||||||||||||||
Less: Rebates and sales return | (8,415) | (7,215) | (1,200) | 17 | % | |||||||||||||||||||||
Product revenue - net | 62,797 | 46,095 | 16,702 | 36 | % |
Three months ended March 31, | ||||||||||||||||
(in thousands) | 2022 | % | 2021 | % | ||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 46,095 | 98.7 | $ | 20,103 | 100.0 | ||||||||||
Collaboration revenue | 629 | 1.3 | — | — | ||||||||||||
Total | $ | 46,724 | 100.0 | $ | 20,103 | 100.0 | ||||||||||
Three Months Ended March 31, | Change | |||||||||||||||||||||||||
2023 | 2022 | $ | % | |||||||||||||||||||||||
ZEJULA | $ | 42,680 | $ | 29,597 | $ | 13,083 | 44 | % | ||||||||||||||||||
Optune | 13,342 | 12,797 | 545 | 4 | % | |||||||||||||||||||||
QINLOCK | 1,306 | 2,959 | (1,653) | (56) | % | |||||||||||||||||||||
NUZYRA | 5,469 | 742 | 4,727 | 637 | % | |||||||||||||||||||||
Total product revenue, net | $ | 62,797 | $ | 46,095 | $ | 16,702 | 36 | % |
(in thousands) | Three months ended March 31, | |||||||||||||||
2022 | % | 2021 | % | |||||||||||||
ZEJULA | $ | 29,597 | 64.2 | $ | 12,606 | 62.7 | ||||||||||
Optune | 12,797 | 27.8 | 7,130 | 35.5 | ||||||||||||
QINLOCK | 2,959 | 6.4 | 367 | 1.8 | ||||||||||||
NUZYRA | 742 | 1.6 | — | — | ||||||||||||
Total product revenue, net | $ | 46,095 | 100.0 | $ | 20,103 | 100.0 | ||||||||||
(in thousands) | Three months ended March 31, | |||||||||||||||||||||||||||||||||||||||||
2022 | % | 2021 | % | |||||||||||||||||||||||||||||||||||||||
Research and development expenses: | ||||||||||||||||||||||||||||||||||||||||||
Three Months Ended March 31, | Change | |||||||||||||||||||||||||||||||||||||||||
2023 | 2022 | $ | % | |||||||||||||||||||||||||||||||||||||||
Personnel compensation and related costs | $ | 24,802 | 46.1 | $ | 12,697 | 6.2 | Personnel compensation and related costs | $ | 28,655 | $ | 24,802 | $ | 3,853 | 16 | % | |||||||||||||||||||||||||||
Licensing fees | — | — | 171,282 | 84.0 | Licensing fees | 1,000 | — | 1,000 | 100 | % | ||||||||||||||||||||||||||||||||
CROs/CMOs/Investigators expenses | 23,550 | 43.7 | 15,526 | 7.6 | CROs/CMOs/Investigators expenses | 12,439 | 23,550 | (11,111) | (47) | % | ||||||||||||||||||||||||||||||||
Other costs | 5,502 | 10.2 | 4,347 | 2.2 | Other costs | 6,378 | 5,502 | 876 | 16 | % | ||||||||||||||||||||||||||||||||
Total | $ | 53,854 | 100.0 | $ | 203,852 | 100.0 | Total | $ | 48,472 | $ | 53,854 | $ | (5,382) | (10) | % | |||||||||||||||||||||||||||
Three Months Ended March 31, | Change | |||||||||||||||||||||||||
2023 | 2022 | $ | % | |||||||||||||||||||||||
Clinical programs | $ | 12,528 | $ | 22,852 | $ | (10,324) | (45) | % | ||||||||||||||||||
Pre-clinical programs | 2,481 | 2,565 | (84) | (3) | % | |||||||||||||||||||||
Unallocated research and development expenses | 33,463 | 28,437 | 5,026 | 18 | % | |||||||||||||||||||||
Total | $ | 48,472 | $ | 53,854 | $ | (5,382) | (10) | % |
(in thousands) | Three months ended March 31, | |||||||||||||||
2022 | % | 2021 | % | |||||||||||||
Research and development expenses: | ||||||||||||||||
Clinical programs | $ | 22,852 | 42.4 | $ | 186,256 | 91.4 | ||||||||||
Pre-clinical programs | 2,565 | 4.8 | 2,500 | 1.2 | ||||||||||||
Unallocated research and development expenses | 28,437 | 52.8 | 15,096 | 7.4 | ||||||||||||
Total | $ | 53,854 | 100.0 | $ | 203,852 | 100.0 | ||||||||||
Three Months Ended March 31, | Change | |||||||||||||||||||||||||
2023 | 2022 | $ | % | |||||||||||||||||||||||
Personnel compensation and related costs | $ | 40,914 | $ | 38,203 | $ | 2,711 | 7 | % | ||||||||||||||||||
Professional service fees | 11,983 | 7,433 | 4,550 | 61 | % | |||||||||||||||||||||
Other costs | 9,613 | 11,355 | (1,742) | (15) | % | |||||||||||||||||||||
Total | $ | 62,510 | $ | 56,991 | $ | 5,519 | 10 | % |
(in thousands) | Three months ended March 31, | |||||||||||||||
2022 | % | 2021 | % | |||||||||||||
Selling, General and Administrative Expenses: | ||||||||||||||||
Personnel compensation and related costs | $ | 38,203 | 67.0 | $ | 23,412 | 65.3 | ||||||||||
Professional service fees | 7,433 | 13.0 | 3,583 | 10.0 | ||||||||||||
Other costs | 11,355 | 20.0 | 8,843 | 24.7 | ||||||||||||
Total | $ | 56,991 | 100.0 | $ | 35,838 | 100.0 | ||||||||||
Three months ended March 31, | ||||||||
(in thousands) | 2022 | 2021 | ||||||
Net cash used in operating activities | $ | (87,127 | ) | $ | (169,500 | ) | ||
Net cash (used in) provided by investing activities | (30,144 | ) | 742,005 | |||||
Net cash provided by (used in) financing activities | 258 | (271 | ) | |||||
Effect of foreign exchange rate changes | (130 | ) | (930 | ) | ||||
Net (decreases) increases in cash, cash equivalents and restricted cash | $ | (117,143 | ) | $ | 571,304 | |||
Three Months Ended March 31, | Change | |||||||||||||||||||
2023 | 2022 | $ | ||||||||||||||||||
Net cash used in operating activities | $ | (69,287) | $ | (87,127) | $ | 17,840 | ||||||||||||||
Net cash used in investing activities | (53,954) | (30,144) | (23,810) | |||||||||||||||||
Net cash (used in) provided by financing activities | (3,886) | 258 | (4,144) | |||||||||||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (1,299) | (130) | (1,169) | |||||||||||||||||
Net decrease in cash, cash equivalents and restricted cash | $ | (128,426) | $ | (117,143) | $ | (11,283) |
Period | Total Number of Shares (or Units) Purchased | Average Price Paid per Share (or Unit) | Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs | Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs | ||||||||||
January 1 – 31, 2023 | 2,661 | $ | 30.70 | — | — | |||||||||
February 1 – 28, 2023 | 914 | $ | 42.50 | — | — | |||||||||
March 1 – 31, 2023 | 123,658 | $ | 40.51 | — | — | |||||||||
Total | 127,233 |
Exhibit Number | Exhibit Title | |||||||
10.1# | ||||||||
10.2# | ||||||||
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: May | By: | /s/ | |||||||||
Name: | |||||||||||
Title: | |||||||||||