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 other jurisdiction of incorporation or organization) | (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 principal executive offices) | (Zip Code) | |||||
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||||
American Depositary Shares, each representing | ||||||||||||||||
10 Ordinary Shares, par value | 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 | September 30, 2022 | December 31, 2021 | |||||||||||||||
$ | $ | ||||||||||||||||
Assets | |||||||||||||||||
Current assets: | |||||||||||||||||
Cash and cash equivalents | 3 | 1,119,476 | 964,100 | ||||||||||||||
Short-term investments | — | 445,000 | |||||||||||||||
Accounts receivable (net of allowance for credit loss of $8 and $11 as of September 30, 2022 and December 31, 2021, respectively) | 27,736 | 47,474 | |||||||||||||||
Notes receivable | 10,251 | 7,335 | |||||||||||||||
Inventories, net | 4 | 29,131 | 18,951 | ||||||||||||||
Value added tax recoverable - current | 1,080 | — | |||||||||||||||
Prepayments and other current assets | 22,157 | 18,021 | |||||||||||||||
Total current assets | 1,209,831 | 1,500,881 | |||||||||||||||
Restricted cash, non-current | 803 | 803 | |||||||||||||||
Long term investments (including the fair value measured investment of $3,316 and $15,383 as of September 30, 2022 and December 31, 2021, respectively) | 3,316 | 15,605 | |||||||||||||||
Prepayments for equipment | 4,068 | 989 | |||||||||||||||
Property and equipment, net | 5 | 50,528 | 43,102 | ||||||||||||||
Operating lease right-of-use assets | 20,269 | 14,189 | |||||||||||||||
Land use rights, net | 6,824 | 7,811 | |||||||||||||||
Intangible assets, net | 1,540 | 1,848 | |||||||||||||||
Long-term deposits | 1,329 | 870 | |||||||||||||||
Value added tax recoverable | 6 | 23,858 | |||||||||||||||
Total assets | 1,298,514 | 1,609,956 | |||||||||||||||
Liabilities and shareholders’ equity | |||||||||||||||||
Current liabilities: | |||||||||||||||||
Accounts payable | 90,112 | 126,163 | |||||||||||||||
Current operating lease liabilities | 6,980 | 5,927 | |||||||||||||||
Other current liabilities | 8 | 58,456 | 60,811 | ||||||||||||||
Total current liabilities | 155,548 | 192,901 | |||||||||||||||
Deferred income | 23,205 | 27,486 | |||||||||||||||
Non-current operating lease liabilities | 13,892 | 9,613 | |||||||||||||||
Total liabilities | 192,645 | 230,000 | |||||||||||||||
Commitments and contingencies (Note 14) | |||||||||||||||||
Shareholders’ equity | |||||||||||||||||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 961,829,720 and 955,363,980 shares issued as of September 30, 2022 and December 31, 2021, respectively; 959,724,940 and 954,981,050 shares outstanding as of September 30, 2022 and December 31, 2021, respectively) | 6 | 6 | |||||||||||||||
Additional paid-in capital | 2,877,361 | 2,825,948 | |||||||||||||||
Accumulated deficit | (1,799,591) | (1,418,074) | |||||||||||||||
Accumulated other comprehensive income (loss) | 39,549 | (23,645) | |||||||||||||||
Treasury Stock (at cost, 2,104,780 and 382,930 shares as of September 30, 2022 and December 31, 2021, respectively) | (11,456) | (4,279) | |||||||||||||||
Total shareholders’ equity | 1,105,869 | 1,379,956 | |||||||||||||||
Total liabilities and shareholders’ equity | 1,298,514 | 1,609,956 |
As of | ||||||||||||
Notes | September 30, 2021 | December 31, 2020 | ||||||||||
$ | $ | |||||||||||
Assets | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | 3 | 1,398,498 | 442,116 | |||||||||
Short-term investments | 5 | 170,000 | 744,676 | |||||||||
Accounts receivable (net of allowance for credit loss of $6 and $1 as of September 30, 2021 and December 31, 2020, respectively) | 21,018 | 5,165 | ||||||||||
Inventories | 6 | 12,494 | 13,144 | |||||||||
Prepayments and other current assets | 17,077 | 10,935 | ||||||||||
Total current assets | 1,619,087 | 1,216,036 | ||||||||||
Restricted cash, non-current | 4 | 743 | 743 | |||||||||
Long - term investments | 7 | 20,801 | 1,279 | |||||||||
Prepayments for equipment | 1,129 | 274 | ||||||||||
Property and equipment, net | 8 | 37,087 | 29,162 | |||||||||
Operating lease right-of-use assets | 15,514 | 17,701 | ||||||||||
Land use rights, net | 7,749 | 7,908 | ||||||||||
Intangible assets, net | 1,678 | 1,532 | ||||||||||
Long-term deposits | 901 | 862 | ||||||||||
Value added tax recoverable | 23,390 | 22,141 | ||||||||||
Total assets | 1,728,079 | 1,297,638 | ||||||||||
Liabilities and shareholders’ equity | ||||||||||||
Current liabilities: | ||||||||||||
Accounts payable | 51,406 | 62,641 | ||||||||||
Current operating lease liabilities | 6,312 | 5,206 | ||||||||||
Other current liabilities | 11 | 54,292 | 30,196 | |||||||||
Total current liabilities | 112,010 | 98,043 | ||||||||||
Deferred income | 17,487 | 16,858 | ||||||||||
Non-current operating lease liabilities | 10,652 | 13,392 | ||||||||||
Total liabilities | 140,149 | 128,293 | ||||||||||
Commitments and contingencies (Note 17) | 0 | 0 | ||||||||||
Shareholders’ equity | ||||||||||||
Ordinary shares (par value of $0.00006 per share; 500,000,000 shares authorized, 95,273,589 and 87,811,026 shares issued and outstanding as of September 30, | 6 | 5 | ||||||||||
Additional paid-in capital | 2,812,830 | 1,897,467 | ||||||||||
Accumulated deficit | (1,206,249 | ) | (713,603 | ) | ||||||||
Accumulated other comprehensive loss | (15,124 | ) | (14,524 | ) | ||||||||
Treasury Stock (at cost, 27,722 and 0nil shares as of September 30, 2021 and December 31, 2020, respectively) | (3,533 | ) | — | |||||||||
Total shareholders’ equity | 1,587,930 | 1,169,345 | ||||||||||
Total liabilities and shareholders’ equity | 1,728,079 | 1,297,638 | ||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
Notes | 2022 | 2021 | 2022 | 2021 | |||||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||||||
Product revenue, net | 6 | 56,963 | 43,103 | 150,633 | 100,141 | ||||||||||||||||||||||||
Collaboration revenue | 6 | 577 | — | 1,806 | — | ||||||||||||||||||||||||
Total revenues | 57,540 | 43,103 | 152,439 | 100,141 | |||||||||||||||||||||||||
Expenses: | |||||||||||||||||||||||||||||
Cost of sales | (20,044) | (12,162) | (53,094) | (30,535) | |||||||||||||||||||||||||
Research and development | (99,524) | (55,144) | (219,462) | (401,220) | |||||||||||||||||||||||||
Selling, general, and administrative | (66,555) | (59,002) | (186,947) | (149,254) | |||||||||||||||||||||||||
Loss from operations | (128,583) | (83,205) | (307,064) | (480,868) | |||||||||||||||||||||||||
Interest income | 3,872 | 713 | 5,235 | 1,171 | |||||||||||||||||||||||||
Other income (expenses), net | (36,479) | (13,580) | (79,467) | (12,401) | |||||||||||||||||||||||||
Loss before income tax and share of loss from equity method investment | (161,190) | (96,072) | (381,296) | (492,098) | |||||||||||||||||||||||||
Income tax expense | 7 | — | — | — | — | ||||||||||||||||||||||||
Share of loss from equity method investment | — | (340) | (221) | (548) | |||||||||||||||||||||||||
Net loss | (161,190) | (96,412) | (381,517) | (492,646) | |||||||||||||||||||||||||
Net loss attributable to ordinary shareholders | (161,190) | (96,412) | (381,517) | (492,646) | |||||||||||||||||||||||||
Loss per share - basic and diluted | 9 | (0.17) | (0.10) | (0.40) | (0.53) | ||||||||||||||||||||||||
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 959,085,960 | 950,354,320 | 957,439,910 | 921,748,380 | |||||||||||||||||||||||||
Loss per American Depositary Shares (“ADS”) - basic and diluted | (1.68) | (1.01) | (3.98) | (5.34) | |||||||||||||||||||||||||
Weighted-average ADSs used in calculating net loss per ADS - basic and diluted | 95,908,596 | 95,035,432 | 95,743,991 | 92,174,838 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||||
Notes | 2021 | 2020 | 2021 | 2020 | ||||||||||||||||
$ | $ | $ | $ | |||||||||||||||||
Revenue | 9 | 43,103 | 14,651 | �� | 100,141 | 33,864 | ||||||||||||||
Expenses: | ||||||||||||||||||||
Cost of sales | (12,162 | ) | (4,934 | ) | (30,535 | ) | (9,914 | ) | ||||||||||||
Research and development | (55,144 | ) | (58,100 | ) | (401,220 | ) | (160,149 | ) | ||||||||||||
Selling, general and administrative | (59,002 | ) | (27,874 | ) | (149,254 | ) | (70,346 | ) | ||||||||||||
Loss from operations | (83,205 | ) | (76,257 | ) | (480,868 | ) | (206,545 | ) | ||||||||||||
Interest income | 713 | 866 | 1,171 | 3,748 | ||||||||||||||||
Interest expenses | — | (43 | ) | — | (157 | ) | ||||||||||||||
Other (expense s ) income, net | (13,580 | ) | 11,958 | (12,401 | ) | 11,267 | ||||||||||||||
Loss before income tax and share of loss from equity method investment | (96,072 | ) | (63,476 | ) | (492,098 | ) | (191,687 | ) | ||||||||||||
Income tax expense | 10 | 0— | — | 0— | — | |||||||||||||||
Share of loss from equity method investment | (340 | ) | (265 | ) | (548 | ) | (671 | ) | ||||||||||||
Net loss | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) | ||||||||||||
Net loss attributable to ordinary shareholders | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) | ||||||||||||
Loss per share - basic and diluted | 12 | (1.01 | ) | (0.84 | ) | (5.34 | ) | (2.59 | ) | |||||||||||
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 95,035,432 | 75,436,646 | 92,174,838 | 74,381,115 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||||||||
Net loss | (161,190) | (96,412) | (381,517) | (492,646) | |||||||||||||||||||||||||
Other comprehensive income (loss), net of tax of nil: | |||||||||||||||||||||||||||||
Foreign currency translation adjustments | 35,062 | 1,741 | 63,194 | (600) | |||||||||||||||||||||||||
Comprehensive loss | (126,128) | (94,671) | (318,323) | (493,246) |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Net loss | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) | ||||||||
Other comprehensive income (loss), net of tax of NaN: | ||||||||||||||||
Foreign currency translation adjustments | 1,741 | (9,901 | ) | (600 | ) | (7,535 | ) | |||||||||
Comprehensive loss | (94,671 | ) | (73,642 | ) | (493,246 | ) | (199,893 | ) | ||||||||
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, 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 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 683,700 | 0 | 0 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares options | 2,801,000 | 0 | 4,322 | — | — | — | — | 4,322 | |||||||||||||||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (1,627,230) | (6,782) | (6,782) | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | 14,225 | — | — | — | — | 14,225 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | (137,933) | — | — | — | (137,933) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | 30,325 | — | — | 30,325 | |||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2022 | 960,520,140 | 6 | 2,857,202 | (1,638,401) | 4,487 | (2,025,310) | (11,129) | 1,212,165 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 230,250 | 0 | 0 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares options | 1,079,330 | 0 | 1,052 | — | — | — | — | 1,052 | |||||||||||||||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (79,470) | (327) | (327) | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | 19,107 | — | — | — | — | 19,107 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | (161,190) | — | — | — | (161,190) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | 35,062 | — | — | 35,062 | |||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2022 | 961,829,720 | 6 | 2,877,361 | (1,799,591) | 39,549 | (2,104,780) | (11,456) | 1,105,869 |
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 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares options | 583,640 | 0 | 702 | — | — | — | — | 702 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares in connection with collaboration and license arrangement | 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 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 321,000 | 0 | 0 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares option | 4,905,170 | 0 | 3,289 | — | — | — | — | 3,289 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon follow-on public offering, net of issuance cost of $879 | 57,164,000 | 1 | 817,995 | — | — | — | — | 817,996 | |||||||||||||||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (60,860) | (924) | (924) | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | 10,232 | — | — | — | — | 10,232 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | (163,324) | — | — | — | (163,324) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (5,241) | — | — | (5,241) | |||||||||||||||||||||||||||||||||||||||
Balance at June 30, 2021 | 947,581,890 | 6 | 2,799,318 | (1,109,837) | (16,865) | (60,860) | (924) | 1,671,698 | |||||||||||||||||||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 540,500 | 0 | 0 | — | — | — | — | — | |||||||||||||||||||||||||||||||||||||||
Exercise of shares option | 4,613,500 | 0 | 2,916 | — | — | — | — | 2,916 | |||||||||||||||||||||||||||||||||||||||
Issuance cost adjustment for follow-on public offering | — | — | 40 | — | — | — | — | 40 | |||||||||||||||||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (216,360) | (2,609) | (2,609) | |||||||||||||||||||||||||||||||||||||||
Share-based compensation | — | — | 10,556 | — | — | — | — | 10,556 | |||||||||||||||||||||||||||||||||||||||
Net loss | — | — | — | (96,412) | — | — | — | (96,412) | |||||||||||||||||||||||||||||||||||||||
Foreign currency translation | — | — | — | — | 1,741 | — | — | 1,741 | |||||||||||||||||||||||||||||||||||||||
Balance at September 30, 2021 | 952,735,890 | 6 | 2,812,830 | (1,206,249) | (15,124) | (277,220) | (3,533) | 1,587,930 |
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 | 87,811,026 | 5 | 1,897,467 | (713,603 | ) | (14,524 | ) | — | — | 1,169,345 | ||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 81,600 | 0 | 0 | — | — | — | — | — | ||||||||||||||||||||||||
Exercise of shares option | 58,364 | 0 | 702 | — | — | — | — | 702 | ||||||||||||||||||||||||
Issuance of ordinary shares in connection with collaboration and license arrangement (Note 15) | 568,182 | 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 translatio n | — | — | — | — | 2,900 | — | — | 2,900 | ||||||||||||||||||||||||
Balance at March 31, 2021 | 88,519,172 | 5 | 1,967,802 | (946,513 | ) | (11,624 | ) | — | — | 1,009,670 | ||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 32,100 | 0 | 0 | — | — | — | — | 0 | ||||||||||||||||||||||||
Exercise of shares option | 490,517 | 0 | 3,289 | — | — | — | — | 3,289 | ||||||||||||||||||||||||
Issuance of ordinary shares upon follow-on public offering, net of issuance cost of $879 | 5,716,400 | 1 | 817,995 | — | — | — | — | 817,996 | ||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (6,086 | ) | (924 | ) | (924 | ) | |||||||||||||||||||||
Share-based compensation | — | — | 10,232 | — | — | — | — | 10,232 | ||||||||||||||||||||||||
Net loss | — | — | — | (163,324 | ) | — | — | — | (163,324 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (5,241 | ) | — | — | (5,241 | ) | ||||||||||||||||||||||
Balance at June 30, 2021 | 94,758,189 | 6 | 2,799,318 | (1,109,837 | ) | (16,865 | ) | (6,086 | ) | (924 | ) | 1,671,698 | ||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 54,050 | 0 | 0 | — | — | — | — | 0 | ||||||||||||||||||||||||
Exercise of shares option | 461,350 | 0 | 2,916 | — | — | — | — | 2,916 | ||||||||||||||||||||||||
Issuance cost adjustment for follow-on public offering | — | — | 40 | — | — | — | — | 40 | ||||||||||||||||||||||||
Receipt of employees’ shares to satisfy tax withholding obligations related to share-based compensation | — | — | — | — | — | (21,636 | ) | (2,609 | ) | (2,609 | ) | |||||||||||||||||||||
Share-based compensation | — | — | 10,556 | — | — | — | — | 10,556 | ||||||||||||||||||||||||
Net loss | — | — | — | (96,412 | ) | — | — | — | (96,412 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | 1,741 | — | — | 1,741 | ||||||||||||||||||||||||
Balance at September 30, 2021 | 95,273,589 | 6 | 2,812,830 | (1,206,249 | ) | (15,124 | ) | (27,722 | ) | (3,533 | ) | 1,587,930 | ||||||||||||||||||||
Balance at December 31, 2019 | 68,237,247 | 4 | 734,734 | (444,698 | ) | 4,620 | — | — | 294,660 | |||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 80,200 | 0 | 0 | — | — | — | — | — | ||||||||||||||||||||||||
Exercise of shares option | 49,278 | 0 | 346 | — | — | — | — | 346 | ||||||||||||||||||||||||
Issuance of ordinary shares upon follow-on public offering, net of issuance cost of $740 | 6,300,000 | 0 | 280,568 | — | — | — | — | 280,568 | ||||||||||||||||||||||||
Share-based compensation | — | — | 6,463 | — | — | — | — | 6,463 | ||||||||||||||||||||||||
Net loss | — | — | — | (47,988 | ) | — | — | — | (47,988 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | 3,539 | — | — | 3,539 | ||||||||||||||||||||||||
Balance at March 31, 2020 | 74,666,725 | 4 | 1,022,111 | (492,686 | ) | 8,159 | — | — | 537,588 | |||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 36,000 | 0 | 0 | — | — | — | — | 0 | ||||||||||||||||||||||||
Exercise of shares option | 179,613 | 0 | 2,729 | — | — | — | — | 2,729 | ||||||||||||||||||||||||
Issuance cost adjustment for follow-on public offering | — | — | (13 | ) | — | — | — | — | (13 | ) | ||||||||||||||||||||||
Share-based compensation | — | — | 6,964 | — | — | — | — | 6,964 | ||||||||||||||||||||||||
Net loss | — | — | — | (80,629 | ) | — | — | — | (80,629 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (1,173 | ) | — | — | (1,173 | ) | ||||||||||||||||||||||
Balance at June 30, 2020 | 74,882,338 | 4 | 1,031,791 | (573,315 | ) | 6,986 | — | — | 465,466 | |||||||||||||||||||||||
Issuance of ordinary shares upon vesting of restricted shares | 90,468 | 0 | 0 | — | — | — | — | 0 | ||||||||||||||||||||||||
Exercise of shares option | 560,662 | 0 | 1,008 | — | — | — | — | 1,008 | ||||||||||||||||||||||||
Issuance of ordinary shares upon secondary listing, net of issuance cost of $5,634 | 10,564,050 | 1 | 739,232 | — | — | — | — | 739,233 | ||||||||||||||||||||||||
Issuance cost adjustment for follow-on public offering | — | — | (2 | ) | — | — | — | — | (2 | ) | ||||||||||||||||||||||
Share-based compensation | — | — | 6,978 | — | — | — | — | 6,978 | ||||||||||||||||||||||||
Net loss | — | — | — | (63,741 | ) | — | — | — | (63,741 | ) | ||||||||||||||||||||||
Foreign currency translation | — | — | — | — | (9,901 | ) | — | — | (9,901 | ) | ||||||||||||||||||||||
Balance at September 00030, 2020 | 86,097,518 | 5 | 1,779,007 | (637,056 | ) | (2,915 | ) | — | — | 1,139,041 | ||||||||||||||||||||||
Nine Months Ended September 30, | |||||||||||
2022 | 2021 | ||||||||||
$ | $ | ||||||||||
Operating activities | |||||||||||
Net loss | (381,517) | (492,646) | |||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
Allowance for credit (gain) loss | (3) | 5 | |||||||||
Inventory write-down | 480 | 402 | |||||||||
Depreciation and amortization expenses | 6,100 | 4,612 | |||||||||
Amortization of deferred income | (2,041) | (234) | |||||||||
Share-based compensation | 45,742 | 28,106 | |||||||||
Noncash research and development expenses | — | 62,250 | |||||||||
Share of loss from equity method investment | 221 | 548 | |||||||||
Loss from fair value changes of equity investment with readily determinable fair value | 12,067 | 9,930 | |||||||||
(Gain) loss on disposal of property and equipment | (11) | 12 | |||||||||
Noncash lease expenses | 5,820 | 4,595 | |||||||||
Foreign currency remeasurement loss | 73,052 | 2,838 | |||||||||
Changes in operating assets and liabilities: | |||||||||||
Accounts receivable | 16,483 | (15,858) | |||||||||
Notes receivable | (3,861) | — | |||||||||
Inventories | (13,235) | 248 | |||||||||
Prepayments and other current assets | (5,860) | (6,142) | |||||||||
Long-term deposits | (459) | (39) | |||||||||
Value added tax recoverable | 21,432 | (1,249) | |||||||||
Accounts payable | (28,850) | (11,235) | |||||||||
Other current liabilities | 1,628 | 20,591 | |||||||||
Operating lease liabilities | (6,008) | (3,834) | |||||||||
Deferred income | 470 | 863 | |||||||||
Net cash used in operating activities | (258,350) | (396,237) | |||||||||
Cash flows from investing activities: | |||||||||||
Purchases of short-term investments | (260,274) | (170,000) | |||||||||
Proceeds from maturity of short-term investment | 705,274 | 743,902 | |||||||||
Purchase of property and equipment | (20,172) | (11,917) | |||||||||
Purchase of intangible assets | (439) | (539) | |||||||||
Payment for investment in equity investee | — | (30,000) | |||||||||
Net cash provided by investing activities | 424,389 | 531,446 | |||||||||
Cash flows from financing activities: | |||||||||||
Proceeds from exercises of stock options | 5,640 | 6,907 | |||||||||
Proceeds from issuance of ordinary shares upon public offerings | — | 818,874 | |||||||||
Payment of public offering costs | — | (1,836) | |||||||||
Employee taxes paid related to net share settlement of equity awards | (7,171) | (3,467) | |||||||||
Net cash (used in) provided by financing activities | (1,531) | 820,478 | |||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (9,132) | 695 | |||||||||
Net increase in cash, cash equivalents and restricted cash | 155,376 | 956,382 | |||||||||
Cash, cash equivalents and restricted cash - beginning of period | 964,903 | 442,859 | |||||||||
Cash, cash equivalents and restricted cash - end of period | 1,120,279 | 1,399,241 | |||||||||
Supplemental disclosure on non-cash investing and financing activities: | |||||||||||
Payables for purchase of property and equipment | 3,234 | 1,797 | |||||||||
Payables for intangible assets | 32 | 24 | |||||||||
Payables for treasury stock | 32 | — | |||||||||
Receivables for stock option exercise under equity incentive plans | 31 | — | |||||||||
Right-of-use asset acquired under operating leases | 12,861 | — | |||||||||
Supplemental disclosure of cash flow information: | |||||||||||
Cash and cash equivalents | 1,119,476 | 1,398,498 | |||||||||
Restricted cash, non-current | 803 | 743 | |||||||||
Total cash and cash equivalents and restricted cash | 1,120,279 | 1,399,241 |
Nine Months Ended September 30, | ||||||||
2021 | 2020 | |||||||
$ | $ | |||||||
Operating activities | ||||||||
Net loss | (492,646 | ) | (192,358 | ) | ||||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Allowance for doubtful accounts | 5 | 2 | ||||||
Inventory write-down | 402 | — | ||||||
Depreciation and amortization expenses | 4,612 | 3,253 | ||||||
Amortization of deferred income | (234 | ) | (234 | ) | ||||
Share-based compensation | 28,106 | 20,405 | ||||||
Noncash research and development expenses (Note 15) | 62,250 | — | ||||||
Share of loss from equity method investment | 548 | 671 | ||||||
Loss from fair value changes of equity investment with readily determinable fair value | 9,930 | 0 | ||||||
Loss on disposal of property and equipment | 12 | 1 | ||||||
Noncash lease expenses | 4,595 | 3,251 | ||||||
Changes in operating assets and liabilities: | ||||||||
Accounts receivable | (15,858 | ) | (3,704 | ) | ||||
Inventories | 248 | (3,631 | ) | |||||
Prepayments and other current assets | (6,142 | ) | (3,564 | ) | ||||
Long - term deposits | (39 | ) | (474 | ) | ||||
Value added tax recoverable | (1,249 | ) | (6,845 | ) | ||||
Accounts payable | (11,235 | ) | 5,217 | |||||
Other current liabilities | 23,429 | (4,981 | ) | |||||
Operating lease liabilities | (3,834 | ) | (2,335 | ) | ||||
Deferred income | 863 | 13,606 | ||||||
Net cash used in operating activities | (396,237 | ) | (171,720 | ) | ||||
Cash flows from investing activities: | ||||||||
Purchases of short-term investments | (170,000 | ) | (749,676 | ) | ||||
Proceeds from maturity of short-term investment | 743,902 | — | ||||||
Payment for investment in equity investee | (30,000 | ) | — | |||||
Disposal of property and equipment | 3 | — | ||||||
Purchase of property and equipment | (11,920 | ) | (4,835 | ) | ||||
Purchase of intangible assets | (539 | ) | (370 | ) | ||||
Net cash provided by (used in) investing activities | 531,446 | (754,881 | ) | |||||
Cash flows from financing activities: | ||||||||
Repayment of short-term borrowings | — | (4,292 | ) | |||||
Proceeds from exercises of stock options | 6,907 | 4,083 | ||||||
Proceeds from issuance of ordinary shares upon public offerings | 818,874 | 1,025,970 | ||||||
Payment of public offering costs | (1,836 | ) | (1,275 | ) | ||||
Employee taxes paid related to net share settlement of equity awards | (3,467 | ) | — | |||||
Net cash provided by financing activities | 820,478 | 1,024,486 | ||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | 695 | 2,062 | ||||||
Net increase in cash, cash equivalents and restricted cash | 956,382 | 99,947 | ||||||
Cash, cash equivalents and restricted cash - beginning of period | 442,859 | 76,442 | ||||||
Cash, cash equivalents and restricted cash - end of period | 1,399,241 | 176,389 | ||||||
Supplemental disclosure on non-cash investing and financing activities: | ||||||||
Payables for purchase of property and equipment | 1,797 | 2,334 | ||||||
Payables for intangible assets | 24 | 21 | ||||||
Payables for public offering costs | — | 4,909 | ||||||
Supplemental disclosure of cash flow information: | ||||||||
Cash and cash equivalents | 1,398,498 | 175,879 | ||||||
Restricted cash, non-current | 743 | 510 | ||||||
Total cash and cash equivalents and restricted cash | 1,399,241 | 176,389 | ||||||
Interest paid | — | 157 |
Description | Fair Value as of September 30, 2022 $ | 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 | 3,316 | 3,316 | |||||||||
Description | Fair Value as of December 31, 2021 $ | 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 |
Description | Fair Value as of September 30, 2021 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 | 20,070 | 20,070 |
As of | ||||||||
September 30, 2021 | December 31, 2020 | |||||||
$ | $ | |||||||
Cash at bank and in hand | 1,097,430 | 441,283 | ||||||
Cash equivalents (note (i)) | 301,068 | 833 | ||||||
1,398,498 | 442,116 | |||||||
Denominated in: | ||||||||
US$ | 762,209 | 297,813 | ||||||
RMB (note (ii)) | 28,802 | 23,898 | ||||||
Hong Kong dollar (“HK$”) | 607,323 | 119,695 | ||||||
Australian dollar (“A$”) | 134 | 710 | ||||||
Taiwan dollar (“TW$”) | 30 | — | ||||||
1,398,498 | 442,116 | |||||||
September 30, 2022 | December 31, 2021 | ||||||||||
$ | $ | ||||||||||
Cash at bank and in hand | 818,407 | 663,472 | |||||||||
Cash equivalents (i) | 301,069 | 300,628 | |||||||||
1,119,476 | 964,100 | ||||||||||
Denominated in: | |||||||||||
US$ | 1,072,376 | 932,888 | |||||||||
RMB (ii) | 41,138 | 23,791 | |||||||||
Hong Kong dollar (“HK$”) | 5,035 | 6,674 | |||||||||
Australian dollar (“A$”) | 579 | 475 | |||||||||
Taiwan dollar (“TW$”) | 348 | 272 | |||||||||
1,119,476 | 964,100 |
September 30, 2022 | December 31, 2021 | ||||||||||
$ | $ | ||||||||||
Finished goods | 8,703 | 5,632 | |||||||||
Raw materials | 20,397 | 13,231 | |||||||||
Work in Progress | 31 | 88 | |||||||||
Inventories, net | 29,131 | 18,951 |
As of | ||||||||
September 30, 2021 | December 31, 2020 | |||||||
$ | $ | |||||||
Finished goods | 5,298 | 3,041 | ||||||
Raw materials | 7,196 | 10,103 | ||||||
Inventories | 12,494 | 13,144 | ||||||
September 30, 2022 | December 31, 2021 | ||||||||||
$ | $ | ||||||||||
Office equipment | 818 | 836 | |||||||||
Electronic equipment | 6,744 | 5,036 | |||||||||
Vehicle | 198 | 220 | |||||||||
Laboratory equipment | 18,673 | 17,069 | |||||||||
Manufacturing equipment | 14,366 | 14,600 | |||||||||
Leasehold improvements | 10,160 | 10,432 | |||||||||
Construction in progress | 19,882 | 11,334 | |||||||||
70,841 | 59,527 | ||||||||||
Less: accumulated depreciation | (20,313) | (16,425) | |||||||||
Property and equipment, net | 50,528 | 43,102 |
As of | ||||||||
September 30, 2021 | December 31, 2020 | |||||||
$ | $ | |||||||
Office equipment | 802 | 430 | ||||||
Electronic equipment | 3,771 | 2,646 | ||||||
Vehicle | 217 | 143 | ||||||
Laboratory equipment | 15,274 | 11,933 | ||||||
Manufacturing equipment | 13,313 | 12,198 | ||||||
Leasehold improvements | 9,909 | 9,641 | ||||||
Construction in progress | 8,306 | 2,423 | ||||||
51,592 | 39,414 | |||||||
Less: accumulated depreciation | (14,505 | ) | (10,252 | ) | ||||
Property and equipment, net | 37,087 | 29,162 | ||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Product revenue - gross | 60,446 | 47,555 | 168,095 | 135,490 | |||||||||||||||||||
Less: Rebate and sales return | (3,483) | (4,452) | (17,462) | (35,349) | |||||||||||||||||||
Product revenue - net | 56,963 | 43,103 | 150,633 | 100,141 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Product revenue - gross | 47,555 | 17,152 | 135,490 | 37,567 | ||||||||||||
Less: Rebate and sales return | (4,452 | ) | (2,501 | ) | (35,349 | ) | (3,703 | ) | ||||||||
Product revenue - net | 43,103 | 14,651 | 100,141 | 33,864 | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
ZEJULA | 39,214 | 28,162 | 102,863 | 64,134 | |||||||||||||||||||
Optune | 10,662 | 10,653 | 35,051 | 27,318 | |||||||||||||||||||
QINLOCK | 5,541 | 4,288 | 9,123 | 8,689 | |||||||||||||||||||
NUZYRA | 1,546 | — | 3,596 | — | |||||||||||||||||||
Product revenue - net | 56,963 | 43,103 | 150,633 | 100,141 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
ZEJULA | 28,162 | 8,503 | 64,134 | 22,294 | ||||||||||||
Optune | 10,653 | 5,950 | 27,318 | 11,372 | ||||||||||||
QINLOCK | 4,288 | 198 | 8,689 | 198 | ||||||||||||
Product revenue - net | 43,103 | 14,651 | 100,141 | 33,864 | ||||||||||||
September 30, 2022 | December 31, 2021 | ||||||||||
$ | $ | ||||||||||
Payroll | 25,208 | 25,685 | |||||||||
Accrued rebate to distributors | 8,843 | 15,001 | |||||||||
Tax payables | 10,405 | 8,817 | |||||||||
Accrued professional service fee | 5,927 | 4,319 | |||||||||
Other (i) | 4,839 | 4,421 | |||||||||
Payables for purchase of property and equipment | 3,234 | 2,568 | |||||||||
Total | 58,456 | 60,811 |
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Numerator: | |||||||||||||||||||||||
Net loss attributable to ordinary shareholders | (161,190) | (96,412) | (381,517) | (492,646) | |||||||||||||||||||
Denominator: | |||||||||||||||||||||||
Weighted average number of ordinary shares - basic and diluted | 959,085,960 | 950,354,320 | 957,439,910 | 921,748,380 | |||||||||||||||||||
Net loss per share - basic and diluted | (0.17) | (0.10) | (0.40) | (0.53) |
As of | ||||||||
September 30, 2021 | December 31, 2020 | |||||||
$ | $ | |||||||
Payroll | 18,926 | 13,694 | ||||||
Accrued professional service fee | 3,607 | 3,128 | ||||||
Payables for purchase of property and equipment | 1,797 | 788 | ||||||
Accrued rebate to distributors | 10,803 | 7,067 | ||||||
Tax payable | 10,989 | 952 | ||||||
Others (note (i)) | 8,170 | 4,567 | ||||||
Total | 54,292 | 30,196 | ||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Numerator: | ||||||||||||||||
Net loss attributable to ordinary shareholders | (96,412 | ) | (63,741 | ) | (492,646 | ) | (192,358 | ) | ||||||||
Denominator: | ||||||||||||||||
Weighted average number of ordinary shares- basic and diluted | 95,035,432 | 75,436,646 | 92,174,838 | 74,381,115 | ||||||||||||
Net loss per share - basic and diluted | (1.01 | ) | (0.84 | ) | (5.34 | ) | (2.59 | ) | ||||||||
September 30, 2022 | September 30, 2021 | ||||||||||
Share options | 90,511,530 | 81,801,570 | |||||||||
Non-vested restricted shares | 34,103,830 | 6,366,190 |
As of | ||||||||
September 30, 2021 | September 30, 2020 | |||||||
Share options | 8,180,157 | 9,093,582 | ||||||
Non-vested restricted shares | 636,619 | 597,850 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Selling, general and administrative | 4,119 | 2,952 | 11,501 | 8,500 | ||||||||||||
Research and development | 3,056 | 2,411 | 8,450 | 7,218 | ||||||||||||
Total | 7,175 | 5,363 | 19,951 | 15,718 | ||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||||||||||
$ | $ | $ | $ | ||||||||||||||||||||
Selling, general and administrative | 11,298 | 6,147 | 27,221 | 16,579 | |||||||||||||||||||
Research and development | 7,809 | 4,409 | 18,521 | 11,527 | |||||||||||||||||||
Total | 19,107 | 10,556 | 45,742 | 28,106 |
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Selling, general and administrative | 2,028 | 1,065 | 5,078 | 3,179 | ||||||||||||
Research and development | 1,353 | 550 | 3,077 | 1,508 | ||||||||||||
Total | 3,381 | 1,615 | 8,155 | 4,687 | ||||||||||||
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | $ | % | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Revenues: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Product revenue, net | 56,963 | 43,103 | 13,860 | 32 | % | 150,633 | 100,141 | 50,492 | 50 | % | ||||||||||||||||||||||||||||||||||||||||
Collaboration revenue | 577 | — | 577 | 100 | % | 1,806 | — | 1,806 | 100 | % | ||||||||||||||||||||||||||||||||||||||||
Total revenues | 57,540 | 43,103 | 14,437 | 33 | % | 152,439 | 100,141 | 52,298 | 52 | % | ||||||||||||||||||||||||||||||||||||||||
Expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Cost of sales | (20,044) | (12,162) | (7,882) | 65 | % | (53,094) | (30,535) | (22,559) | 74 | % | ||||||||||||||||||||||||||||||||||||||||
Research and development | (99,524) | (55,144) | (44,380) | 80 | % | (219,462) | (401,220) | 181,758 | (45) | % | ||||||||||||||||||||||||||||||||||||||||
Selling, general, and administrative | (66,555) | (59,002) | (7,553) | 13 | % | (186,947) | (149,254) | (37,693) | 25 | % | ||||||||||||||||||||||||||||||||||||||||
Loss from operations | (128,583) | (83,205) | (45,378) | 55 | % | (307,064) | (480,868) | 173,804 | (36) | % | ||||||||||||||||||||||||||||||||||||||||
Interest income | 3,872 | 713 | 3,159 | 443 | % | 5,235 | 1,171 | 4,064 | 347 | % | ||||||||||||||||||||||||||||||||||||||||
Other income (expenses), net | (36,479) | (13,580) | (22,899) | 169 | % | (79,467) | (12,401) | (67,066) | 541 | % | ||||||||||||||||||||||||||||||||||||||||
Loss before income tax and share of loss from equity method investment | (161,190) | (96,072) | (65,118) | 68 | % | (381,296) | (492,098) | 110,802 | (23) | % | ||||||||||||||||||||||||||||||||||||||||
Income tax expense | — | — | — | — | % | — | — | — | — | % | ||||||||||||||||||||||||||||||||||||||||
Share of loss from equity method investment | — | (340) | 340 | (100) | % | (221) | (548) | 327 | (60) | % | ||||||||||||||||||||||||||||||||||||||||
Net loss | (161,190) | (96,412) | (64,778) | 67 | % | (381,517) | (492,646) | 111,129 | (23) | % | ||||||||||||||||||||||||||||||||||||||||
Net loss attributable to ordinary shareholders | (161,190) | (96,412) | (64,778) | 67 | % | (381,517) | (492,646) | 111,129 | (23) | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | $ | % | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Product revenue - gross | $ | 60,446 | $ | 47,555 | $ | 12,891 | 27 | % | $ | 168,095 | $ | 135,490 | 32,605 | 24 | % | |||||||||||||||||||||||||||||||||||
Less: Rebate and sales return | (3,483) | (4,452) | 969 | (22) | % | (17,462) | (35,349) | 17,887 | (51) | % | ||||||||||||||||||||||||||||||||||||||||
Product revenue - net | 56,963 | 43,103 | 13,860 | 32 | % | 150,633 | 100,141 | 50,492 | 50 | % |
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | $ | % | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
ZEJULA | $ | 39,214 | $ | 28,162 | $ | 11,052 | 39 | % | $ | 102,863 | $ | 64,134 | 38,729 | 60 | % | |||||||||||||||||||||||||||||||||||
Optune | 10,662 | 10,653 | 9 | — | % | 35,051 | 27,318 | 7,733 | 28 | % | ||||||||||||||||||||||||||||||||||||||||
QINLOCK | 5,541 | 4,288 | 1,253 | 29 | % | 9,123 | 8,689 | 434 | 5 | % | ||||||||||||||||||||||||||||||||||||||||
NUZYRA | 1,546 | — | 1,546 | — | % | 3,596 | — | 3,596 | — | % | ||||||||||||||||||||||||||||||||||||||||
Total product revenue, net | $ | 56,963 | $ | 43,103 | $ | 13,860 | 32 | % | $ | 150,633 | $ | 100,141 | $ | 50,492 | 50 | % |
Three months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||
(in thousands, except share and per share data) | ||||||||||||||||
Comprehensive Loss Data: | ||||||||||||||||
Revenue | $ | 43,103 | $ | 14,651 | $ | 100,141 | $ | 33,864 | ||||||||
Expenses: | ||||||||||||||||
Cost of sales | (12,162 | ) | (4,934 | ) | (30,535 | ) | (9,914 | ) | ||||||||
Research and development | (55,144 | ) | (58,100 | ) | (401,220 | ) | (160,149 | ) | ||||||||
Selling, general and administrative | (59,002 | ) | (27,874 | ) | (149,254 | ) | (70,346 | ) | ||||||||
Loss from operations | $ | (83,205 | ) | $ | (76,257 | ) | $ | (480,868 | ) | $ | (206,545 | ) | ||||
Interest income | 713 | 866 | 1,171 | 3,748 | ||||||||||||
Interest expenses | — | (43 | ) | — | (157 | ) | ||||||||||
Other (expenses) income, net | (13,580 | ) | 11,958 | (12,401 | ) | 11,267 | ||||||||||
Loss before income tax and share of loss from equity method investment | $ | (96,072 | ) | $ | (63,476 | ) | $ | (492,098 | ) | $ | (191,687 | ) | ||||
Income tax expense | — | — | — | — | ||||||||||||
Share of loss from equity method investment | (340 | ) | (265 | ) | (548 | ) | (671 | ) | ||||||||
Net loss attributable to ordinary shareholders | $ | (96,412 | ) | $ | (63,741 | ) | $ | (492,646 | ) | $ | (192,358 | ) | ||||
Weighted-average shares used in calculating net loss per ordinary share, basic and diluted | 95,035,432 | 75,436,646 | 92,174,838 | 74,381,115 | ||||||||||||
Net loss per share, basic and diluted | $ | (1.01 | ) | $ | (0.84 | ) | $ | (5.34 | ) | $ | (2.59 | ) |
Three Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
ZEJULA | $ | 28,162 | 65.3 | % | $ | 8,503 | 58.0 | % | ||||||||
Optune | 10,653 | 24.7 | % | 5,950 | 40.6 | % | ||||||||||
QINLOCK | 4,288 | 10.0 | % | 198 | 1.4 | % | ||||||||||
Total product revenue—Net | $ | 43,103 | 100.0 | % | $ | 14,651 | 100.0 | % | ||||||||
Three Months Ended September 30, | Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Research and Development Expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | $ | % | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Research and development expenses: | Research and development expenses: | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Personnel compensation and related costs | $ | 20,564 | 37.3 | % | $ | 12,204 | 21.0 | % | Personnel compensation and related costs | $ | 28,478 | $ | 20,564 | $ | 7,914 | 38 | % | $ | 80,325 | $ | 50,543 | $ | 29,782 | 59 | % | |||||||||||||||||||||||||||||||||||||||||
Licensing fees | 5,051 | 9.2 | % | 25,911 | 44.6 | % | Licensing fees | 39,769 | 5,051 | 34,718 | 687 | % | 50,205 | 274,299 | (224,094) | (82) | % | |||||||||||||||||||||||||||||||||||||||||||||||||
Payment to CROs/CMOs/Investigators | 17,102 | 31.0 | % | 14,414 | 24.8 | % | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
CROs/CMOs/Investigators expenses | CROs/CMOs/Investigators expenses | 23,407 | 17,102 | 6,305 | 37 | % | 70,325 | 52,246 | 18,079 | 35 | % | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Other costs | 12,427 | 22.5 | % | 5,571 | 9.6 | % | Other costs | 7,870 | 12,427 | (4,557) | (37) | % | 18,607 | 24,132 | (5,525) | (23) | % | |||||||||||||||||||||||||||||||||||||||||||||||||
Total | $ | 55,144 | 100.0 | % | $ | 58,100 | 100.0 | % | Total | $ | 99,524 | $ | 55,144 | $ | 44,380 | 80 | % | $ | 219,462 | $ | 401,220 | $ | (181,758) | (45) | % | |||||||||||||||||||||||||||||||||||||||||
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | $ | % | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Research and development expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Clinical programs | $ | 63,324 | $ | 20,248 | $ | 43,076 | 213 | % | $ | 119,468 | $ | 299,937 | $ | (180,469) | (60) | % | ||||||||||||||||||||||||||||||||||
Pre-clinical programs | 2,965 | 9,988 | (7,023) | (70) | % | 7,487 | 41,033 | (33,546) | (82) | % | ||||||||||||||||||||||||||||||||||||||||
Unallocated research and development expenses | 33,235 | 24,908 | 8,327 | 33 | % | 92,507 | 60,250 | 32,257 | 54 | % | ||||||||||||||||||||||||||||||||||||||||
Total | $ | 99,524 | $ | 55,144 | $ | 44,380 | 80 | % | $ | 219,462 | $ | 401,220 | $ | (181,758) | (45) | % |
Three Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
Research and Development Expenses: | ||||||||||||||||
Clinical programs | $ | 20,248 | 36.7 | % | $ | 39,736 | 68.4 | % | ||||||||
Pre-clinical programs | 9,988 | 18.1 | % | 2,728 | 4.7 | % | ||||||||||
Unallocated research and development expenses | 24,908 | 45.2 | % | 15,636 | 26.9 | % | ||||||||||
Total | $ | 55,144 | 100.0 | % | $ | 58,100 | 100.0 | % | ||||||||
Three Months Ended September 30, | Change | Nine Months Ended September 30, | Change | |||||||||||||||||||||||||||||||||||||||||||||||
2022 | 2021 | $ | % | 2022 | 2021 | $ | % | |||||||||||||||||||||||||||||||||||||||||||
Selling, General and Administrative Expenses: | ||||||||||||||||||||||||||||||||||||||||||||||||||
Personnel compensation and related costs | $ | 41,859 | $ | 34,088 | $ | 7,771 | 23 | % | $ | 121,382 | $ | 87,560 | $ | 33,822 | 39 | % | ||||||||||||||||||||||||||||||||||
Professional service fees | 9,381 | 6,194 | 3,187 | 51 | % | 24,886 | 14,583 | 10,303 | 71 | % | ||||||||||||||||||||||||||||||||||||||||
Other costs | 15,315 | 18,720 | (3,405) | (18) | % | 40,679 | 47,111 | (6,432) | (14) | % | ||||||||||||||||||||||||||||||||||||||||
Total | $ | 66,555 | $ | 59,002 | $ | 7,553 | 13 | % | $ | 186,947 | $ | 149,254 | $ | 37,693 | 25 | % |
Three Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
Selling, General and Administrative Expenses: | ||||||||||||||||
Personnel compensation and related costs | $ | 34,088 | 57.8 | % | $ | 15,869 | 56.9 | % | ||||||||
Professional service fees | 6,194 | 10.5 | % | 2,258 | 8.1 | % | ||||||||||
Other costs | 18,720 | 31.7 | % | 9,747 | 35.0 | % | ||||||||||
Total | $ | 59,002 | 100.0 | % | $ | 27,874 | 100.0 | % | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
ZEJULA | $ | 64,134 | 64.0 | % | $ | 22,294 | 65.8 | % | ||||||||
Optune | 27,318 | 27.3 | % | 11,372 | 33.6 | % | ||||||||||
QINLOCK | 8,689 | 8.7 | % | 198 | 0.6 | % | ||||||||||
Total product revenue—Net | $ | 100,141 | 100.0 | % | $ | 33,864 | 100.0 | % | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
Research and Development Expenses: | ||||||||||||||||
Personnel compensation and related costs | $ | 50,543 | 12.6 | % | $ | 33,804 | 21.1 | % | ||||||||
Licensing fees | 274,299 | 68.4 | % | 77,631 | 48.5 | % | ||||||||||
Payment to CROs/CMOs/Investigators | 52,246 | 13.0 | % | 34,226 | 21.4 | % | ||||||||||
Other costs | 24,132 | 6.0 | % | 14,488 | 9.0 | % | ||||||||||
Total | $ | 401,220 | 100.0 | % | $ | 160,149 | 100.0 | % | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
Research and Development Expenses: | ||||||||||||||||
Clinical programs | $ | 299,937 | 74.8 | % | $ | 112,071 | 70.0 | % | ||||||||
Pre-clinical programs | 41,033 | 10.2 | % | 5,643 | 3.5 | % | ||||||||||
Unallocated research and development expenses | 60,250 | 15.0 | % | 42,435 | 26.5 | % | ||||||||||
Total | $ | 401,220 | 100.0 | % | $ | 160,149 | 100.0 | % | ||||||||
Nine Months Ended September 30, | ||||||||||||||||
(in thousands) | 2021 | % | 2020 | % | ||||||||||||
Selling, General and Administrative Expenses: | ||||||||||||||||
Personnel compensation and related costs | $ | 87,560 | 58.7 | % | $ | 42,951 | 61.1 | % | ||||||||
Professional service fees | 14,583 | 9.8 | % | 6,828 | 9.7 | % | ||||||||||
Other costs | 47,111 | 31.5 | % | 20,567 | 29.2 | % | ||||||||||
Total | $ | 149,254 | 100.0 | % | $ | 70,346 | 100.0 | % | ||||||||
Description | Fair Value as of September 30, 2021 | Fair Value Measurement at Reporting Date Using Quoted Prices in Active Markets for Identical Assets (Level 1) | ||||||
(in thousands) | ||||||||
Equity Investments with Readily Determinable Fair Value | $ | 20,070 | $ | 20,070 |
Nine months ended September 30, | ||||||||
(in thousands) | 2021 | 2020 | ||||||
Net cash used in operating activities | $ | (396,237 | ) | $ | (171,720 | ) | ||
Net cash provided by (used in) investing activities | 531,446 | (754,881 | ) | |||||
Net cash provided by financing activities | 820,478 | 1,024,486 | ||||||
Effect of foreign exchange rate changes | 695 | 2,062 | ||||||
Net increases in cash, cash equivalents and restricted cash | $ | 956,382 | $ | 99,947 | ||||
Nine Months Ended September 30, | Change | |||||||||||||||||||
2022 | 2021 | $ | ||||||||||||||||||
Net cash used in operating activities | $ | (258,350) | $ | (396,237) | $ | 137,887 | ||||||||||||||
Net cash provided by investing activities | 424,389 | 531,446 | (107,057) | |||||||||||||||||
Net cash (used in) provided by financing activities | (1,531) | 820,478 | (822,009) | |||||||||||||||||
Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash | (9,132) | 695 | (9,827) | |||||||||||||||||
Net increase in cash, cash equivalents and restricted cash | $ | 155,376 | $ | 956,382 | $ | (801,006) |
(in thousands) | Total | Less than 1 year | 1 to 3 years | 3 to 5 years | More than 5 years | |||||||||||||||
Purchase Obligations | $ | 24,191 | $ | 24,191 | $ | — | $ | — | $ | — | ||||||||||
Operating Lease Obligations | 17,497 | 6,573 | 5,349 | 4,160 | 1,415 |
ZAI LAB LIMITED | |||||||||||
Dated: November 9, | By: | /s/ | |||||||||
Name: | |||||||||||
Title: | |||||||||||