Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2022 | May 05, 2022 | |
Document Information [Line Items] | ||
Amendment Flag | false | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Entity Registrant Name | Zai Lab Ltd | |
Entity Central Index Key | 0001704292 | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Interactive Data Current | Yes | |
Entity File Number | 001-38205 | |
Entity Incorporation, State or Country Code | E9 | |
Entity Address, Address Line One | 4560 Jinke Road | |
Entity Address, Address Line Two | Bldg. 1, Fourth FloorPudong | |
Entity Address, City or Town | Shanghai | |
Entity Address, Country | CN | |
Entity Address, Postal Zip Code | 201210 | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Tax Identification Number | 98-1144595 | |
Entity Small Business | false | |
Local Phone Number | 6163 2588 | |
City Area Code | 86 21 | |
American Depositary Shares | ||
Document Information [Line Items] | ||
Trading Symbol | ZLAB | |
Entity Common Stock, Shares Outstanding | 729,604,650 | |
Title of 12(b) Security | American Depositary Shares, each representing 10 Ordinary Share, par value $0.000006 per share | |
Security Exchange Name | NASDAQ | |
Ordinary Shares | ||
Document Information [Line Items] | ||
Trading Symbol | 9688 | |
Entity Common Stock, Shares Outstanding | 979,087,430 | |
Title of 12(b) Security | Ordinary Shares, par value $0.000006 per share | |
Security Exchange Name | CHX |
Consolidated balance sheets
Consolidated balance sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 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 | 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 | 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 |
Current liabilities: | ||
Accounts payable | 98,161 | 126,163 |
Current operating lease liabilities | 6,795 | 5,927 |
Other current liabilities | 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 | ||
Shareholders' equity | ||
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 957,035,440 and 955,363,980 shares 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 |
Consolidated balance sheets (Pa
Consolidated balance sheets (Parenthetical) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Accounts receivable, allowance | $ 10 | $ 11 |
Ordinary shares, par value | $ 0.000006 | $ 0.000006 |
Ordinary shares, shares authorized | 5,000,000,000 | 5,000,000,000 |
Ordinary shares, shares issued | 957,035,440 | 955,363,980 |
Ordinary shares, shares outstanding | 956,637,360 | 954,981,050 |
Treasury Stock, Shares | 398,080 | 382,930 |
Investments, fair value disclosure | $ 8,444 | $ 15,383 |
Consolidated statements of oper
Consolidated statements of operations - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Product revenue, net | $ 46,095 | $ 20,103 |
Collaboration revenue | 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 | 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 | $ (0.09) | $ (0.26) |
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 955,499,030 | 883,749,280 |
ADR [Member] | ||
Expenses: | ||
Loss per share - basic and diluted | $ (0.86) | $ (2.64) |
Weighted-average shares used in calculating net loss per ordinary share - basic and diluted | 95,549,903 | 88,374,928 |
Consolidated statements of comp
Consolidated statements of comprehensive loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (82,394) | $ (232,910) |
Other comprehensive income (loss), net of tax of nil: | ||
Foreign currency translation adjustments | (2,193) | 2,900 |
Comprehensive loss | $ (84,587) | $ (230,010) |
Consolidated statements of co_2
Consolidated statements of comprehensive loss (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Comprehensive Income [Abstract] | ||
Other comprehensive income, tax | $ 0 | $ 0 |
Consolidated statements of shar
Consolidated statements of shareholders' equity - USD ($) $ in Thousands | Total | Ordinary Shares | Additional Paid In Capital | Accumulated Deficit | Accumulated Other Comprehensive (Loss) Income | Treasury Stock |
Balance at Dec. 31, 2020 | $ 1,169,345 | $ 5 | $ 1,897,467 | $ (713,603) | $ (14,524) | |
Balance, Shares at Dec. 31, 2020 | 878,110,260 | |||||
Issuance of ordinary shares upon vesting of restricted shares | 62,250 | $ 0 | 62,250 | |||
Issuance of ordinary shares upon vesting of restricted shares, Shares | 5,681,820 | |||||
Exercise of shares options | 702 | $ 0 | 702 | |||
Exercise of shares options, Shares | 583,640 | |||||
Issuance of ordinary shares in connection with collaboration and license arrangement | 0 | $ 0 | 0 | |||
Issuance of ordinary shares in connection with collaboration and license arrangement, Shares | 816,000 | |||||
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 Mar. 31, 2021 | 1,009,670 | $ 5 | 1,967,802 | (946,513) | (11,624) | |
Balance, Shares at Mar. 31, 2021 | 885,191,720 | |||||
Balance at Dec. 31, 2021 | $ 1,379,956 | $ 6 | 2,825,948 | (1,418,074) | (23,645) | $ (4,279) |
Balance, Shares at Dec. 31, 2021 | 954,981,050 | 955,363,980 | (382,930) | |||
Issuance of ordinary shares upon vesting of restricted shares | $ 0 | 0 | ||||
Issuance of ordinary shares upon vesting of restricted shares, Shares | 514,800 | |||||
Exercise of shares options | $ 297 | $ 0 | 297 | |||
Exercise of shares options, Shares | 1,156,660 | |||||
Receipt of employees' shares to satisfy tax withholding obligations related to share-based compensation, Shares | (15,150) | |||||
Receipt of employees' shares to satisfy tax withholding obligations related to share-based compensation | (68) | $ (68) | ||||
Share-based compensation | 12,410 | 12,410 | ||||
Net loss | (82,394) | (82,394) | ||||
Foreign currency translation | (2,193) | (2,193) | ||||
Balance at Mar. 31, 2022 | $ 1,308,008 | $ 6 | $ 2,838,655 | $ (1,500,468) | $ (25,838) | $ (4,347) |
Balance, Shares at Mar. 31, 2022 | 956,637,360 | 957,035,440 | (398,080) |
Consolidated statements of cash
Consolidated statements of cash flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 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 treasury stock | 55 | |
Payables for public offering costs | 0 | 26 |
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 |
Organization and principal acti
Organization and principal activities | 3 Months Ended |
Mar. 31, 2022 | |
Organization and principal activities | |
Organization and Principal Activities | 1. 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 Law of the Cayman Islands (as amended). Zai Lab Limited and its subsidiaries (collectively referred to as the “Company”) are focused on developing and commercializing therapies that address medical conditions with unmet medical needs including, in particular, oncology, autoimmune disorders, infectious diseases, and neuroscience. The Company’s principal operations and geographic markets are in mainland China, Hong Kong, Macau and Taiwan (hereinafter collectively referred to as “Greater China”). The Company has a substantial presence in Greater China and the United States. |
Basis of presentation and conso
Basis of presentation and consolidation and significant accounting policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation and consolidation and significant accounting policies | 2. Basis of presentation and consolidation and significant accounting policies (a) Basis of presentation The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the instructions to Form 10-Q S-X. 10-K Effective as of March 30, 2022, the Company subdivided each of its issued and unissued ordinary shares into ten ordinary shares (the “Share Subdivision”). Following the Share Subdivision, the Company’s authorized share capital became $30 divided into 5,000,000,000 shares with a par value of US$0.000006 each. The numbers of issued and unissued ordinary shares and per share data as disclosed elsewhere in these unaudited condensed consolidated financial statements and notes thereto are presented on a basis after taking into account the effects of the Share Subdivision and have been retrospectively adjusted, where applicable. In connection with the Share Subdivision, the conversion ratio of our ADSs to ordinary shares changed from one ADS to one ordinary share to a new ratio of one ADS representing ten ordinary shares (the “ADS Ratio Change”). The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company. (b) Principles of consolidation The unaudited condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All intercompany transactions and balances among the Company and its subsidiaries 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 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 expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating the current expected credit losses for financial assets, assessing the impairment of long-lived assets, discount rate of operating lease liabilities, accrual of rebate, allocation of the research and development service expenses to the appropriate financial reporting period based on the progress of the research and development projects, share-based compensation expenses, recoverability of deferred tax assets and a lack of marketability discount of the ordinary shares issued in connection with collaboration and license arrangements (Note 1 2 (d) Fair value measurements As of March 31, 2022 and December 31, 2021, information about inputs into the fair value measurement of the Company’s assets that are measured at a fair value on a recurring basis in periods subsequent to their initial recognition is as follows: Description Fair Value as of March 31, 2022 Fair Value Measurement at Reporting 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 Fair Value Measurement at Reporting for Identical Assets (Level 1) US$ Equity Investments with Readily Determinable Fair Value 15,383 15,383 The Company does not have assets or liabilities measured at fair value on a nonrecurring basis during the periods presented. Financial instruments of the Company primarily include cash, cash equivalents and restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable and other current liabilities. As of March 31, 2022 and December 31, 2021, the carrying values of cash and cash equivalents, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable and other current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of restricted cash approximates its fair value based on the nature of the assessment of the ability to recover these amounts. (e) Recent accounting pronouncements Adopted Accounting Standards In November 2021, the FASB issued ASU2021-10, Government Assistance (Topic 832) — Disclosures by Business Entities about Government Assistance. The amendments in this ASU require disclosures about transactions with a government that have been accounted for by analogizing to a grant or contribution accounting model to increase transparency about (1) the types of transactions, (2) the accounting for the transactions, and (3) the effect of the transactions on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted this standard as of January 1, 2022. There was no material impact to the Company’s financial position or results of operations upon the adoption. (f) Significant accounting policies For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K |
Cash and cash equivalents
Cash and cash equivalents | 3 Months Ended |
Mar. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Cash and cash equivalents | 3. Cash and cash equivalents 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 Notes: (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 Chinese |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2022 | |
Inventories | |
Inventories | 4. Inventories The Company’s inventory balance of $20,288 and $18,951 as of March 31, 2022 and December 31, 2021, respectively, mainly consisted of finished goods purchased from Tesaro Inc., now GlaxoSmithKline (“GSK”), for distribution in Hong Kong, and from NovoCure Limited (“NovoCure”) for distribution in Hong Kong and mainland China and NUZYRA mainland As of March 31, 2022 December 31, 2021 $ $ Finished goods 4,733 5,632 Raw materials 15,555 13,231 Work in Progress — 88 Inventories 20,288 18,951 The Company writes down inventory for any excess or obsolete inventories or when the Company believes that the net realizable value of inventories is less than the carrying value. During the three months ended March 31, 2022 and 2021, the Company recorded write-downs of $138 and $43, in cost of revenues, respectively. |
Property and Equipment, net
Property and Equipment, net | 3 Months Ended |
Mar. 31, 2022 | |
Property and equipment, net | |
Property and equipment, net | 5 Property and equipment , net 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 Depreciation expenses for the three months |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2022 | |
Revenue | |
Revenue | 6. Revenue Product revenue, net The Company’s product 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 Sales rebates are offered to distributors in mainland Due to the inclusion of ZEJULA in the National Reimbursement Drug List (“NRDL”) in December 2020 and December 2021 for certain therapies, the Company accrued sales rebates of The following table disaggregates net revenue by product for the three months Three Months Ended March 31, 2022 2021 $ $ ZEJULA 29,597 12,606 Optune 12,797 7,130 QINLOCK 2,959 367 NUZYRA 742 — Product revenue - net 46,095 20,103 Collaboration revenue The Company’s collaboration revenue for the three months ended March 31, 2022 amounted to $629 was from the collaborative arrangement with Huizheng (Shanghai) Pharmaceutical Technology Co., Lt d. |
Income Tax
Income Tax | 3 Months Ended |
Mar. 31, 2022 | |
Income tax | |
Income tax | 7. Income Tax No provision for income taxes has been required to be accrued because the Company and all of its subsidiaries are in cumulative loss positions for all 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 March 31, |
Other current liabilities
Other current liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Other current liabilities | |
Other current liabilities | 8. Other current liabilities Other current liabilities consist of the following: 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 Note: (i) Others are mainly payables to employees for exercising the share-based compensations, payables related to travel and business entertainment expenses. |
Loss per share
Loss per share | 3 Months Ended |
Mar. 31, 2022 | |
Loss per share | |
Loss per share | 9 Basic and diluted net loss per share for each of the period presented are calculated as follows: Three Months Ended 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 ) As a result of the Company’s net loss for the three months ended March , and , 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. As of March 31, 2022 March 31, 2021 Share options 80,514,330 86,932,740 Non-vested 9,846,360 4,800,100 |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related party transactions | |
Related party transactions | 10. Related party transactions The table below sets forth the major related party and the relationship with the Company as of March 31, 2021: Company Name Relationship with the Company MEDx (Suzhou) Translational Medicine Co., Ltd. Significant influence held by Samantha Du’s (Director, Chairwoman and Chief Executive Officer of the Company) immediate family For the three months ended March 31, 2022 and 2021, the Company incurred $74 and $103 research and development expenses for product research and development services provided by ., |
Share-based compensation
Share-based compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based compensation | |
Share-based compensation | 1 1 Share options On March 5, 2015, the Board of Directors of the Company approved an Equity Incentive Plan (the “2015 Plan”) which is administered by the Board of Directors. Under the 2015 Plan, the Board of Directors may grant options to purchase ordinary shares to management including officers, directors, employees and individual advisors who render services to the Company to purchase an aggregate of no more than 41,409,450 ordinary shares of the Company (“Option Pool”). Subsequently, the Board of Directors approved the increase in the Option Pool to 73,697,670 ordinary shares. In connection with the completion of the initial public offering (the “IPO”), the Board of Directors approved the 2017 Equity Incentive Plan (the “2017 Plan”) and all equity-based awards subsequent to the IPO would be granted under the 2017 Plan. increased by 38,563,500. The aggregate number of shares reserved and available for issuance under our 2017 Plan as of April 1, 2022 was 75,562,170. On April 20, 2022, the Board of Directors of the Company approved the Zai Lab Limited 2022 Equity Incentive Plan (the “2022 Plan”), which is conditioned on and subject to the dual-primary listing of the Company on the Main Board of The Stock Exchange of Hong Kong Limited becoming effective and shareholder approval at the annual general meeting scheduled on June 22, 2022, and subject to the granting of the waiver on Note 1 to Rule 17.03(9) of the HK Listing Rules by The Stock Exchange of Hong Kong Limited. If approved and adopted, the aggregate number of shares that may be delivered in satisfaction of awards under the 2022 Plan is 97,908,743 ordinary shares. Once the 2022 Plan becomes effective, no new grants will be made under the 2015 Plan or the 2017 Plan. For For the three months ended March 31, 2022, the Company granted 984,310 share options to certain management and employees of the Company at the exercise price ranging from $5.26 to $6.29 per share under the 2017 Plan. These options granted have a contractual term of ten years and generally vest over a five-year period, with 20% of the awards vesting beginning on the anniversary date one year after the grant date. The weighted-average grant-date fair value of the options granted in the three months ended March 31, 2022 and 2021 were $3.24 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 As of March , , there was $ of total unrecognized compensation expense related to unvested share options granted. That cost is expected to be recognized over a weighted-average period of years which is determined based on the number of unvested shares and unrecognized years. Non-vested restricted shares For the three months ended March 31, 2021, 192,600 ordinary shares were authorized for grant to the independent directors. The restricted shares will vest and be released from the restrictions in full on the first anniversary from the date of the agreement. Upon termination of the independent directors’ service with the Company for any reason, any shares that are outstanding and not yet vested will be immediately forfeited. For the three months ended March 31, 2021, 31,000 ordinary shares were authorized for grant to certain management. One-fifth For the three months ended March 31, 202 2 forfeited. For One-fifth The Company measured the fair value of the non-vested As of March 31, 2022, there was $68,292 of total unrecognized compensation expense related to non-vested $ 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 |
Licenses and collaborative arra
Licenses and collaborative arrangements pursuant to which milestone payments were made | 3 Months Ended |
Mar. 31, 2022 | |
Licenses And Collaborative Arrangement [Abstract] | |
Licenses and collaborative arrangements pursuant to which milestone payments were made | 12. Licenses and collaborative arrangements pursuant to which milestone payments were made The following is a description of the Company’s significant ongoing collaboration agreements under which the Company has made milestone payments for the three months ended March 31, 2022. Collaboration and license agreement with argenx BV (“argenx”) In January 2021, the Company entered into a collaboration and license agreement with argenx. The Company received an exclusive license to develop and commercialize products containing argenx’s proprietary antibody fragment, known as efgartigimod, in Greater China. The Company is responsible for the development of the licensed compound and licensed product and will have the right to commercialize such licensed product in the territory. Pursuant to the collaboration and license agreement, a share issuance agreement was entered into between the Company and argenx. As the upfront payment to argenx, the Company issued 5,681,820 ordinary shares of the Company to argenx with par value $0.000006 per share on the closing date of January 13, 2021. In determining the fair value of the ordinary shares at closing, the Company considered the closing price of the ordinary shares on the closing date and included a lack of marketability discount because the shares are subject to certain restrictions. The fair value of the shares on the closing date was determined to be $62,250 in the aggregate. In addition, the Company made a non-creditable, non-refundable territory. License and collaboration agreement with Paratek Bermuda Ltd. (“Paratek”) In April 2017, the Company entered into a license and collaboration agreement with Paratek Bermuda Ltd., a subsidiary of Paratek Pharmaceuticals, Inc., pursuant to which it obtained both an exclusive license under certain patents and know-how of Paratek and an exclusive sub-license under certain intellectual property that Paratek licensed from Tufts University to develop, manufacture and commercialize products containing omadacycline (ZL-2401) as an active ingredient in Greater China in the field of all human therapeutic and preventative uses other than biodefense. Under certain circumstances, the exclusive sub-license to certain intellectual property Paratek licensed from Tufts University may be converted to a non-exclusive license if Paratek’s exclusive license from Tufts University is converted to a non-exclusive license under the Tufts Agreement. The Company also obtained the right of first negotiation to be Paratek’s partner to develop certain derivatives or modifications of omadacycline in our licensed territory. Paratek retains the right to manufacture the licensed product in our licensed territory to support development and commercialization of the same outside our licensed territory. The Company also granted to Paratek a non-exclusive license to certain of our intellectual property. Under the agreement, the Company agreed not to commercialize certain competing products in our licensed territory. Under the terms of the agreement, the Company made an upfront payment of $7,500 to Paratek in 2017, $5,000 upon approval by the FDA of a New Drug Application (“NDA”) submission in 2018, $3,000 upon submission of the first regulatory approval application for a licensed product in the People’s Republic of China in 2020. The Company made another milestone payment of $6,000 during the three months ended March 31, 2022 upon regulatory approval of omadacycline for the treatment of adults with Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”) and Community-Acquired Bacterial Pneumonia (“CABP”) in the People’s Republic of China in December 2021.The Company may be required to pay further commercial milestone payments of up to an aggregate of $40,500 to Paratek for the achievement of certain development and sales milestone events. In addition, the Company will pay to Paratek tiered royalties on the net sales of licensed products, until the later of the abandonment, expiration or invalidation of the last-to-expire licensed patent covering the licensed product, or the eleventh anniversary of the first commercial sale of the licensed product, in each case on a product-by-product and region-by-region basis. The Company has the right to terminate this agreement at any time by providing written notice of termination to Paratek. Full details of the licenses and collaborative arrangements are included in the notes to financial statements in our Annual Report on Form 10-K |
Restricted Net Assets
Restricted Net Assets | 3 Months Ended |
Mar. 31, 2022 | |
Restricted net assets | |
Restricted net assets | 13. 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 after-tax 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. During the three months ended March 31, 2022 and 2021, no appropriation to statutory reserves was made 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 Foreign exchange and other regulation in mainland China may further restrict the Company’s Chinese subsidiaries from transferring funds to the Company in the form of dividends, loans and advances. As of March 31, 2022 and December 31, 2021, amounts restricted are the paid-in |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 14. Commitments and Contingencies (a) Purchase commitments As of March 31, 2022, the Company’s commitments related to purchase of property and equipment contracted but not yet reflected in the unaudited condensed consolidated financial statement were $22,294 which is expected to be incurred within one year. (b) Contingencies The Company is a party to or assignee of license and collaboration agreements that may require it to make future payments relating to milestone fees and royalties on future sales of licensed products (Note 1 2 |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Event | 15. Subsequent Event From April 1, 2022 to May 5, 2022, the Company granted 16,614,930 shares of stock options to certain management and employees of the Company at exercise prices ranging from $3.96 to $4.55 per share under the 2017 Plan. These options granted have a contractual term of ten years and generally vest over a 5-year period, with 20% of the awards vesting beginning on the anniversary date one year after the grant date. During the same period, the Company also granted 5,173,390 restricted ordinary shares to certain management and employees of the Company. One-fifth |
Basis of presentation and con_2
Basis of presentation and consolidation and significant accounting policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of presentation | (a) Basis of presentation The unaudited condensed consolidated financial statements of the Company have been prepared in accordance with the instructions to Form 10-Q S-X. 10-K Effective as of March 30, 2022, the Company subdivided each of its issued and unissued ordinary shares into ten ordinary shares (the “Share Subdivision”). Following the Share Subdivision, the Company’s authorized share capital became $30 divided into 5,000,000,000 shares with a par value of US$0.000006 each. The numbers of issued and unissued ordinary shares and per share data as disclosed elsewhere in these unaudited condensed consolidated financial statements and notes thereto are presented on a basis after taking into account the effects of the Share Subdivision and have been retrospectively adjusted, where applicable. In connection with the Share Subdivision, the conversion ratio of our ADSs to ordinary shares changed from one ADS to one ordinary share to a new ratio of one ADS representing ten ordinary shares (the “ADS Ratio Change”). The Share Subdivision and ADS Ratio Change did not result in any change to the number of outstanding ADSs of the Company. |
Principles of consolidation | (b) Principles of consolidation The unaudited condensed consolidated financial statements include the financial statements of the Company and its subsidiaries. All intercompany transactions and balances among the Company and its subsidiaries are eliminated upon consolidation. |
Use of estimates | (c) Use of estimates The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates 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 expenses during the period. Areas where management uses subjective judgment include, but are not limited to, estimating the useful lives of long-lived assets, estimating the current expected credit losses for financial assets, assessing the impairment of long-lived assets, discount rate of operating lease liabilities, accrual of rebate, allocation of the research and development service expenses to the appropriate financial reporting period based on the progress of the research and development projects, share-based compensation expenses, recoverability of deferred tax assets and a lack of marketability discount of the ordinary shares issued in connection with collaboration and license arrangements (Note 1 2 |
Fair value measurements | (d) Fair value measurements As of March 31, 2022 and December 31, 2021, information about inputs into the fair value measurement of the Company’s assets that are measured at a fair value on a recurring basis in periods subsequent to their initial recognition is as follows: Description Fair Value as of March 31, 2022 Fair Value Measurement at Reporting 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 Fair Value Measurement at Reporting for Identical Assets (Level 1) US$ Equity Investments with Readily Determinable Fair Value 15,383 15,383 The Company does not have assets or liabilities measured at fair value on a nonrecurring basis during the periods presented. Financial instruments of the Company primarily include cash, cash equivalents and restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable and other current liabilities. As of March 31, 2022 and December 31, 2021, the carrying values of cash and cash equivalents, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, accounts payable and other current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of restricted cash approximates its fair value based on the nature of the assessment of the ability to recover these amounts. |
Recent accounting pronouncements | (e) Recent accounting pronouncements Adopted Accounting Standards In November 2021, the FASB issued ASU2021-10, Government Assistance (Topic 832) — Disclosures by Business Entities about Government Assistance. The amendments in this ASU require disclosures about transactions with a government that have been accounted for by analogizing to a grant or contribution accounting model to increase transparency about (1) the types of transactions, (2) the accounting for the transactions, and (3) the effect of the transactions on an entity’s financial statements. The amendments in this ASU are effective for all entities within their scope for financial statements issued for annual periods beginning after December 15, 2021. The Company adopted this standard as of January 1, 2022. There was no material impact to the Company’s financial position or results of operations upon the adoption. |
Significant accounting policies | (f) Significant accounting policies For a more complete discussion of the Company’s significant accounting policies and other information, the unaudited condensed consolidated financial statements and notes thereto should be read in conjunction with the consolidated financial statements included in the Company’s Annual Report on Form 10-K |
Basis of presentation and con_3
Basis of presentation and consolidation and significant accounting policies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of assets and liabilities that are measured at fair value on a recurring basis | Description Fair Value as of March 31, 2022 Fair Value Measurement at Reporting 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 Fair Value Measurement at Reporting for Identical Assets (Level 1) US$ Equity Investments with Readily Determinable Fair Value 15,383 15,383 |
Cash and cash equivalents (Tabl
Cash and cash equivalents (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Cash and Cash Equivalents [Abstract] | |
Summary of cash and cash equivalents | 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 Notes: (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 Chinese |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventories | |
Schedule of inventory | As of March 31, 2022 December 31, 2021 $ $ Finished goods 4,733 5,632 Raw materials 15,555 13,231 Work in Progress — 88 Inventories 20,288 18,951 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property and equipment, net | |
Schedule of property and equipment | Property and equipment , net 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 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Revenue | |
Schedule of net product sales | 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 |
Schedule of disaggregation of net revenue | The following table disaggregates net revenue by product for the three months Three Months Ended March 31, 2022 2021 $ $ ZEJULA 29,597 12,606 Optune 12,797 7,130 QINLOCK 2,959 367 NUZYRA 742 — Product revenue - net 46,095 20,103 |
Other current liabilities (Tabl
Other current liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Other current liabilities | |
Schedule of other current liabilities | Other current liabilities consist of the following: 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 Note: (i) Others are mainly payables to employees for exercising the share-based compensations, payables related to travel and business entertainment expenses. |
Loss per share (Tables)
Loss per share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Loss per share | |
Summary of basic and diluted net loss per share | Basic and diluted net loss per share for each of the period presented are calculated as follows: Three Months Ended 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 ) |
Summary of anti-dilutive excluded from the calculation of diluted loss per share | As a result of the Company’s net loss for the three months ended March , and , 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. As of March 31, 2022 March 31, 2021 Share options 80,514,330 86,932,740 Non-vested 9,846,360 4,800,100 |
Related Party Transactions (Tab
Related Party Transactions (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Related party transactions | |
Schedule of Major Related Party and Relationship | The table below sets forth the major related party and the relationship with the Company as of March 31, 2021: Company Name Relationship with the Company MEDx (Suzhou) Translational Medicine Co., Ltd. Significant influence held by Samantha Du’s (Director, Chairwoman and Chief Executive Officer of the Company) immediate family |
Share-based compensation (Table
Share-based compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Allocation of compensation expense related to options | The weighted-average grant-date fair value of the options granted in the three months ended March 31, 2022 and 2021 were $3.24 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 |
Allocation of compensation expense related to restricted shares | As of March 31, 2022, there was $68,292 of total unrecognized compensation expense related to non-vested $ 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 |
Basis of presentation and con_4
Basis of presentation and consolidation and significant accounting policies - Summary of Assets and Liabilities that are Measured at Fair Value on a Recurring Basis (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity Investments with Readily Determinable Fair Value | $ 8,444 | $ 15,383 |
Fair value input level 1 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Equity Investments with Readily Determinable Fair Value | $ 8,444 | $ 15,383 |
Basis of presentation and con_5
Basis of presentation and consolidation and significant accounting policies - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | Mar. 31, 2022 | Mar. 30, 2022 | Dec. 31, 2021 |
Accounting Policies [Abstract] | |||
Common stock authorized share capital | $ 30 | ||
Common Stock, Shares Authorized | 5,000,000,000 | 5,000,000,000 | 5,000,000,000 |
Common Stock, Par or Stated Value Per Share | $ 0.000006 | $ 0.000006 | $ 0.000006 |
Cash and cash equivalents - Sum
Cash and cash equivalents - Summary of Cash and Cash Equivalents (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | Mar. 31, 2021 | |
Cash And Cash Equivalents [Line Items] | ||||
Cash at bank and in hand | $ 547,259 | $ 663,472 | ||
Cash equivalents | [1] | 299,698 | 300,628 | |
Cash and cash equivalents | 846,957 | 964,100 | $ 1,013,420 | |
Denominated in US$ | ||||
Cash And Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | 782,295 | 932,888 | ||
Denominated in RMB | ||||
Cash And Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | [2] | 58,569 | 23,791 | |
Denominated in Hong Kong dollar | ||||
Cash And Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | 5,551 | 6,674 | ||
Denominated in Australia dollar | ||||
Cash And Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | 495 | 475 | ||
Denominated in Taiwan dollar | ||||
Cash And Cash Equivalents [Line Items] | ||||
Cash and cash equivalents | $ 47 | $ 272 | ||
[1] | (i) Cash equivalents represent short-term and highly liquid investments in a money market fund. | |||
[2] | (ii) Certain cash and bank balances denominated in RMB were deposited with banks in 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 government of the People’s Republic of China (“PRC”). |
Inventories - Additional Inform
Inventories - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Inventory [Line Items] | |||
Inventory write-down | $ 138 | $ 43 | |
Inventory balance | $ 20,288 | $ 18,951 |
Inventories - Schedule of inven
Inventories - Schedule of inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventories | ||
Finished goods | $ 4,733 | $ 5,632 |
Raw materials | 15,555 | 13,231 |
Work in Progress | 0 | 88 |
Inventories | $ 20,288 | $ 18,951 |
Property and Equipment, net - S
Property and Equipment, net - Schedule of Property and Equipment (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property Plant And Equipment | ||
Property and equipment, gross | $ 63,475 | $ 59,527 |
Less: accumulated depreciation | (18,248) | (16,425) |
Property and equipment, net | 45,227 | 43,102 |
Office Equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 838 | 836 |
Electronic Equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 5,932 | 5,036 |
Vehicle | ||
Property Plant And Equipment | ||
Property and equipment, gross | 222 | 220 |
Laboratory Equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 18,130 | 17,069 |
Manufacturing Equipment | ||
Property Plant And Equipment | ||
Property and equipment, gross | 14,721 | 14,600 |
Leasehold Improvements | ||
Property Plant And Equipment | ||
Property and equipment, gross | 10,506 | 10,432 |
Construction in Progress | ||
Property Plant And Equipment | ||
Property and equipment, gross | $ 13,126 | $ 11,334 |
Property and Equipment, net - A
Property and Equipment, net - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property and equipment, net | ||
Depreciation expenses | $ 1,869 | $ 1,340 |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue | ||
Amount of compensation to distributors included in sales rebates | $ 2,587 | $ 22,009 |
Collaboration revenue | $ 629 |
Revenue - (Details)
Revenue - (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue | ||
Product revenue - gross | $ 53,310 | $ 46,555 |
Less: Rebate and sales return | (7,215) | (26,452) |
Product revenue - net | $ 46,095 | $ 20,103 |
Revenue - Disaggregation of net
Revenue - Disaggregation of net revenue by product (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation of Revenue | ||
Product revenue - net | $ 46,095 | $ 20,103 |
ZEJULA | ||
Disaggregation of Revenue | ||
Product revenue - net | 29,597 | 12,606 |
Optune | ||
Disaggregation of Revenue | ||
Product revenue - net | 12,797 | 7,130 |
QINLOCK | ||
Disaggregation of Revenue | ||
Product revenue - net | 2,959 | 367 |
Nuzyra [Member] | ||
Disaggregation of Revenue | ||
Product revenue - net | $ 742 | $ 0 |
Income Tax - Additional Informa
Income Tax - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Line Items] | ||
Unrecognized tax benefits | $ 0 | $ 0 |
Unrecognized tax benefits, interest and penalties | $ 0 | $ 0 |
Other current liabilities - Sch
Other current liabilities - Schedule of Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | |
Other current liabilities | |||
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 | [1] | 3,244 | 4,421 |
Total | $ 49,956 | $ 60,811 | |
[1] | Others are mainly payables to employees for exercising the share-based compensations, payables related to travel and business entertainment expenses. |
Loss per share - Summary of Bas
Loss per share - Summary of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 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) |
Loss per share - Summary of Ant
Loss per share - Summary of Anti-Dilutive Shares Excluded from Calculation of Diluted Loss Per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares excluded from calculation of diluted loss per share | 80,514,330 | 86,932,740 |
Non-Vested Restricted Shares | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive shares excluded from calculation of diluted loss per share | 9,846,360 | 4,800,100 |
Related party transactions - Sc
Related party transactions - Schedule of Major Related Party and Relationship (Details) | 3 Months Ended |
Mar. 31, 2022 | |
MEDx (Suzhou) Translational Medicine Co., Ltd. | |
Related Party Transaction [Line Items] | |
Relationship with the Group | Significant influence held by Samantha Du’s (Director, Chairwoman and Chief Executive Officer of the Company) immediate family |
Related party transactions - Ad
Related party transactions - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Research and development | MEDx (Suzhou) Translational Medicine Co., Ltd. | ||
Related Party Transaction [Line Items] | ||
Transactions between its related party | $ 74 | $ 103 |
Share-based compensation - Sha
Share-based compensation - Share Options - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 20, 2022 | Jan. 01, 2022 | May 05, 2022 | Mar. 31, 2022 | Mar. 31, 2021 | Apr. 01, 2022 | Mar. 05, 2015 |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Shares authorized | 73,697,670 | 41,409,450 | |||||
Weighted-average grant-date fair value of options granted | $ 3.24 | $ 9.88 | |||||
Subsequent Event [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Options granted | 16,614,930 | ||||||
Options granted contractual term | 10 years | ||||||
Vesting period | 5 years | ||||||
Option vesting percentage | 20.00% | ||||||
Stock Options | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Compensation expense | $ 7,207 | $ 5,549 | |||||
Unrecognized compensation expense related to unvested share options granted | $ 89,126 | ||||||
Recognized over a weighted-average period | 2 years 9 months 14 days | ||||||
Two Thousand Seventeen Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Threshold annual increase to the number of ordinary shares reserved to percentage of number of ordinary shares outstanding | 4.00% | ||||||
Aggregate number of shares reserved and available for issuance under plan | 38,563,500 | ||||||
Two Thousand Seventeen Equity Incentive Plan | Subsequent Event [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Aggregate number of shares reserved and available for issuance under plan | 75,562,170 | ||||||
2022 Incentive Plan | Subsequent Event [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Aggregate number of shares may be delivered in satisfaction of awards under plan subject to approval and adoption of plan | 97,908,743 | ||||||
Minimum | Subsequent Event [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Exercise price of options | $ 3.96 | ||||||
Maximum | Subsequent Event [Member] | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Exercise price of options | $ 4.55 | ||||||
Management, Employees and Individual Advisors | Two Thousand Seventeen Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Options granted | 984,310 | 151,000 | |||||
Options granted contractual term | 10 years | 10 years | |||||
Vesting period | 5 years | 5 years | |||||
Management, Employees and Individual Advisors | Vesting anniversary year after the grant date | Two Thousand Seventeen Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Option vesting percentage | 20.00% | ||||||
Management, Employees and Individual Advisors | Minimum | Two Thousand Seventeen Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Exercise price of options | $ 5.26 | ||||||
Management, Employees and Individual Advisors | Maximum | Two Thousand Seventeen Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Exercise price of options | $ 6.29 | $ 16.20 | |||||
Management, Employees and Individual Advisors | Maximum | Vesting anniversary year after the grant date | Two Thousand Seventeen Equity Incentive Plan | |||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||||||
Option vesting percentage | 20.00% |
Share-based compensation - Allo
Share-based compensation - Allocation of Compensation Expense Related to Option (Details) - Stock Options - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Compensation expense | $ 7,207 | $ 5,549 |
Selling, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Compensation expense | 4,069 | 3,259 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Compensation expense | $ 3,138 | $ 2,290 |
Share-based compensation - Non-
Share-based compensation - Non-vested Restricted Shares - Additional Information (Details) - Non-Vested Restricted Shares - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Unrecognized share-based compensation | $ 68,292 | |
Compensation expense | $ 5,203 | $ 1,769 |
Independent Directors | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Shares granted | 388,150 | 192,600 |
Management | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Shares granted | 477,150 | 31,000 |
Management | Each yearly anniversary from the date of the agreement | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Option vesting percentage | 20.00% | 20.00% |
Share-based compensation - Al_2
Share-based compensation - Allocation of Compensation Expense Related to Restricted Shares (Details) - Non-Vested Restricted Shares - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Compensation expense | $ 5,203 | $ 1,769 |
Selling, General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Compensation expense | 2,923 | 1,211 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Compensation expense | $ 2,280 | $ 558 |
Licenses and collaborative ar_2
Licenses and collaborative arrangements pursuant to which milestone payments were made (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 13, 2021 | Apr. 30, 2017 | Mar. 31, 2022 | Mar. 31, 2021 | Mar. 30, 2022 | Dec. 31, 2021 |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Common stock par value | $ 0.000006 | $ 0.000006 | $ 0.000006 | |||
Issuance of ordinary shares in connection with collaboration and license arrangement | $ 0 | |||||
Maximum | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Future milestone payments to be made upon achievement | $ 5,589,801 | |||||
Paratek | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
License agreement date | 2017-04 | |||||
Payment of milestone fees | $ 7,500 | |||||
Additional milestone payments | 6,000 | |||||
Paratek | Upon Approval By FDA of a New Drug Application [Member] | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Payment of milestone fees | 5,000 | |||||
Paratek | Submission of the first regulatory approval application for a licensed product IN A People Republic Of China [Member] | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Payment of milestone fees | 3,000 | |||||
Paratek | Maximum | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
Additional milestone payments | $ 40,500 | |||||
Argenx BV | ||||||
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Line Items] | ||||||
License agreement date | 2021-01 | |||||
Development cost-sharing payment | 75,000 | |||||
Issuance of ordinary shares in connection with collaboration and license arrangement, Shares | 5,681,820 | |||||
Common stock par value | $ 0.000006 | |||||
Issuance of ordinary shares in connection with collaboration and license arrangement | 62,250 | |||||
Milestone payments | $ 25,000 | |||||
Shares Issued Date | Jan. 13, 2021 |
Restricted Net Assets (Details)
Restricted Net Assets (Details) - PRC - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | |
Restricted net assets | |||
Minimum required percentage of statutory reserves | 10.00% | ||
Percentage of statutory reserves to respective registered capital | 50.00% | ||
Statutory reserves | $ 0 | $ 0 | |
Restricted amount by subsidiaries | $ 406,010 | $ 406,010 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Thousands | Mar. 31, 2022USD ($) |
Property and Equipment | |
Loss Contingencies [Line Items] | |
Purchase obligation | $ 22,294 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event | 1 Months Ended |
May 05, 2022$ / sharesshares | |
Subsequent Event [Line Items] | |
Options granted | shares | 16,614,930 |
Options granted contractual term | 10 years |
Vesting period | 5 years |
Vesting percentage | 20.00% |
Minimum | |
Subsequent Event [Line Items] | |
Exercise price of options | $ / shares | $ 3.96 |
Maximum | |
Subsequent Event [Line Items] | |
Exercise price of options | $ / shares | $ 4.55 |
Vest on each yearly anniversary from the date of the agreement | Restricted Shares | |
Subsequent Event [Line Items] | |
Vesting percentage | 0.20% |
Management, Employees and Individual Advisors | Restricted Shares | |
Subsequent Event [Line Items] | |
Shares granted | shares | 5,173,390 |