Zai Lab Ltd
For the period ended Mar 31, 2024. Filed May 8, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2024 · Filed May 8, 2024
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Notes to the Unaudited Condensed Consolidated Financial Statements
- Organization and Principal Activities
Zai Lab Limited was incorporated on March 28, 2013 in the Cayman Islands as an exempted company with limited liability under the Companies Act of the Cayman Islands (as amended). Zai Lab Limited and its subsidiaries (collectively referred to as the “Company”) are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, autoimmune disorders, infectious disease, and neuroscience.
The Company’s principal operations and geographic markets are in Greater China. The Company has a substantial presence in Greater China and the United States.
- Basis of Presentation and Consolidation and Significant Accounting Policies
(a) Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), and applicable rules and regulations of the U.S. Securities and Exchange Commission (the “SEC”), regarding interim financial reporting. Certain information and note disclosures normally included in the financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. As such, the information included in this report should be read in conjunction with the consolidated financial statements and accompanying notes included in the Annual Report on Form 10-K for the year ended December 31, 2023 (the “2023 Annual Report”). The December 31, 2023 condensed consolidated balance sheet data included in this report were derived from the audited financial statements in the 2023 Annual Report.
The accompanying condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the year ending December 31, 2024.
(b) Principles of Consolidation
The unaudited condensed consolidated financial statements include the accounts of Zai Lab Limited and its subsidiaries, which are wholly owned. All intercompany transactions and balances are eliminated upon consolidation.
(c) Use of Estimates
The preparation of the unaudited condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates, judgments, and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Areas where management uses subjective judgment include, but are not limited to, accrual of rebates, recognition of research and development expenses, fair value of share-based compensation expenses, and recoverability of deferred tax assets. These estimates, judgments, and assumptions can affect the reported amounts of assets and liabilities as of the date of the financial statements as well as the reported amounts of revenues and expenses during the periods presented. Actual results could differ from these estimates.
(d) Fair Value Measurements
Equity investments with readily determinable fair value are measured using level 1 inputs and were $14.1 million and $9.2 million as of March 31, 2024 and December 31, 2023, respectively. The unrealized gains from fair value changes are recognized in other income, net in the condensed consolidated statements of operations.
Financial instruments of the Company primarily include cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, non-current restricted cash, accounts payable, short-term debts, and other current liabilities. As of March 31, 2024 and December 31, 2023, the carrying values of cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, prepayments and other current assets, accounts payable, short-term debts, and other current liabilities approximated their fair values due to the short-term maturity of these instruments, and the carrying value of notes receivable and non-current restricted cash approximated their fair value based on the assessment of the ability to recover these amounts.
(e)Recent Accounting Pronouncements
In November 2023, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2023-07, Improvements to Reportable Segment Disclosures (Topic 280). This ASU requires all public entities, including public entities with a single reportable segment, to disclose the title and position of the Chief Operating Decision Maker (“CODM”) and the significant segment expenses and any additional measures of a segment’s profit or loss used by the CODM to allocate resources and assess performance. This ASU is effective on a retrospective basis for fiscal years beginning after December 15, 2023 and for interim periods beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact of this ASU and expects to adopt it for the year ending December 31, 2024.
In December 2023, the FASB issued ASU No. 2023-09, Improvements to Income Tax Disclosures (Topic 740). This ASU requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as additional information on income taxes paid. This ASU is effective on a prospective basis for annual periods beginning after December 15, 2024. Early adoption is permitted. This ASU will result in additional disclosure in the consolidated financial statements, once adopted. The Company is currently evaluating the impact of this ASU and expects to adopt it for the year ending December 31, 2025.
The Company did not adopt any new accounting standards in the first quarter of 2024 that had a material impact on the Consolidated Financial Statements. For additional information on the Company’s significant accounting policies, refer to the notes to the consolidated financial statements in the 2023 Annual Report.
- Cash and Cash Equivalents
The following table presents the Company’s cash and cash equivalents ($ in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Cash | 649,666 | 789,051 |
| Cash equivalents (i) | 1,114 | 1,100 |
| 650,780 | 790,151 | |
| Denominated in: | ||
| US$630,583 | 762,436 | |
| Renminbi (“RMB”) (ii) | 17,878 | 25,093 |
| Hong Kong dollar (“HK$”) | 1,513 | 1,974 |
| Australian dollar (“A$”) | 557 | 587 |
| Taiwan dollar (“TW$”) | 249 | 61 |
| 650,780 | 790,151 | |
(i)Cash equivalents represent short-term and highly liquid investments in a money market fund.
(ii)Certain cash and bank balances denominated in RMB were deposited with banks in mainland China. The conversion of these RMB-denominated balances into foreign currencies is subject to the rules and regulations of foreign exchange control promulgated by the Chinese government.
- Inventories, Net
The following table presents the Company’s inventories, net ($ in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Finished goods | 19,076 | 22,702 |
| Raw materials | 16,675 | 17,655 |
| Work in progress | 2,100 | 4,470 |
| Inventories, net | 37,851 | 44,827 |
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. The Company recorded write-downs in inventory, which were included in cost of sales, of insignificant amount and $0.4 million in the first quarter of 2024 and 2023, respectively.
- Property and Equipment, Net
The following table presents the components of the Company’s property and equipment, net ($ in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Office equipment | 1,046 | 1,047 |
| Electronic equipment | 9,315 | 9,161 |
| Vehicle | 198 | 199 |
| Laboratory equipment | 20,162 | 20,140 |
| Manufacturing equipment | 17,658 | 17,680 |
| Leasehold improvements | 11,361 | 11,371 |
| Construction in progress | 24,834 | 24,272 |
| 84,574 | 83,870 | |
| Less: accumulated depreciation | (32,188) | (30,136) |
| Property and equipment, net | 52,386 | 53,734 |
Depreciation expense was $2.2 million and $2.5 million in the first quarter of 2024 and 2023, respectively.
- Revenue
The Company’s revenue is derived from the sales of its commercial products primarily in mainland China. The table below presents the Company’s gross and net product revenue ($ in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Product revenue - gross | 93,112 | 71,212 |
| Less: Rebates and sales returns | (5,963) | (8,415) |
| Product revenue - net | 87,149 | 62,797 |
Sales rebates are offered to distributors in mainland China, and the amounts are recorded as a reduction of revenue. Estimated rebates are determined based on contracted rates, sales volumes, and level of distributor inventories.
The following table presents the Company’s net revenue by product ($ in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| ZEJULA | 45,501 | 42,680 |
| OPTUNE | 12,480 | 13,342 |
| QINLOCK | 6,093 | 1,306 |
| NUZYRA | 9,913 | 5,469 |
| VYVGART | 13,162 | — |
| Product revenue - net | 87,149 | 62,797 |
- Income Tax
No provision for income taxes has been required to be accrued because the Company is in a cumulative loss position for the periods presented.
The Company recorded a full valuation allowance against deferred tax assets of all its consolidated entities because all entities were in a cumulative loss position as of March 31, 2024 and December 31, 2023. No unrecognized tax benefits and related interest and penalties were recorded in the periods presented.
- Loss Per Share
The following table presents the computation of the basic and diluted net loss per share ($ in thousands, except share and per share data):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Numerator: | ||
| Net loss | (53,471) | (49,144) |
| Denominator: | ||
| Weighted average number of ordinary shares - basic and diluted | 973,145,760 | 961,444,780 |
| Net loss per share - basic and diluted | (0.05) | (0.05) |
As a result of the Company’s net loss in the first quarter of 2024 and 2023, share options and non-vested restricted shares outstanding in the respective periods were excluded from the calculation of diluted loss per share as their inclusion would have been anti-dilutive.
| March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Share options | 104,244,590 | 86,242,060 |
| Non-vested restricted shares | 29,893,540 | 32,154,670 |
- Borrowings
In February 2024, the Company entered into certain debt arrangements with the Bank of China, SPD Bank, and Ningbo Bank to support its working capital needs in mainland China. The following table presents the Company’s short-term debts as of March 31, 2024 ($ in thousands):
| Weighted average interest rate per annum | March 31, 2024 | |
|---|---|---|
| Bank of China Working Capital Loan | 2.95% | 34,179 |
| SPD Bank Working Capital Loan | 3.45% | 14,094 |
| Total short-term debts | 3.10% | 48,273 |
Bank of China Working Capital Loan Facility
On February 5, 2024, the Company entered into an uncommitted facility letter with the Bank of China (Hong Kong) Limited (the “BOC HK”) pursuant to which the BOC HK will provide standby letters of credit for loans of up to $100.0 million for a term ofone year. In connection with this agreement, the Company paid a one-time, non-refundable fee of $0.7 million. The Company also maintained restricted deposits of $100.0 million, which are presented as restricted cash-current on the condensed consolidated balance sheet, to secure the standby letters of credit. On February 6, 2024, upon the
Company’s application, the BOC HK provided a standby letter of credit in favor of the Bank of China Pudong Development Zone Branch (the “BOC Pudong Branch”) for $50.0 million which are or may become payable by the Company’s wholly-owned subsidiary, Zai Lab (Shanghai) Co., Ltd. (“Zai Lab Shanghai”), and Zai Lab Shanghai subsequently entered into a working capital loan contract with the BOC Pudong Branch on February 7, 2024 for a loan of RMB 340.0 million (approximately $47.8 million), of which an aggregate principal amount of RMB 242.5 million (approximately $34.2 million) was withdrawn and outstanding as of March 31, 2024. Each working capital loan withdrawal has aone-year term and is subject to a floating interest rate of approximately 2.95% initially, and is subject to adjustment everysix months.
SPD Bank Working Capital Loan Facility
On February 6, 2024, the Company entered into a maximum-amount guarantee contract with the Shanghai Pudong Development Bank Co., Ltd. Zhangjiang Hi-Tech Park Sub-branch (the “SPD Bank”) pursuant to which the Company will guarantee working capital loans of up to RMB 300.0 million (approximately $42.0 million) from SPD Bank to Zai Lab Shanghai over athree-year period. In the first quarter of 2024, Zai Lab Shanghai has entered into working capital loan contracts with SPD Bank under this debt facility for an aggregate principal amount of RMB 100.0 million (approximately $14.1 million). These working capital loans haveone-year terms and are subject to a fixed interest rate of 3.45%.
Ningbo Bank Working Capital Loan Facility
On February 6, 2024, the Company’s wholly-owned subsidiary, Zai Lab (Suzhou) Co., Ltd. (“Zai Lab Suzhou”), entered into a maximum credit contract with Bank of Ningbo Co., Ltd. Suzhou Sub-branch (“Ningbo Bank”) as well as an Electronic Commercial Draft Discounting Master Agreement and Online Working Capital Loan Master Agreement (collectively, the “Ningbo Bank Agreements”). The Ningbo Bank Agreements permit Zai Lab Suzhou to utilize, including through discounting or working capital loan agreements and subject to the terms and conditions in related master agreements, up to RMB 230.3 million (approximately $32.4 million), of which the Company is authorized to utilize up to RMB 160.0 million (approximately $22.5 million). In connection with the arrangements described in the Ningbo Bank Agreements, Zai Lab Suzhou agreed to pledge interests in certain real property it owns in Suzhou. As of March 31, 2024, Zai Lab Suzhou has not entered into any discounting arrangements or working capital loans under this Ningbo Bank working capital loan facility.
- Other Current Liabilities
The following table presents the Company’s other current liabilities ($ in thousands):
| March 31, 2024 | December 31, 2023 | |
|---|---|---|
| Accrued payroll | 11,920 | 33,711 |
| Accrued professional service fee | 3,478 | 7,520 |
| Payables for purchase of property and equipment | 2,481 | 2,474 |
| Accrued rebate to distributors | 20,593 | 16,926 |
| Tax payables | 6,910 | 16,988 |
| Other (i) | 2,794 | 5,353 |
| Total | 48,176 | 82,972 |
(i)Other mainly includes accrued travel and business-related expenses.
- Share-Based Compensation
During the first quarter of 2024, the Company granted share options to purchase up to 398,000 ordinary shares and restricted shares representing 370,500 ordinary shares under the 2022 Plan. The share options granted have a contractual term often years. Share options granted since April 2023 generally vest ratably over afour-year period, and share options granted prior to April 2023 generally vest ratably over afive-year period, with 25% or 20% of the awards vesting on each anniversary of the grant date, respectively, subject to continued employment/service with the Company on the vesting date. The restricted shares granted generally vest ratably over a specified period on the anniversary of the grant date, subject to continued employment/service with the Company on the vesting date. For a description of the Company’s equity incentive plans and more details on the terms of the share-based awards, refer to Note 15 of the 2023 Annual Report.
The following table presents the share-based compensation expense that has been reported in the Company’s condensed consolidated statements of operations and comprehensive loss as follows ($ in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Selling, general and administrative | 11,036 | 10,063 |
| Research and development | 6,944 | 6,598 |
| Total | 17,980 | 16,661 |
As of March 31, 2024, there was unrecognized share-based compensation expense related to unvested share options and unvested restricted shares of $93.2 million and $92.0 million, respectively, which the Company expects to recognize over a weighted-average period of 2.89 years and 2.54 years, respectively.
- License and Collaboration Agreements
The Company has entered into various license and collaboration agreements with third parties to develop and commercialize product candidates.
For a description of the material terms of the Company’s significant license and collaboration agreements, see Note 16 of the 2023 Annual Report. In the first quarter of 2024, the Company did not enter into any new significant license and collaboration agreements or incur any milestone fees under our existing significant license and collaboration agreements.
- Other Income, Net
The following table presents the Company’s other income, net ($ in thousands):
| Three Months Ended March 31, | ||
|---|---|---|
| 2024 | 2023 | |
| Government grants | 2,791 | — |
| Gain on equity investments with readily determinable fair value | 4,889 | 441 |
| Others miscellaneous gain | 1,681 | 793 |
| Total | 9,361 | 1,234 |
- Restricted Net Assets
The Company’s ability to pay dividends may depend on the Company receiving distributions of funds from its Chinese subsidiaries. Relevant Chinese laws and regulations permit payments of dividends by the Company’s Chinese subsidiaries only out of its retained earnings, if any, as determined in accordance with Chinese accounting standards and
regulations. The results of operations reflected in the unaudited condensed consolidated financial statements prepared in accordance with U.S. GAAP differ from those reflected in the statutory financial statements of the Company’s Chinese subsidiaries.
In accordance with the Company Law of the People’s Republic of China, a domestic enterprise is required to provide statutory reserves of at least 10% of its annual after-tax profit until such reserve has reached 50% of its respective registered capital based on the enterprise’s Chinese statutory accounts. A domestic enterprise may provide discretionary surplus reserve, at the discretion of the Board of Directors, from the profits determined in accordance with the enterprise’s Chinese statutory accounts. The aforementioned reserves can only be used for specific purposes and are not distributable as cash dividends. The Company’s Chinese subsidiaries were established as domestic enterprises and therefore are subject to the above-mentioned restrictions on distributable profits.
No appropriation to statutory reserves was made in the first quarter of 2024 and 2023 because the Chinese subsidiaries had substantial losses during such periods.
As a result of these Chinese laws and regulations, subject to the limits discussed above that require annual appropriations of 10% of after-tax profit to be set aside, prior to payment of dividends, as a general reserve fund, the Company’s Chinese subsidiaries are restricted in their ability to transfer out a portion of their net assets.
Foreign exchange and other regulation in mainland China may further restrict the Company’s subsidiaries in mainland China from transferring out funds in the form of dividends, loans, and advances. As of March 31, 2024 and December 31, 2023, amounts restricted were the paid-in capital of the Company’s subsidiaries in mainland China, which both amounted to $506.0 million.
- Commitments and Contingencies
(a) Purchase Commitments
The Company’s commitments related to purchase of property and equipment contracted but not yet reflected in the unaudited condensed consolidated financial statements were $1.1 million as of March 31, 2024 and were expected to be incurred within one year.
(b) Legal Proceedings
The Company is not currently a party to any material legal proceedings.
(c) Indemnifications
In the normal course of business, the Company enters into agreements that indemnify others for certain liabilities that may arise in connection with a transaction or certain events and activities. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.