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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
____________________
FORM 10-Q
____________________
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2025
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______ to ______
Commission File Number: 001-38205
____________________
ZAI LAB LIMITED
(Exact Name of Registrant as Specified in its Charter)
____________________
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| Cayman Islands |
98-1144595 |
(State or Other Jurisdiction of
Incorporation or Organization) |
(I.R.S. Employer
Identification No.) |
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4560 Jinke Road
Bldg. 1, 4th Floor, Pudong
Shanghai
China
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201210 |
314 Main Street
4th Floor, Suite 100
Cambridge, MA, USA |
02142 |
| (Address of Principal Executive Offices) |
(Zip Code) |
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+86 216163 2588
+1 857 706 2604
(Registrant’s Telephone Number, Including Area Code)
____________________
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class |
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Trading
Symbol(s)
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Name of each exchange
on which registered
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| American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per share |
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ZLAB |
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The Nasdaq Global Market |
Ordinary Shares, par value $0.000006 per share* |
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9688 |
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The Stock Exchange of Hong Kong Limited |
*Included in connection with the registration of the American Depositary Shares with the Securities and Exchange Commission. The ordinary shares are not registered or listed for trading in the United States but are listed for trading on The Stock Exchange of Hong Kong Limited.
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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| Large accelerated filer |
x |
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Accelerated filer |
o |
| Non-accelerated filer |
o |
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Smaller reporting company |
o |
| Emerging growth company |
o |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of May 2, 2025, 1,084,743,860 ordinary shares of the registrant, par value $0.000006 per share, were outstanding, of which 486,853,250 ordinary shares were held in the form of American Depositary Shares.
Zai Lab Limited
Quarterly Report on Form 10-Q
For the First Quarter of 2025
SPECIAL NOTES REGARDING THE COMPANY
Forward-Looking Statements
This report contains certain forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; the market for our commercial and pipeline products; capital allocation and investment strategy; clinical development programs and related clinical trials; clinical trial data, data readouts, and presentations; risks and uncertainties associated with drug development and commercialization; regulatory discussions, submissions, filings, and approvals and the timing thereof; the potential benefits, safety, and efficacy of our products and product candidates and those of our collaboration partners; the anticipated benefits and potential of investments, collaborations, and business development activities; our profitability and timeline to profitability; and our future financial and operating results. All statements, other than statements of historical fact, included in this report are forward-looking statements, and can be identified by words such as “aim,” “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expect,” “forecast,” “goal,” “intend,” “may,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “target,” “will,” “would,” or the negative of these terms or similar expressions. Such statements constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not guarantees or assurances of future performance. Forward-looking statements are based on our expectations and assumptions as of the date of this report and are subject to inherent uncertainties, risks, and changes in circumstances that may differ materially from those contemplated by the forward-looking statements. We may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in our forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including but not limited to the following:
• Our ability to successfully commercialize and generate revenue from our approved products;
• Our ability to obtain funding for our operations and business initiatives;
• The results of our clinical and pre-clinical development of our product candidates;
• The content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates;
• Changes in U.S. and China trade policies and relations, as well as relations with other countries, and/or changes in laws, regulations, and/or sanctions;
• Actions the Chinese government may take to intervene in or influence our operations;
• Economic, political, and social conditions in mainland China as well as governmental policies;
• Uncertainties in the Chinese legal system, including with respect to the anti-corruption enforcement efforts in mainland China and the Counter-Espionage Law, the Data Security Law, the Cyber Security Law, the Cybersecurity Review Measures, the Personal Information Protection Law, the Regulation on the Administration of Human Genetic Resources, the Biosecurity Law, the Security Assessment Measures, and other future laws and regulations or amendments to such laws and regulations;
• Approval, filing, or procedural requirements imposed by the China Securities Regulatory Commission or other Chinese regulatory authorities in connection with issuing securities to foreign investors under Chinese law;
• Any violation or liability under the U.S. Foreign Corrupt Practices Act or Chinese anti-corruption, anti-bribery, and anti-fraud laws;
• Restrictions on currency exchange;
• Limitations on the ability of our Chinese subsidiaries to make payments to us;
• Chinese requirements on the ability of residents in mainland China to establish offshore special purpose companies;
• Chinese regulations regarding acquisitions of companies based in mainland China by foreign investors;
• Any issues that our Chinese manufacturing facilities may have with operating in conformity with established GMPs and international best practices, and with passing FDA, NMPA, and EMA inspections;
• Expiration of, or changes to, financial incentives or discretionary policies granted by local governments in mainland China;
• Restrictions or limitations on the ability of overseas regulators to conduct investigations or collect evidence within mainland China;
• Significant business disruptions caused by events or developments outside of our control, such as pandemics, international war or conflict, natural disasters or extreme weather events, and other geopolitical events;
• Unfavorable tax consequences to us and our non-Chinese shareholders or ADS holders if we were to be classified as a Chinese resident enterprise for Chinese income tax purposes;
• Failure to comply with applicable Chinese, U.S., and Hong Kong regulations that could lead to government enforcement actions, fines, other legal or administrative sanctions, and/or harm to our business or reputation;
• Delays or obstacles for closing transactions, such as review by the CFIUS in our investments;
• Any inability to renew our current leases on desirable terms or otherwise locate desirable alternatives for our leased properties;
• Any inability of third parties on whom we rely, such as our licensors, CMOs, and others that supply certain of our products and product candidates; CROs that conduct or support some of our pre-clinical and clinical trials; and distributors that sell our commercial products, to successfully carry out their contractual duties or meet expected deadlines; and
• Any inability to obtain or maintain sufficient patent protection for our products and product candidates.
These factors should not be construed as exhaustive and should be read with the other cautionary statements and information in our Annual Report on Form 10-K for the year ended December 31, 2024 (the “2024 Annual Report”), our Quarterly Reports on Form 10-Q, and our other filings with the U.S. Securities and Exchange Commission. Forward-looking statements are based on our management’s beliefs and assumptions and information currently available to our management. These statements, like all statements in this report, speak only as of their date. We anticipate that subsequent events and developments will cause our expectations and assumptions to change, and we undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as may be required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this report.
Usage of Terms
Throughout this report, we use certain acronyms and terms that are defined in the Glossary of our 2024 Annual Report. References to “Zai Lab,” the “Company,” “we,” “us,” and “our” refer to Zai Lab Limited, a holding company, and its subsidiaries, on a consolidated basis; and references to “Zai Lab Limited” refer to Zai Lab Limited, a holding company. Zai Lab Limited is the entity in which investors hold their interest.
Our operating subsidiaries consist of Zai Lab (Hong Kong) Limited, domiciled in Hong Kong; Zai Auto Immune (Hong Kong) Limited, domiciled in Hong Kong; Zai Anti Infectives (Hong Kong) Limited, domiciled in Hong Kong; Zai Lab (Shanghai) Co., Ltd., domiciled in mainland China; Zai Lab International Trading (Shanghai) Co., Ltd., domiciled in mainland China; Zai Lab (Suzhou) Co., Ltd., domiciled in mainland China; Zai Biopharmaceutical (Suzhou) Co., Ltd., domiciled in mainland China; Zai Lab Trading (Suzhou) Co., Ltd., domiciled in mainland China; Zai Lab (Taiwan) Limited, domiciled in Taiwan; Zai Lab (AUST) Pty. Ltd., domiciled in Australia; and Zai Lab (US) LLC, domiciled in the United States.
We own various trademarks, including various forms of the Zai Lab brand (in English and Chinese), as well as several domain names that incorporate such trademarks. Trademarks and trade names of other companies appearing in this report are the property of their respective holders. Solely for convenience, some of the trademarks and trade names in this report are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto. We do not intend our use or display of other companies’ trademarks and trade names to imply a relationship with, or endorsement or sponsorship of, any other company.
PART I – FINANCIAL INFORMATION
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensed consolidated financial statements and the accompanying notes included in this report and the audited consolidated financial information and the accompanying notes included in our 2024 Annual Report.
Item 1. Financial Statements.
Zai Lab Limited
Unaudited Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars (“$”), except for number of shares and per share data)
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Notes |
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March 31,
2025 |
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December 31,
2024 |
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| Assets |
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| Current assets |
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| Cash and cash equivalents |
3 |
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757,263 |
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449,667 |
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| Restricted cash, current |
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100,000 |
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100,000 |
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| Short-term investments |
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— |
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330,000 |
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Accounts receivable (net of allowance for credit losses of $22 and $25 as of March 31, 2025 and December 31, 2024, respectively) |
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76,555 |
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85,178 |
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| Notes receivable |
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11,118 |
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4,233 |
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| Inventories, net |
4 |
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53,054 |
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39,875 |
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| Prepayments and other current assets |
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43,878 |
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41,527 |
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| Total current assets |
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1,041,868 |
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1,050,480 |
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| Restricted cash, non-current |
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1,113 |
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1,114 |
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| Property and equipment, net |
5 |
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49,654 |
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47,961 |
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| Operating lease right-of-use assets |
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19,081 |
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21,496 |
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| Land use rights, net |
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2,882 |
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2,907 |
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| Intangible assets, net |
6 |
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56,198 |
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56,027 |
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| Other non-current assets |
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2,534 |
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5,768 |
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| Total assets |
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1,173,330 |
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1,185,753 |
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| Liabilities and shareholders’ equity |
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| Current liabilities |
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| Accounts payable |
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103,017 |
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100,906 |
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| Current operating lease liabilities |
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6,574 |
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8,048 |
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| Short-term debt |
10 |
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173,405 |
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131,711 |
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| Other current liabilities |
11 |
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36,811 |
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58,720 |
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| Total current liabilities |
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|
319,807 |
|
|
299,385 |
|
| Deferred income |
|
|
30,126 |
|
|
31,433 |
|
| Non-current operating lease liabilities |
|
|
12,319 |
|
|
13,712 |
|
| Other non-current liabilities |
|
|
325 |
|
|
325 |
|
| Total liabilities |
|
|
362,577 |
|
|
344,855 |
|
| Commitments and contingencies (Note 17) |
|
|
|
|
|
| Shareholders’ equity |
|
|
|
|
|
Ordinary shares (par value of $0.000006 per share; 5,000,000,000 shares authorized; 1,089,076,400 and 1,082,614,740 shares issued as of March 31, 2025 and December 31, 2024, respectively; 1,084,164,200 and 1,077,702,540 shares outstanding as of March 31, 2025 and December 31, 2024, respectively) |
|
|
7 |
|
|
7 |
|
| Additional paid-in capital |
|
|
3,283,800 |
|
|
3,264,295 |
|
| Accumulated deficit |
|
|
(2,501,521) |
|
|
(2,453,083) |
|
| Accumulated other comprehensive income |
|
|
49,303 |
|
|
50,515 |
|
Treasury Stock (at cost, 4,912,200 shares as of both March 31, 2025 and December 31, 2024) |
|
|
(20,836) |
|
|
(20,836) |
|
| Total shareholders’ equity |
|
|
810,753 |
|
|
840,898 |
|
| Total liabilities and shareholders’ equity |
|
|
1,173,330 |
|
|
1,185,753 |
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Operations
(in thousands of $, except for number of shares and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
Notes |
|
2025 |
|
2024 |
|
|
|
|
| Revenues |
|
|
|
|
|
|
|
|
|
| Product revenue, net |
7 |
|
105,650 |
|
|
87,149 |
|
|
|
|
|
| Collaboration revenue |
7 |
|
837 |
|
|
— |
|
|
|
|
|
| Total revenues |
|
|
106,487 |
|
|
87,149 |
|
|
|
|
|
| Expenses |
|
|
|
|
|
|
|
|
|
| Cost of product revenue |
|
|
(38,452) |
|
|
(33,619) |
|
|
|
|
|
| Cost of collaboration revenue |
|
|
(195) |
|
|
— |
|
|
|
|
|
| Research and development |
|
|
(60,729) |
|
|
(54,645) |
|
|
|
|
|
| Selling, general, and administrative |
|
|
(63,422) |
|
|
(69,194) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Loss from operations |
|
|
(56,311) |
|
|
(70,309) |
|
|
|
|
|
| Interest income |
|
|
8,606 |
|
|
9,658 |
|
|
|
|
|
| Interest expenses |
|
|
(1,187) |
|
|
(113) |
|
|
|
|
|
| Foreign currency gains (losses) |
|
|
651 |
|
|
(2,068) |
|
|
|
|
|
| Other (expense) income, net |
15 |
|
(197) |
|
|
9,361 |
|
|
|
|
|
| Loss before income tax |
|
|
(48,438) |
|
|
(53,471) |
|
|
|
|
|
| Income tax expense |
8 |
|
— |
|
|
— |
|
|
|
|
|
| Net loss |
|
|
(48,438) |
|
|
(53,471) |
|
|
|
|
|
| Loss per share - basic and diluted |
9 |
|
(0.04) |
|
|
(0.05) |
|
|
|
|
|
| Weighted-average shares used in calculating net loss per ordinary share - basic and diluted |
|
|
1,080,825,300 |
|
|
973,145,760 |
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Comprehensive Loss
(in thousands of $)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
2025 |
|
2024 |
|
|
|
|
| Net loss |
|
|
(48,438) |
|
|
(53,471) |
|
|
|
|
|
Other comprehensive income, net of tax of nil: |
|
|
|
|
|
|
|
|
|
| Foreign currency translation adjustments |
|
|
(1,212) |
|
|
1,542 |
|
|
|
|
|
| Comprehensive loss |
|
|
(49,650) |
|
|
(51,929) |
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Shareholders’ Equity
(in thousands of $, except for number of shares)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary Shares |
|
Additional
paid
in capital |
|
Accumulated
deficit |
|
Accumulated
other
comprehensive
income
|
|
Treasury Stock |
|
Total |
|
Number
of
Shares |
|
Amount |
|
|
|
|
Shares |
|
Amount |
|
| Balance at December 31, 2024 |
1,082,614,740 |
|
|
7 |
|
|
3,264,295 |
|
|
(2,453,083) |
|
|
50,515 |
|
|
(4,912,200) |
|
|
(20,836) |
|
|
840,898 |
|
| Issuance of ordinary shares upon vesting of restricted shares |
137,540 |
|
|
0 |
|
0 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
| Exercise of share options |
6,324,120 |
|
|
0 |
|
3,733 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
3,733 |
|
| Issuance cost of the follow-on public offering |
— |
|
|
— |
|
|
(28) |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(28) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Share-based compensation |
— |
|
|
— |
|
|
15,800 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
15,800 |
|
| Net loss |
— |
|
|
— |
|
|
— |
|
|
(48,438) |
|
|
— |
|
|
— |
|
|
— |
|
|
(48,438) |
|
| Foreign currency translation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(1,212) |
|
|
— |
|
|
— |
|
|
(1,212) |
|
| Balance at March 31, 2025 |
1,089,076,400 |
|
|
7 |
|
|
3,283,800 |
|
|
(2,501,521) |
|
|
49,303 |
|
|
(4,912,200) |
|
|
(20,836) |
|
|
810,753 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ordinary Shares |
|
Additional
paid
in capital |
|
Accumulated
deficit |
|
Accumulated
other
comprehensive
income |
|
Treasury Stock |
|
Total |
|
Number
of
Shares |
|
Amount |
|
|
|
|
Shares |
|
Amount |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Balance at December 31, 2023 |
977,151,270 |
|
|
6 |
|
|
2,975,302 |
|
|
(2,195,980) |
|
|
37,626 |
|
|
(4,912,200) |
|
|
(20,836) |
|
|
796,118 |
|
| Issuance of ordinary shares upon vesting of restricted shares |
1,046,440 |
|
|
0 |
|
0 |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Share-based compensation |
— |
|
|
— |
|
|
17,980 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
17,980 |
|
| Net loss |
— |
|
|
— |
|
|
— |
|
|
(53,471) |
|
|
— |
|
|
— |
|
|
— |
|
|
(53,471) |
|
| Foreign currency translation |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,542 |
|
|
— |
|
|
— |
|
|
1,542 |
|
| Balance at March 31, 2024 |
978,197,710 |
|
|
6 |
|
|
2,993,282 |
|
|
(2,249,451) |
|
|
39,168 |
|
|
(4,912,200) |
|
|
(20,836) |
|
|
762,169 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements. “0” in above table means less than 1,000 dollars.
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Cash Flows
(in thousands of $)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2025 |
|
2024 |
| Cash flows from operating activities |
|
|
|
| Net loss |
(48,438) |
|
|
(53,471) |
|
| Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
| Allowance for credit losses |
(3) |
|
|
1 |
|
| Inventory write-down |
27 |
|
|
37 |
|
| Depreciation and amortization expenses |
3,458 |
|
|
3,012 |
|
| Amortization of deferred income |
(1,331) |
|
|
(840) |
|
| Share-based compensation |
15,800 |
|
|
17,980 |
|
| Loss (gain) from fair value changes of equity investment with readily determinable fair value |
1,912 |
|
|
(4,889) |
|
| Losses on disposal of property and equipment |
— |
|
|
407 |
|
|
|
|
|
| Noncash lease expenses |
2,466 |
|
|
2,069 |
|
|
|
|
|
| Debt issuance costs |
— |
|
|
700 |
|
| Foreign currency remeasurement impact |
(651) |
|
|
2,068 |
|
| Changes in operating assets and liabilities: |
|
|
|
| Accounts receivable |
8,737 |
|
|
(1,328) |
|
| Notes receivable |
(6,885) |
|
|
(9,239) |
|
| Inventories |
(13,198) |
|
|
6,818 |
|
| Prepayments and other current assets |
(1,601) |
|
|
(1,253) |
|
| Other non-current assets |
1,401 |
|
|
(271) |
|
|
|
|
|
| Accounts payable |
2,720 |
|
|
(13,370) |
|
| Other current liabilities |
(23,275) |
|
|
(34,204) |
|
| Operating lease liabilities |
(2,827) |
|
|
(2,783) |
|
| Deferred income |
(11) |
|
|
(1,550) |
|
|
|
|
|
| Net cash used in operating activities |
(61,699) |
|
|
(90,106) |
|
| Cash flows from investing activities |
|
|
|
|
|
|
|
| Proceeds from maturity of short-term investment |
330,000 |
|
|
16,300 |
|
| Purchases of property and equipment |
(1,534) |
|
|
(974) |
|
|
|
|
|
| Acquisition of intangible assets |
(2,333) |
|
|
(12,034) |
|
|
|
|
|
|
|
|
|
| Net cash provided by investing activities |
326,133 |
|
|
3,292 |
|
| Cash flows from financing activities |
|
|
|
| Proceeds from short-term debt |
101,890 |
|
|
48,248 |
|
| Repayment of short-term bank borrowings |
(60,904) |
|
|
— |
|
| Payments of debt issuance costs |
— |
|
|
(700) |
|
| Proceeds from exercises of stock options |
3,009 |
|
|
— |
|
|
|
|
|
| Payments of public offering costs |
(854) |
|
|
— |
|
|
|
|
|
| Net cash provided by financing activities |
43,141 |
|
|
47,548 |
|
| Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash |
20 |
|
|
(104) |
|
| Net increase (decrease) in cash, cash equivalents and restricted cash |
307,595 |
|
|
(39,370) |
|
| Cash, cash equivalents and restricted cash - beginning of period |
550,781 |
|
|
791,264 |
|
| Cash, cash equivalents and restricted cash - end of period |
858,376 |
|
|
751,894 |
|
| Supplemental disclosure on non-cash investing and financing activities |
|
|
|
| Payables for purchase of property and equipment |
2,645 |
|
|
2,481 |
|
| Payables for acquisition of intangible assets |
2,075 |
|
|
78 |
|
| Payables for public offering costs |
168 |
|
|
— |
|
|
|
|
|
| Right-of-use asset acquired under operating leases |
— |
|
|
2,395 |
|
Receivable from sales of equity investments |
1,203 |
|
|
— |
|
| Receivables for stock option exercise under equity incentive plans |
794 |
|
|
— |
|
|
|
|
|
| Supplemental disclosure of cash flow information |
|
|
|
| Cash paid for interest |
1,101 |
|
|
45 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
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 Act of the Cayman Islands (as amended). Zai Lab Limited and its subsidiaries (collectively referred to as the “Company”) are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease.
The Company’s principal operations and geographic markets are in Greater China. The Company has a substantial presence in Greater China and the United States.
2. 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, 2024 (the “2024 Annual Report”). The December 31, 2024 condensed consolidated balance sheet data included in this report were derived from the audited financial statements in the 2024 Annual Report.
The accompanying unaudited condensed consolidated financial statements reflect all normal recurring adjustments that are necessary to present fairly the results for the interim periods presented. Interim results are not necessarily indicative of the results for the year ending December 31, 2025.
(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 based on the Company’s estimates of the actual services performed by the CROs and CMOs, fair value of share-based compensation expenses, recoverability of deferred tax assets, and useful life of intangible assets for commercial products. 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
Financial instruments of the Company primarily include cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, notes receivable, prepayments and other current assets, non-current restricted cash, accounts payable, short-term debt, and other current liabilities. As of March 31, 2025 and December 31, 2024, the carrying values of cash and cash equivalents, current restricted cash, short-term investments, accounts receivable, prepayments and other current assets, accounts payable, short-term debt, and other current liabilities approximated their fair value due to the short-term maturity of these instruments, and the carrying value of notes receivable and non-current restricted cash approximated their fair value based on the assessment of the ability to recover these amounts.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
(e) Recent Accounting Pronouncements
Recently Issued Accounting Pronouncements Not Yet Adopted
In December 2023, the Financial Accounting Standards Board (“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.
In November 2024, the FASB issued ASU No. 2024-03, Income Statement - Reporting Comprehensive Income - Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses. This ASU requires disclosure in the notes to financial statements of specified information about certain costs and expenses. This ASU will be effective for annual reporting periods beginning after December 15, 2026 and interim reporting periods beginning after December 15, 2027. 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, 2027.
For additional information on the Company’s significant accounting policies, refer to the notes to the consolidated financial statements in the 2024 Annual Report.
3. Cash and Cash Equivalents
The following table presents the Company’s cash and cash equivalents ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
December 31, 2024 |
|
|
|
|
| Cash |
756,089 |
|
|
448,508 |
|
| Cash equivalents (i) |
1,174 |
|
|
1,159 |
|
| |
757,263 |
|
|
449,667 |
|
| Denominated in: |
|
|
|
| US$ |
734,857 |
|
|
429,887 |
|
| Renminbi (“RMB”) (ii) |
21,245 |
|
|
18,979 |
|
| Hong Kong dollar (“HK$”) |
306 |
|
|
114 |
|
| Australian dollar (“A$”) |
521 |
|
|
522 |
|
| Taiwan dollar (“TW$”) |
334 |
|
|
165 |
|
|
757,263 |
|
|
449,667 |
|
(i)Cash equivalents represent short-term and highly liquid investments in a money market fund.
(ii)Certain cash and bank balances denominated in RMB were deposited with banks in mainland China. The conversion of these RMB-denominated balances into foreign currencies is subject to the rules and regulations of foreign exchange control promulgated by the Chinese government.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
4. Inventories, Net
The following table presents the Company’s inventories, net ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
December 31, 2024 |
|
|
|
|
| Finished goods |
33,432 |
|
|
24,063 |
|
| Raw materials |
15,317 |
|
|
13,268 |
|
| Work in progress |
4,305 |
|
|
2,544 |
|
| Inventories, net |
53,054 |
|
|
39,875 |
|
The Company writes down inventory for any excess or obsolete inventory or when the Company believes that the net realizable value of inventory is less than the carrying value. The Company recorded write-downs in inventory, which were included in cost of product revenue, of insignificant amounts in the first quarter of 2025 and 2024.
5. Property and Equipment, Net
The following table presents the components of the Company’s property and equipment, net ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
December 31, 2024 |
|
|
|
|
| Office equipment |
1,231 |
|
|
1,230 |
|
| Electronic equipment |
9,498 |
|
|
9,211 |
|
| Vehicle |
196 |
|
|
196 |
|
| Laboratory equipment |
20,537 |
|
|
20,516 |
|
| Manufacturing equipment |
17,525 |
|
|
17,493 |
|
| Leasehold improvements |
11,324 |
|
|
11,306 |
|
| Building |
24,084 |
|
|
— |
|
| Construction in progress |
4,274 |
|
|
25,129 |
|
|
88,669 |
|
|
85,081 |
|
| Less: accumulated depreciation |
(39,015) |
|
|
(37,120) |
|
| Property and equipment, net |
49,654 |
|
|
47,961 |
|
Depreciation expense was $2.0 million and $2.2 million in the first quarter of 2025 and 2024, respectively.
6. Intangible Assets, Net
The following table presents the components of the Company’s intangible assets, net ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
December 31, 2024 |
|
Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Value |
|
Gross Carrying Amount |
Accumulated Amortization |
Net Carrying Value |
| Finite-lived intangible assets |
|
|
|
|
|
|
|
| Commercial products |
58,744 |
|
(3,953) |
|
54,791 |
|
|
57,104 |
|
(2,637) |
|
54,467 |
|
| Software |
4,366 |
|
(2,959) |
|
1,407 |
|
|
4,360 |
|
(2,800) |
|
1,560 |
|
| Total |
63,110 |
|
(6,912) |
|
56,198 |
|
|
61,464 |
|
(5,437) |
|
56,027 |
|
Intangible assets for commercial products include capitalized post-approval milestone fees and acquired commercial manufacturing know-how and related development costs. The Company is amortizing intangible assets for commercial products as cost of product revenue over the estimated remaining useful life of the related products. Intangible assets for externally purchased software are amortized over three to five years on a straight-line basis.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
Amortization expense was $1.5 million and $0.7 million in the first quarter of 2025 and 2024, respectively.
7. Revenues
Product Revenue, Net
The Company’s product revenue is derived from the sales of its commercial products in Greater China. The table below presents the Company’s gross and net product revenue ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2025 |
|
2024 |
|
|
|
|
|
|
|
|
|
|
|
|
| Product revenue - gross |
112,333 |
|
|
93,112 |
|
|
|
|
|
| Less: Rebates and sales returns |
(6,683) |
|
|
(5,963) |
|
|
|
|
|
| Product revenue - net |
105,650 |
|
|
87,149 |
|
|
|
|
|
Sales rebates are offered to distributors in mainland China, and the amounts are recorded as a reduction of product revenue. Estimated rebates are determined based on contracted rates, sales volumes, and level of distributor inventories.
The following table presents the Company’s net revenue by commercial program ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2025 |
|
2024 |
|
|
|
|
|
|
|
|
|
|
|
|
| ZEJULA |
49,529 |
|
|
45,501 |
|
|
|
|
|
| VYVGART / VYVGART Hytrulo |
18,105 |
|
|
13,162 |
|
|
|
|
|
| NUZYRA |
15,118 |
|
|
9,913 |
|
|
|
|
|
| OPTUNE |
11,363 |
|
|
12,480 |
|
|
|
|
|
| QINLOCK |
8,509 |
|
|
6,093 |
|
|
|
|
|
| XACDURO |
1,117 |
|
|
— |
|
|
|
|
|
| AUGTYRO |
1,626 |
|
|
— |
|
|
|
|
|
| Other (i) |
283 |
|
|
— |
|
|
|
|
|
| Product revenue - net |
105,650 |
|
|
87,149 |
|
|
|
|
|
(i)Other includes product candidates sold in patient programs prior to commercialization.
Collaboration Revenue
Collaboration revenue was $0.8 million in the first quarter of 2025 and related to promotional activities in mainland China. We had no such collaboration revenue in the first quarter of 2024.
8. Income Tax
No provision for income taxes has been required to be accrued because the Company is in a cumulative loss position for the periods presented.
The Company recorded a full valuation allowance against deferred tax assets of all its consolidated entities because all entities were in a cumulative loss position as of March 31, 2025 and December 31, 2024. No unrecognized tax benefits and related interest and penalties were recorded in the periods presented.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
9. Loss Per Share
The following table presents the computation of the basic and diluted net loss per share ($ in thousands, except share and per share data):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2025 |
|
2024 |
|
|
|
|
|
|
|
|
|
|
|
|
| Numerator: |
|
|
|
|
|
|
|
| Net loss |
(48,438) |
|
|
(53,471) |
|
|
|
|
|
| Denominator: |
|
|
|
|
|
|
|
| Weighted average number of ordinary shares - basic and diluted |
1,080,825,300 |
|
|
973,145,760 |
|
|
|
|
|
| Net loss per share - basic and diluted |
(0.04) |
|
|
(0.05) |
|
|
|
|
|
As a result of the Company’s net loss in the first quarter of 2025 and 2024, 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, |
|
2025 |
|
2024 |
| Share options |
98,164,510 |
|
|
104,244,590 |
|
| Non-vested restricted shares |
32,537,760 |
|
|
29,893,540 |
|
10. Borrowings
The Company has debt arrangements with the Bank of China, SPD Bank, CMB, BOCOM, and Ningbo Bank to support its working capital needs in mainland China. The following table presents the Company’s short-term debt as of March 31, 2025 ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
interest rate per annum |
|
March 31, 2025 |
| Bank of China Working Capital Loans |
2.60 |
% |
|
48,132 |
|
| SPD Bank Working Capital Loans |
2.80 |
% |
|
41,793 |
|
| China Merchant Bank Working Capital Loans |
2.91 |
% |
|
34,799 |
|
| Bank of Communications Working Capital Loans |
2.75 |
% |
|
41,793 |
|
| Ningbo Bank Electronic Commercial Draft Discounting Agreement |
1.90 |
% |
|
6,888 |
|
| Total short-term debt |
2.72 |
% |
|
173,405 |
|
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 (“BOC HK”) pursuant to which BOC HK will provide standby letters of credit for loans of up to $100.0 million for a term of one year. In connection with this agreement, the Company paid a one-time, non-refundable fee of $0.7 million in the first quarter of 2024. In accordance with this agreement, the Company also maintained restricted deposits of $100.0 million, which are presented as restricted cash-current on the unaudited condensed consolidated balance sheet, to secure the standby letters of credit. On June 20, 2024 and January 22, 2025, upon the Company’s application, BOC HK provided standby letters of credit in favor of the Bank of China Pudong Development Zone Branch (“BOC Pudong Branch”) for $23.0 million and $27.0 million, respectively, which are or may become payable by the Company’s wholly-owned subsidiary, Zai Lab (Shanghai) Co., Ltd. (“Zai Lab Shanghai”). BOC HK and BOC Pudong Branch are collectively referred to as Bank of China.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
As of March 31, 2025, the aggregate principal amount outstanding was RMB345.5 million (approximately $48.1 million). Each working capital loan has a one-year term and is subject to a floating interest rate, which is subject to adjustment every six months.
SPD Bank Working Capital Loan Facility
On February 6, 2024, the Company entered into a maximum-amount guarantee contract with the Shanghai Pudong Development Bank Co., Ltd. Zhangjiang Hi-Tech Park Sub-Branch (“SPD Bank”) pursuant to which the Company will guarantee working capital loans of up to RMB300.0 million (approximately $42.0 million) from SPD Bank to Zai Lab Shanghai over a three-year period. As of March 31, 2025, the aggregate principal amount outstanding was RMB300.0 million (approximately $41.8 million). Each working capital loan has a one-year term and is subject to a fixed interest rate.
China Merchants Bank Working Capital Loan Facility
On July 5, 2024, the Company issued a maximum-amount irrevocable letter of guarantee to China Merchants Bank Co., Ltd., Shanghai Branch (“CMB”) pursuant to which the Company will guarantee working capital loans of up to RMB250.0 million (approximately $34.4 million) from CMB to Zai Lab Shanghai, and Zai Lab Shanghai entered into a Credit Agreement with CMB with respect to the RMB250.0 million facility. The credit facility will be available for one year. As of March 31, 2025, the aggregate principal amount outstanding was RMB249.8 million (approximately $34.8 million) under this debt facility. Each working capital loan has a one-year term and is subject to a floating interest rate, which is subject to adjustment every three months.
Bank of Communications Working Capital Loan Facility
On January 2, 2025, the Company entered into a guarantee contract with Bank of Communications Co., Ltd. Shanghai Zhangjiang Sub-Branch (“BOCOM”) pursuant to which the Company will guarantee working capital loans from BOCOM to Zai Lab Shanghai, and Zai Lab Shanghai entered into a working capital loan contract with BOCOM with respect to a revolving credit facility of up to RMB300.0 million (approximately $41.1 million). As of March 31, 2025, the aggregate principal amount outstanding was RMB300.0 million (approximately $41.8 million) under this debt facility. The working capital loan has a one-year term and is subject to a floating interest rate, which is subject to adjustment every three months.
Ningbo Bank Working Capital Loan Facility
On February 6, 2024, the Company’s wholly-owned subsidiary, Zai Lab (Suzhou) Co., Ltd. (“Zai Lab Suzhou”), entered into a maximum credit contract with Bank of Ningbo Co., Ltd. Suzhou Sub-branch (“Ningbo Bank”) as well as an Electronic Commercial Draft Discounting Master Agreement and Online Working Capital Loan Master Agreement (collectively, the “Ningbo Bank Agreements”). The Ningbo Bank Agreements permit Zai Lab Suzhou to utilize, including through discounting or working capital loan agreements and subject to the terms and conditions in related master agreements, up to RMB230.3 million (approximately $32.4 million), of which Zai Lab Suzhou is authorized to utilize up to RMB160.0 million (approximately $22.5 million). In March 2025, pursuant to the Ningbo Bank Agreements, Zai Lab Suzhou entered into an electronic commercial draft discounting agreement with Ningbo Bank, and discounted RMB49.4 million (approximately $6.9 million) of its intercompany receivables. The cash proceeds from the discounting arrangement were classified as short-term debt. The discounted bill has a 6-month term.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
11. Other Current Liabilities
The following table presents the Company’s other current liabilities ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2025 |
|
December 31, 2024 |
|
|
|
|
| Accrued payroll |
12,168 |
|
|
30,198 |
|
| Accrued professional service fee |
3,475 |
|
|
5,728 |
|
| Payables for purchase of property and equipment |
2,645 |
|
|
449 |
|
| Accrued rebate to distributors |
11,773 |
|
|
10,839 |
|
| Tax payables |
3,770 |
|
|
5,154 |
|
| Other (i) |
2,980 |
|
|
6,352 |
|
| Total |
36,811 |
|
|
58,720 |
|
(i)Other primarily includes accrued travel, business-related expenses, and advance payments from partners.
12. Related Party Transactions
In January 2025, the Company entered into a license agreement with Zenas BioPharma (HK) Limited (“Zenas”), pursuant to which the Company obtained a license under certain patents and know-how of Zenas to develop and commercialize products containing a differentiated humanized monoclonal antibody targeting IGF-1R as an active ingredient in Greater China. One of the members of the Company’s Board of Directors, Mr. Moulder, is also the Chairman of the Board of Directors and Chief Executive Officer of Zenas. The Company recorded a $10.0 million upfront fee into research and development expenses in the first quarter of 2025. As of March 31, 2025, the Company may be required to pay an additional aggregate amount of up to $117.0 million in development and sales-based milestones as well as certain royalties at tiered percentage rates ranging from high-single digits to mid-teens on annual net sales of the licensed products in the licensed territories.
13. Share-Based Compensation
During the first quarter of 2025, the Company granted share options to purchase up to 5,062,710 ordinary shares and restricted shares representing 1,825,540 ordinary shares under its equity incentive plans. The share options granted have a contractual term of ten years. Share options granted since April 2023 generally vest ratably over a four-year period, and share options granted prior to April 2023 generally vest ratably over a five-year period, with 25% or 20% of the awards vesting on each anniversary of the grant date, respectively, subject to continued employment/service with the Company on the vesting date. The restricted shares granted generally vest ratably over a specified period on the anniversary of the grant date, subject to continued employment/service with the Company on the vesting date. For a description of the Company’s equity incentive plans and more details on the terms of the share-based awards, see Note 15 of the 2024 Annual Report.
The following table presents the share-based compensation expense that has been reported in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss as follows ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2025 |
|
2024 |
|
|
|
|
|
|
|
|
|
|
|
|
| Selling, general and administrative |
10,226 |
|
|
11,036 |
|
|
|
|
|
| Research and development |
5,574 |
|
|
6,944 |
|
|
|
|
|
| Total |
15,800 |
|
|
17,980 |
|
|
|
|
|
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
As of March 31, 2025, there was unrecognized share-based compensation expense related to unvested share options and unvested restricted shares of $71.9 million and $69.0 million, respectively, which the Company expects to recognize over a weighted-average period of 2.60 years and 2.28 years, respectively.
14. License and Collaboration Agreements
The Company has entered into various license and collaboration agreements with third parties to develop and commercialize product candidates.
Significant License and Collaboration Arrangements
For a description of the material terms of the Company’s significant license and collaboration agreements, see Note 16 of the 2024 Annual Report. During the first quarter of 2025, the Company did not enter into any new significant license or collaboration agreements or incur any milestone fees under our existing significant license and collaboration agreements.
Other License and Collaboration Arrangements That Are Not Individually Significant
The Company recorded upfront fees of $20.0 million into research and development expenses in the first quarter of 2025 for license and collaboration agreements that are not individually significant.
15. Other (Expense) Income, Net
The following table presents the Company’s other income, net ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2025 |
|
2024 |
|
|
|
|
| Government grants |
16 |
|
|
2,791 |
|
|
|
|
|
| (Loss) Gain on equity investments with readily determinable fair value |
(1,912) |
|
|
4,889 |
|
|
|
|
|
| Other miscellaneous gain |
1,699 |
|
|
1,681 |
|
|
|
|
|
| Total |
(197) |
|
|
9,361 |
|
|
|
|
|
16. 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 2025 and 2024 because the Chinese subsidiaries had substantial losses during such periods.
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
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, 2025 and December 31, 2024, amounts restricted included the paid-in capital of the Company’s subsidiaries in mainland China and were $506.0 million.
17. Commitments and Contingencies
(a) Purchase Commitments
As of March 31, 2025, the Company’s commitments related to commercial manufacturing development and facilities construction and improvement activities that are contracted but not yet reflected in the unaudited condensed consolidated financial statements were $3.8 million and were expected to be incurred within one year.
(b) Legal Proceedings
The Company is not currently a party to any material legal proceedings.
(c) Indemnifications
In the normal course of business, the Company enters into agreements that indemnify others for certain liabilities that may arise in connection with a transaction or certain events and activities. To date, the Company has not paid any claims or been required to defend any action related to its indemnification obligations.
18. Segment Information
The Company operates as a single operating segment that is engaged in discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. A global research and development organization and a supply chain organization discover, develop, manufacture, and supply our products. A global commercial organization markets, distributes, and sells the products. The business is also supported by global corporate staff functions. The Company’s CODM is the Chief Executive Officer, who assesses performance and allocates resources based on the significant expenses and net income on a consolidated basis. The significant expenses that are regularly provided to the CODM include those amounts that are also reported on the consolidated statement of operations as well as below additional disaggregated measures. The CODM also reviews cash position (which are cash and cash equivalents, current restricted cash, and short-term investments) that are also reported on the consolidated balance sheets when making operating decisions. In accordance with ASC 280, the Company has only one reportable segment.
The following tables present disaggregated expenses that are regularly provided to the CODM:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2025 |
|
2024 |
| Personnel compensation and related costs |
|
24,079 |
|
|
28,008 |
|
| Licensing fees |
|
19,997 |
|
|
— |
|
| CROs/CMOs/Investigators expenses |
|
9,830 |
|
|
19,904 |
|
| Other costs |
|
6,823 |
|
|
6,733 |
|
| Total research and development expenses |
|
60,729 |
|
|
54,645 |
|
Zai Lab Limited
Notes to the unaudited condensed consolidated financial statements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2025 |
|
2024 |
| Clinical programs |
|
28,092 |
|
|
18,788 |
|
| Pre-Clinical programs |
|
3,314 |
|
|
2,049 |
|
| Unallocated research and development expenses |
|
29,323 |
|
|
33,808 |
|
| Total research and development expenses |
|
60,729 |
|
|
54,645 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2025 |
|
2024 |
| Personnel compensation and related costs |
|
40,643 |
|
|
45,894 |
|
| Other costs |
|
22,779 |
|
|
23,300 |
|
| Total selling, general, and administrative expenses |
|
63,422 |
|
|
69,194 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
2025 |
|
2024 |
| Selling and marketing expenses |
|
41,939 |
|
|
43,594 |
|
| General and administrative expenses |
|
21,483 |
|
|
25,600 |
|
| Total selling, general, and administrative expenses |
|
63,422 |
|
|
69,194 |
|
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our 2024 Annual Report and our unaudited condensed consolidated financial statements and the accompanying notes for the first quarter of 2025 included in Item 1. Financial Statements.
Overview
We are a patient-focused, innovative, commercial-stage, global biopharmaceutical company with a substantial presence in both Greater China and the United States. We are focused on discovering, developing, and commercializing products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. We intend to leverage our competencies and resources to positively impact human health in Greater China and worldwide. We currently have seven commercial programs – ZEJULA,VYVGART / VYVGART Hytrulo, NUZYRA, OPTUNE, QINLOCK, XACDURO, and AUGTYRO – with products that have received marketing approval and that we have commercially launched in one or more territories in Greater China. We also have multiple programs in late-stage product development and a number of ongoing pivotal trials across our portfolio.
Since our inception, we have incurred net losses and negative cash flows from our operations. Substantially all of our losses have resulted from funding our research and development programs and selling, general and administrative costs associated with our operations. Developing high quality product candidates requires significant investment in our research and development activities over a prolonged period of time, and a core part of our strategy is to continue making sustained investments in this area. Our ability to generate profits and positive cash flow from operations depends upon our ability to successfully market our commercial products and to successfully expand the indications for these products and develop and commercialize our other product candidates. As discussed further below, we expect to continue to incur substantial costs related to our research and development and commercialization activities.
As we pursue our corporate strategic goals, we anticipate that our financial results will fluctuate from quarter to quarter and year to year depending in part on the balance between the success of our commercial products and the level of our research and development expenses. We cannot predict whether or when our product candidates will receive regulatory approval. Further, if we receive such regulatory approval, we cannot predict whether or when we may be able to successfully commercialize such products or whether or when such products may become profitable.
Recent Developments
Commercial Products
Net product revenue was $105.7 million for the first quarter of 2025, an increase of 21% compared to the prior year period, primarily driven by increased sales for NUZYRA, VYVGART, and ZEJULA. Increased sales for these products were supported by increased patient access supported by their listings in the NRDL.
Product Candidates
We continued to advance our product candidates through our research and development activities, including the following developments with respect to our clinical trials and regulatory approvals:
Oncology
•ZL-1310 (DLL3 ADC): In April 2025, we initiated a global Phase I/II study in patients with selected solid neuroendocrine tumors, allowing us to evaluate its therapeutic potential beyond ES-SCLC.
•Tisotumab Vedotin (TIVDAK, Tissue Factor ADC): In March 2025, China’s NMPA accepted the BLA for TIVDAK for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after systemic therapy. The BLA submission is supported by the results from the global, randomized, Phase III innovaTV 301 clinical trial and the results from the China subpopulation of this study. As reported in January 2025, the China subpopulation results were consistent with those in the global population. TIVDAK demonstrated a 45% reduction in the risk of death compared to chemotherapy.
•Repotrectinib: In April 2025, China’s NMPA accepted the supplemental NDA for repotrectinib for the treatment of adult patients with NTRK+ solid tumors. The application is intended for patients whose disease is locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity, and who have either progressed following prior therapies or have no satisfactory alternative treatment options.
•ZL-6201 (LRRC15 ADC): In April 2025, we presented new data at the AACR Annual Meeting 2025 reflecting that ZL-6201 efficiently internalizes within and kills tumor cells, while also exhibiting a strong bystander killing effect in the tumor microenvironment. Based on these findings, we plan to initiate IND-enabling studies of ZL-6201 as a potential treatment for patients with sarcoma and other LRRC15-positive solid tumors, such as breast cancer and other malignancies, in 2025.
•ZL-1222 (PD-1 / IL-12): In April 2025, we presented data at the AACR Annual Meeting 2025, marking the first public disclosure of this global asset. Findings from the pre-clinical studies demonstrate its potent antitumor activity in both anti-PD-1 sensitive and -resistant tumor models, with improved systemic safety. These results indicate its potential to benefit patients who are unresponsive or resistant to the current immune-oncology therapies.
Immunology, Neuroscience, and Infectious Disease
•Efgartigimod (FcRn): In April 2025, our partner argenx announced that the FDA had approved VYVGART Hytrulo prefilled syringe (PFS) for self-injection in gMG and CIDP. PFS is the third approved administration option for efgartigimod, providing additional flexibility and convenience for patients. Zai Lab plans to submit for Chemical Manufacturing and Control (CMC) variation for PFS for these indications in China in 2025.
•KarXT: In January 2025, the NMPA accepted the NDA for KarXT for the treatment of schizophrenia. The NDA submission was supported by data from the Phase I PK study, Phase III China study, the global Phase III EMERGENT-2 and EMERGENT-3 clinical trials, and long-term follow-up results. This follows FDA approval of KarXT, under the brand name COBENFY, for the treatment of schizophrenia in adults in September 2024. COBENFY does not have atypical antipsychotic class warnings and precautions and does not have a boxed warning.
•ZL-1102 (IL-17 Humabody®): We have decided to discontinue the global Phase II clinical trial of ZL-1102 following a comprehensive review of interim analysis from the first 40 enrolled participants, and the subsequent recommendation of the independent Data and Safety Monitoring Board.
•Povetacicept (APRIL/BAFF): Our partner Vertex has completed enrollment of the interim analysis cohort in the global Phase III RAINIER study of povetacicept in IgA nephropathy. Zai Lab participated in the study in Greater China.
Factors Affecting Our Results of Operations
Our Commercial Products
We generate product revenue through the sale of our commercial products in Greater China, net of any related sales returns and rebates to distributors. Our cost of product revenue mainly consists of the costs of manufacturing ZEJULA and NUZYRA; costs of purchasing VYVGART / VYVGART Hytrulo, OPTUNE, QINLOCK, XACDURO, and AUGTYRO from our collaboration partners; any royalty fees incurred as a result of sales of our commercial products under our license and collaboration agreements; and amortization of capitalized post-approval milestone fees incurred under our license and collaboration agreements. We expect our product revenue to increase in coming years as we continue to focus on increasing patient access to our existing commercial products, such as through NRDL listing or increased supplemental insurance coverage in the private-pay market, and as we launch additional commercial products, if and when we obtain required regulatory approvals. We expect our cost of product revenue to increase as the volume of products sold increases.
Research and Development Expenses
We believe our ability to successfully develop product candidates will be the primary factor affecting our long-term competitiveness, as well as our future growth and development. Developing high quality product candidates requires a significant investment of resources over a prolonged period of time. We are committed to advancing and expanding our pipeline of potential best-in-class and first-in-class products, such as through clinical and pre-clinical trials and business development activities. As a result, we expect to continue making significant investments in research and development, including internal discovery activities.
Elements of research and development expenditures primarily include:
•payroll and other related costs of personnel engaged in research and development activities;
•fees for exclusive development rights of products granted to the Company;
•costs related to pre-clinical testing of the Company’s technologies and clinical trials, such as payments to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”), investigators, and clinical trial sites that conduct our clinical studies; and
•costs to produce the product candidates, including raw materials and supplies, product testing, depreciation, and facility-related expenses.
Selling, General, and Administrative Expenses
Our selling, general, and administrative expenses consist primarily of personnel compensation and related costs, including share-based compensation for commercial and administrative personnel. Other selling, general, and administrative expenses include product distribution and promotion costs, and professional service fees for legal, intellectual property, consulting, auditing, and tax services as well as other direct and allocated expenses for rent and maintenance of facilities, insurance, and other supplies used in selling, general, and administrative activities. We expect these costs to continue to be significant to support sales of our commercial products and preparation to launch and subsequent sales of additional product candidates if and when approved.
Our Ability to Commercialize Our Product Candidates
We have multiple product candidates in late-stage clinical development and various others in clinical and pre-clinical development in Greater China and globally. Our ability to generate revenue from our product candidates is dependent on our receipt of regulatory approvals for and successful commercialization of such product candidates, which may not occur. Certain of our product candidates may require additional pre-clinical and/or clinical development, regulatory approvals in multiple jurisdictions, manufacturing supply, and significant marketing efforts before we generate any revenue from product sales.
License and Collaboration Arrangements
Our results of operations have been, and will continue to be, affected by our license and collaboration agreements. In accordance with these agreements, we may be required to make upfront payments and milestone payments upon the achievement of certain development, regulatory, and sales-based milestones for the relevant products as well as certain royalties at tiered percentage rates based on annual net sales of the licensed products in the licensed territories. As of March 31, 2025, we may in the future be required to pay development and regulatory milestone payments of up to an additional aggregate amount of $247.5 million for our current clinical programs and $684.9 million for other programs. Such development and regulatory milestone payments are contingent on the progress of our product candidates prior to commercialization, and we see these payments as favorable because they indicate that product candidates are advancing. As of March 31, 2025, we also in the future may be required to pay sales-based milestone payments of up to an additional aggregate amount of $2,555.0 million as well as certain royalties at tiered percentage rates on annual net sales. Such sales-based milestone and royalty payments are contingent on the performance of our commercial products, and we see these payments as favorable because they signify that a product is achieving higher sales levels.
Results of Operations
In this section, we discuss our results of operations for the first quarter of 2025 compared to the first quarter of 2024.
The following table presents our results of operations ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
|
|
|
|
|
|
2025 |
|
2024 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
| Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Product revenue, net |
|
105,650 |
|
|
87,149 |
|
|
18,501 |
|
|
21 |
% |
|
|
|
|
|
|
|
|
| Collaboration revenue |
|
837 |
|
|
— |
|
|
837 |
|
|
NM |
|
|
|
|
|
|
|
|
| Total revenues |
|
106,487 |
|
|
87,149 |
|
|
19,338 |
|
|
22 |
% |
|
|
|
|
|
|
|
|
| Expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Cost of product revenue |
|
(38,452) |
|
|
(33,619) |
|
|
(4,833) |
|
|
14 |
% |
|
|
|
|
|
|
|
|
| Cost of collaboration revenue |
|
(195) |
|
|
— |
|
|
(195) |
|
|
NM |
|
|
|
|
|
|
|
|
| Research and development |
|
(60,729) |
|
|
(54,645) |
|
|
(6,084) |
|
|
11 |
% |
|
|
|
|
|
|
|
|
| Selling, general, and administrative |
|
(63,422) |
|
|
(69,194) |
|
|
5,772 |
|
|
(8) |
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Loss from operations |
|
(56,311) |
|
|
(70,309) |
|
|
13,998 |
|
|
(20) |
% |
|
|
|
|
|
|
|
|
| Interest income |
|
8,606 |
|
|
9,658 |
|
|
(1,052) |
|
|
(11) |
% |
|
|
|
|
|
|
|
|
| Interest expenses |
|
(1,187) |
|
|
(113) |
|
|
(1,074) |
|
|
NM |
|
|
|
|
|
|
|
|
| Foreign currency gains (losses) |
|
651 |
|
|
(2,068) |
|
|
2,719 |
|
|
(131) |
% |
|
|
|
|
|
|
|
|
| Other (expense) income, net |
|
(197) |
|
|
9,361 |
|
|
(9,558) |
|
|
(102) |
% |
|
|
|
|
|
|
|
|
| Loss before income tax |
|
(48,438) |
|
|
(53,471) |
|
|
5,033 |
|
|
(9) |
% |
|
|
|
|
|
|
|
|
| Income tax expense |
|
— |
|
|
— |
|
|
— |
|
|
— |
% |
|
|
|
|
|
|
|
|
| Net loss |
|
(48,438) |
|
|
(53,471) |
|
|
5,033 |
|
|
(9) |
% |
|
|
|
|
|
|
|
|
NM - Not Meaningful
Revenues
Product Revenue, Net
The following table presents net revenue by commercial program ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
|
|
|
|
|
|
2025 |
|
2024 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
| ZEJULA |
|
49,529 |
|
|
45,501 |
|
|
4,028 |
|
|
9 |
% |
|
|
|
|
|
|
|
|
| VYVGART / VYVGART Hytrulo |
|
18,105 |
|
|
13,162 |
|
|
4,943 |
|
|
38 |
% |
|
|
|
|
|
|
|
|
| NUZYRA |
|
15,118 |
|
|
9,913 |
|
|
5,205 |
|
|
53 |
% |
|
|
|
|
|
|
|
|
| OPTUNE |
|
11,363 |
|
|
12,480 |
|
|
(1,117) |
|
|
(9) |
% |
|
|
|
|
|
|
|
|
| QINLOCK |
|
8,509 |
|
|
6,093 |
|
|
2,416 |
|
|
40 |
% |
|
|
|
|
|
|
|
|
| XACDURO |
|
1,117 |
|
|
— |
|
|
1,117 |
|
|
NM |
|
|
|
|
|
|
|
|
| AUGTYRO |
|
1,626 |
|
|
— |
|
|
1,626 |
|
|
NM |
|
|
|
|
|
|
|
|
| Other (i) |
|
283 |
|
|
— |
|
|
283 |
|
|
NM |
|
|
|
|
|
|
|
|
| Total product revenue, net |
|
105,650 |
|
|
87,149 |
|
|
18,501 |
|
|
21 |
% |
|
|
|
|
|
|
|
|
(i)Other includes product candidates sold in patient programs prior to commercialization.
Our product revenue is primarily derived from the sales of our commercial products primarily in mainland China, net of sales returns and rebates to distributors with respect to the sales of these products.
Our net product revenue increased by $18.5 million in the first quarter of 2025, primarily driven by higher sales of VYVGART, driven by increasing market coverage and penetration since its NRDL listing in January 2024 for the treatment of gMG; ZEJULA, which continued to deliver strong sales as the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China; and NUZYRA, supported by increasing market coverage and penetration.
Cost of Product Revenue
Cost of product revenue increased by $4.8 million in the first quarter of 2025 primarily due to increasing sales volumes.
Collaboration Revenue and Cost of Collaboration Revenue
In the first quarter of 2025, collaboration revenue related to promotional activities in mainland China was $0.8 million and cost of collaboration revenue was $0.2 million. We had no such collaboration revenue in the first quarter of 2024.
Research and Development Expenses
The following table presents the components of our research and development expenses ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
|
|
|
|
|
|
2025 |
|
2024 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Personnel compensation and related costs |
|
24,079 |
|
|
28,008 |
|
|
(3,929) |
|
|
(14) |
% |
|
|
|
|
|
|
|
|
| Licensing fees |
|
19,997 |
|
|
— |
|
|
19,997 |
|
|
NM |
|
|
|
|
|
|
|
|
| CROs/CMOs/Investigators expenses |
|
9,830 |
|
|
19,904 |
|
|
(10,074) |
|
|
(51) |
% |
|
|
|
|
|
|
|
|
| Other costs |
|
6,823 |
|
|
6,733 |
|
|
90 |
|
|
1 |
% |
|
|
|
|
|
|
|
|
| Total |
|
60,729 |
|
|
54,645 |
|
|
6,084 |
|
|
11 |
% |
|
|
|
|
|
|
|
|
NM - Not Meaningful
Research and development expenses increased by $6.1 million in the first quarter of 2025, primarily due to:
•an increase of $20.0 million upfront fees for our license and collaboration agreements; partially offset by
•a decrease of $10.0 million in CROs/CMOs/Investigators expenses and other costs related to ongoing clinical trials; and
•a decrease of $3.9 million in personnel compensation and related costs primarily driven by the Company’s resource prioritization and efficiency efforts.
The following table presents our research and development expenses by program ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
|
|
|
|
|
|
2025 |
|
2024 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
| Clinical programs |
|
28,092 |
|
|
18,788 |
|
|
9,304 |
|
|
50 |
% |
|
|
|
|
|
|
|
|
Pre-Clinical programs |
|
3,314 |
|
|
2,049 |
|
|
1,265 |
|
|
62 |
% |
|
|
|
|
|
|
|
|
| Unallocated research and development expenses |
|
29,323 |
|
|
33,808 |
|
|
(4,485) |
|
|
(13) |
% |
|
|
|
|
|
|
|
|
| Total |
|
60,729 |
|
|
54,645 |
|
|
6,084 |
|
|
11 |
% |
|
|
|
|
|
|
|
|
Research and development expenses attributable to clinical programs increased by $9.3 million in the first quarter of 2025 primarily driven by an increase of $20.0 million in licensing fees, offset by a decrease of $10.7 million in CROs/CMOs/Investigators expenses related to the progress of existing studies. Research and development expenses attributable to pre-clinical programs increased by $1.3 million in the first quarter of 2025 primarily driven by an increase of CROs/CMOs/Investigators expenses related to newly initiated studies and progress of existing studies.
Although we manage our external research and development expenses by program, we do not allocate our internal research and development expenses by program because our employees and internal resources may be engaged in projects for multiple programs at any given time.
Selling, General, and Administrative Expenses
The following table presents our selling, general and administrative expenses by category ($ in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
|
|
|
|
|
|
2025 |
|
2024 |
|
$ |
|
% |
|
|
|
|
|
|
|
|
| Personnel compensation and related costs |
|
40,643 |
|
|
45,894 |
|
|
(5,251) |
|
|
(11) |
% |
|
|
|
|
|
|
|
|
| Other costs |
|
22,779 |
|
|
23,300 |
|
|
(521) |
|
|
(2) |
% |
|
|
|
|
|
|
|
|
| Total |
|
63,422 |
|
|
69,194 |
|
|
(5,772) |
|
|
(8) |
% |
|
|
|
|
|
|
|
|
Selling, general, and administrative expenses decreased by $5.8 million in the first quarter of 2025, primarily due to a decrease of $5.3 million in personnel compensation and related costs related to the Company’s resource prioritization and efficiency efforts.
Interest Income
Interest income decreased by $1.1 million in the first quarter of 2025 primarily due to decreased interest rates.
Interest Expenses
Interest expense increased by $1.1 million in the first quarter of 2025 primarily due to increased short-term debts.
Foreign Currency Gains (Losses)
Foreign currency gain was $0.7 million in the first quarter of 2025, primarily driven by remeasurement gain due to appreciation of the RMB against the U.S. dollar, compared to foreign currency losses of $2.1 million in the first quarter of 2024, driven by remeasurement losses due to depreciation of the RMB against the U.S. dollar.
Other (Expense) Income, Net
Other expense, net was $0.2 million in the first quarter of 2025, compared to other income, net of $9.4 million in the first quarter of 2024, primarily due to the shift from a gain of $4.9 million in the first quarter of 2024 to a loss of $1.9 million in the first quarter of 2025 for our equity investment in MacroGenics, Inc. as a result of changes in its stock price, and a decrease of $2.8 million in government grants.
Income Tax Expense
Income tax expense was nil in both the first quarter of 2025 and 2024.
Net Loss
Net loss was $48.4 million in the first quarter of 2025, or a loss per ordinary share attributable to common stockholders of $0.04 (or loss per ADS of $0.45), compared to a net loss of $53.5 million in the first quarter of 2024, or a loss per ordinary share of $0.05 (or loss per ADS of $0.55).
Critical Accounting Policies and Significant Judgments and Estimates
We prepare our financial statements in conformity with U.S. GAAP, which requires management to make judgments, estimates, and assumptions that affect the reported amounts of assets, liabilities, revenues, expenses, and related disclosures. Some of those judgments can be subjective and complex. Actual results could differ from our estimates.
Our most critical accounting policies and estimates, including those that require the most difficult, subjective, or complex judgments and are the most inherently uncertain, are described below.
Revenue Recognition
We sell our products to distributors (our customers), who ultimately sell the products to healthcare providers, primarily in mainland China. We recognize revenue when the performance obligations are satisfied upon the product’s delivery to distributors.
We offer rebates to our distributors to compensate the distributors consistent with pharmaceutical industry practices. We are required to establish a provision for rebates in the same period the related product sales are recognized. The estimated amount of rebates, if any, is recorded as a reduction of revenue.
Significant judgments are required in making these estimates. In determining the appropriate accrual amount, we consider our contracted rates, sales volumes, levels of distributor inventories, and historical experiences and trends. If actual results vary from our estimates or our expectations change, we will adjust these estimates accordingly, which would affect net product revenue and earnings in the period such variances become expected or known.
Research and Development Expenses
We have a significant amount of research and development expenses, including with respect to pre-clinical and clinical trials for our product candidates. Such costs are expensed as incurred when they have no alternative future uses.
We contract with third parties to perform various pre-clinical and clinical trial activities on our behalf in the ongoing development of our product candidates. Expenses related to pre-clinical and clinical trial activities are accrued based on the Company’s estimates of the actual services performed by the third parties, such as CROs and CMOs.
Significant judgments are required in estimating the actual services performed by the third parties for the respective period and the related expense accruals. In determining the appropriate accrual, we consider a variety of factors, including contractual requirements with respect to services to be provided, related rates, and our assessment of services performed during the period and progress with respect to any contractual milestones when we have not yet been invoiced or otherwise notified by third parties of actual costs. If the actual status and timing of services performed vary from our estimates, our reported expenses and earnings for the corresponding period may be affected.
Share-Based Compensation
We grant share-based awards, including share options and restricted shares, to eligible employees, non-employees, and directors. Such share-based awards are measured at grant date fair value.
Significant assumptions are required in determining the fair value of share options, which we estimate using the Black-Scholes option valuation model. These assumptions include: (i) the volatility of our ADS price, (ii) the periods of time over which grantees are expected to hold their options prior to exercise (expected term), (iii) the expected dividend yield on our ADSs, and (iv) risk-free interest rates. Since we do not have sufficient historical information to develop reasonable expectations about future exercise patterns and post-vesting employment termination behavior, the expected term is derived from the average midpoint between the weighted average vesting and the contractual term, also known as the simplified method. The expected dividend yield is zero as we have never paid dividends and do not currently anticipate paying any in the foreseeable future, and risk-free interest rates are based on quoted U.S. Treasury rates for securities with maturities approximating the expected term. If actual results vary from our estimates or our expectations change, our reported expenses and earnings for the corresponding period may be affected.
Income Taxes
We recognize deferred tax assets and liabilities for temporary differences between the financial statement and income tax bases of assets and liabilities, which are measured using enacted tax rates and laws that will be in effect when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some or all of a deferred tax asset will not be realized.
Significant judgements are required when evaluating tax positions in accordance with ASC 740, Income Taxes.
We recognize in our financial statements the benefit of a tax position if the tax position is “more likely than not” to prevail based on the facts and technical merits of the position. Tax positions that meet the “more likely than not” recognition threshold are measured at the largest amount of tax benefit that has a greater than fifty percent likelihood of being realized upon settlement. We estimate our liability for unrecognized tax benefits which are periodically assessed and may be affected by changing interpretations of laws, rulings by tax authorities, changes and/or developments with respect to tax audits, and the expiration of the applicable statute of limitations. The ultimate outcome for a particular tax position may not be determined with certainty prior to the conclusion of a tax audit and, in some cases, appeal or litigation process.
We consider positive and negative evidence when determining whether some or all of our deferred tax assets will not be realized. This assessment considers various factors, including the nature, frequency, and severity of current and cumulative losses, forecasts of future profitability, the duration of statutory carry-forward periods, our historical results of operations, and our tax planning strategies. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the periods in which those temporary differences become deductible. Our estimates may be affected by changing interpretations of laws, rulings by tax authorities, changes and/or developments with respect to tax audits, and expiration of the statute of limitations. If actual benefits vary from our estimates or our expectations change, we will adjust the recognition and measurement estimates accordingly, which would affect reported expenses and earnings in the corresponding period.
Liquidity and Capital Resources
To date, we have financed our activities primarily through private placements, our September 2017 initial public offering and various follow-on offerings on Nasdaq, and our September 2020 secondary listing and initial public offering on the Hong Kong Stock Exchange. In addition, we have raised approximately $164.6 million in private equity financing and approximately $2,677.8 million in net proceeds after deducting underwriting commissions and the offering expenses payable by us in our initial public offering and subsequent follow-on offerings on Nasdaq and our initial public offering on the Hong Kong Stock Exchange. Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was $61.7 million and $90.1 million in the first quarter of 2025 and 2024, respectively. For information on our research and development activities and related expenditures, see the Research and Development Expenses, Selling, General, and Administrative Expenses, License and Collaboration Arrangements, and Results of Operations sections above. In addition, as of March 31, 2025, we had commitments for capital expenditures of $3.8 million mainly for the purpose of commercial manufacturing development, and facilities construction and improvement activities.
As of March 31, 2025, we had cash and cash equivalents, current restricted cash, and short-term investments of $857.3 million, which we expect will enable us to meet our cash requirements including the funding of operating expenses, capital expenditures, and debt obligations for at least the next 12 months.
Although we believe that we have sufficient capital to fund our operations for at least the next twelve months, we may, from time to time, identify opportunities to access capital through debt arrangements on favorable commercial terms. As of March 31, 2025, we had such debt arrangements with Chinese financial institutions that allow certain of our subsidiaries to borrow up to approximately $240.2 million (or RMB1,721.7 million) to support our working capital needs in mainland China. As of March 31, 2025, we had short-term debt outstanding of $173.4 million (or RMB1,244.7 million) pursuant to these debt arrangements. These debt arrangements will provide us with additional capital capacity that gives us enhanced flexibility to execute on our corporate strategic goals. For more information, see Note 10.
We may consider, or we may ultimately need, additional funding sources to bring to fruition our strategic objectives, and there can be no assurances that such funding will be made available to us on acceptable terms or at all.
The following table presents information regarding our cash flows ($ in thousands):
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Three Months Ended
March 31, |
|
Change |
|
|
2025 |
|
2024 |
|
$ |
| Net cash used in operating activities |
|
(61,699) |
|
|
(90,106) |
|
|
28,407 |
|
| Net cash provided by investing activities |
|
326,133 |
|
|
3,292 |
|
|
322,841 |
|
| Net cash provided by financing activities |
|
43,141 |
|
|
47,548 |
|
|
(4,407) |
|
| Effect of foreign exchange rate changes on cash, cash equivalents and restricted cash |
|
20 |
|
|
(104) |
|
|
124 |
|
| Net increase (decrease) in cash, cash equivalents and restricted cash |
|
307,595 |
|
|
(39,370) |
|
|
346,965 |
|
Net Cash Used in Operating Activities
Net cash used in operating activities decreased by $28.4 million in the first quarter of 2025, primarily due to an increase of $22.2 million in net changes in operating assets and liabilities, a decrease of $5.0 million in net loss, and an increase of $1.1 million in adjustments to reconcile net loss to net cash used in operating activities.
Net Cash Provided by Investing Activities
Net cash provided by investing activities increased by $322.8 million in the first quarter of 2025, primarily due to an increase of $313.7 million in proceeds from the maturity of short-term investments and a decrease of $9.7 million from acquisition of intangible assets, partially offset by an increase of $0.6 million in purchases of property and equipment.
Net Cash Provided by Financing Activities
Net cash provided by financing activities decreased by $4.4 million in the first quarter of 2025, primarily due to $60.9 million in repayment of short-term bank borrowings and $0.9 million in payments of public offering costs, partially offset by $54.3 million increased in short-term debt proceeds and an increase of $3.0 million in proceeds from exercises of stock options.
Recently Issued Accounting Standards
For more information regarding recently issued accounting standards, see Part II – Item 8. Financial Statements and Supplementary Data – Recent Accounting Pronouncements in our 2024 Annual Report.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to market risk including foreign exchange risk, credit risk, and interest rate risk.
Foreign Exchange Risk
Renminbi, or RMB, is not a freely convertible currency. The State Administration of Foreign Exchange, under the authority of the People’s Bank of China (“PBOC”), controls the conversion of RMB into foreign currencies. The value of RMB is subject to changes in central government policies and to international economic and political developments affecting supply and demand in the China Foreign Exchange Trading System market. The cash and cash equivalents of the Company included aggregated amounts of $21.2 million and $19.0 million, which were denominated in RMB, representing 3% and 4% of the cash and cash equivalents as of March 31, 2025 and December 31, 2024, respectively.
While our financial statements are presented in U.S. dollars, our business mainly operates in mainland China with a significant portion of our transactions settled in RMB, and as such, we do not believe that we currently have significant direct foreign exchange risk and have not used derivative financial instruments to hedge our exposure to such risk. Although, in general, our exposure to foreign exchange risk should be limited, the value of your investment in our ADSs and ordinary shares will be affected by the exchange rate between the U.S. dollar and the RMB and between the HK dollar and the RMB, respectively, because the value of our business is effectively denominated in RMB, while ADSs and ordinary shares are traded in U.S. dollars and HK dollars, respectively.
The value of the RMB against the U.S. dollar and other currencies may fluctuate and is affected by, among other things, changes in Greater China’s political and economic conditions. The conversion of RMB into foreign currencies, including U.S. dollars, has been based on rates set by the PBOC.
The value of our ADSs and our ordinary shares will be affected by the foreign exchange rates between U.S. dollars, HK dollars, and the RMB. For example, to the extent that we need to convert U.S. dollars or HK dollars into RMB for our operations or if any of our arrangements with other parties are denominated in U.S. dollars or HK dollars and need to be converted into RMB, appreciation of the RMB against the U.S. dollar or the HK dollar would have an adverse effect on the RMB amount we receive from the conversion. Conversely, if we decide to convert RMB into U.S. dollars or HK dollars for the purpose of making payments for dividends on ordinary shares or ADSs or for other business purposes, appreciation of the U.S. dollar or the HK dollar against the RMB would have a negative effect on the conversion amounts available to us.
Since 1983, the Hong Kong Monetary Authority (“HKMA”) has pegged the HK dollar to the U.S. dollar at the rate of approximately HK$7.80 to US$1.00. However, there is no assurance that the HK dollar will continue to be pegged to the U.S. dollar or that the HK dollar conversion rate will remain at HK$7.80 to US$1.00. If the HK dollar conversion rate against the U.S. dollar changes and the value of the HK dollar depreciates against the U.S. dollar, our assets denominated in HK dollars will be adversely affected. Additionally, if the HKMA were to repeg the HK dollar to, for example, the RMB rather than the U.S. dollar, or otherwise restrict the conversion of HK dollars into other currencies, then our assets denominated in HK dollars will be adversely affected.
Credit Risk
Financial instruments that are potentially subject to significant concentration of credit risk consist of cash and cash equivalents, restricted cash, short-term investments, accounts receivable, and notes receivable.
The carrying amounts of cash and cash equivalents and short-term investments represent the maximum amount of losses due to credit risk. As of March 31, 2025 and December 31, 2024, we had cash and cash equivalents of $757.3 million and $449.7 million, respectively, restricted cash of $101.1 million and $101.1 million, respectively, and short-term investments of nil and $330.0 million, respectively. As of March 31, 2025 and December 31, 2024, all of our cash and cash equivalents, restricted cash, and short-term investments were held by major financial institutions located in mainland China and international financial institutions outside of mainland China which we believe are of high credit quality and for which we monitor continued credit worthiness.
Accounts receivable are typically unsecured and are derived from product revenue. We manage credit risk related to our accounts receivable through ongoing monitoring of outstanding balances and limiting the amount of credit extended based upon payment history and credit worthiness. Historically, we have collected receivables from customers within the credit terms with no significant credit losses incurred. As of March 31, 2025, our two largest customers accounted for approximately 20% of our total accounts receivable collectively.
Certain accounts receivable balances are settled in the form of notes receivable. As of March 31, 2025, such notes receivable included bank acceptance promissory notes that are non-interest bearing and due within six months. These notes receivable were used to collect the receivables based on an administrative convenience, given these notes are readily convertible to known amounts of cash. In accordance with the sales agreements, whether to use cash or bank acceptance promissory notes to settle the receivables is at our discretion, and this selection does not impact the agreed contractual purchase prices.
Interest Rate Risk
We are exposed to risks related to changes in interest rates on our cash and cash equivalents, restricted cash, and short-term investments. As of March 31, 2025 and December 31, 2024, we had cash and cash equivalents of $757.3 million and $449.7 million, respectively, restricted cash of $101.1 million and $101.1 million, respectively, and short-term investments of nil and $330.0, respectively. Our investment portfolio, which relates to cash equivalents and short-term investments, primarily consists of time deposits. The primary objectives of our investment activities are to preserve principal, provide liquidity, and maximize income without significantly increasing risk. Given the short‑term nature of our deposits and investments, we believe that a sudden change in market interest rates would not be expected to have a material impact on our financial condition and/or results of operation.
For example, a hypothetical 10% relative change in interest rates during any of the periods presented would not have a material impact on future interest income.
We are also exposed to risks related to changes in interest rates on our short-term debt, which is currently subject to a mix of fixed and floating interest rates. As of March 31, 2025 and December 31, 2024, we had short-term debt of $173.4 million and $131.7 million, respectively. A 100-basis point increase in interest rates would not materially increase our interest expense. Our interest rate exposure from short-term debt is also offset by our exposure in cash and cash equivalents, restricted cash, and short-term investments, as discussed above. For more information on our short-term debt, see Note 10.
Item 4. Controls and Procedures
Management’s Evaluation of Our Disclosure Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, performed an evaluation of the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rule 13a-15(e)) as of the end of the period covered by this report. Our disclosure controls and procedures are designed to ensure that the information required to be disclosed in the reports that we file or furnish under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow timely decisions regarding required disclosure. Any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objective. Based upon that evaluation, our management has concluded that, as of March 31, 2025, our disclosure controls and procedures were effective.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting (as such item is defined in Rules 13a-15(f)) during the fiscal quarter ended March 31, 2025 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
We may be, from time to time, subject to claims and suits arising in the ordinary course of business. We are not currently a party to any material legal or administrative proceedings.
Item 1A. Risk Factors.
We are subject to risks and uncertainties that could, directly or indirectly, adversely affect our business, results of operations, financial condition, liquidity, cash flows, strategies, and/or prospects. There have been no material changes in our risk factors from those disclosed in the “Risk Factors” section of our 2024 Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
None.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
Item 5. Other Information.
Other than as described below, during the first quarter of 2025, none of the Company’s directors or executive officers (as defined in Rule 16a-1(f) under the Exchange Act) has adopted, modified, or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement (each as defined in Item 408 of Regulation S-K).
On March 3, 2025, Yajing Chen, the Company’s Chief Financial Officer, adopted a new written Rule 10b5-1 trading arrangement for the sale of up to 15,494 ADSs. This Rule 10b5-1 trading arrangement is scheduled to terminate no later than March 4, 2026.
On March 4, 2025, William Lis, one of the Company’s directors, amended his written Rule 10b5-1 trading arrangement adopted on November 20, 2024. Mr. Lis increased the number of shares to be sold pursuant to the plan by 2,125 ADSs. This Rule 10b5-1 trading arrangement is scheduled to terminate no later than June 1, 2026.
Item 6. Exhibits.
Exhibit Index
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Exhibit
Number |
|
Exhibit Title |
| 10.1# |
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10.2+ |
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10.3+ |
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| 31.1 |
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| 31.2 |
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| 32.1 |
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| 32.2 |
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| 101.INS |
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Inline XBRL Instance Document-the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document |
| 101.SCH |
|
Inline XBRL Taxonomy Extension Schema Document |
| 101.CAL |
|
Inline XBRL Taxonomy Extension Calculation Linkbase Document |
| 101.LAB |
|
Inline XBRL Taxonomy Extension Label Linkbase Document |
| 101.PRE |
|
Inline XBRL Taxonomy Extension Presentation Linkbase Document |
| 101.DEF |
|
Inline XBRL Taxonomy Extension Definitions Linkbase Document |
| 104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101) |
# Management contract or compensatory plan, contract, or arrangement.
+ Portions of this exhibit have been redacted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
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ZAI LAB LIMITED |
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Dated: May 8, 2025 |
By: |
/s/ Yajing Chen |
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Name: |
Yajing Chen |
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Title: |
Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
EX-31.1
3
zlab-20250331x10qxexx311.htm
EX-31.1
Document
Exhibit 31.1
Certification by the Principal Executive Officer
Pursuant to Exchange Act Rule 13a-14(a),
As Adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Samantha (Ying) Du, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 of Zai Lab Limited;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 8, 2025 |
/s/ Samantha (Ying) Du |
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Samantha (Ying) Du |
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Chief Executive Officer |
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(Principal Executive Officer) |
EX-31.2
4
zlab-20250331x10qxexx312.htm
EX-31.2
Document
Exhibit 31.2
Certification by the Principal Financial Officer
Pursuant to Exchange Act Rule 13a-14(a),
As Adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Yajing Chen, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 of Zai Lab Limited;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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Date: May 8, 2025 |
/s/ Yajing Chen |
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Yajing Chen |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
EX-32.1
5
zlab-20250331x10qxexx321.htm
EX-32.1
Document
Exhibit 32.1
Certification by the Principal Executive Officer
Pursuant to 18 U.S.C. Section 1350,
As Adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 of Zai Lab Limited (the “Company”), as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Samantha (Ying) Du, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: May 8, 2025 |
/s/ Samantha (Ying) Du |
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Samantha (Ying) Du |
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Chief Executive Officer |
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(Principal Executive Officer) |
EX-32.2
6
zlab-20250331x10qxexx322.htm
EX-32.2
Document
Exhibit 32.2
Certification by the Principal Financial Officer
Pursuant to 18 U.S.C. Section 1350,
As Adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report on Form 10-Q for the quarter ended March 31, 2025 of Zai Lab Limited (the “Company”), as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Yajing Chen, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that to my knowledge:
(1)The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2)The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
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Date: May 8, 2025 |
/s/ Yajing Chen |
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Yajing Chen |
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Chief Financial Officer |
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(Principal Financial and Accounting Officer) |
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