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Q3 2025 revenue rose 14% year-over-year to $116.1M, led by Nuzyra and VYVGART, while profitability is now expected beyond Q4 due to a slower ramp in China. Zoci advanced to pivotal trials, and the pipeline remains robust with strong cash reserves supporting growth.
Based on Zai Lab Ltd. [9688] Q3 2025 Audio Transcript — Nov. 6 2025
3Q'25 revenues grew 14% year-over-year to $116.1M, driven by strong performance in VYVGART, NUZYRA, and OPTUNE, while ZEJULA stabilized after competitive pressures. Operational efficiency improved, losses narrowed, and a robust pipeline positions the company for multiple blockbuster launches in 2026-27.
Original document: Zai Lab Ltd. [9688] Slides Release — Nov. 6 2025
Q3 2025 saw 13% revenue growth to $115.4M, led by NUZYRA and XACDURO, with net loss narrowing to $36M. R&D expenses fell, cash reserves remained strong at $817M, and new credit facilities were secured to support ongoing pipeline and commercial expansion.
Original document: Zai Lab Ltd. [9688] SEC 10-Q Quarterly Report — Nov. 6 2025
Revenue grew 14% year-over-year to $116.1M in Q3 2025, with improved operating loss and strong cash reserves. Key pipeline advances include zoci's global study and KarXT's inclusion in China's schizophrenia guidelines. Full-year revenue guidance raised to at least $460M.
Original document: Zai Lab Ltd. [9688] SEC 8-K Current Report — Nov. 6 2025
Conference call and webcast today, November 6, 2025, at 8:00 a.m. ET (9:00 p.m. HKT)
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--November 06, 2025--
Zai Lab Limited (; ) today announced financial results for the third quarter of 2025, along with recent product highlights and corporate updates.
"Zai Lab is entering the next phase of our growth, powered by the rapid advancement of our global pipeline and supported by a commercially profitable and scalable business in China," said Dr. Samantha Du, Founder, Chairperson, and CEO of Zai Lab. "With zoci moving into pivotal development less than two years after IND and multiple differentiated global programs progressing in parallel, we are demonstrating the speed, scientific rigor, and global ambition of our R&D engine. At the same time, our commercial platform in China remains strong, with new products and indications — including KarXT, povetacicept and VYVGART — broadening our long-term growth profile. Together, we are building a company that will make a lasting difference for patients and create long-term value for our shareholders."
"This quarter, we continued to deepen the foundations of the VYVGART launch," said Josh Smiley, President and COO of Zai Lab. "In gMG, we are seeing steady new patient starts and increasing treatment duration, supported by updated treatment guidelines and real-world experience. While adoption is building gradually, physician confidence continues to grow and reinforces the long-term potential of VYVGART as a new standard of care in the treatment of this chronic disease. Looking ahead, we are preparing for our next expected launch for KarXT in schizophrenia. We remain focused on disciplined execution as we position for the significant opportunities ahead, supported by a growing regional business and a rapidly progressing, global pipeline."
(1) Refers to adjusted income (loss) from operations (non-GAAP), calculated as GAAP income (loss) from operations adjusted to exclude certain non-cash expenses, including depreciation, amortization, and share-based compensation. For additional information on this adjusted profitability measure, refer to the "Non-GAAP Measures" section.
Recent Pipeline Highlights
Below are key product updates since our last earnings release:
Oncology Pipeline
Immunology Pipeline
Third Quarter 2025 Financial Results
Anticipated Major Milestones in the Fourth Quarter of 2025 and Full Year 2026
Expected Clinical Developments and Data Readouts
Global Pipeline
Zocilurtatug Pelitecan (zoci, DLL3 ADC) (formerly ZL-1310)
ZL-1503 (IL-13/IL-31R)
ZL-6201 (LRRC15 ADC)
Upcoming Potential NMPA Submissions
Upcoming Potential NMPA Approvals
Regional Pipeline
Efgartigimod (FcRn)
Povetacicept (APRIL/BAFF)
VRDN-003 (anti-IGF-1R, subcutaneous)
Full-Year 2025 Outlook
Zai Lab is revising total revenue guidance for the full year 2025 to at least $460 million.
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, November 6, 2025, at 8:00 a.m. ET (9:00 p.m. HKT). Listeners may access the live webcast by visiting the Company's website at http://ir.zailaboratory.com. Participants must register in advance of the conference call.
Details of registration links are as follows:
All participants must use the link provided above to complete the online registration process in advance of the conference call. Dial-in details will be in the confirmation email which the participant will receive upon registering.
A replay will be available shortly after the call and can be accessed by visiting the Company's website.
About Zai Lab
Zai Lab Limited (; ) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States. We are focused on discovering, developing, and commercializing innovative products that address medical conditions with significant unmet needs in the areas of oncology, immunology, neuroscience, and infectious disease. Our goal is to leverage our competencies and resources to positively impact human health worldwide.
For additional information about Zai Lab, please visit www.zailaboratory.com or follow us at https://x.com/ZaiLab_Global.
Non-GAAP Measures
In addition to results presented in accordance with GAAP, we disclose growth rates that have been adjusted to exclude the impact of changes due to the translation of foreign currencies into U.S. dollars. We have also presented a measure of adjusted loss from operations that adjusts GAAP loss from operations to exclude the impact of certain non-cash expenses including depreciation, amortization, and share-based compensation, which we refer to as "profitability." These adjusted growth rates and adjusted loss from operations are non-GAAP financial measures. We believe that these non-GAAP financial measures are important for an understanding of the performance of our business operations and financial results and provide investors with an additional perspective on operational trends and greater transparency into our historical and projected operating performance. Although we believe the non-GAAP financial measures enhance investors' understanding of our business and performance, these non-GAAP financial measures should not be considered an exclusive alternative to the corresponding GAAP financial measures.
Zai Lab Forward-Looking Statements
This press release 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; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding our commercial products and launches, clinical stage products, revenue growth, profitability, and cash flow); 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; our future financial and operating results; and financial guidance, including with respect to our capital allocation and investment strategy and our expected path to profitability. All statements, other than statements of historical fact, included in this press release are forward-looking statements, and can be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "poised," "positioned," "possible," "potential," "will," "would," and other 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 press release 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 (1) our ability to successfully commercialize and generate revenue from our approved products; (2) our ability to obtain funding for our operations and business initiatives; (3) the results of our clinical and pre-clinical development of our product candidates; (4) the content and timing of decisions made by the relevant regulatory authorities regarding regulatory approvals of our product candidates; (5) risks related to doing business in China; and (6) other factors identified in our most recent annual and quarterly reports and in other reports we have filed with the U.S. Securities and Exchange Commission (SEC). 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 press release.
Our SEC filings can be found on our website at www.zailaboratory.com and on the SEC's website at www.SEC.gov.
Zai Lab Limited
Unaudited Condensed Consolidated Balance Sheets
(in thousands of U.S. dollars ($), except for number of shares and per
share data)
September 30, December 31,
2025 2024
-------------- ---------------
Assets
Current assets
Cash and cash equivalents 717,155 449,667
Restricted cash, current 100,000 100,000
Short-term investments -- 330,000
Accounts receivable (net of
allowance for credit losses of
$25 as of both September 30,
2025 and December 31, 2024,
respectively) 85,377 85,178
Notes receivable 19,628 4,233
Inventories, net 67,135 39,875
Prepayments and other current
assets 43,653 41,527
------------- ------------
Total current assets 1,032,948 1,050,480
Restricted cash, non-current 1,115 1,114
Property and equipment, net 48,868 47,961
Operating lease right-of-use
assets 15,751 21,496
Land use rights, net 2,852 2,907
Intangible assets, net 55,278 56,027
Other non-current assets 2,128 5,768
------------- ------------
Total assets 1,158,940 1,185,753
============= ============
Liabilities and shareholders' equity
Current liabilities
Accounts payable 99,706 100,906
Current operating lease
liabilities 5,496 8,048
Short-term debt 203,026 131,711
Other current liabilities 51,541 58,720
------------- ------------
Total current liabilities 359,769 299,385
------------- ------------
Deferred income 28,061 31,433
Non-current operating lease
liabilities 10,840 13,712
Other non-current liabilities 325 325
------------- ------------
Total liabilities 398,995 344,855
------------- ------------
Commitments and contingencies
Shareholders' equity
Ordinary shares (par
value of $0.000006 per
share; 5,000,000,000
shares authorized;
1,113,299,160 and
1,082,614,740 shares
issued as of September
30, 2025 and December
31, 2024,
respectively;
1,105,865,950 and
1,077,702,540 shares
outstanding as of
September 30, 2025 and
December 31, 2024,
respectively) 7 7
Additional paid-in
capital 3,327,557 3,264,295
Accumulated deficit (2,578,211) (2,453,083)
Accumulated other
comprehensive income 39,645 50,515
Treasury Stock (at
cost, 7,433,210 and
4,912,200 shares as of
September 30, 2025 and
December 31, 2024,
respectively) (29,053) (20,836)
------------- ------------
Total shareholders' equity 759,945 840,898
------------- ------------
Total liabilities and shareholders'
equity 1,158,940 1,185,753
============= ============
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Operations
(in thousands of $, except for number of shares and per share data)
Three Months Ended September Nine Months Ended September
30, 30,
---------------------------- ------------------------------
2025 2024 2025 2024
-------------- ------------ -------------- --------------
Revenues
Product revenue,
net 115,361 101,847 330,095 289,102
Collaboration
revenue 734 418 2,464 816
------------- ----------- ------------- -----------
Total revenues 116,095 102,265 332,559 289,918
Expenses
Cost of product
revenue (46,764) (36,569) (128,219) (105,336)
Cost of
collaboration
revenue (119) (348) (531) (433)
Research and
development (47,928) (65,982) (159,271) (182,252)
Selling,
general, and
administrative (70,106) (67,219) (204,566) (216,123)
------------- ----------- ------------- -----------
Loss from operations (48,822) (67,853) (160,028) (214,226)
Interest income 8,345 9,029 25,794 28,017
Interest
expenses (1,400) (745) (3,848) (1,350)
Foreign currency
gains 6,422 14,457 9,909 8,281
Other income
(expense), net (508) 3,441 3,045 3,859
------------- ----------- ------------- -----------
Loss before income tax (35,963) (41,671) (125,128) (175,419)
Income tax expense -- -- -- --
------------- ----------- ------------- -----------
Net loss (35,963) (41,671) (125,128) (175,419)
============= =========== ============= ===========
Loss per share - basic
and diluted (0.03) (0.04) (0.11) (0.18)
Weighted-average shares
used in calculating net
loss per ordinary share
- basic and diluted 1,102,072,680 981,687,390 1,091,690,340 976,941,030
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Comprehensive Loss
(in thousands of $)
Three Months Ended Nine Months Ended
September 30, September 30,
------------------------ -------------------------
2025 2024 2025 2024
----------- ----------- ------------ -----------
Net loss (35,963) (41,671) (125,128) (175,419)
Other
comprehensive
loss, net of
tax of nil:
Foreign
currency
translation
adjustments (6,703) (14,503) (10,870) (9,356)
------- ------- -------- --------
Comprehensive loss (42,666) (56,174) (135,998) (184,775)
Zai Lab Limited
Non-GAAP Measures
(unaudited)
($ in thousands)
Growth on a Constant Exchange Rate (CER) Basis
Three Months Ended Year over Year % Nine Months Ended Year over Year %
September 30, Growth September 30, Growth
------------------------ ------------------- -------------------- -------------------
As As
2025 2024 reported At CER* 2025 2024 reported At CER*
----------- ----------- ---------- ------- --------- --------- ---------- -------
Product
revenue,
net 115,361 101,847 13% 14% 330,095 289,102 14% 15%
Loss from
operations (48,822) (67,853) (28)% (28)% (160,028) (214,226) (25)% (25)%
* The growth rates at CER were calculated assuming the same foreign currency
exchange rates were in effect for the current and prior year periods.
Reconciliation of Loss from Operations (GAAP) to Adjusted Loss from Operations (Non-GAAP)
Three Months Ended September 30, Nine Months Ended September 30,
------------------------------------------------ -----------------------------------
2025 2024 2025 2024
----------------------- ----------------------- ---------------------- -----------
GAAP loss from
operations (48,822) (67,853) (160,028) (214,226)
Plus:
Depreciation
and
amortization
expenses 3,901 2,871 11,094 8,824
Plus:
Share-based
compensation 16,923 16,795 49,696 53,413
---------------------- ---------------------- --------------------- --------
Adjusted loss
from
operations (27,998) (48,187) (99,238) (151,989)
====================== ====================== ===================== ========
View source version on businesswire.com: https://www.businesswire.com/news/home/20251106957927/en/
CONTACT:
For more information, please contact:
Investor Relations:
Christine Chiou / Cyan Liu
+1 (917) 886-6929 / +86 195 3130 8895
christine.chiou1@zailaboratory.com / cyan.liu@zailaboratory.com
Media:
Shaun Maccoun / Xiaoyu Chen
+1 (415) 317-7255 / +86 185 0015 5011
shaun.maccoun@zailaboratory.com / xiaoyu.chen@zailaboratory.com
Phase 1 results for zocilurtatug pelitecan in small cell lung cancer showed a 68% ORR at 1.6 mg/kg, strong activity in patients with brain metastases, and a favorable safety profile. A global Phase 3 trial has started to further evaluate efficacy and safety.
Original document: Zai Lab Ltd. [9688] Press release — Oct. 24 2025
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