Zai Lab ZLAB
Zai Lab reports $46.14 million net loss for Q3 2026
- Form
- 10-Q
- Filed
- Importance
- Notable
- Accession
- 0001628280-26-070521
- Revenue of $108.21 million for the three months ended Sep 30, 2026
- Net loss of $46.14 million for the three months ended Sep 30, 2026
- Diluted EPS of -$0.04 for the three months ended Sep 30, 2026
- Cash and equivalents of $549.66 million as of Sep 30, 2026
Written from the 10-Q on EDGAR. Check the filing before you rely on it.
What changed
12 changes since the June 2026 10-Q
Compared with the 10-Q 0001628280-26-053793, filed Aug 6, 2026.
EPS up 20% from Jun 30
−$0.04, was −$0.05.
From the filings
Before
−$0.05Now
−$0.04Cash down 9.5% from Jun 30
$550M, was $608M.
From the filings
Before
$608MNow
$550MNet income up 9.2% from Jun 30
−$46.1M, was −$50.8M.
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Before
−$50.8MNow
−$46.1MRevenue up 1.8% from Jun 30
$108M, was $106M.
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$106MNow
$108M• Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC) (formerly ZL-1310): In October 2026, we presented…
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• Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC) (formerly ZL-1310): In October 2026, we presented promising data at the European Society for Medical Oncology Congress 2026 from the ongoing Phase 1 study evaluating zoci in combination with atezolizumab as a 1L treatment for ES-SCLC. At the selected zoci dose of 1.6 mg/kg, the zoci plus atezolizumab doublet achieved a confirmed objective response rate of 81.8% and an estimated 6-month progression-free survival rate of 81.9% among 33 efficacy evaluable patients in 1L ES-SCLC. Among the first 15 patients with at least six months of follow-up, who had a median follow-up of 10.0 months, median progression-free survival had not been reached. The doublet regimen was generally well tolerated, with 9.1% of patients experiencing Grade 3 or higher adverse events attributed to zoci and only one reported case of Grade 1 interstitial lung disease or pneumonitis. Based on the encouraging efficacy and favorable safety profile, Zai Lab is advancing the zoci 1.6 mg/kg plus atezolizumab doublet into a global Phase 3 study in 1L ES-SCLC.• ZL-1503 (IL-13/IL-31Rα): We expect to share initial first-in-human data from the single ascending dose…
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• ZL-1503 (IL-13/IL-31Rα): We expect to share initial first-in-human data from the single ascending dose (SAD) portion of the global Phase 1/1b study of ZL-1503 for atopic dermatitis in healthy volunteers at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting, taking place November 12–16, 2026. Findings will include pharmacokinetic data following single-dose administration, as well as pharmacodynamic data on atopic dermatitis-related biomarkers across a range of ZL-1503 doses. The presentation will also include initial safety and immunogenicity data. In August 2026, we initiated enrollment for a global Phase 1 intravenous-to-subcutaneous bioavailability bridging study.• Efgartigimod (FcRn): In August 2026, we and our partner argenx announced positive topline results from the…
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Now
• Efgartigimod (FcRn): In August 2026, we and our partner argenx announced positive topline results from the Phase 3 ALKIVIA study evaluating VYVGART Hytrulo in adults with autoimmune myositis. The study met its primary endpoint of mean Total Improvement Score at week 52 in the combined study population of immune-mediated necrotizing myopathy ("IMNM") and dermatomyositis ("DM") patients (p=0.0011). Patient improvements were observed early and sustained throughout the study, with a consistent treatment effect across IMNM and DM. We participated in the ALKIVIA study in Greater China.In October 2026, argenx announced that it will discontinue the Phase 3 UNITY study of efgartigimod SC in…
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In October 2026, argenx announced that it will discontinue the Phase 3 UNITY study of efgartigimod SC in adults with moderate-to-severe Sjögren's disease. The decision is based on a recommendation from an Independent Data Monitoring Committee to stop the study for futility following an interim analysis, having concluded that the UNITY study is unable to meet its primary endpoint. Safety was consistent with efgartigimod's established profile, and no new safety signals were identified.CROs/CMOs/Investigators expenses and other costs 33,132 26,389 6,743 26 % 82,306 71,207 11,099 16 %
Adds "and other costs 33,132 26,389 6,743 26"; drops "18,259 19,935 (1,676) (8)".
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Before
CROs/CMOs/Investigators expenses 18,259 19,935 (1,676) (8) % 37,800 29,765 8,035 27 %Now
CROs/CMOs/Investigators expenses and other costs 33,132 26,389 6,743 26 % 82,306 71,207 11,099 16 %Our operations have consumed substantial amounts of cash since inception.
Adds "$133.2"; drops "To date, we have financed".
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Before
To date, we have financed our activities primarily through private placements and public offerings, including 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. We have raised approximately $164.6 million in private equity financing and approximately $2,677.8 million in net proceeds from public offerings after deducting underwriting commissions and the offering expenses payable by us. Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was $75.3 million and $92.7 million in the six months ended June 30, 2026 and 2025, 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 June 30, 2026, we had commitments of $1.8 million related to commercial manufacturing development activities and capital expenditures.Now
Our operations have consumed substantial amounts of cash since inception. The net cash used in our operating activities was $133.2 million and $124.8 million in the nine months ended September 30, 2026 and 2025, 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 ofOperations sections above.
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Operations sections above. In addition, as of September 30, 2026, we had commitments of $0.7 million related to capital expenditures.As of September 30, 2026, we had cash and cash equivalents, current restricted cash, and short-term…
Adds "September"; drops "June".
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As of June 30, 2026, we had cash and cash equivalents, current restricted cash, and short-term investments of $717.5 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.Now
As of September 30, 2026, we had cash and cash equivalents, current restricted cash, and short-term investments of $659.7 million. Additionally, in October 2026, we entered into a securities purchase agreement with certain accredited investors and raised net proceeds of approximately $241.2 million from a private placement, after deducting placement agent fees and other offering expenses. We intend to use the net proceeds from this private placement to fund the development of pipeline assets and for working capital and other general corporate purposes. For more information, see Note 18. We believe we have sufficient capital to meet our cash requirements including the funding of operating expenses, capital expenditures, and debt obligations for at least the next 12 months.
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Section by section. Added words and removed words against the earlier filing.
Cover page 3 changes
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For the quarterly period ended June September 30, 2026
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As of July October 31, 2026, 1,122,662,280 1,124,448,350 ordinary shares of the registrant, par value $0.000006 per share, were outstanding, of which 430,452,680 506,386,050 ordinary shares were held in the form of American Depositary Shares.
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For the Second Third Quarter of 2026
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Financial Statements (Unaudited) 5 changes
Condensed Consolidated Balance Sheets as of June September 30, , 2026 and December 31, 2025
Condensed Consolidated Statements of Operations for the Three and Six Nine Months Ended June September 30, , 2026 and 2025
Condensed Consolidated Statements of Comprehensive Loss for the Three and Six Nine Months Ended June September 30, , 2026 and 2025
Condensed Consolidated Statements of Shareholders' Equity for the Three and Six Nine Months Ended June September 30, , 2026 and 2025
Condensed Consolidated Statements of Cash Flows for the Three and Six Nine Months Ended June September 30, , 2026 and 2025
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Financial statements 299 changes
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Notes receivable 3,395 12,169
Accounts receivable (net of allowance for credit losses of $ 20 19 and $ 31 as of June September 30, 2026 and December 31, 2025, respectively)
Notes receivable 10,102 12,169
Prepayments and other current assets 32,635 44,051 36,683
Total current assets 914,037 864,398 1,019,286
Restricted cash, non-current 1,118 1,119 1,116
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Operating lease right-of-use assets 16,159 14,897 19,152
Land use rights, net 2,883 2,884 2,853
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Deferred tax assets 4,848 6,481 3,390
Other non-current assets 3,543 2,738 3,054
Total assets 1,074,793 1,023,896 1,172,384
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Accounts payable 136,692 141,608
Accounts payable 120,246 141,608
Current operating lease liabilities 5,025 5,528 6,344
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Deferred income 27,500 27,333
Total liabilities 467,756 456,884
Total current liabilities 428,584 424,249 416,166
Deferred income 26,242 27,333
Non-current operating lease liabilities 11,447 9,556 13,385
Other non-current liabilities 225 570 —
Total liabilities 460,617 456,884
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Accumulated other comprehensive income 214 29,697
Ordinary shares (par value of $ 0.000006 per share; 5,000,000,000 shares authorized; 1,132,222,310 1,134,218,030 and 1,113,822,550 shares issued as of June September 30, 2026 and December 31, 2025, respectively; 1,122,445,390 1,124,322,530 and 1,106,389,340 shares outstanding as of June September 30, 2026 and December 31, 2025, respectively)
Additional paid-in capital 3,370,798 3,384,485 3,343,469
Accumulated deficit ( 2,730,461 2,776,597 ) ( 2,628,620 )
Accumulated other comprehensive (loss) income ( 10,861 ) 29,697
Treasury Stock (at cost, 9,776,920 9,895,500 and 7,433,210 shares as of June September 30, 2026 and December 31, 2025, respectively)
Total shareholders' equity 607,037 563,279 715,500
Total liabilities and shareholders' equity 1,074,793 1,023,896 1,172,384
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Three Months Ended June 30, Six Months Ended June 30,
Three Months Ended September 30, Nine Months Ended September 30,
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Total revenues 106,311 109,977 205,922 216,464
Cost of product revenue ( 48,162 ) ( 43,003 ) ( 86,477 ) ( 81,455 )
Research and development ( 61,766 ) ( 50,614 ) ( 127,357 ) ( 111,343 )
Selling, general, and administrative ( 72,872 ) ( 71,038 ) ( 137,942 ) ( 134,460 )
Loss from operations ( 76,489 ) ( 54,895 ) ( 145,874 ) ( 111,206 )
Interest income 5,879 8,843 12,326 17,449
Interest expenses ( 1,587 ) ( 1,262 ) ( 3,224 ) ( 2,449 )
Foreign currency gains 15,065 2,837 29,902 3,488
Other income, net 5,285 3,750 5,447 3,553
Loss before income tax ( 51,847 ) ( 40,727 ) ( 101,423 ) ( 89,165 )
Net loss ( 50,825 ) ( 40,727 ) ( 101,841 ) ( 89,165 )
Total revenues 108,208 116,095 314,130 332,559
Cost of product revenue ( 51,305 ) ( 46,764 ) ( 137,782 ) ( 128,219 )
Cost of collaboration revenue — ( 217 119 ) ( 20 ) ( 412 531 )
Research and development ( 49,810 ) ( 47,928 ) ( 177,167 ) ( 159,271 )
Selling, general, and administrative ( 70,071 ) ( 70,106 ) ( 208,013 ) ( 204,566 )
Loss from operations ( 62,978 ) ( 48,822 ) ( 208,852 ) ( 160,028 )
Interest income 5,731 8,345 18,057 25,794
Interest expenses ( 1,577 ) ( 1,400 ) ( 4,801 ) ( 3,848 )
Foreign currency gains 10,528 6,422 40,430 9,909
Other income (expense), net 288 ( 508 ) 5,735 3,045
Loss before income tax ( 48,008 ) ( 35,963 ) ( 149,431 ) ( 125,128 )
Income tax benefit (expense) 8
Net loss ( 46,136 ) ( 35,963 ) ( 147,977 ) ( 125,128 )
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Weighted-average shares used in calculating net loss per ordinary share - basic and diluted 1,116,973,380 1,091,933,150 1,112,208,460 1,086,413,130 1,123,397,940 1,102,072,680 1,116,916,210 1,091,690,340
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Three Months Ended June 30, Six Months Ended June 30,
Net loss ( 50,825 ) ( 40,727 ) ( 101,841 ) ( 89,165 )
Three Months Ended September 30, Nine Months Ended September 30,
Net loss ( 46,136 ) ( 35,963 ) ( 147,977 ) ( 125,128 )
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Foreign currency translation adjustments ( 14,891 ) ( 2,955 ) ( 29,483 ) ( 4,167 )
Comprehensive loss ( 65,716 ) ( 43,682 ) ( 131,324 ) ( 93,332 )
Foreign currency translation adjustments ( 11,075 ) ( 6,703 ) ( 40,558 ) ( 10,870 )
Comprehensive loss ( 57,211 ) ( 42,666 ) ( 188,535 ) ( 135,998 )
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(loss) income Treasury Stock Total
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Balance at June 30, 2026 1,132,222,310 7 3,370,798 ( 2,730,461 ) 214 ( 9,776,920 ) ( 33,521 ) 607,037 paid in capital Accumulated deficit Accumulated other comprehensive income Treasury Stock Total of
Issuance of ordinary shares upon vesting of restricted shares 455,990 0 0 — — — — —
Exercise of share options 1,539,730 0 2,688 — — — — 2,688
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation — — — — — ( 118,580 ) ( 234 ) ( 234 )
Share-based compensation — — 10,999 — — — — 10,999
Net loss — — — ( 46,136 ) — — — ( 46,136 )
Foreign currency translation — — — — ( 11,075 ) — — ( 11,075 )
Balance at September 30, 2026 1,134,218,030 7 3,384,485 ( 2,776,597 ) ( 10,861 ) ( 9,895,500 ) ( 33,755 ) 563,279 paid in capital Accumulated deficit Accumulated other comprehensive (loss) income Treasury Stock Total of
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Issuance of ordinary shares upon vesting of restricted shares 593,670 0 0 — — — — —
Exercise of share options 8,672,580 0 2,143 — — — — 2,143
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensation — — — — — ( 2,513,190 ) ( 8,190 ) ( 8,190 )
Share-based compensation — — 16,923 — — — — 16,923
Net loss — — — ( 35,963 ) — — — ( 35,963 )
Foreign currency translation — — — — ( 6,703 ) — — ( 6,703 )
Balance at September 30, 2025 1,113,299,160 7 3,327,557 ( 2,578,211 ) 39,645 ( 7,433,210 ) ( 29,053 ) 759,945
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and 219 more changes in the filing
MD&A 142 changes
You should read the following discussion and analysis of our financial condition and results of operations together with our 2025 Annual Report and our unaudited condensed consolidated financial statements and the accompanying notes for the three and six nine months ended June September 30, 2026 included in Item 1. Financial Statements .
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In June 2026, we launched KarXT in mainland China for the treatment of schizophrenia in adults. KarXT is the first schizophrenia therapy with a novel mechanism of action approved in over 70 years, offering a new approach to treating schizophrenia through selective activation of M1 and M4 muscarinic receptors. We are preparing to seek inclusion of KarXT in China's NRDL in 2027.
Net product revenue was $105.8 $107.6 million for the second third quarter of 2026, a decrease of 3% 7% compared to the prior year period, primarily driven by decreased revenue for ZEJULA, due to a shift in hospital utilization patterns following volume-based procurement for generic olaparib, OPTUNE, due to evolving competition in the glioblastoma market, and VYVGART, primarily due to a pricing adjustment related to NRDL renewal. These decreases were partially offset by increased sales for NUZYRA, supported by increased market coverage and penetration, increased sales for XACDURO, driven by strong patient demand and expanding hospital adoption but partially constrained by supply limitations, and increased sales for NUZYRA, supported by increased market coverage and penetration. KarXT, which was launched in June 2026.
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• Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC) (formerly ZL-1310): In April 2026, we presented compelling clinical data at the American Association for Cancer Research ("AACR") Annual Meeting 2026 demonstrating that zoci delivers rapid and robust intracranial responses in patients with previously treated ES-SCLC and brain metastases as measured by blinded independent assessment using mRANO-BM criteria, as well as promising data in patients with extrapulmonary NECs.
◦ SCLC with Brain Metastases : Zoci showed a 53.7% confirmed intracranial objective response rate with 62.5% (10/16) at the 1.6 mg/kg dose, including complete responses. Notably, responses were observed in patients without prior brain radiotherapy (9/15, 60%), highlighting the net drug effect on the intracranial lesions. Zoci was well tolerated, with Grade ≥3 treatment-related adverse events ("TRAEs") in 19.9% (27/136) of the overall population and in 16.4% (9/55) of patients who received 1.6 mg/kg.
◦ Extrapulmonary NECs : Encouraging activity was observed with a 38.2% confirmed objective response rate across extrapulmonary NECs of different primary origins. The safety profile in extrapulmonary NECs was consistent with that previously observed in SCLC with Grade ≥3 TRAEs in 15.2% of patients in Phase 1b. We are actively engaging with health authorities on a registrational plan for extrapulmonary NECs.
Combination Collaborations: In April 2026, we announced a global clinical trial collaboration with Amgen to evaluate zoci in combination with Amgen's IMDELLTRA ® (tarlatamab-dlle), a DLL3/CD3 bispecific T-cell engager, for ES-SCLC and a clinical collaboration with Boehringer Ingelheim to evaluate zoci in combination with obrixtamig, a DLL3/CD3 bispecific T-cell engager, for SCLC and other NECs. In April 2026, Amgen initiated enrollment in the global Phase 1b study (DeLLphi-313) evaluating zoci in combination with tarlatamab with or without anti-PD-L1 in patients with SCLC.
Regulatory Designations: In May 2026, we received Fast Track Designation from the FDA for zoci for the treatment of patients with extrapulmonary NECs. This is the second FDA Fast Track Designation for zoci. In June 2026, we received Orphan Drug Designation (ODD) from the EMA for zoci for the treatment of patients with pulmonary NECs, and in July 2026, we received ODD from the FDA for zoci for the treatment of NECs.
• TIVDAK (tisotumab vedotin): In June 2026, China's NMPA approved the BLA for TIVDAK for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. TIVDAK is the first ADC approved in China for this indication. TIVDAK demonstrated a statistically significant overall survival benefit in the global Phase 3 innovaTV 301 clinical trial, including in the trial's China subpopulation.
• Zocilurtatug Pelitecan (Zoci, DLL3-Targeting ADC) (formerly ZL-1310): In October 2026, we presented promising data at the European Society for Medical Oncology Congress 2026 from the ongoing Phase 1 study evaluating zoci in combination with atezolizumab as a 1L treatment for ES-SCLC. At the selected zoci dose of 1.6 mg/kg, the zoci plus atezolizumab doublet achieved a confirmed objective response rate of 81.8% and an estimated 6-month progression-free survival rate of 81.9% among 33 efficacy evaluable patients in 1L ES-SCLC. Among the first 15 patients with at least six months of follow-up, who had a median follow-up of 10.0 months, median progression-free survival had not been reached. The doublet regimen was generally well tolerated, with 9.1% of patients experiencing Grade 3 or higher adverse events attributed to zoci and only one reported case of Grade 1 interstitial lung disease or pneumonitis. Based on the encouraging efficacy and favorable safety profile, Zai Lab is advancing the zoci 1.6 mg/kg plus atezolizumab doublet into a global Phase 3 study in 1L ES-SCLC.
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• ZL-1503 (IL-13/IL-31Rα): In April 2026, we announced new data from a preclinical study of ZL-1503, demonstrating that our internally developed long-acting IL-13/IL-31Rα bispecific antibody may lead to sustained suppression of intense pruritus (itch) and inflammation caused by atopic diseases. The findings reinforce the potential of ZL-1503 to be a first-in-class treatment option for moderate-to-severe atopic dermatitis and other IL-13 and IL-31-driven diseases. A global Phase 1/1b study is ongoing, and we expect to report the first-in-human data from the global Phase 1 portion in the second half of 2026.
• Efgartigimod (FcRn): In May 2026, the FDA approved the supplemental BLA submitted by our partner argenx for VYVGART and VYVGART Hytrulo, expanding the label to include all serotypes of adult patients living with gMG — anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative. The approval is based on data from the Phase 3 ADAPT SERON study. We participated in the ADAPT SERON study in Greater China.
• Povetacicept (Pove, Anti-APRIL/BAFF): In June 2026, our partner Vertex announced that the FDA accepted its BLA submission for pove for accelerated approval in adults with IgAN, with a PDUFA target action date of November 30, 2026. We participated in the global Phase 3 RAINIER study in Greater China.
• Elegrobart (Anti-IGF-1R, SC): Viridian Therapeutics announced positive topline data from REVEAL-2, elegrobart's pivotal Phase 3 clinical trial for chronic TED, in May 2026. Elegrobart was generally well tolerated, and the trial met its primary endpoint with a highly statistically significant treatment effect. Both elegrobart Q4W and Q8W treatment arms achieved statistically significant and clinically meaningful 50% and 54% proptosis responder rates, respectively, versus 15% placebo at week 24. The Q4W treatment arm additionally provided meaningful diplopia benefit to patients with chronic TED. We have an exclusive license from Zenas BioPharma to develop and commercialize elegrobart in Greater China and are currently conducting a Phase 3 bridging study in the region.
Organizational Updates
During the second quarter, we continued to strengthen our business through key additions to our global leadership team. For example, in April 2026, we appointed Yizhe Wang, Ph.D., as Operating Partner, to strengthen our commercial capabilities and execution. Dr. Wang brings extensive experience in global oncology and immunology commercial operations, having led commercial teams across China, the U.S., and the U.K. at GSK and Eli Lilly.
In May 2026, Josh Smiley, President and Chief Operating Officer, departed the Company.
• ZL-1503 (IL-13/IL-31Rα): We expect to share initial first-in-human data from the single ascending dose (SAD) portion of the global Phase 1/1b study of ZL-1503 for atopic dermatitis in healthy volunteers at the American College of Allergy, Asthma & Immunology (ACAAI) 2026 Annual Scientific Meeting, taking place November 12–16, 2026. Findings will include pharmacokinetic data following single-dose administration, as well as pharmacodynamic data on atopic dermatitis-related biomarkers across a range of ZL-1503 doses. The presentation will also include initial safety and immunogenicity data. In August 2026, we initiated enrollment for a global Phase 1 intravenous-to-subcutaneous bioavailability bridging study.
• Efgartigimod (FcRn): In August 2026, we and our partner argenx announced positive topline results from the Phase 3 ALKIVIA study evaluating VYVGART Hytrulo in adults with autoimmune myositis. The study met its primary endpoint of mean Total Improvement Score at week 52 in the combined study population of immune-mediated necrotizing myopathy ("IMNM") and dermatomyositis ("DM") patients (p=0.0011). Patient improvements were observed early and sustained throughout the study, with a consistent treatment effect across IMNM and DM. We participated in the ALKIVIA study in Greater China.
In October 2026, argenx announced that it will discontinue the Phase 3 UNITY study of efgartigimod SC in adults with moderate-to-severe Sjögren's disease. The decision is based on a recommendation from an Independent Data Monitoring Committee to stop the study for futility following an interim analysis, having concluded that the UNITY study is unable to meet its primary endpoint. Safety was consistent with efgartigimod's established profile, and no new safety signals were identified.
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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 June September 30, 2026, we may in the future be required to pay development and regulatory milestone payments of up to an additional aggregate amount of $197.0 $231.0 million for our current clinical programs and $863.0 $421.0 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 June September 30, 2026, we also in the future may be required to pay sales-based milestone payments of up to an additional aggregate amount of $3,078.0 $2,351.0 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.
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In this section, we discuss our results of operations for the three and six nine months ended June September 30, 2026 compared to the same periods in 2025.
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Three Months Ended June 30, Change Six Months Ended June 30, Change
Product revenue, net 105,751 109,085 (3,334) (3) % 201,307 214,735 (13,428) (6) %
Collaboration revenue 560 892 (332) (37) % 4,615 1,729 2,886 167 %
Total revenues 106,311 109,977 (3,666) (3) % 205,922 216,464 (10,542) (5) %
Cost of product revenue (48,162) (43,003) (5,159) 12 % (86,477) (81,455) (5,022) 6 %
Cost of collaboration revenue — (217) 217 (100) % (20) (412) 392 (95) %
Research and development (61,766) (50,614) (11,152) 22 % (127,357) (111,343) (16,014) 14 %
Selling, general, and administrative (72,872) (71,038) (1,834) 3 % (137,942) (134,460) (3,482) 3 %
Loss from operations (76,489) (54,895) (21,594) 39 % (145,874) (111,206) (34,668) 31 %
Interest income 5,879 8,843 (2,964) (34) % 12,326 17,449 (5,123) (29) %
Interest expenses (1,587) (1,262) (325) 26 % (3,224) (2,449) (775) 32 %
Foreign currency gains 15,065 2,837 12,228 431 % 29,902 3,488 26,414 757 %
Other income, net 5,285 3,750 1,535 41 % 5,447 3,553 1,894 53 %
Loss before income tax (51,847) (40,727) (11,120) 27 % (101,423) (89,165) (12,258) 14 %
Income tax benefit (expense) 1,022 — 1,022 — % (418) — (418) — %
Net loss (50,825) (40,727) (10,098) 25 % (101,841) (89,165) (12,676) 14 %
Three Months Ended September 30, Change Nine Months Ended September 30, Change
Product revenue, net 107,648 115,361 (7,713) (7) % 308,955 330,095 (21,140) (6) %
Collaboration revenue 560 734 (174) (24) % 5,175 2,464 2,711 110 %
Total revenues 108,208 116,095 (7,887) (7) % 314,130 332,559 (18,429) (6) %
Cost of product revenue (51,305) (46,764) (4,541) 10 % (137,782) (128,219) (9,563) 7 %
Cost of collaboration revenue — (119) 119 (100) % (20) (531) 511 (96) %
Research and development (49,810) (47,928) (1,882) 4 % (177,167) (159,271) (17,896) 11 %
Selling, general, and administrative (70,071) (70,106) 35 — % (208,013) (204,566) (3,447) 2 %
Loss from operations (62,978) (48,822) (14,156) 29 % (208,852) (160,028) (48,824) 31 %
Interest income 5,731 8,345 (2,614) (31) % 18,057 25,794 (7,737) (30) %
Interest expenses (1,577) (1,400) (177) 13 % (4,801) (3,848) (953) 25 %
Foreign currency gains 10,528 6,422 4,106 64 % 40,430 9,909 30,521 308 %
Other income (expense), net 288 (508) 796 (157) % 5,735 3,045 2,690 88 %
Loss before income tax (48,008) (35,963) (12,045) 33 % (149,431) (125,128) (24,303) 19 %
Income tax benefit 1,872 — 1,872 NM 1,454 — 1,454 NM
Net loss (46,136) (35,963) (10,173) 28 % (147,977) (125,128) (22,849) 18 %
2 unchanged paragraphs
Three Months Ended June 30, Change Six Months Ended June 30, Change
ZEJULA 32,079 41,042 (8,963) (22) % 62,046 90,571 (28,525) (31) %
VYVGART / VYVGART Hytrulo 23,866 26,497 (2,631) (10) % 41,417 44,602 (3,185) (7) %
NUZYRA 17,097 14,292 2,805 20 % 33,359 29,410 3,949 13 %
OPTUNE 12,202 12,355 (153) (1) % 24,272 23,718 554 2 %
QINLOCK 9,590 8,536 1,054 12 % 18,575 17,045 1,530 9 %
XACDURO 7,957 4,622 3,335 72 % 16,529 5,739 10,790 188 %
AUGTYRO 2,213 1,399 814 58 % 4,005 3,025 980 32 %
KarXT 552 — 552 NM 552 — 552 NM
Other (i) 195 342 (147) (43) % 552 625 (73) (12) %
Three Months Ended September 30, Change Nine Months Ended September 30, Change
ZEJULA 32,284 42,432 (10,148) (24) % 94,330 133,002 (38,672) (29) %
VYVGART / VYVGART Hytrulo 24,071 27,727 (3,656) (13) % 65,488 72,329 (6,841) (9) %
NUZYRA 21,089 15,430 5,659 37 % 54,448 44,840 9,608 21 %
OPTUNE 7,821 12,657 (4,836) (38) % 32,093 36,375 (4,282) (12) %
QINLOCK 8,829 8,901 (72) (1) % 27,404 25,946 1,458 6 %
XACDURO 8,421 6,445 1,976 31 % 24,950 12,184 12,766 105 %
AUGTYRO 2,822 1,677 1,145 68 % 6,827 4,702 2,125 45 %
KarXT 2,015 — 2,015 NM 2,567 — 2,567 NM
Other (i) 296 92 204 222 % 848 717 131 18 %
Total product revenue, net 105,751 109,085 (3,334) (3) 107,648 115,361 (7,713) (7) % 201,307 214,735 (13,428) 308,955 330,095 (21,140) (6) % (i) Other includes product candidates sold in patient programs prior to commercialization.
1 unchanged paragraph
Our net product revenue decreased by $3.3 $7.7 million and $13.4 $21.1 million in the three and six nine months ended June September 30, 2026, respectively, primarily driven by decreased revenue for ZEJULA, due to a shift in hospital utilization patterns following volume-based procurement for generic olaparib, OPTUNE, due to evolving competition in the glioblastoma market, and VYVGART, primarily due to a pricing adjustment related to NRDL renewal. These decreases were partially offset by increased sales for NUZYRA, supported by increased market coverage and penetration, increased sales for XACDURO, driven by strong patient demand and expanding hospital adoption but partially constrained by supply limitations, and increased sales for NUZYRA, supported by increased market coverage and penetration. KarXT, which was launched in June 2026.
1 unchanged paragraph
Cost of product revenue increased by $5.2 $4.5 million and $5.0 $9.6 million in the three and six nine months ended June September 30, 2026, primarily due to a shift in product mix and the inventory write-down in the second quarter in 2026.
1 unchanged paragraph
In the three and six nine months ended June September 30, 2026, collaboration revenue increased by $0.3 million and $2.9 $2.7 million, respectively, mainly related to a regional license and collaboration arrangement. Collaboration revenue was insignificant in the three months ended September 30, 2026. Cost of collaboration revenue was insignificant in the three and six nine months ended June September 30, 2026.
2 unchanged paragraphs
Three Months Ended June 30, Change Six Months Ended June 30, Change
Personnel compensation and related costs 22,713 22,447 266 1 % 41,183 46,527 (5,344) (11) %
1 unchanged paragraph
1 unchanged paragraph
1 unchanged paragraph
3 unchanged paragraphs
1 unchanged paragraph
13 unchanged paragraphs
3 unchanged paragraphs
2 unchanged paragraphs
1 unchanged paragraph
1 unchanged paragraph
1 unchanged paragraph
1 unchanged paragraph
and 62 more changes in the filing
Market risk 6 changes
2 unchanged paragraphs
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, 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 $21.0 $12.1 million and $25.4 million, which were denominated in RMB, representing 3% 2% and 4% of the cash and cash equivalents as of June September 30, 2026 and December 31, 2025, respectively.
5 unchanged paragraphs
The carrying amounts of cash and cash equivalents, short-term investments, and restricted cash represent the maximum amount of losses due to credit risk. As of June September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $607.5 $549.7 million and $679.6 million, respectively, restricted cash of $101.1 million, and short-term investments of $10.0 million. As of June September 30, 2026 and December 31, 2025, 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 June September 30, 2026, our largest customer accounted for approximately 18% 14% of our total accounts receivable. collectively.
Certain accounts receivable balances are settled in the form of notes receivable. As of June September 30, 2026, 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.
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 June September 30, 2026 and December 31, 2025, we had cash and cash equivalents of $607.5 $549.7 million and $679.6 million, respectively, restricted cash of $101.1 million, and short-term investments of $10.0 million. 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 June September 30, 2026 and December 31, 2025, we had short-term debt of $238.1 $252.4 million and $204.5 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 .
Controls and procedures 2 changes
1 unchanged paragraph
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 June September 30, 2026, our disclosure controls and procedures were effective.
1 unchanged paragraph
There were no changes in our internal control over financial reporting (as such item is defined in Rules Rule 13a-15(f)) during the fiscal quarter ended June September 30, 2026 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Unregistered sales of stock 2 changes
2 unchanged paragraphs
The following table presents acquisitions of the Company's ADSs to satisfy tax withholding obligations due in connection with exercise of option shares or vesting of restricted shares during the second third quarter of 2026:
4 unchanged paragraphs
September 1 – 30, 2026
Other information 3 changes
Other than as described below, during the second third quarter of 2026, 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 September 16, 2026 , F. Ty Edmondson , the Company's Chief Legal Officer and Corporate Secretary , adopted a new written Rule 10b5-1 trading arrangement for (1) the sale of ADSs up to $ 300,000 and (2) the sale of up to 12,500 ADSs. This Rule 10b5-1 trading arrangement is scheduled to terminate no later than September 16, 2027 .
On August 11, 2026 , William Lis , one of the Company's director s, adopted a new written Rule 10b5-1 trading arrangement for the sale of up to 23,048 ADSs. This Rule 10b5-1 trading arrangement is scheduled to terminate no later than September 16, 2027 .
Exhibits 4 changes
1 unchanged paragraph
10.1^ Addendum to Collaboration and License Agreement between argenx BV and Zai Auto Immune (Hong Kong) Limited, dated September 10, 2026
11 unchanged paragraphs
# Management contract or compensatory plan, contract, or arrangement.
2 unchanged paragraphs
Dated: August 6, 2026
Dated: November 5, 2026
2 unchanged paragraphs
Unchanged: Forward-looking statements, Legal proceedings, Risk factors, Defaults on senior securities, Mine Safety Disclosures
Compared by code from the two filings' text and XBRL. Not advice.
The reading, claim by claim
- It also includes risk factors that could affect the company's future performance.
- The unaudited condensed consolidated balance sheets show total assets of $1,023,896 thousand as of September 30, 2026.
- Total current liabilities were $424,249 thousand as of the same date.
- The company had a net loss of $46.1 million, with a gross margin of 52.3% and an operating margin of -58.5%.
- These statements are based on current expectations and assumptions and could differ materially from actual results.
- The company outlines various factors that could affect its future performance, including regulatory approvals and market conditions.
6 of 7 claims matched the filing text.
Not found in the filing text
- The filing includes forward-looking statements that involve risks and uncertainties.
From the filing's financial data, not stated in its text
From this 10-Q's financial data (XBRL) for the quarter ended September 30, 2026
- For the quarter ended September 30, 2026, Zai Lab Ltd reported revenue of $107.6 million.
- The net margin was -42.9%.
- In its 10-Q for the quarter ended September 30, 2026, Zai Lab Ltd reported a revenue decline of 6.7% compared to the same period in the previous year.
From the filing
Item 6.
Item 6.
Exhibits
32
Signatures
33
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;1 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 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.5 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:6
• 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;
• 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;
• 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;
• Any inability to obtain or maintain sufficient patent protection for our products and 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;
• 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;
• Uncertainties in the Chinese legal system, including with respect to the anti-corruption enforcement efforts in mainland China and those addressing espionage, protection of and transfer restrictions on data, including personal information, data processing and security, and cybersecurity, 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;
• Variations in currency exchange rates and 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;
• 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;
• 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; and
• Any inability to renew our current leases on desirable terms or otherwise locate desirable alternatives for our leased properties.
These factors should not be construed as exhaustive and should be read with th
Item 1. Financial Statements.
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)
Notes September 30,
2026 December 31,
2025
Assets
Current assets
Cash and cash equivalents 3
Inventories, net 4
85,292 74,745
Prepayments and other current assets 44,051 36,683
Property and equipment, net 5
46,084 47,389
Operating lease right-of-use assets 14,897 19,152
Land use rights, net 2,884 2,853
Intangible assets, net 6
Liabilities and shareholders' equity
Current liabilities
Short-term debt 10
252,365 204,530
Other current liabilities 11
Non-current operating lease liabilities 9,556 13,385
Other non-current liabilities 570 —
Total liabilities 460,617 456,884
Commitments and contingencies (Note 16)
Shareholders' equity
Accumulated other comprehensive (loss) income ( 10,861 ) 29,697
Total liabilities and shareholders' equity 1,023,896 1,172,384
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
2
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 30, Nine Months Ended September 30,
Notes 2026 2025 2026 2025
Revenues
Product revenue, net 7
107,648 115,361 308,955 330,095
Collaboration revenue 7
Expenses
Income tax benefit 8
Loss per share - basic and diluted 9
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Zai Lab Limited
Unaudited Condensed Consolidated Statements of Comprehensive Loss (in thousands of $)
Three Months Ended September 30, Nine Months Ended September 30,
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
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 (loss) income Treasury Stock Total
Number of Shares Amount Shares Amount
Receipt of shares netted to satisfy tax withholding obligations related to share-based compensati
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