-- Total revenues grew 17% y-o-y to $127.6 million for the fourth quarter of 2025 and 15% y-o-y to $460.2 million for the full-year 2025
-- Zocilurtatug pelitecan (zoci) on track to become Zai Lab's first global oncology launch, with three registration-enabling studies across 2L+ SCLC, 1L SCLC, and extrapulmonary NECs by the end of 2026
-- Advancing a differentiated global pipeline, including ZL-1503 (IL-13/IL-31R<ALPHA>), ZL-6201 (LRRC15 ADC), ZL-1222 (PD-1/IL-12) and ZL-1311 (MUC17/CD3 TCE)
-- Key regional programs continue to advance, with KarXT approved in China and commercial launch preparations underway; pivotal data readouts for povetacicept in IgAN and elegrobart in TED expected in 2026
Conference call and webcast today, February 26, 2026, at 8:00 a.m. ET (9:00 p.m. HKT)
SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--February 26, 2026--
Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced financial results for the fourth quarter and full-year 2025, along with recent product highlights and corporate updates.
"2025 was a year of disciplined execution across both engines of our business with significant advancement across our global innovation pipeline and steady progress in our commercial business," said Dr. Samantha Du, Founder, Chairperson and Chief Executive Officer of Zai Lab. "We accelerated multiple global programs, including the rapid progression of zoci into pivotal development, enabled by our integrated U.S./China infrastructure which allows us to operate with speed and capital efficiency. In 2026, our focus is on executing against important catalysts -- advancing late-stage immunology and oncology programs while preparing for the next wave of commercial growth. Together, these efforts mark an important step in Zai Lab's continued evolution into a global biopharma leader."
"KarXT represents a significant new growth driver for Zai Lab, and its recent inclusion in a national expert consensus underscores the growing recognition of its novel mechanism and potential to meaningfully impact patients living with schizophrenia," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "We are strengthening the VYVGART franchise by expanding hospital coverage and supporting longer treatment persistence. Concurrently, we are preparing for the potential approvals of TIVDAK, which would further strengthen our women's health franchise, and TTFields in pancreatic cancer. Looking beyond 2026, the combination of new launches, potential label expansions and advancing global programs, positions us for multi-year growth and continued financial improvement."
Fourth Quarter and Full-Year 2025 Financial Results
-- Total revenue was $127.6 million in the fourth quarter of 2025 and
$460.2 million for the full-year 2025. Product revenue, net was $127.1
million in the fourth quarter of 2025, compared to $108.5 million for the
same period in 2024, representing 17% y-o-y growth and 16% at constant
exchange rate (CER); and was $457.2 million in full-year 2025, compared
to $397.6 million for the same period in 2024, representing 15% y-o-y
growth and 16% y-o-y growth at CER. This increase was primarily due to
higher revenue for XACDURO and NUZYRA.
-- ZEJULA was $56.0 million in the fourth quarter of 2025, an increase of 16% y-o-y from $48.4 million; and was $189.0 million in full-year 2025, compared to $187.1 million for the same period in 2024. ZEJULA continued to be the leading PARP inhibitor in hospital sales for ovarian cancer despite evolving competitive dynamics within the PARPi class in mainland China.
-- VYVGART and VYVGART Hytrulo were $21.9 million in the fourth quarter of 2025 which includes a $5.6 million rebate for VYVGART related to the National Reimbursement Drug List (NRDL) renewal, compared to $30.0 million for the same period in 2024; and was $94.2 million in full-year 2025, compared to $93.6 million for the same period in 2024.
-- XACDURO, which was launched in the fourth quarter of 2024, was $10.7 million in the fourth quarter of 2025, an increase of 225% y-o-y from $3.3 million; and was $22.9 million in full-year 2025, an increase of 593% y-o-y from $3.3 million. Growth was driven by strong patient demand and expanding hospital adoption but was partially constrained by supply limitations during the year.
-- NUZYRA was $16.0 million in the fourth quarter of 2025, an increase of 45% y-o-y from $11.0 million; and was $60.8 million in full-year 2025, an increase of 41% y-o-y from $43.2 million. This growth was supported by increased market coverage and penetration.
-- Research and Development (R&D) expenses were $61.6 million in the
fourth quarter of 2025, compared to $52.3 million for the same period in
2024, and $220.9 million for full-year 2025, compared to $234.5 million
for the same period in 2024. The fourth-quarter increase resulted from
progress in clinical trials. The full year decline was primarily driven
by lower personnel compensation due to strategic resource optimization.
-- Selling, General and Administrative (SG&A) expenses were $73.0 million
in the fourth quarter of 2025, compared to $82.6 million for the same
period in 2024, and $277.6 million for full-year 2025, compared to $298.7
million for the same period in 2024. The decrease was primarily due to a
reduction in general and administrative expenses due to strategic
resource optimization.
-- Loss from operations was $69.4 million and $229.4 million in the fourth
quarter of 2025 and full-year 2025, respectively, and $49.6 million and
$148.8 million, respectively, when adjusted to exclude non-cash expenses,
including depreciation, amortization, and share-based compensation. Loss
from operations was $67.9 million and $282.1 million in the fourth
quarter of 2024 and full-year 2024, respectively. A reconciliation of
loss from operations (GAAP) to adjusted loss from operations (non-GAAP)
is included at the end of this release.
-- Net loss was $50.4 million in the fourth quarter of 2025, or a loss per
ordinary share attributable to common stockholders of $0.05 (or loss per
American Deposit Share (ADS) of $0.46), compared to a net loss of $81.7
million for the same period in 2024 or a loss per ordinary share of $0.08
(or loss per ADS of $0.80). The net loss was $175.5 million for full-year
2025, or a loss per ordinary share attributable to common stockholders of
$0.16 (or loss per ADS of $1.60), compared to a net loss of $257.1
million for full-year 2024, or a loss per ordinary share of $0.26 (or
loss per ADS of $2.60). These decreases in net loss were primarily due to
product revenue growing faster than net operating expenses and shift from
foreign currency losses to foreign currency gains, offset by decreased
interest income.
-- Cash and cash equivalents, short-term investments and current
restricted cash totaled $789.6 million as of December 31, 2025, compared
to $879.7 million as of December 31, 2024.
2026 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2026 to drive near-term performance and long-term global value creation:
Advancing Differentiated Global Programs Across Oncology and Immunology
-- Zocilurtatug pelitecan (zoci) (DLL3-targeting ADC): Advance three
registration-enabling studies across 2L+ SCLC, 1L SCLC, and other
neuroendocrine carcinomas (NECs) by the end of 2026. Three data readouts
expected in 2026, including:
-- 2L+ SCLC: Updated global Phase 1 data highlighting intracranial response in patients with brain metastases.
-- 1L SCLC: Data from an ongoing Phase 1 combination study evaluating doublet and triplet regimens with a PD-L1 inhibitor, with or without chemotherapy; initiation of global Phase 1 study with novel combination.
-- Extrapulmonary NECs: Data from the Phase 1b portion of the ongoing global Phase 1b/2 study.
-- ZL-1503 (IL-13/IL-31R<ALPHA> bispecific antibody): First-in-Human (FIH)
data from the ongoing global Phase 1/1b study expected in the second half
of 2026, paving the way for Phase 2 development in atopic dermatitis
$(AD)$.
-- ZL-6201 (LRRC15-targeting ADC): Global Phase 1 ongoing.
-- ZL-1222 (PD-1/IL-12 immunocytokine): Investigational New Drug
$(IND)$-enabling studies expected to be completed in 2026.
-- ZL-1311 (T-cell engager (TCE) targeting MUC17): IND submission expected
by year end.
-- Zai Lab is building capabilities in TCEs and exploring additional
immunocytokines beyond IL-12, with further details to be provided
throughout the year.
Commercial Execution and Key Near-Term Regional Launches to Drive Steady Growth
-- VYVGART and VYVGART Hytrulo: Continue to increase patient utilization
and duration of treatment in generalized myasthenia gravis (gMG) and
chronic inflammatory demyelinating polyneuropathy (CIDP).
-- KarXT: Planned commercial launch in the first half of 2026, supported
by a targeted commercial strategy, physician education, real-world
evidence generation, and preparation for potential NRDL inclusion in
2027.
-- Povetacicept and elegrobart: Both have pivotal readouts in 2026 and are
expected to further strengthen regional revenue growth in the near term.
Key Corporate Updates
Below are key corporate updates since our last earnings release:
-- Business Development:
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February 26, 2026 07:00 ET (12:00 GMT)
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