Zai Lab Limited (ZLAB) Q2 2025 Earnings Call Transcript

Access earnings results, analyst expectations, report, slides, earnings call, and transcript.

Overview

The earnings call summary reveals strong financial guidance, optimistic growth projections for key products like VYVGART, and strategic initiatives in China. Despite some management vagueness, the overall sentiment is positive due to expected profitability, revenue growth, and strategic expansions. The market cap suggests moderate stock price movement, likely in the 2% to 8% range, as the company is not small-cap.

Key Financial Performance

Total Revenue $110 million in Q2 2025, a 9% year-over-year increase, primarily driven by higher sales of VYVGART due to therapy extension and increasing market penetration, as well as contributions from AUGTYRO and XACDURO launched since Q4 2024.

Operating Loss $54.9 million in Q2 2025, a 28% year-over-year improvement, attributed to financial discipline and efficiency efforts.

Adjusted Operating Loss $34.2 million in Q2 2025, a 37% year-over-year improvement, reflecting resource prioritization and efficiency improvements.

R&D Expenses Decreased by 18% year-over-year in Q2 2025, mainly due to reduced personnel costs and clinical trial costs as a result of resource prioritization and efficiency efforts.

SG&A Expenses Decreased by 11% year-over-year in Q2 2025, mainly due to strategic resource allocation and efficiency improvements.

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Operating Highlights

VYVGART: Strong commercial execution driving momentum in generalized Myasthenia Gravis (gMG). Record levels of patient utilization, increased treatment duration, and a shift towards maintenance use. New guidelines in China elevate VYVGART's positioning, recommending early use and sustained long-term treatment. Potential to exceed $1 billion in peak sales.

ZEJULA: Softer quarter due to competitive dynamics in the PARP class. Signs of stabilization and expected return to growth in first-line ovarian cancer later this year.

XACDURO: Robust demand for treating CRAB infections in China. Supply constraints may limit near-term growth, but demand remains strong.

AUGTYRO: Focused commercialization approach for ROS1-positive non-small cell lung cancer. Near-term revenue expected to be limited, but strong clinical profile positions it as an important treatment option.

China Market Expansion: New guidelines in China for VYVGART elevate its positioning in gMG treatment. Anticipated regulatory approvals for KarXT in schizophrenia and TIVDAK in cervical cancer. Submission plans for bemarituzumab (gastric cancer) and Tumor Treating Fields (pancreatic cancer).

Global Market Expansion: Advancing innovative global programs like ZL-1310 (DLL3 ADC for small cell lung cancer) and ZL-1503 (bispecific IL-13/IL-31 antibody for atopic dermatitis). Leveraging AI to optimize clinical trials and commercial analytics.

Profitability Plan: Operating loss reduced by 28% to $54.9 million. Adjusted loss reduced by 37% to $34.2 million. On track to achieve profitability in Q4 2025.

Operational Efficiencies: Scaling support for VYVGART, localizing manufacturing for key products, and improving cost leverage across the portfolio.

AI Integration: Leveraging AI to optimize clinical trials, accelerate timelines, and improve commercial analytics.

Business Development: Focus on strengthening global pipeline with external innovation, expanding China portfolio, and pursuing out-licensing and global partnerships.

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Risk or Challenges

Competitive Dynamics: ZEJULA experienced a softer quarter due to evolving competitive dynamics within the PARP class, which could impact its market share and revenue growth.

Supply Constraints: XACDURO's growth may be modestly limited in 2025 due to supply constraints as the company works to localize manufacturing.

Regulatory Approvals: The company is awaiting regulatory approvals for key products like KarXT and TIVDAK in China, which could delay market entry and revenue generation if not approved on time.

Operational Efficiency: Efforts to scale support for VYVGART and localize manufacturing for key products are ongoing, but delays or inefficiencies in these processes could impact cost leverage and profitability.

Economic Uncertainty: Economic conditions and healthcare policy changes in China could affect patient access and the adoption of key products like VYVGART.

Pipeline Risks: Several pipeline products, including ZL-1310 and ZL-1503, are in early or mid-stage development. Any setbacks in clinical trials or regulatory hurdles could delay commercialization and revenue realization.

Market Penetration: VYVGART's penetration in gMG is currently only 10%, and its broader adoption depends on successful NRDL listing and market expansion efforts.

Manufacturing Localization: Delays in localizing manufacturing for products like XACDURO could lead to supply shortages and limit growth potential.

Product Launch Challenges: The company faces challenges in efficiently launching new products like AUGTYRO, which has limited near-term revenue expectations despite its clinical potential.

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Guidance & Outlook

Revenue Guidance: Reaffirmed full-year revenue guidance of USD 560 million to USD 590 million for 2025.

Profitability: On track to achieve profitability in the fourth quarter of 2025.

Product Launches and Approvals: Anticipates approvals for KarXT in schizophrenia and TIVDAK in cervical cancer in China. Preparing submissions for bemarituzumab for gastric cancer and Tumor Treating Fields for pancreatic cancer.

Pipeline Development: Advancing global R&D programs, including ZL-1310 for small cell lung cancer and ZL-1503 for atopic dermatitis. Plans to initiate a Phase I study for ZL-1503 later this year.

AI Integration: Expanding the use of AI to optimize clinical trials, accelerate timelines, and improve commercial analytics.

VYVGART Expansion: Plans to expand VYVGART's label to include additional indications such as Seronegative gMG, Ocular MG, Myositis, Lupus Nephritis, and Sjogren's disease. Expects VYVGART to exceed $1 billion in peak sales in China.

ZEJULA Growth: Anticipates a return to growth for ZEJULA in first-line ovarian cancer later in 2025.

XACDURO Demand: Strong demand for XACDURO in treating CRAB infections, though supply constraints may limit growth in 2025.

Operational Efficiency: Scaling support for VYVGART, localizing manufacturing, and improving cost leverage to drive growth and margin expansion.

Business Development: Focused on strengthening the global pipeline, expanding the China portfolio, and pursuing out-licensing and global partnerships.

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Shareholder Return Plan

The selected topic was not discussed during the call.

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Key Q&A

Q:Can you help us understand the potential opportunity for bema in frontline gastric cancer? What biomarker status and FGFR2b threshold would patients need for treatment with bema? And can you help us characterize the safety profile observed in the 101 study?

A:The potential opportunity for bema in frontline gastric cancer is significant, with over 450,000 patients in China, about 1/3 of whom overexpress FGFR2b. This translates to approximately 140,000-150,000 new cases annually. The biomarker threshold is 2+ to 3+ FGFR2b expression in at least 10% of cells. The safety profile includes myelosuppression (likely related to chemotherapy) and ocular toxicity, such as corneal toxicity affecting visual acuity, which was more pronounced in the treatment arm of the 101 study. These toxicities are manageable and reversible, with details to be presented at an upcoming meeting.

Q:Can you discuss your confidence levels in achieving your 2025 revenue guidance and profitability goal by year-end? And how should we think about the contribution of VYVGART in achieving these goals?

A:The company reaffirmed its 2025 revenue guidance of $560 million to $590 million and expects to achieve profitability on a non-GAAP basis in Q4. VYVGART is a key driver, with accelerating growth expected in the second half of the year due to increased patient starts, duration, and new national guidelines for gMG. ZEJULA is also expected to recover and grow in the second half, despite earlier declines due to market disruptions.

Q:Is there any outsized growth expected from the broader commercial franchise in terms of NUZYRA or XACDURO that might contribute meaningfully to getting to the guidance and profitability by the end of the year?

A:XACDURO and AUGTYRO are in early launch phases and expected to show good growth, though XACDURO may face supply constraints. NUZYRA continues to be a strong growth driver. These products are expected to contribute to the company's guidance and profitability goals.

Q:Can you provide perspective on the expected OS data for FORTITUDE-101 and 102 studies, and the likely regimen uptake in China for gastric cancer?

A:Management could not provide specific OS data for FORTITUDE-101 due to embargoed information but emphasized the clinical meaningfulness of the results. For FORTITUDE-102, the survival difference with nivo is expected to be modest. In China, chemotherapy plus bema is expected to be a significant advance, with PD-1 inhibitors having variable uptake.

Q:How are you thinking about the combo dose for DLL3 with atezo, and what is the potential for overlapping toxicities?

A:The toxicity profiles of DLL3 and atezo are different, and the 1.6 mg/kg dose of DLL3 is well-tolerated. Management believes the combination is feasible without significant overlapping toxicities and is working towards this dose for the combination.

Q:How does the addition of new trials for VYVGART change the potential overall peak for this drug?

A:The addition of new trials (e.g., lupus, seronegative gMG, Sjogren's disease) expands the patient population from 170,000 to over 500,000 in China. This supports the company's projection of over $1 billion in annual sales potential for VYVGART.

Q:Was VYVGART still under inventory management in the second quarter, and what is the strategy for subcu versus IV formulation in China?

A:Inventory management was closely monitored in the second quarter, and normal inventory build is expected in the second half. The subcutaneous (subcu) formulation, Hytrulo, is expected to become a significant treatment option in China once approved and listed on NRDL.

Q:What is the company's strategy for the DLL3 ADC pivotal study and commercialization in the U.S.?

A:The company plans to initiate the pivotal study for DLL3 ADC by year-end, focusing on a 1.6 mg/kg dose. While discussions for partnerships remain open, the company is committed to independently launching the study and potentially commercializing the product in the U.S.

Q:What steps are left to file bema in China, and when could NRDL listing be expected?

A:The company is working with Amgen to expedite the registration process for bema in China, leveraging its breakthrough designation. NRDL listing timing will depend on the approval date, but the company aims for a swift process.

Q:What additional information will be shared in the next DLL3 ADC data update, and how does the company view competition in this space?

A:The next DLL3 ADC update will include data on durability, progression-free survival, and brain metastases responses. Management believes their ADC is differentiated by its antibody, payload, and linker, and is confident in its competitive position.

Q:Review of Unclear Management Responses

A:Management avoided providing specific OS data for the FORTITUDE-101 study, citing embargoed information. Similarly, they could not provide a clear answer on the expected uptake of PD-1 inhibitors in China for gastric cancer, offering only qualitative statements. Additionally, no specific timeline was given for the NRDL listing of bema in China, and the response on the DLL3 ADC first-line data timeline was vague, indicating it might be available early next year.

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Earnings Word Cloud

The most frequently occurring keywords in this quarter's earning call

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