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Zai Lab Reports Q2 2024 Financials and Corporate Updates
16 August 2024
Zai Lab Limited, a biopharmaceutical company listed on NASDAQ and HKEX, reported its financial results for the second quarter of 2024, showcasing remarkable commercial growth and strategic advancements in its product portfolio. Dr. Samantha Du, the company's Founder, Chairperson, and CEO, highlighted the company's achievements, particularly the successful launch of VYVGART for generalized myasthenia gravis (gMG), and emphasized the firm's commitment to high-value initiatives aimed at enhancing human health. The company also expanded its oncology pipeline with the addition of a new ROR1 ADC program, ZL-6301.
Josh Smiley, President and COO, noted that the company’s net product revenues saw a 45% year-on-year increase in the second quarter, driven primarily by the launch and commercialization of VYVGART. Zai Lab plans to focus on the strong execution of VYVGART’s launch while preparing for upcoming product launches. With these efforts and an innovative pipeline, the company aims to achieve profitability by the end of 2025.
In financial terms, the company reported net product revenue of $100.1 million for the second quarter of 2024, up from $68.9 million in the same period in 2023. This revenue growth was primarily fueled by increased sales of VYVGART, ZEJULA, and NUZYRA. ZEJULA achieved $45 million in revenue, a 5% increase year-on-year, while NUZYRA saw significant growth of 165% year-on-year, reaching $12.3 million.
Research and Development (R&D) expenses were reduced to $61.6 million from $76.7 million in the same quarter of the previous year, primarily due to lower milestone fees associated with license and collaboration agreements. However, this was partially offset by increased clinical trial expenses. Selling, General, and Administrative expenses grew to $79.7 million from $67.9 million, driven by higher selling expenses and an increase in headcount to support VYVGART.
The company’s net loss for the quarter was $80.3 million, compared to a net loss of $120.9 million in the same period of 2023. Cash and cash equivalents, short-term investments, and current restricted cash totaled $730 million as of June 30, 2024.
In terms of business developments, Zai Lab entered into a strategic partnership and global license agreement with MabCare Therapeutics in July 2024, expanding its oncology pipeline with ZL-6301, a next-generation ADC targeting ROR1. This collaboration aims to address solid tumors and hematological malignancies where ROR1 is a validated target. ZL-6301 is currently in the IND-enabling stage.
On the organizational front, Zai Lab appointed Dr. Rafael Amado as President and Head of Global Research and Development in June 2024, following the retirement of Dr. Harald Reinhart. This leadership change aims to maintain momentum and strategic focus on the company’s pipeline.
Recent updates in the company’s pipeline include advancements in its oncology and immunology, neuroscience, and infectious disease segments. Key highlights include:
- Niraparib, a Zai-supported study published in "Cell," offers new insights for treating HRD-positive ovarian cancers.
- Bemarituzumab, with completed enrollment for the Phase 3 FORTITUDE-101 study in gastric cancer.
- AUGTYRO, approved by China’s National Medical Products Administration (NMPA) for treating ROS1-positive NSCLC in May 2024 and by the U.S. FDA for NTRK-positive solid tumors in June 2024.
- Efgartigimod, approved by the NMPA as an add-on therapy for gMG patients in July 2024.
- XACDURO, approved by the NMPA in May 2024 for treating hospital-acquired and ventilator-associated bacterial pneumonia.
Zai Lab also anticipates several key milestones, including potential regulatory submissions and clinical data readouts, in the coming months. Notably, they aim for the Marketing Authorization Application submission for TTFields in NSCLC and the Biologics License Application for Tisotumab Vedotin in cervical cancer, both expected in the latter part of 2024.
The company’s focus remains on leveraging its scientific expertise and resources to bring innovative treatments to the market, addressing significant unmet medical needs globally.
Josh Smiley, President and COO, noted that the company’s net product revenues saw a 45% year-on-year increase in the second quarter, driven primarily by the launch and commercialization of VYVGART. Zai Lab plans to focus on the strong execution of VYVGART’s launch while preparing for upcoming product launches. With these efforts and an innovative pipeline, the company aims to achieve profitability by the end of 2025.
In financial terms, the company reported net product revenue of $100.1 million for the second quarter of 2024, up from $68.9 million in the same period in 2023. This revenue growth was primarily fueled by increased sales of VYVGART, ZEJULA, and NUZYRA. ZEJULA achieved $45 million in revenue, a 5% increase year-on-year, while NUZYRA saw significant growth of 165% year-on-year, reaching $12.3 million.
Research and Development (R&D) expenses were reduced to $61.6 million from $76.7 million in the same quarter of the previous year, primarily due to lower milestone fees associated with license and collaboration agreements. However, this was partially offset by increased clinical trial expenses. Selling, General, and Administrative expenses grew to $79.7 million from $67.9 million, driven by higher selling expenses and an increase in headcount to support VYVGART.
The company’s net loss for the quarter was $80.3 million, compared to a net loss of $120.9 million in the same period of 2023. Cash and cash equivalents, short-term investments, and current restricted cash totaled $730 million as of June 30, 2024.
In terms of business developments, Zai Lab entered into a strategic partnership and global license agreement with MabCare Therapeutics in July 2024, expanding its oncology pipeline with ZL-6301, a next-generation ADC targeting ROR1. This collaboration aims to address solid tumors and hematological malignancies where ROR1 is a validated target. ZL-6301 is currently in the IND-enabling stage.
On the organizational front, Zai Lab appointed Dr. Rafael Amado as President and Head of Global Research and Development in June 2024, following the retirement of Dr. Harald Reinhart. This leadership change aims to maintain momentum and strategic focus on the company’s pipeline.
Recent updates in the company’s pipeline include advancements in its oncology and immunology, neuroscience, and infectious disease segments. Key highlights include:
- Niraparib, a Zai-supported study published in "Cell," offers new insights for treating HRD-positive ovarian cancers.
- Bemarituzumab, with completed enrollment for the Phase 3 FORTITUDE-101 study in gastric cancer.
- AUGTYRO, approved by China’s National Medical Products Administration (NMPA) for treating ROS1-positive NSCLC in May 2024 and by the U.S. FDA for NTRK-positive solid tumors in June 2024.
- Efgartigimod, approved by the NMPA as an add-on therapy for gMG patients in July 2024.
- XACDURO, approved by the NMPA in May 2024 for treating hospital-acquired and ventilator-associated bacterial pneumonia.
Zai Lab also anticipates several key milestones, including potential regulatory submissions and clinical data readouts, in the coming months. Notably, they aim for the Marketing Authorization Application submission for TTFields in NSCLC and the Biologics License Application for Tisotumab Vedotin in cervical cancer, both expected in the latter part of 2024.
The company’s focus remains on leveraging its scientific expertise and resources to bring innovative treatments to the market, addressing significant unmet medical needs globally.
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