On February 27, 2025 Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) reported financial results for the fourth quarter and full-year 2024, along with recent product highlights and corporate updates (Press release, Zai Laboratory, FEB 27, 2025, View Source [SID1234650721]).
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"2024 was a defining year for Zai Lab, marked by strong sales growth, financial strength, and significant pipeline progress. As we look ahead, 2025 is set to be a transformative year with VYVGART’s continued momentum, three new product launches, progress with ZL-1310, and potential regulatory milestones for key assets," said Dr. Samantha Du, Founder, Chairperson, and Chief Executive Officer of Zai Lab. "The VYVGART franchise generated $93.6 million in net product revenue in its exceptional first full year of launch, highlighting the strong demand for innovative therapies in China. With the recent acceptance of KarXT’s New Drug Application (NDA) by China’s National Medical Products Administration (NMPA) in January, we are one step closer to bringing this novel medicine to patients in need in China. Meanwhile, our global asset, ZL-1310, demonstrated strong safety and efficacy data, reinforcing its potential as a first- and best-in-class DLL3 antibody-drug conjugate (ADC) for the treatment of small cell lung cancer (SCLC). Zai Lab is stronger than ever, with the infrastructure, innovation, and execution needed to bring medicines to patients around the world and create value for our shareholders."
"Our total revenue for the fourth quarter and full-year 2024 grew 66% and 50% y-o-y, respectively, driven by the continued strong uptake of VYVGART along with continued growth in ZEJULA and NUZYRA sales," said Josh Smiley, President and Chief Operating Officer of Zai Lab. "Looking ahead, we expect substantial topline growth, targeting $2 billion in revenue by 2028, fueled by the VYVGART franchise for generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP) as well as upcoming potential blockbuster launches, including KarXT for schizophrenia and bemarituzumab for gastric cancer. Our innovative pipeline with global rights remains a key focus, with multiple data readouts expected this year and the potential for U.S. Food and Drug Administration (FDA) approval of ZL-1310 as early as 2027. Additionally, we significantly improved our financial position, delivering a substantial reduction in operating loss and advancing towards our goal of achieving profitability1 in the fourth quarter of 2025. With a robust cash position2, we are well-funded to reach this milestone while continuing to invest in high-impact growth opportunities."
Fourth Quarter and Full-Year 2024 Financial Results
•Product revenue, net was $108.5 million in the fourth quarter of 2024, compared to $65.8 million for the same period in 2023, representing 65% y-o-y growth at both actual exchange rate and constant exchange rate (CER); and was $397.6 million in full-year 2024, compared to $266.7 million for the same period in 2023, representing 49% y-o-y growth and 50% y-o-y growth at CER. This revenue growth was primarily driven by increased sales for VYVGART and was also supported by increased sales for ZEJULA and NUZYRA.
–VYVGART and VYVGART Hytrulo were $30.0 million in the fourth quarter of 2024, compared to $5.1 million for the same period in 2023; and was $93.6 million in full-year 2024, compared to $10.0 million for the same period in 2023. This growth was driven by increased sales of VYVGART since its launch in September 2023 and listing on China’s National Reimbursement Drug List (NRDL) for the treatment of gMG effective January 1, 2024.
–ZEJULA was $48.4 million in the fourth quarter of 2024, an increase of 16% y-o-y from $41.6 million; and was $187.1 million in full-year 2024, an increase of 11% y-o-y from $168.8 million. ZEJULA sales remained strong as it continued to be the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China.
–NUZYRA was $11.0 million in the fourth quarter of 2024, an increase of 81% y-o-y from $6.1 million; and was $43.2 million in full-year 2024, an increase of 99% y-o-y from $21.7 million. This growth was supported by the inclusion in the NRDL for its IV formulation in January 2023 and its oral formulation in January 2024 for the treatment of community-acquired bacterial pneumonia (CABP) and acute bacterial skin and/or skin structure infections (ABSSSI). The NRDL listing for the IV formulation of NUZYRA was renewed in January 2025.
•Research and Development (R&D) expenses were $52.3 million in the fourth quarter of 2024, compared to $81.9 million for the same period in 2023; and were $234.5 million for full-year 2024, compared to $265.9 million for the same period in 2023. These decreases were primarily driven by the progress of existing studies, partially offset by increases in licensing fees.
•Selling, General and Administrative (SG&A) expenses were $82.6 million in the fourth quarter of 2024, flat compared to the same period in 2023. SG&A expenses were $298.7 million for full-year 2024, compared to $281.6 million for the same period in 2023, primarily due to higher general selling expenses related to the launch of VYVGART and growing sales for NUZYRA, partially offset by a decrease in selling expenses for other products and a decrease in general and administrative expenses.
•Loss from operations was $67.9 million and $282.1 million in the fourth quarter of 2024 and full-year 2024, respectively, $47.6 million and $199.6 million, respectively, when adjusted to exclude non-cash expenses, including depreciation, amortization, and share-based compensation. Loss from operations was $124.0 million and $366.6 million in the fourth quarter of 2023 and full-year 2023, 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 $81.7 million in the fourth quarter of 2024, or a loss per ordinary share attributable to common stockholders of $0.08 (or loss per American Deposit Share (ADS) of $0.80), compared to a net loss of $95.4 million for the same period in 2023 or a loss per ordinary share of $0.10 (or loss per ADS of $0.98). The net loss was $257.1 million for full-year 2024, or a loss per ordinary share attributable to common stockholders of $0.26 (or loss per ADS of $2.60), compared to a net loss of $334.6 million for full-year 2023, or a loss per ordinary share of $0.35 (or loss per ADS of $3.46). These decreases in net loss were primarily due to product revenue growing faster than net operating expenses, offset by decreased interest income and increased foreign currency loss.
•Cash and cash equivalents, short-term investments and current restricted cash totaled $879.7 million as of December 31, 2024, compared to $806.5 million as of December 31, 2023.
2025 Strategic Priorities
Zai Lab will focus on the following strategic priorities in 2025 to drive innovation and growth in China and beyond:
Commercial Execution and Readiness
•Drive the ramp-up of VYVGART in gMG and VYVGART Hytrulo in gMG and CIDP through new patient acquisition and expansion of duration of treatment
•Maintain ZEJULA leadership position in ovarian cancer in China
•Prepare for launch of potential blockbuster products including bemarituzumab in gastric cancer and KarXT in schizophrenia
Clinical Development
•Rapidly advance the global Phase 1 study for ZL-1310 (DLL3 ADC with global rights) in SCLC and explore its potential in other neuroendocrine tumors
•Advance other assets with global rights including ZL-6201 (LRRC15 ADC) and ZL-1503 (IL-13/IL-31R) into Phase 1 development
•Within our regional immunology franchise, accelerate the clinical development of efgartigimod (FcRn), povetacicept (APRIL/BAFF), and ZL-1108 (IGF-1R) with several indications in registrational stage
Clinical Data and Regulatory Actions
•Data readouts for ZL-1310 (DLL3 ADC) in second-line+ and first-line SCLC
•Data readouts for Phase 3 studies of bemarituzumab in first-line gastric cancer; and potential Biologics License Application (BLA) submission to NMPA in the first half of 2025
•Potential NMPA submissions for Tumor Treating Fields (TTFields) in second-line+ non-small cell lung cancer (NSCLC) and first-line pancreatic cancer
2025 Guidance
Zai Lab expects continued rigorous financial discipline and:
•Total revenue to be in the range of $560 million to $590 million for full-year 2025
•On a non-GAAP basis, achieve profitability1 in the fourth quarter of 2025
Corporate Updates
Below are key corporate updates since our last earnings release:
•Business Development:
–We expanded and strengthened our global and regional pipelines through synergistic business development activities, including a strategic collaboration and worldwide license agreement with MediLink to use MediLink’s TMALIN ADC platform for the development of ZL-6201, a novel potential first-in-class LRRC15 ADC consisting of an antibody discovered by Zai Lab, for the treatment of certain solid tumors; a strategic collaboration with Vertex for the license of povetacicept, a potential best-in-class treatment for immunoglobulin A nephropathy (IgAN) and other B-cell mediated diseases, in mainland China, Hong Kong, Macau, Taiwan, and Singapore; and the license of ZL-1108, or veligrotug, a differentiated humanized monoclonal antibody targeting IGF-1R from Zenas BioPharma for the treatment of thyroid eye disease (TED) in mainland China, Hong Kong, Macau, Taiwan, and Singapore.
–We also entered into a strategic collaboration with Pfizer on the novel antibacterial drug XACDURO (Sulbactam-Durlobactam), which was launched in mainland China in January 2025. Through this collaboration, Zai Lab will leverage the industry-leading commercialization infrastructure of Pfizer’s affiliated companies in the anti-infective therapeutic area to help accelerate access to this important therapy for patients in need in mainland China.
•NRDL Updates: In November 2024, Zai Lab announced the inclusion of AUGTYRO (repotrectinib) for ROS1+ NSCLC as well as the successful renewals of NUZYRA (omadacycline) for CABP and ABSSSI and QINLOCK (ripretinib) for fourth-line+ gastrointestinal stromal tumor (GIST) patients in China’s NRDL.
•Capital Markets: In November 2024, Zai Lab completed a public offering of ADSs, which resulted in aggregate net proceeds to the Company of approximately $215.1 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
Recent Pipeline Highlights
Below are key product updates since our last earnings release:
Oncology Pipeline
•ZL-1310 (DLL3 ADC): In January 2025, the FDA granted Orphan Drug Designation to ZL-1310 for the treatment of SCLC. Receiving an Orphan Drug Designation for ZL-1310 reflects its potential to treat patients with SCLC, and ZL-1310 will be eligible for certain development incentives, including the potential to receive a seven-year U.S. market exclusivity period granted by the FDA upon product approval.
•Tumor Treating Fields (TTFields): In December 2024, Zai Lab and partner Novocure announced that the pivotal Phase 3 PANOVA-3 trial for pancreatic cancer met its primary endpoint, demonstrating a statistically significant improvement in median overall survival versus control group. PANOVA-3 is the first and only Phase 3 trial to demonstrate a statistically significant benefit in overall survival specifically in unresectable, locally advanced pancreatic cancer. Zai Lab participated in the study in Greater China and plans to file for regulatory approval in China in the second half of 2025.
•Tisotumab Vedotin (Tissue Factor ADC): In January 2025, Zai Lab announced positive topline results from the China subpopulation of the global Phase 3 innovaTV 301 study, demonstrating a clinically meaningful improvement in overall survival with TIVDAK treatment for patients with previously treated recurrent or metastatic cervical cancer compared to chemotherapy. Zai Lab plans to submit an NDA to the NMPA in the first quarter of 2025 and will leverage its commercial footprint of ZEJULA in women’s cancer to accelerate patient access to this therapy in China if approved.
•Repotrectinib (ROS1/TRK): In February 2025, China’s NMPA granted priority review to repotrectinib for the treatment of patients with advanced solid tumors that have an NTRK gene fusion. Zai Lab plans to submit a supplemental NDA to the NMPA in the first half of 2025.
Immunology, Neuroscience, and Infectious Disease Pipeline
•Efgartigimod (FcRn): In November 2024, Zai Lab partner argenx announced the decision to advance clinical development of the subcutaneous formulation of efgartigimod (efgartigimod SC) in the ongoing Phase 2/3 ALKIVIA study for the treatment of idiopathic inflammatory myopathies (IIM, or myositis), following analysis of topline data from the Phase 2 portion of the study. Zai Lab is participating in the study in Greater China.
•Xanomeline and Trospium Chloride (KarXT) (M1/M4-agonist): In January 2025, China’s NMPA accepted the NDA for KarXT for the treatment of schizophrenia in adults. If approved, KarXT has the potential to redefine the treatment landscape for patients with schizophrenia in mainland China.
Anticipated Major Milestones in 2025
Upcoming Potential NMPA Submissions
•Tisotumab Vedotin (Tissue Factor ADC): BLA submission in recurrent or metastatic cervical cancer following progression on or after chemotherapy in the first quarter of 2025.
•Bemarituzumab (FGFR2b): BLA submission in first-line gastric cancer in the first half of 2025.
•Repotrectinib (ROS1/TRK): supplementary NDA submission in NTRK+ solid tumors in the first half of 2025.
•Tumor Treating Fields (TTFields): Marketing Authorization Application submissions in second-line+ NSCLC following progression on or after platinum-based chemotherapy and in first-line pancreatic cancer.
Expected Clinical Developments and Data Readouts in 2025
Global Pipeline
ZL-1310 (DLL3 ADC)
•Second-Line+ Extensive-Stage SCLC (ES-SCLC): Zai Lab to present updated data at a major medical conference in the first half of 2025. Zai Lab plans to initiate a pivotal study in 2025.
•First-Line ES-SCLC: Zai Lab to provide data readout for dose escalation of ZL-1310 doublet in combination with atezolizumab and initiate dose escalation for ZL-1310 triplet in combination with atezolizumab and platinum-based chemotherapy.
•Other neuroendocrine tumors: Zai Lab to initiate a global Phase 1 study in the first half of 2025.
ZL-1102 (IL-17 Humabody)
•Zai Lab to provide interim analysis in the global Phase 2 study in chronic plaque psoriasis in the first half of 2025.
ZL-1503 (IL-13/IL-31R)
•Zai Lab to provide preclinical data update and initiate a global Phase 1 study in moderate-to-severe atopic dermatitis.
ZL-6201 (LRRC15 ADC)
•Zai Lab to provide preclinical data update and initiate a global Phase 1 study in sarcoma.
Regional Pipeline
Bemarituzumab (FGFR2b)
•Zai Lab partner Amgen to provide data readout from the Phase 3 FORTITUDE-101 study of bemarituzumab combined with chemotherapy versus chemotherapy alone in first-line gastric cancer in the first half of 2025. Zai Lab is participating in the study in Greater China.
•Zai Lab partner Amgen to provide data readout from the Phase 3 FORTITUDE-102 study of bemarituzumab plus chemotherapy and nivolumab versus chemotherapy and nivolumab in first-line gastric cancer in the second half of 2025. Zai Lab is participating in the study in Greater China.
Efgartigimod (FcRn)
•Seronegative gMG: Zai Lab partner argenx to provide topline results from the Phase 3 ADAPT-SERON study in seronegative gMG. Zai Lab participated in the study in Greater China.
•Lupus Nephritis (LN): Zai Lab to provide topline results from the Phase 2 study in LN.
Conference Call and Webcast Information
Zai Lab will host a live conference call and webcast today, February 27, 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 View Source Participants must register in advance of the conference call.
Details are as follows:
Registration Link: https://register.vevent.com/register/BI628d3dd054cb4c45b3d01b61fa5779b1
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.