Financial Performance - Zai Lab Limited reported revenue of $106.49 million for the quarter ended March 2025, reflecting a year-over-year increase of 22.2% [1] - The earnings per share (EPS) for the quarter was -$0.45, an improvement from -$0.55 in the same quarter last year [1] - The reported revenue was below the Zacks Consensus Estimate of $117.09 million by 9.06% [1] - The EPS exceeded the consensus estimate of -$0.50 by 10.00% [1] Key Metrics - Product revenue for ZEJULA was $49.53 million, surpassing the average estimate of $48.32 million from three analysts [4] - Product revenue for OPTUNE reached $11.36 million, exceeding the average estimate of $8.35 million [4] - Product revenue for VYVGART was $18.11 million, falling short of the average estimate of $31.75 million [4] - Product revenue for NUZYRA was $15.12 million, slightly above the average estimate of $14.39 million [4] - Product revenue for QINLOCK was $8.51 million, exceeding the average estimate of $8.21 million [4] Stock Performance - Shares of Zai Lab Limited have returned +4.8% over the past month, compared to the Zacks S&P 500 composite's +11.3% change [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]

Financial Data and Key Metrics Changes - Total revenue grew 22% year over year to $106.5 million in Q1 2025, driven by increased sales for VivGuard, Zejula, and NUZYRA [29][30] - Operating loss improved by 20% to $56.3 million, and adjusted loss from operations decreased by 25% to $37.1 million [16][30] - The company reaffirmed its full-year revenue guidance of $560 million to $590 million, anticipating significant sales growth in the latter part of the year [8][30] Business Line Data and Key Metrics Changes - VivGuard sales are expected to grow faster than total revenue growth, with a rebound in patient volumes observed in March and April after a seasonal decline [12][36] - Other products, including Zejula and NUZYRA, delivered sequential growth supported by NRDL access, with early contributions from OGTYRO and ZACDURO [15] - The company is preparing for upcoming NRDL cycles targeting IV renewal for gMG and initial listing of the SC formulation [14] Market Data and Key Metrics Changes - The company noted a significant opportunity in the gMG market in China, with approximately 70,000 patients, and less than 10% currently receiving newer biologic therapies [63] - The competitive landscape for gMG is expected to benefit from the introduction of new therapies, which will enhance overall market education and treatment options [63] Company Strategy and Development Direction - The company aims to expand its global R&D pipeline, with a focus on differentiated and high-potential assets, including GL1310 and other novel therapies [9][10] - Investments are being made to accelerate the global R&D pipeline, with plans to present updated Phase I data at ASCO [10][20] - The company is committed to achieving profitability by Q4 2025, leveraging operational efficiencies and a robust late-stage opportunity pipeline [30][31] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue targets and surpassing $2 billion by 2028, with strong momentum expected to carry into the 2030s [9] - The management team highlighted the importance of strategic initiatives to extend treatment duration and improve patient access [12][14] - The company remains optimistic about its financial position, ending Q1 with a cash position of $857.3 million [31] Other Important Information - The company is advancing its internal pipeline while also considering external opportunities for in-licensing [102][103] - Regulatory discussions with the FDA are ongoing, with no significant changes noted in the approval process despite recent leadership changes at the FDA [53][105] Q&A Session Summary Question: Can you provide more color on VIBGART's sequential change? - Management indicated that the sequential decline was influenced by seasonality and inventory dynamics, with confidence in recovery based on strong patient volumes in April [33][36] Question: Are you comfortable with consensus estimates for VIBGART and fiscal year revenues? - Management reaffirmed their revenue guidance and expressed confidence that VIBGART sales would grow faster than overall business rates [42][44] Question: How do recent FDA changes impact Zai Lab? - Management noted no anticipated impact from tariffs and indicated that FDA interactions have remained productive [50][53] Question: What is the competitive landscape for gMG in China? - Management believes that new approvals will benefit the market and enhance treatment options for patients [63] Question: What is the strategy regarding in-house developed assets? - The company plans to maintain a balanced approach between in-house development and external licensing opportunities [102][103]

Financial Data and Key Metrics Changes - Total revenue grew 22% year over year to $106.5 million in Q1 2025, driven by increased sales for VivGuard, Zejula, and NUZYRA [27] - Operating loss improved by 20% to $56.3 million, and adjusted loss from operations decreased by 25% to $37.1 million, reflecting operational efficiency [15][27] - The company reaffirmed its full-year revenue guidance of $560 million to $590 million, anticipating significant sales growth in the latter part of the year [6][28] Business Line Data and Key Metrics Changes - VivGuard sales are expected to grow faster than total revenue growth, with a rebound in patient volumes observed in March and April after a seasonal decline [11][12] - Other products, including Zejula and NUZYRA, showed sequential growth supported by NRDL access, with early contributions from newly launched products like OGTYRO and ZACDURO [14] - The company is preparing for the upcoming NRDL cycle targeting IV renewal for gMG and initial listing of the SC formulation, effective January 1, 2026 [12] Market Data and Key Metrics Changes - The company noted a significant opportunity in the gMG market in China, with approximately 70,000 patients, and less than 10% currently receiving newer biologic therapies [60] - The competitive landscape for gMG is expected to benefit from the introduction of new therapies, which will enhance overall market education and treatment options [60] Company Strategy and Development Direction - The company aims to expand its global R&D pipeline, with a focus on innovative therapies and maintaining a balanced approach between in-house development and business development opportunities [8][100] - Investments are being made to accelerate the global R&D pipeline, with a commitment to advancing at least one global product to IND submission stage every year [23] - The company is focused on achieving profitability by Q4 2025, leveraging operational efficiencies and a robust late-stage pipeline [15][28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability by Q4 2025, citing strong business fundamentals and strategic direction [6][27] - The company anticipates accelerating sales growth in the next three quarters, which will translate into significant operating leverage [6] - Management highlighted the importance of new product launches and regulatory approvals in driving future growth [15][28] Other Important Information - The company ended the quarter with a strong cash position of $857.3 million, providing a solid foundation for future investments and growth initiatives [29] - The company is actively pursuing regulatory reviews for multiple products, including CAR XT for schizophrenia and TIVDAC for cervical cancer [15] Q&A Session Summary Question: Can you describe the sequential change in VIBGART sales? - Management indicated that the sequential decline was influenced by seasonal trends and inventory dynamics, with a strong recovery in patient volumes observed in March and April [31][32] Question: Are you comfortable with the current consensus for VIBGART and fiscal year revenues? - Management reaffirmed confidence in the revenue guidance range of $560 million to $590 million, indicating that VIBGART sales are expected to grow faster than overall sales growth [41] Question: How do recent FDA changes and tariffs impact Zai Lab? - Management noted no anticipated impact from tariffs, as local manufacturing is in place for many products, and FDA interactions have remained productive [46][50] Question: What is the competitive landscape for gMG in China? - Management expressed optimism about the competitive dynamics, stating that new approvals will benefit the overall market and enhance treatment options for patients [60] Question: What is the strategy regarding in-house developed assets versus in-licensing? - Management indicated a balanced approach, continuing to pursue both in-house development and high-quality external opportunities [100]

Financial Data and Key Metrics Changes - Total revenue for 2024 grew 50% year-on-year, with a remarkable 66% growth in Q4 [9][16] - Loss from operations improved by 45% in Q4 and 23% for the full year [14][57] - Cash position at the end of the quarter was $879.7 million, supporting future growth [14][58] Business Line Data and Key Metrics Changes - VYVGART generated $93.6 million in sales for 2024, marking a successful launch [9][17] - ZEJULA and NUZYRA also contributed to revenue growth, with ZEJULA being the leading PARP inhibitor for ovarian cancer in China [27][31] - New product launches, including VYVGART Hytrulo, AUGTYRO, and XACDURO, are expected to drive future revenue [30][31] Market Data and Key Metrics Changes - VYVGART's market penetration in China is currently under 10%, indicating significant growth potential [24] - Approximately 170,000 gMG patients in China present a large market opportunity for VYVGART [24] - The upcoming update to national gMG guidelines in mid-2025 is expected to enhance VYVGART's market position [25] Company Strategy and Development Direction - The company aims for a five-year CAGR of 50% through 2028, with a target of reaching $2 billion in revenue by 2028 [8][14] - Focus on advancing a global pipeline with multiple product launches and regulatory submissions planned for 2025 [10][12] - Emphasis on optimizing cost structure while investing in key growth drivers [13][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability by Q4 2025, supported by strong revenue growth and operational efficiency [14][59] - The company is positioned at a major value inflection point, with a commitment to innovation and execution excellence [14][32] - Anticipated strong performance across brands, particularly VYVGART, ZEJULA, and NUZYRA, in 2025 [31] Other Important Information - The company has made significant advancements in its global pipeline, including promising results for ZL-1310 in small cell lung cancer [34][35] - Regulatory discussions for accelerated approval of ZL-1310 are ongoing, with plans to initiate pivotal studies [38][74] - The company is actively exploring additional indications for its products to maximize patient benefit [12][39] Q&A Session Summary Question: Regarding 2025 revenue guidance and potential growth products - Management highlighted ZEJULA and NUZYRA as key growth drivers alongside VYVGART, with expectations for strong performance across all brands [63] Question: Growth trajectory for VYVGART in 2025 - Management expects stronger growth in the second half of 2025, driven by new patient starts and updates to treatment guidelines [70] Question: Regulatory strategy for DLL3 and pivotal study plans - Management confirmed plans to start a pivotal study this year, with confidence in achieving accelerated approval [74] Question: Observations on CIDP and KarXT's commercial potential - Management noted limited impact from CIDP in 2025 due to lack of NRDL listing, focusing on gMG instead [98] - Excitement about KarXT's potential in schizophrenia treatment, with plans for a dedicated sales force [100] Question: Strategy for povetacicept and key catalysts for 2025 - Management indicated participation in global trials for povetacicept, aiming for accelerated approval [121] - Key catalysts include data updates for DLL3 assets and regulatory submissions for bemarituzumab [126]

February 2025 Fourth Quarter and Full Year 2024 Financial Results and Recent Corporate Updates NASDAQ:ZLAB | HKEX:9688 © 2025. Zai Lab. All Rights Reserved. Forward-Looking Statements This presentation contains forward-looking statements, including statements relating to our strategy and plans; potential of and expectations for our business, commercial products, and pipeline programs; our goals, objectives, and priorities and our expectations under our growth strategy (including our expectations regarding o ...