Summary of Zai Lab (ZLAB) 2025 Conference Call Company Overview - **Company**: Zai Lab (ZLAB) - **Event**: 2025 Conference Call held on June 4, 2025 Key Industry Insights - **Market Focus**: Zai Lab is actively executing its commercial strategy in China, particularly with its product Vivgart and its wholly owned pipeline of drugs [2][5][6] - **Sales Guidance**: For 2025, Zai Lab has provided a sales guidance range of $560 million to $590 million, indicating a growth rate of over 40% [5][6] Core Product Insights - **Vivgart Performance**: - First quarter sales for Vivgart were $18 million, which was lower than expected due to seasonal impacts from the Chinese New Year [7][8] - Total sales for Vivgart in its first year reached $93 million, showcasing strong initial market acceptance [7] - Anticipated strong sequential growth for Vivgart in Q2, Q3, and Q4, driven by increased patient utilization and changes in treatment guidelines [14][19] - Current patient base on Vivgart is approximately 12,000, with a potential market of 150,000 patients in China [16] Regulatory and Pricing Strategy - **NRDL Negotiation**: Zai Lab is approaching the two-year reset for Vivgart's pricing under the National Reimbursement Drug List (NRDL), with expectations of a single-digit price decline [21][25] - **New Indications**: Zai Lab is pursuing additional indications for Vivgart, including a subcutaneous version and a new indication for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) [26][29] Pipeline Developments - **DLL3 ADC Program**: - Zai Lab presented promising data at ASCO for its DLL3 ADC program in small cell lung cancer, reporting a 79% overall response rate with a favorable safety profile [41][42] - Plans to initiate a pivotal study for DLL3, with data expected in 2026 for accelerated approval [50][68] - **IL-13 Bispecific Antibody**: - Zai Lab is developing an IL-13 bispecific antibody, expected to start Phase 1 trials later this year, with potential advantages in dosing frequency and efficacy [71][78] Commercial Strategy - **Sales Force Considerations**: Zai Lab is open to establishing its own sales force in the U.S. for DLL3, while also considering partnerships [80][81] - **Focus on Oncology and Immunology**: The company aims to leverage its expertise in oncology and immunology for future business development and drug acquisitions [90][88] Additional Insights - **Market Competition**: Zai Lab acknowledges competition in the DLL3 space but believes its product has a clear value proposition due to its administration advantages [51][56] - **Long-term Profitability**: The company aims to achieve profitability by the end of 2025, with a focus on maintaining flat operational expenses while growing sales [32][35] This summary encapsulates the key points discussed during the Zai Lab conference call, highlighting the company's strategic direction, product performance, and market positioning.

Financial Data and Key Metrics Changes - The company reported a confirmed overall response rate (ORR) of 68% and a disease control rate of 93% across all dose levels in the ongoing clinical trial for ZL1310 [12][21] - The median follow-up for the efficacy evaluable patients was 3.4 months, with some patients remaining in response for over 9 months [22][43] Business Line Data and Key Metrics Changes - ZL1310, the investigational DLL3 targeted antibody-drug conjugate, demonstrated promising clinical activity in patients with relapsed or refractory extensive stage small cell lung cancer [6][19] - The safety profile of ZL1310 was reported as manageable, with only 16% of patients in the low-dose group requiring dose interruptions [10][19] Market Data and Key Metrics Changes - Small cell lung cancer accounts for approximately 15% of all lung cancers, affecting around 372,000 patients worldwide, with a poor prognosis and a median overall survival of about 13 months [6][19] - The estimated global prevalence of DLL3 expressing neuroendocrine carcinomas is roughly 350,000 to 400,000 patients, indicating a significant market opportunity for ZL1310 [26] Company Strategy and Development Direction - The company plans to initiate a registrational study in second-line small cell lung cancer later this year, with overall survival as the primary endpoint [22][23] - There is a strategy to expand ZL1310 into first-line small cell lung cancer and other DLL3 expressing solid tumors, aiming to reduce treatment burden for patients [25][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential for accelerated approval based on the promising data and ongoing discussions with the FDA [56][57] - The company is optimistic about the efficacy of ZL1310 in the competitive landscape, particularly in comparison to existing therapies [48][49] Other Important Information - The company is exploring combination therapies with ZL1310, including carboplatin and atezolizumab, to enhance treatment efficacy [38][39] - The company has received fast track designation from the FDA, which may facilitate the development process [32] Q&A Session Summary Question: Can you comment on the therapeutic window and confidence in the selected dose for pivotal studies? - Management indicated that the 1.6 mg/kg dose shows a good balance of efficacy and safety, with a slight attrition in response at higher doses [29][30] Question: What is the dosing strategy and safety consideration for the combination trial? - The company is methodically exploring combinations with existing chemotherapy regimens and is confident in the competitive activity of ZL1310 [37][38] Question: How does the durability of ZL1310 compare to competitors in refractory small cell lung cancer? - Management noted that the durability of response is clinically meaningful, with a median follow-up of 6.9 months for the most mature data set [42][43] Question: What gives confidence in potential accelerated approval for ZL1310? - Ongoing discussions with the FDA suggest that accelerated approval is a viable option, contingent on the results of the randomized trial [56][57] Question: What are the remaining items to align with the FDA before initiating the pivotal study? - The main focus is to finalize the dosing strategy and ensure alignment on study design with the FDA [65][66]

Summary of Zai Lab (ZLAB) Update / Briefing June 02, 2025 Company and Industry Overview - **Company**: Zai Lab (ZLAB) - **Industry**: Oncology, specifically focusing on small cell lung cancer (SCLC) and DLL3 targeted therapies Key Points and Arguments Clinical Data and Efficacy - **ZL1310**: Investigational DLL3 targeted antibody-drug conjugate (ADC) showing promising clinical activity in patients with recurrent SCLC [4][8] - **Patient Demographics**: 89 patients enrolled in the trial, with 47% having one prior line of therapy and 53% having failed at least two prior lines [10] - **Efficacy Results**: - Confirmed overall response rate (ORR) of 68% and disease control rate (DCR) of 93% across all dose levels [14] - In second-line patients, ORR remains robust at 67% with a DCR of 97% [15] - Notably, the 1.6 mg/kg dose arm achieved an unconfirmed ORR of 79% and a 100% DCR [16] - **Intracranial Activity**: 68% ORR in patients with brain metastases, with 86% response in those without prior cranial radiation [21] Safety Profile - **Safety Analysis**: ZL1310 demonstrated a well-tolerated safety profile, with only 16% of patients in the low-dose group requiring dose interruptions [12] - **Adverse Events**: Most common treatment-related adverse events included anemia (40%), neutropenia (30%), and nausea (26%) [13] - **High-Grade Adverse Events**: Only 6% experienced grade three or greater toxicity in the lower dose group [12] Future Development Plans - **Phase III Trial**: A registrational study in second-line SCLC is planned to start later this year, comparing ZL1310 against investigator's choice of therapy [24][25] - **Combination Studies**: Exploring combinations with checkpoint inhibitors and chemotherapy, aiming to demonstrate competitive efficacy [40] - **Expansion into Other Tumors**: Plans to pursue opportunities in first-line SCLC and neuroendocrine carcinoma, targeting DLL3 expressing tumors [27] Regulatory Considerations - **Accelerated Approval**: Discussions with the FDA indicate potential for accelerated approval based on response rates in the randomized trial [58] - **Study Design**: The pivotal study will include patients with extensive stage SCLC who have progressed after first-line platinum-based therapy [25][66] Additional Important Insights - **Therapeutic Window**: The 1.6 mg/kg dose shows a promising balance of efficacy and tolerability, with ongoing discussions about dose optimization [33][34] - **Durability of Response**: Median follow-up for responders is 6.9 months, with a significant number of patients remaining in response [44] - **Comparison with Competitors**: ZL1310 is positioned as a more easily administered outpatient option compared to other therapies like pirilatumab, which may have logistical challenges [52] This summary encapsulates the critical findings and future directions for Zai Lab's ZL1310 program, highlighting its potential impact on the treatment landscape for small cell lung cancer.

ZL-1310 ASCO 2025 Highlights June 2, 2025 NASDAQ:ZLAB | HKEX:9688 © 2024. Zai Lab. All Rights Reserved. Associate Director of Drug Development, Sarah Cannon Research Institute Forward-Looking Statements This presentation contains forward-looking statements about future expectations, plans, and prospects for Zai Lab, including, without limitation, statements regarding product candidates in our pipeline including ZL-1310 and related clinical trials and preclinical studies, the potential benefits and safety an ...

Core Insights - Zai Lab Limited (NASDAQ: ZLAB) has demonstrated its capability to adopt and commercialize new drugs in China by leveraging therapies that have already been tested or approved elsewhere, which helps to minimize trial-related risks [1] Company Strategy - The company's strategy focuses on developing drugs by utilizing existing therapies, thereby reducing the risks associated with clinical trials [1] Investment Perspective - The analysis highlights the potential for Zai Lab to identify and capitalize on investment opportunities within the biotech sector, particularly through its innovative approach to drug commercialization [1]

Core Insights - The article emphasizes the importance of understanding the science behind biotech investments to avoid pitfalls in the industry [1]. Group 1 - The author has a PhD in biochemistry and extensive experience analyzing clinical trials and biotech companies [1]. - The mission is to educate investors on the scientific aspects of biotech businesses to facilitate informed decision-making [1].

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]

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 our commercial products and launches, clinical stage products, revenue growth / CAGR, profitabil ...