Financial Performance - For Q2 2024, Zai Lab reported a product revenue of $100.1 million, a 45% increase year-over-year, and a 47% increase at constant exchange rates[6]. - Total revenue for the three months ended June 30, 2024, was $100.5 million, a 46% increase compared to $68.9 million for the same period in 2023[35]. - Product revenue for the six months ended June 30, 2024, reached $187.3 million, up 42% from $131.7 million in the same period of 2023[35]. - The net loss for Q2 2024 was $80.3 million, with a loss per share of $0.08, compared to a net loss of $120.9 million and a loss per share of $0.13 in Q2 2023[8]. - The company reported a net loss of $80.3 million for the three months ended June 30, 2024, compared to a net loss of $120.9 million for the same period in 2023[35]. - The net loss for the six months ended June 30, 2024, was $133,748 thousand, a decrease from $170,039 thousand in the same period of 2023, showing a 21% improvement[37]. - The comprehensive loss for the three months ended June 30, 2024, was $76,672 thousand, down from $85,987 thousand in the same period of 2023, indicating a 13% reduction[37]. - The comprehensive loss for the six months ended June 30, 2024, was $128,601 thousand, down from $143,544 thousand in the same period of 2023, indicating a 10% reduction[37]. Research and Development - R&D expenses for Q2 2024 were $61.6 million, a decrease from $76.7 million in the same period last year[8]. - The company plans to submit at least four new drug applications to the NMPA within the next 12 months, including for KarXT for schizophrenia[6]. - Niraparib's new adjuvant monotherapy and combination with CCR8 antibody ZL-1218 show promise for improving efficacy in HRD-positive ovarian cancer patients, with data published in *Cell* magazine[11]. - Bemarituzumab's global Phase 3 study for first-line gastric cancer treatment has completed patient recruitment, with ongoing studies in Greater China[11]. - Approval of Repotrectinib for ROS1-positive NSCLC in China and accelerated FDA approval for NTRK-positive solid tumors in the U.S.[11]. - Approval of Efgartigimod for adult generalized myasthenia gravis (gMG) patients in China, providing more treatment options[14]. - Xanomeline-Trospium is now part of a global Phase 3 study for Alzheimer's-related psychiatric disorders in Greater China[14]. - Anticipated submission of applications for tumor treating fields therapy for NSCLC in Q4 2024[14]. - Expected data release for the global Phase 1 study of ZL-1310 in late 2024 or early 2025 for relapsed and refractory SCLC patients[18]. - ZL-1218's preliminary clinical pharmacokinetics and pharmacodynamics analysis will be presented at the ESMO 2024 conference[19]. - Recruitment for schizophrenia registration bridging study in China is expected to conclude by the end of 2024[20]. Strategic Initiatives - Zai Lab entered a strategic collaboration and global licensing agreement with Macrogenics in July 2024 to expand its global oncology pipeline with the ROR1 ADC ZL-6301[8]. - The company aims to achieve profitability by the end of 2025 through its innovative pipeline and organizational enhancements[6]. - The company expects to continue focusing on its growth strategy, including commercialization of products and clinical development plans[27]. Cash and Assets - The company’s cash reserves totaled $730 million as of June 30, 2024, down from $750.8 million as of March 31, 2024[6]. - Cash and cash equivalents as of June 30, 2024, were $630.0 million, down from $790.2 million as of December 31, 2023[31]. - Total assets decreased to $987.4 million as of June 30, 2024, from $1,036.3 million as of December 31, 2023[31]. - The company had a total equity of $704.2 million as of June 30, 2024, compared to $796.1 million as of December 31, 2023[33]. Upcoming Events - Upcoming conference call scheduled for August 7, 2024, to discuss company updates and future outlook[21].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ____________________ FORM 10-Q ____________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ACT OF 1934 For the quarterly period ended June 30, 2024 OR o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ACT OF 1934 For the transition period from ______ to ______ Commission File Number: 001-38205 ____________________ ZAI LAB LIMITED (Exact Name of Registrant as Specif ...

Exhibit 99.1 Zai Lab Announces Second Quarter 2024 Financial Results and Recent Corporate Updates – Net product revenue of $100.1 million for the second quarter of 2024, representing 45% y-o-y growth; 47% y-o-y growth at constant exchange rate (CER) – VYVGART (efgartigimod alfa injection) sales of $23.2 million for the second quarter of 2024; raising full-year VYVGART revenue guidance to exceed $80.0 million ® – Expansion of Zai Lab's global oncology pipeline with a next generation ROR1 antibody-drug conjug ...

It’s not often that a genuine hidden-gem candidate appears in the market. But that label might apply to Chinese biotechnology firm Zai Lab (NASDAQ:ZLAB). Developing and commercializing a range of therapeutics, the company offers solutions for autoimmune disorders, infectious diseases and neurologic conditions. Arguably the most compelling business unit undergirding ZLAB stock, though, is oncology.According to its public profile, Zai Lab features a cancer therapy called Optune. This innovation uses electric ...

Financial Data and Key Metrics Changes - Total revenues grew 39% year over year to reach $87.1 million, driven by strong execution with the launch of VYVGART and uptake across the existing portfolio [10][28] - Net loss for Q1 2024 was $53.5 million, compared to a net loss of $49.1 million for the same period in 2023, with a loss per share of $0.05 for both periods [31] Business Line Data and Key Metrics Changes - ZEJULA's net product sales were $45.5 million, an increase of 7% year over year [28] - VYVGART's net product sales were $13.2 million for Q1 2024, following its launch in September 2023 [29] - OPTUNE's net product sales increased 49% sequentially from Q4 2023 to $12.5 million [29] - QINLOCK grew 367% year over year to $6.1 million, while NUZYRA increased 81% to $9.9 million [29] Market Data and Key Metrics Changes - The launch of VYVGART has seen nearly 2,700 new patients treated in Q1 2024, with strong initial uptake driven by NRDL inclusion and targeted outreach to physicians [11][12] - ZEJULA maintains its leadership position in the PARP inhibitor class for ovarian cancer, with key growth drivers being new patient penetration and extended treatment duration [10] Company Strategy and Development Direction - The company aims to achieve significant revenue growth and profitability by the end of 2025, supported by a strong balance sheet with over $750 million in cash [9][15] - The company is focused on expanding its operational efficiency and productivity while maintaining R&D expenses at similar levels to 2023 [13][14] - The late-stage pipeline includes multiple potential blockbuster products expected to contribute significantly to revenue beyond 2028 [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the objectives outlined in the five-year strategic plan, anticipating a strong year in 2024 [9] - The company is optimistic about the approval of several products in 2024, including repotrectinib for ROS1+ non-small cell lung cancer and SUL-DUR for ABC infections [12][24] Other Important Information - The company has appointed Andrew Zhu as Chief Commercial Officer for Greater China, bringing over 20 years of experience in marketing and sales management [14] - The company expects to maintain R&D expenses while modestly increasing sales and marketing expenses as it enters a phase of significant revenue growth [13] Q&A Session Summary Question: Can you quantify the number of key hospitals currently on formulary for VYVGART? - The company is targeting 1,000 hospitals for NRDL pull-through, with a goal of getting at least two-thirds listed by mid-2024 [34] Question: What is the regulatory status of KarXT? - The regulatory update indicates that a bridging study is being executed, with completion expected this year [38] Question: How should VYVGART's sales ramp be modeled? - The company expects steady growth through the quarters, with a confident outlook for exceeding $70 million in sales for 2024 [41] Question: What is the current standard of care for CIDP in China? - Currently, there is no approved treatment for CIDP, with patients relying on steroids and IVIg, making VYVGART a significant opportunity [60] Question: What are the expectations for ZL-1310's dose escalation data? - Initial data is expected by the end of 2024 or early 2025, with a focus on platinum-exposed patients [67]

Financial Performance - For Q1 2024, Zai Lab reported product revenue of $87.1 million, a 39% increase year-over-year, and a 43% increase when adjusted for constant exchange rates (CER) [8]. - Revenue for the three months ended March 31, 2024, was $87,149,000, representing a 39% increase compared to $62,797,000 in the same period of 2023 [41]. - The net income for Q1 2024 showed a loss of $53.5 million, compared to a loss of $49.1 million in the same period last year [8]. - The company reported a net loss of $53,471,000 for the three months ended March 31, 2024, compared to a net loss of $49,144,000 in the same period of 2023 [39]. - Operating loss for the same period was $70,309,000, a slight increase of 1% from $69,522,000 year-over-year [41]. - Cash reserves as of March 31, 2024, totaled $750.8 million, down from $806.5 million at the end of 2023 [6]. - Cash and cash equivalents as of March 31, 2024, totaled $650,780,000, down from $790,151,000 as of December 31, 2023 [33]. - Total assets decreased to $988,437,000 as of March 31, 2024, from $1,036,295,000 at the end of 2023 [33]. - The company had total liabilities of $226,268,000 as of March 31, 2024, down from $240,177,000 at the end of 2023 [33]. - The company’s cash reserves included $100,000,000 in restricted cash as of March 31, 2024 [33]. Research and Development - Research and development expenses for Q1 2024 were $54.6 million, up from $48.5 million in Q1 2023, driven by new clinical studies [8]. - Research and development expenses for the first quarter of 2024 were $54,645,000, compared to $48,472,000 in the same quarter of 2023 [37]. - Zai Lab is recruiting patients in Greater China for the global Phase 3 clinical studies FORTITUDE-101 and FORTITUDE-102, evaluating bemarituzumab in combination with chemotherapy for gastric cancer [11]. - Zai Lab is assessing clinical data from the global Phase 3 study KRYSTAL-12 for adagrasib in previously treated KRASG12C mutation NSCLC patients [11]. - Zai Lab plans to submit a marketing authorization application for tumor-treating fields therapy for NSCLC patients with disease progression after platinum-based therapy [19]. - Zai Lab aims to complete patient enrollment for a bridging study in schizophrenia in China and will join global Phase 3 studies for Alzheimer's-related psychiatric disorders [21]. - The company expects to announce dose escalation data from the global Phase 1 study of ZL-1310 for relapsed and refractory small cell lung cancer (SCLC) by the end of 2024 or early 2025 [15]. - Zai Lab submitted a sBLA for the subcutaneous formulation of efgartigimod for chronic inflammatory demyelinating polyneuropathy (CIDP) to the NMPA [20]. - The company is participating in the PANOVA-3 Phase 3 clinical study for locally advanced pancreatic cancer, with primary data expected in Q4 2024 [19]. - Zai Lab is conducting a global Phase 2 study for ZL-1102 targeting moderate to severe chronic plaque psoriasis, set to start in Q2 2024 [18]. Product Launch and Sales - Sales of the newly launched drug, Weiwei Jia, reached $13.2 million in Q1 2024, with approximately 2,700 new patients treated, marking a significant entry into the market [6]. - The launch of Weiwei Jia in September 2023 has positively impacted sales, contributing to a strong growth trajectory for the company [5]. - The sales of the drug Zealor increased to $45.5 million in Q1 2024, a 7% increase from $42.7 million in Q1 2023 [8]. - The company anticipates accelerating commercialization efforts and preparing for the launch of three new potential products in 2024 [5]. - The company appointed Mr. Zhu Tong as Chief Commercial Officer for Greater China in April 2024 to enhance commercialization operations [9]. Future Outlook - The company anticipates future events and developments may lead to changes in its expectations and assumptions, but it has no obligation to update or revise any forward-looking statements [28].

Revenue and Sales Performance - Net product revenue for Q1 2024 was $87.1 million, a 39% increase from $62.8 million in Q1 2023, primarily driven by increased sales volume and the launch of VYVGART[89]. - Total product revenue for the first quarter of 2024 was $87.1 million, representing a 39% increase from $62.8 million in the same period of 2023[109]. - ZEJULA sales increased by 7% to $45.5 million, while QINLOCK saw a significant increase of 367% to $6.1 million[109]. - VYVGART was commercially launched in September 2023 and included in the NRDL in Q1 2024, contributing to revenue growth[106]. - QINLOCK and NUZYRA saw increased sales due to their inclusion in the NRDL, with QINLOCK added in Q1 2023 and NUZYRA's oral formulation added in Q1 2024[106]. - ZEJULA remained the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China, with continued support from NRDL listings[106]. Expenses and Losses - The cost of sales increased by 58% to $33.6 million in Q1 2024 from $21.3 million in Q1 2023, reflecting higher product sales volume[103]. - Research and development expenses rose by 13% to $54.6 million in Q1 2024 compared to $48.5 million in Q1 2023, indicating continued investment in product development[103]. - Selling, general, and administrative expenses increased by 11% to $69.2 million in Q1 2024 from $62.5 million in Q1 2023, supporting commercial operations[103]. - The net loss for Q1 2024 was $53.5 million, a 9% increase from a net loss of $49.1 million in Q1 2023[103]. - The company’s net loss increased by $4.3 million in Q1 2024, contributing to the rise in cash used in operating activities[140]. Cash Flow and Financial Position - As of March 31, 2024, the company had cash and cash equivalents of $750.8 million, expected to meet cash requirements for at least the next 12 months[136]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $39.4 million in Q1 2024, an improvement from a decrease of $128.4 million in Q1 2023[139]. - Net cash used in operating activities increased by $20.8 million to $90.1 million in Q1 2024, primarily due to a $24.7 million increase in net changes in operating assets and liabilities[140]. - Net cash provided by investing activities was $3.3 million in Q1 2024, a significant shift from net cash used of $54.0 million in Q1 2023, mainly due to a $100.0 million decrease in purchases of short-term investments[141]. - Net cash provided by financing activities was $47.5 million in Q1 2024, compared to net cash used of $3.9 million in Q1 2023, driven by $48.2 million in proceeds from short-term debts[142]. - The company had cash and cash equivalents of $650.8 million as of March 31, 2024, down from $790.2 million as of December 31, 2023[153]. Research and Development - Clinical program expenses within R&D increased by 50% to $18.8 million, driven by newly initiated studies[114]. - Research and development expenses rose by 13% to $54.6 million, primarily due to a $7.5 million increase in CROs/CMOs/Investigators expenses[112]. Debt and Obligations - As of March 31, 2024, the company may be required to pay up to $303.5 million in development and regulatory milestone payments for current clinical programs[101]. - The company entered into debt arrangements allowing subsidiaries to borrow up to approximately $164.5 million to support working capital needs[137]. Foreign Currency and Interest - Foreign currency losses amounted to $2.1 million in the first quarter of 2024, contrasting with a gain of $8.9 million in the same period of 2023[119]. - Interest income decreased by $0.6 million to $9.7 million due to reduced cash and cash equivalents[117]. Customer Concentration - As of March 31, 2024, accounts receivable from the two largest customers accounted for approximately 21% of total accounts receivable[154]. Accounting Standards - The company has not adopted any new accounting standards since December 31, 2023[144]. Foreign Exchange Risk - The company has not used derivative financial instruments to hedge foreign exchange risk, as it does not currently have significant direct exposure[147].

Exhibit 99.1 Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates – Net product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate (CER) ® – VYVGART (efgartigimod alfa injection) sales of $13.2 million for the first quarter of 2024, driven by increased patient access; an estimated 2,700 new patients were treated with VYVGART in the first quarter of 2024 – Regulatory reviews ongoing for sulbactam-dur ...

Financial Performance - The company reported a significant increase in revenue, achieving $500 million in 2023, representing a 25% year-over-year growth[7]. - The gross margin improved to 60%, up from 55% in the previous year, reflecting better cost management and pricing strategies[7]. - The company has incurred significant losses since its inception, with a net loss of $334.6 million in 2023, and expects to continue generating losses at least in the coming year[158]. - The top five customers accounted for approximately 35.0% and 37.7% of total product revenue in 2023 and 2022, respectively[99]. User Growth and Market Expansion - User data showed a total of 1.2 million active users, up from 900,000 in the previous year, indicating a 33% increase[8]. - The company plans to expand its market presence in Europe and Asia, targeting a 10% market share in these regions by 2025[8]. - The company provided guidance for 2024, projecting revenue growth of 20% to $600 million, driven by new product launches and market expansion[8]. Research and Development - Investment in R&D increased by 15% to $75 million, focusing on innovative technologies and product development[8]. - The company emphasizes the importance of R&D for future growth, focusing on unmet medical needs in oncology, autoimmune diseases, infectious diseases, and CNS disorders[38]. - The product pipeline includes several assets at different development stages, including late-stage and clinical assets[38]. - The company has a strong internal R&D team capable of developing candidates with international intellectual property rights[24]. Product Development and Clinical Trials - The company is developing a new drug expected to enter clinical trials in Q3 2024, with potential market value estimated at $1 billion[8]. - The company is preparing to submit a marketing authorization application to the National Medical Products Administration in China for tumor electric field therapy for NSCLC, targeting submission in 2024[44]. - The Phase III LUNAR trial showed statistically significant and clinically meaningful improvement in overall survival (OS) for metastatic NSCLC patients after platinum-based therapy, with low incidence of device-related adverse events[44]. - The company is actively assessing additional indications for tumor electric field therapy, including second-line NSCLC and pancreatic cancer, to expand its treatment options[44]. Regulatory Environment and Compliance - The company highlighted risks related to regulatory changes in China, which could impact operations and market access[22]. - The company must obtain marketing authorization to produce and sell its products in mainland China, with the National Medical Products Administration overseeing the approval process[84]. - The company is subject to complex regulations regarding drug research, approval, and marketing in China, which require significant resources and time to comply with[81]. - The company is subject to ongoing regulatory scrutiny and compliance requirements post-approval, which may incur significant additional expenses[197]. Market Access and Insurance Coverage - The company aims to improve patient accessibility to its products through insurance coverage enhancements in mainland China[32]. - The company is focusing on increasing the insurance coverage for several commercialized products in the out-of-pocket market[88]. - The average price reduction achieved through government negotiations has led to increased accessibility of drugs in public hospitals, which are the primary providers of medical services in China[91]. - The company has committed to ethical business practices and strong corporate governance as part of its Trust for Life strategy[26]. Strategic Collaborations and Acquisitions - A strategic acquisition was announced, with the company acquiring a biotech firm for $200 million to enhance its product pipeline[8]. - The company has established strategic collaborations with leading global biopharmaceutical companies to strengthen its product pipeline[24]. - The company has exclusive licenses for multiple products in the Greater China region, enhancing its market presence[33][35]. Risks and Challenges - The company faces significant risks in obtaining regulatory approvals for its candidate products in Greater China, the U.S., and other jurisdictions, which is a lengthy and costly process[169]. - The company may face significant challenges in obtaining necessary approvals from Chinese regulatory bodies for issuing securities to foreign investors[136]. - The evolving relationship between the US and China could adversely affect the company's business, operational performance, and market price of its securities[122]. - The company may face significant reputational damage if safety issues arise, impacting investor and physician confidence in its products[192]. Production and Supply Chain - The company operates two production facilities that comply with both Chinese and PIC/S drug production standards, supporting commercial and clinical needs[102]. - The company has established a strict quality control system in compliance with national regulations, monitoring operations throughout the production process[106]. - The company relies on third-party manufacturers for production, and any issues with these partners could delay product availability and negatively impact business performance[172]. Financial Strategy and Funding - The company is exploring various funding opportunities, including equity sales and debt financing, which may dilute shareholder equity and impose operational restrictions[163]. - The company has established debt arrangements with Chinese financial institutions, allowing subsidiaries to borrow up to approximately $164.5 million (or RMB 1,171.7 million) to support operational funding needs in mainland China[162]. - The company’s future funding needs will depend on various factors, including revenue from approved products and the costs associated with future commercialization activities[160]. Competitive Landscape - The biopharmaceutical industry is highly competitive, with many companies having more financial and R&D resources than the company[107]. - The company faces intense competition in drug development and commercialization, which could adversely affect its financial condition and ability to sell products[181]. - Competitors may commercialize safer, more effective, or cheaper products, potentially reducing the company's market opportunities[183].

Revenue Growth - Product revenue increased by $54.0 million or 25% to $266.7 million, primarily due to increased sales and the launch of Weiwei Jia® (Egamod α injection), offset by increased sales rebates and recent adjustments in China's pharmaceutical policy environment [5]. - Total revenue for 2023 reached $266.72 million, an increase of 24% compared to $215.04 million in 2022 [23]. - Product revenue, net of $266.72 million, showed a significant rise from $212.67 million in the previous year, reflecting a growth of approximately 25.4% [23]. - Total product revenue for 2023 was $266.7 million, representing a 25% year-over-year growth [180]. - The revenue from the product "則樂" increased by $23.6 million or 16%, while "紐再樂" saw a significant rise of $16.5 million or 316% [196]. Expenses and Losses - R&D expenses decreased by $20.5 million or 7% to $265.9 million, mainly due to reduced prepayments and milestone payments related to licensing and collaboration agreements, partially offset by increased personnel costs [5]. - Selling, general and administrative expenses increased by $22.6 million or 9% to $281.6 million, primarily due to increased general sales expenses related to supporting the launch of Weiwei Jia, partially offset by a decrease in professional service fees [5]. - Operating loss for 2023 was $366.57 million, a slight improvement from a loss of $404.36 million in 2022 [23]. - The company reported a net loss for the year ended December 31, 2023, of $334,620,000, a decrease from the net loss of $443,286,000 in 2022, representing a 24.6% improvement [26]. - Basic and diluted loss per share was $0.35, a decrease of 24% from $0.46 [5]. Cash and Assets - Cash and cash equivalents decreased to $790.15 million from $1,008.47 million, a decline of approximately 21.6% [22]. - Total assets decreased to $1,036.30 million from $1,220.14 million, representing a reduction of about 15.1% [22]. - The company’s total stockholders' equity decreased by approximately 23.9% from the previous year, reflecting challenges in maintaining equity levels amid operational losses [175]. - Cash flow used in operating activities for 2023 was $(198,178,000), an improvement from $(367,642,000) in 2022, reflecting a 46.0% decrease in cash outflow [29]. Research and Development - Research and development expenses for 2023 were $265.9 million, a decrease of 7% from $286.4 million in 2022 [192]. - The company has multiple late-stage product development projects and ongoing key clinical studies [178]. - Research and development expenses are expected to remain significant as the company focuses on advancing its pipeline of potential best-in-class and first-in-class products [184]. - Employee compensation and related costs in R&D rose by $10.2 million or 10% [198]. Strategic Initiatives and Collaborations - The company has entered into a licensing and collaboration agreement with NovoCure for tumor electric field therapy, potentially paying up to $68.0 million in development and sales milestone payments [129]. - A licensing agreement with Deciphera Pharmaceuticals allows the company to develop and commercialize products containing ripretinib in Greater China, with potential payments up to $173.0 million [130]. - The company plans to continue expanding its product pipeline through regional and global collaborations [191]. - The company has strengthened its global leadership team to support business growth, including the appointment of Dr. Chen Yajing as Chief Financial Officer [182]. Financial Position and Liabilities - Total liabilities increased to $240.18 million from $174.55 million, marking an increase of approximately 37.5% [22]. - The total accounts payable increased to $113.0 million in 2023 from $66.0 million in 2022, with significant amounts due within three months [98]. - The company’s operating loss carryforwards as of December 31, 2023, totaled $1.80 billion, an increase from $1.48 billion in 2022 [113]. Share-Based Compensation - The company recognized $79,634,000 in stock-based compensation for the year ended December 31, 2023, compared to $61,302,000 in 2022, marking a 29.9% increase [29]. - The total share-based compensation expense for 2023 was $79.634 million, up from $61.302 million in 2022 [126]. - The fair value of share-based compensation expenses for the executive director and CEO was $14.490 million in 2023, compared to $12.438 million in 2022, representing a significant increase of 16.5% [157]. Future Outlook - The company anticipates continued revenue growth in 2024 from newly included products in the National Medical Insurance Catalogue, such as Weiwei Jia and Newzai oral formulation [180]. - The company aims to achieve overall profitability by the end of 2025 through enhanced efficiency and productivity [191]. - The company’s ability to generate profits and positive cash flow in the coming years depends on the successful commercialization of its products and the development of additional candidates [178].