Financial Performance - Net product revenue for Q3 2024 was $101.8 million, a 47% increase year-over-year, driven by VYVGART sales and renewals of NRDL listings for ZEJULA and NUZYRA[80]. - Total revenues for the three months ended September 30, 2024, were $102.3 million, a 48% increase from $69.2 million in 2023, and for the nine months, revenues were $289.9 million, up 44% from $200.9 million[99]. - Product revenue increased by $32.6 million (47%) and $88.2 million (44%) for the three and nine months ended September 30, 2024, respectively, primarily driven by increased sales of VYVGART and other products[101]. - ZEJULA sales for the three months ended September 30, 2024, were $48.2 million, a 16% increase from $41.6 million in 2023, while VYVGART sales surged by 458% to $27.3 million[102]. - The company reported a net loss of $41.7 million for the three months ended September 30, 2024, a decrease from a net loss of $69.2 million in the same period of 2023[121]. - Net loss for the three months ended September 30, 2024, was $41.7 million, a 40% improvement from a loss of $69.2 million in 2023, and for the nine months, the loss was $175.4 million, down 27% from $239.2 million[99]. Research and Development - The company anticipates continued significant investments in research and development to advance its pipeline of product candidates[93]. - ZL-1310, an investigational DLL3-antibody-drug conjugate, showed a 74% overall response rate in a Phase I study for extensive stage small cell lung cancer[83]. - KarXT demonstrated a statistically significant 9.2-point reduction in PANSS total score in a Phase III study for schizophrenia, with results expected to support a New Drug Application in early 2025[85]. - The company appointed Prista Charuworn, M.D., as Vice President of Immunology, Global R&D, to strengthen its R&D strategy[91]. - As of September 30, 2024, the company may incur up to $284.5 million in development and regulatory milestone payments for current clinical programs[97]. Expenses and Costs - Research and development expenses increased by $7.2 million (12%) for the three months ended September 30, 2024, primarily due to a $22.6 million increase in licensing fees[106]. - Cost of product revenue increased by $11.1 million (44%) and $34.8 million (49%) for the three and nine months ended September 30, 2024, respectively, due to rising sales volumes[103]. - Selling, general, and administrative expenses decreased by $1.3 million (2%) for the three months ended September 30, 2024, but increased by $17.1 million (9%) for the nine months[112]. - VYVGART, launched in September 2023, contributed to a $17.1 million increase in selling, general, and administrative expenses for the nine months ended September 30, 2024[113]. Cash and Investments - The company had cash and cash equivalents of $716.1 million as of September 30, 2024, expected to meet cash requirements for at least the next 12 months[138]. - Net cash provided by financing activities was $112.1 million in the nine months ended September 30, 2024, compared to a net cash used of $6.8 million in the same period of 2023[144]. - The company had short-term debt of approximately $113.0 million related to new debt arrangements[140]. - The company held short-term investments of $16.3 million as of December 31, 2023, compared to nil as of September 30, 2024[154]. - Net cash used in operating activities decreased by $24.2 million in the nine months ended September 30, 2024, primarily due to a $63.8 million reduction in net loss[142]. Foreign Currency and Credit Risk - Foreign currency gains for the three months ended September 30, 2024, were $14.5 million, a 198% increase from $4.9 million in 2023[99]. - Interest income for the three months ended September 30, 2024, was $9.0 million, a slight decrease of 2% from $9.2 million in 2023[99]. - The company does not currently have significant direct foreign exchange risk, as its transactions are primarily settled in RMB[149]. - The value of the company's ADSs and ordinary shares is affected by the exchange rates between U.S. dollars, HK dollars, and RMB[151]. - The company manages credit risk related to accounts receivable through ongoing monitoring and has historically collected receivables within credit terms[156].

Revenue Performance - Net product revenue for Q3 2024 reached $101.8 million, a 47% year-over-year increase from $69.2 million in Q3 2023[3]. - VYVGART sales were $27.3 million in Q3 2024, up from $4.9 million in Q3 2023, driven by its launch and listing on China's National Reimbursement Drug List[3][4]. - ZEJULA generated $48.2 million in Q3 2024, reflecting a 16% year-over-year growth from $41.6 million in Q3 2023[4]. - NUZYRA sales increased by 82% year-over-year to $10.0 million in Q3 2024, compared to $5.5 million in Q3 2023[5]. - Total revenues for Q3 2024 reached $102.3 million, a 47% increase compared to $69.2 million in Q3 2023[35]. - Product revenue for the nine months ended September 30, 2024, was $289.1 million, reflecting a 44% year-over-year growth from $200.9 million in the same period of 2023[40]. Expenses - Research and Development expenses were $66.0 million in Q3 2024, up from $58.8 million in Q3 2023, primarily due to increased upfront and milestone fees[6]. - Selling, General and Administrative expenses decreased to $67.2 million in Q3 2024 from $68.6 million in Q3 2023[7]. - Adjusted loss from operations for Q3 2024 was $48.2 million, compared to $59.7 million in Q3 2023, indicating a 19% reduction[41]. Net Loss and Financial Position - Net loss for Q3 2024 was $41.7 million, a significant improvement from a net loss of $69.2 million in Q3 2023[9]. - The company reported a net loss of $41.7 million for Q3 2024, an improvement from a net loss of $69.2 million in Q3 2023[37]. - Cash position as of September 30, 2024, was $716.1 million, down from $730.0 million as of June 30, 2024[9]. - Cash and cash equivalents decreased to $616.1 million as of September 30, 2024, down from $790.2 million at the end of 2023[34]. - Total current liabilities increased to $286.3 million as of September 30, 2024, compared to $203.1 million at the end of 2023[34]. - The company’s accumulated deficit grew to $2.37 billion as of September 30, 2024, from $2.20 billion at the end of 2023[34]. Future Outlook - Positive results from the China bridging study of KarXT for schizophrenia are expected to lead to a regulatory submission in early 2025[2][14]. - Zai Lab anticipates three product launches in mainland China by the end of 2024 and up to four potential regulatory submissions to the NMPA in the next six months[1]. - Zai Lab anticipates continued revenue growth and aims to achieve profitability through its growth strategy and product pipeline[31]. - The company experienced foreign currency gains of $14.5 million in Q3 2024, compared to gains of $4.9 million in Q3 2023[35].

Group 1 - Zai Lab Limited's shares increased by 14.7% to close at $33.18, with a significant trading volume compared to normal sessions, and a total gain of 42.3% over the past four weeks [1][2] - The stock price surge followed the announcement of a 74% objective response rate for ZL-1310 in a global phase Ia/Ib study for recurrent extensive-stage small cell lung cancer (SCLC), indicating strong potential for the investigational candidate [2] - Zai Lab plans to further evaluate ZL-1310 both as a single agent and in combination therapies for extensive-stage SCLC, following positive early-stage study results showing that the candidate was generally safe and well-tolerated [2] Group 2 - The company is expected to report a quarterly loss of $0.74 per share, reflecting a year-over-year decrease of 4.2%, while revenues are projected to be $103.54 million, representing a 49.6% increase from the previous year [2] - The consensus EPS estimate for Zai Lab has been revised 3.7% lower over the last 30 days, indicating a negative trend in earnings estimate revisions, which typically does not correlate with price appreciation [3] - Zai Lab is part of the Zacks Medical - Biomedical and Genetics industry, where another company, Adma Biologics, has also been noted with a Zacks Rank of 3 (Hold) [3][4]

Group 1 - Zai Lab Limited's shares increased by 11.1% to $22.60 in the last trading session, with a higher-than-average trading volume, compared to an 8.4% gain over the past four weeks [1] - The stock price surge is attributed to positive investor expectations regarding the performance of its marketed drugs: Zejula, Vyvgart, and Nuzyra, along with a strong pipeline of investigational drugs [1] - The company is projected to report a quarterly loss of $0.72 per share, reflecting a year-over-year change of -1.4%, while revenues are expected to reach $105.19 million, a 51.9% increase from the previous year [1] Group 2 - The consensus EPS estimate for Zai Lab has remained unchanged over the last 30 days, indicating that stock price movements may not sustain without trends in earnings estimate revisions [2] - Zai Lab currently holds a Zacks Rank of 3 (Hold), suggesting a neutral outlook [2] - Zai Lab is part of the Zacks Medical - Biomedical and Genetics industry, which includes TELA Bio, another stock in the same sector that closed 6.5% higher at $2.62 [2]

Group 1 - Zai Lab Limited (NASDAQ: ZLAB) develops therapies across various medical conditions including oncology, autoimmune, infectious, and neurological diseases [1] - The company has collaborated with leading firms to create approved products such as VYVGART, AUGTYRO, and XACDURO, retaining commercialization rights for China [1] - Recent policy reforms in China have supported Zai Lab's efforts, facilitating its operations and market presence [1]

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]

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].