ZAI LAB(ZLAB)
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ZAI LAB(ZLAB) - 2025 Q2 - Earnings Call Transcript
2025-08-07 13:02
Financial Data and Key Metrics Changes - Total revenue grew 9% year over year to $110 million in Q2 2025, primarily driven by higher sales of VIBGART and ZACTURA [34] - Operating loss improved by 28% to $54.9 million, while adjusted loss from operations was reduced by 37% to $34.2 million [17][35] - The company reaffirmed its full year revenue guidance of $560 million to $590 million, expecting profitability on an adjusted basis in Q4 2025 [7][36] Business Line Data and Key Metrics Changes - VIBGART saw record levels of patient utilization, with a meaningful shift toward maintenance use, reflecting growing physician confidence [12] - Zejula experienced a softer quarter due to evolving competitive dynamics but is expected to stabilize and grow in the second half of the year [15] - Zakduro continues to see robust demand, although supply constraints may limit near-term growth [16] Market Data and Key Metrics Changes - The new national guidelines for gMG in China elevate VIBGART's positioning, recognizing minimal symptom expression as the primary treatment goal [13] - Approximately 450,000 patients with gastric cancer in China, with about one-third overexpressing FGFR2b, represent a significant market opportunity for bemarituzumab [39] Company Strategy and Development Direction - The company aims to become a leading global biopharma, focusing on commercial business growth and advancing its global pipeline [6] - Strategic priorities include strengthening the global pipeline with externally sourced innovation and expanding the China portfolio with best-in-class assets [18] - The company is leveraging AI to optimize clinical trials and enhance commercial analytics [10] Management Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving revenue guidance and profitability goals by year-end, driven by VIBGART and other products [46][47] - The company anticipates significant long-term potential for VIBGART, with expectations of exceeding $1 billion in peak sales [15][71] Other Important Information - The company is preparing for submissions for several late-stage assets, including bemarituzumab and tumor treating fields for pancreatic cancer [17] - The cash position at the end of the quarter was $832.3 million, indicating a strong financial position [36] Q&A Session Summary Question: Potential opportunity for bemarituzumab in frontline gastric cancer - Management highlighted a significant patient population in China, with over 450,000 gastric cancer patients, and expressed confidence in achieving over $1 billion in sales potential [39][40] Question: Confidence in achieving 2025 revenue guidance and profitability - Management reaffirmed confidence in the revenue guidance and profitability, expecting accelerating growth in the second half of the year driven by VIBGART [46][47] Question: Growth expectations from broader commercial franchise - Management indicated that both Zakduro and Onctyro are expected to contribute to growth, with strong demand anticipated [54][56] Question: Steps left to file bemarituzumab in China - Management is focused on expediting the submission process and is in discussions with partners for registration [87][89] Question: Timeline for DLL3 ADC data updates - Management expects to provide updates on the second-line treatment data before the end of the year, with first-line data likely in early next year [95]
ZAI LAB(ZLAB) - 2025 Q2 - Earnings Call Transcript
2025-08-07 13:00
Financial Data and Key Metrics Changes - Total revenue grew 9% year over year to $110 million in the second quarter, primarily driven by higher sales of VIBGART and ZACTURA [32][33] - Operating loss improved by 28% to $54.9 million, while adjusted loss from operations was reduced by 37% to $34.2 million, keeping the company on track to achieve profitability in the fourth quarter [15][33] Business Line Data and Key Metrics Changes - VIBGART saw record levels of patient utilization, with a meaningful shift toward maintenance use, reflecting growing physician confidence [10][11] - Zejula had a softer quarter due to evolving competitive dynamics but is expected to stabilize and grow in the second half of the year [13][47] - Zakduro continues to see robust demand, although supply constraints may limit near-term growth [14] Market Data and Key Metrics Changes - VIBGART penetration in gMG is currently at 10%, indicating significant room for growth [11] - The new national guidelines for gMG in China elevate VIBGART's positioning, recognizing its ability to achieve minimal symptom expression rapidly [11] Company Strategy and Development Direction - The company aims to become a leading global biopharma, focusing on commercial business growth and advancing its global pipeline [5][6] - The strategy includes leveraging AI to optimize clinical trials and enhance commercial analytics [8] - Business development remains a priority, focusing on strengthening the global pipeline and expanding the China portfolio [17] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the full-year revenue guidance of $560 million to $590 million, with expectations for accelerating growth in the second half of the year [6][34] - The company is on track to achieve profitability on an adjusted basis by the fourth quarter, supported by disciplined spending and strategic investments [15][33] Other Important Information - The company is preparing for submissions for several late-stage assets, including Bimetuzumab for gastric cancer and tumor treating fields for pancreatic cancer [6][16] - The cash position at the end of the quarter was $832.3 million, indicating a strong financial position [34] Q&A Session Summary Question: Can you help us understand the potential opportunity for bema in frontline gastric cancer? - Management highlighted a significant patient population in China, estimating over 450,000 gastric cancer patients, with about a third overexpressing FGFR2b, indicating a billion-dollar sales potential [36][39] Question: Can you discuss your confidence levels in achieving your 2025 revenue guidance and profitability goal by year-end? - Management reaffirmed confidence in the revenue guidance and profitability goals, expecting accelerating growth driven by VIBGART and other products [44][46] Question: What is the strategy in China between subcutaneous and IV formulation for VIBGART? - Management expects a shift from almost exclusively IV use to significant subcutaneous use as the product gains traction in the market [80] Question: Are you still actively looking for a partner for clinical development of DLL3? - The company plans to initiate the pivotal trial independently but remains open to partnerships [83] Question: What steps are left to file in China for bema? - The focus is on expediting the submission process and aligning with regulatory feedback for a timely approval [87][89]
ZAI LAB(ZLAB) - 2025 Q2 - Earnings Call Presentation
2025-08-07 12:00
Financial Performance & Profitability - Total revenues for 2Q'25 reached $110.0 million, a 9% increase year-over-year[56] - Adjusted loss from operations improved by 37% year-over-year, from $(54.485) million in 2Q'24 to $(34.187) million in 2Q'25[10, 86] - The company is on track to achieve profitability in 4Q'25, referring to adjusted income from operations[10, 18] - Cash position remains strong at $832.3 million as of June 30, 2025[10] Key Products & Pipeline Updates - VYVGART/VYVGART Hytrulo sales grew 14% year-over-year, reaching $26.5 million in 2Q'25, driven by increased market penetration and extension of DoT[56, 59] - ZL-1310 (DLL3 ADC) showed a 67% ORR in 2L SCLC across all doses and 79% ORR with 1.6 mg/kg (n=14)[42] - Bemarituzumab met the primary endpoint of overall survival in the global Ph3 FORTITUDE-101 study[10, 32] - KarXT's China NDA was accepted in January 2025, showing early and sustained reduction of positive and negative symptoms[26] Strategic Focus & Future Outlook - The company aims to unlock the blockbuster potential of VYVGART and VYVGART Hytrulo through execution excellence, targeting increased HCP coverage and supplemental insurance coverage[19, 20] - Multiple revenue inflections are expected through 2030, with an expected $2 billion revenue in 2028[18] - Zai Lab plans to initiate a global pivotal study of ZL-1310 in 2L ES-SCLC in 2H'25[15, 40]
再鼎医药(09688)上半年总收入同比增长15.35%至约2.16亿美元 创新管线与商业化进程双丰收
智通财经网· 2025-08-07 11:17
Core Viewpoint - Zai Ding Pharma reported a total revenue of $110 million for Q2 2025, representing a year-on-year growth of 9.43%, and reaffirmed its full-year revenue guidance of $560 million to $590 million [1] Financial Performance - The operating loss for Q2 2025 was $54.9 million, a reduction of 28% year-on-year, while the adjusted operating loss narrowed by 37% to $34.2 million [1] - The net loss was $40.73 million, down 49.27% compared to the previous year [1] - As of June 30, 2025, the total cash and cash equivalents, short-term investments, and restricted cash amounted to $832.3 million [1] Revenue Drivers - Revenue growth in Q2 was primarily driven by increased sales of Efgartigimod, DaxibotulinumtoxinA, and Nuvaxovid, partially offset by a slowdown in sales of Zolbetuximab [1] - The product revenue for Efgartigimod in Q2 2025 was $26.5 million, up 46% from $18.1 million in Q1 2025, attributed to extended treatment duration and improved market penetration [1] - Zolbetuximab generated $41 million in product revenue for Q2 2025, down from $45 million in the same period of 2024, due to changes in competitive dynamics for PARPi products [1] - DaxibotulinumtoxinA, launched in Q4 2024, generated $4.6 million in product revenue for Q2 2025 [1] Research and Development Expenditure - R&D expenses for Q2 2025 were $50.6 million, down from $61.6 million in Q2 2024, mainly due to cost reductions from resource prioritization and efficiency measures [2] - Selling, general, and administrative expenses for Q2 2025 were $71 million, a decrease from $79.7 million in the same period of 2024, also attributed to cost-saving initiatives [2] Strategic Outlook - The company is entering a critical development phase focused on innovation, scalability, and efficient execution, with significant progress across various business areas [3] - The CEO highlighted the potential of ZL-1310 in treating second-line small cell lung cancer and the positive data for Bemarituzumab in first-line gastric cancer, reinforcing recent commercialization opportunities [3] - The company anticipates continued growth momentum for Efgartigimod, supported by updated treatment guidelines in China, and is preparing for the launch of several key products [3] - With a robust cash reserve and ongoing growth in commercial operations, the company is positioned to create long-term value for shareholders [3]
再鼎医药(09688.HK)第二季度调整后经营亏损收窄37% 正稳步迈向第四季度实现盈利的目标
Ge Long Hui· 2025-08-07 11:08
Core Viewpoint - Zai Ding Pharma reported a total revenue of $110 million for Q2 2025, reflecting a 9% year-over-year increase, and reaffirmed its full-year revenue guidance of $560 million to $590 million [1] Financial Performance - The operating loss for Q2 2025 was $54.9 million, a 28% year-over-year reduction, while the adjusted operating loss narrowed by 37% to $34.2 million [1] - The company is on track to achieve profitability by Q4 2025, supported by a solid cash reserve and growing commercialization efforts [3] Product Development and Pipeline - The usage of Efgartigimod reached record levels, bolstered by updated treatment guidelines for myasthenia gravis in China [1][3] - ZL-1310 (DLL3 ADC) demonstrated an objective response rate (ORR) of 67% across all dosage groups in a study for second-line extensive-stage small cell lung cancer, with a 79% ORR in the 1.6 mg/kg group [1] - The company plans to initiate a registrational clinical study for ZL-1310 in H2 2025 and is preparing for the global Phase 3 FORTITUDE-101 study of Bemarituzumab for FGFR2b overexpressing gastric cancer [1][2] Strategic Vision - The CEO emphasized that Zai Ding Pharma is entering a critical development phase focused on innovation, scalability, and efficient execution, with substantial progress across all business areas [2] - The company is preparing for the launch of multiple key products, including KarXT and Bemarituzumab, which are expected to drive the next growth phase alongside Efgartigimod and other multi-indication products [3]
再鼎医药(09688) - 2025 Q2 - 季度业绩

2025-08-07 10:57
香港交易及結算所有限公司及香港聯合交易所有限公司對本公告的內容概不負責,對其準確性或完整性亦不發 表任何聲明,並明確表示,概不會對因本公告全部或任何部分內容而產生或因倚賴該等內容而引致的任何損失 承擔任何責任。 Zai Lab Limited 再鼎醫藥有限公司* (於開曼群島註冊成立的有限公司) (股份代號: 9688) 截至2025年6月30日止三個月及六個月的未經審計業績 以及公司進展 再鼎醫藥有限公司(「本公司」)謹此公佈根據美國證券交易委員會的適用規則刊發的本公 司及其附屬公司截至2025年6月30日止三個月及六個月的未經審計簡明合併業績(「2025年第 二季度業績」)以及近期產品亮點和公司進展與2025年和2026年上半年的預期重要里程碑事 件。 2025年第二季度業績乃根據有別於國際財務報告準則(「國際財務報告準則」)的美國公認 會計準則(「美國公認會計準則」)編製。 本公司預期於2025年8月31日或之前根據香港聯合交易所有限公司證券上市規則發佈截至2025 年6月30日止六個月的中期業績,其中將載有聲明,顯示根據美國公認會計準則及國際財務報 告準則報告的財務報表之間的任何重大差異的財務影響。 ...
ZAI LAB(ZLAB) - 2025 Q2 - Quarterly Report

2025-08-07 10:23
Special Notes Regarding the Company This section provides important context on forward-looking statements and defines key terms and subsidiaries [Forward-Looking Statements](index=4&type=section&id=Forward-Looking%20Statements) This section outlines the inherent uncertainties and risks of forward-looking statements, which are not guarantees - Forward-looking statements are not guarantees of future performance and are subject to inherent uncertainties, risks, and changes in circumstances[11](index=11&type=chunk) - Key risk factors include the ability to successfully commercialize products, obtain funding, achieve positive clinical trial results, secure regulatory approvals, manage third-party relationships, ensure manufacturing compliance, protect intellectual property, navigate U.S. and China trade policies, and address economic, political, and legal conditions in mainland China[11](index=11&type=chunk)[16](index=16&type=chunk) [Usage of Terms and Subsidiaries](index=5&type=section&id=Usage%20of%20Terms%20and%20Subsidiaries) This section defines key terms and clarifies that 'the Company' refers to Zai Lab Limited and its consolidated subsidiaries - References to **'Zai Lab,' 'the Company,' 'we,' 'us,' and 'our'** refer to Zai Lab Limited and its subsidiaries on a consolidated basis[13](index=13&type=chunk) - The company's operating subsidiaries are domiciled in Hong Kong, mainland China, Taiwan, Australia, and the United States[14](index=14&type=chunk) PART I. FINANCIAL INFORMATION This part presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis [Item 1. Financial Statements (Unaudited)](index=7&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements, including balance sheets, operations, and cash flows [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) This table presents the company's financial position, detailing assets, liabilities, and shareholders' equity at specific dates | Metric | June 30, 2025 (in thousands $) | December 31, 2024 (in thousands $) | Change ($) | Change (%) | | :-------------------------------- | :----------------------------- | :------------------------------- | :--------- | :--------- | | Total current assets | 1,034,062 | 1,050,480 | (16,418) | (1.6)% | | Total assets | 1,164,101 | 1,185,753 | (21,652) | (1.8)% | | Total current liabilities | 331,501 | 299,385 | 32,116 | 10.7% | | Total liabilities | 372,366 | 344,855 | 27,511 | 8.0% | | Total shareholders' equity | 791,735 | 840,898 | (49,163) | (5.8)% | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) This table presents the company's financial performance, detailing revenues, expenses, and net loss over specific periods | Metric (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :---------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Total revenues | 109,977 | 100,504 | 9,473 | 9.4% | 216,464 | 187,653 | 28,811 | 15.3% | | Loss from operations | (54,895) | (76,064) | 21,169 | (27.8)% | (111,206) | (146,373) | 35,167 | (24.0)% | | Net loss | (40,727) | (80,277) | 39,550 | (49.3)% | (89,165) | (133,748) | 44,583 | (33.3)% | | Loss per share - basic and diluted | (0.04) | (0.08) | 0.04 | (50.0)% | (0.08) | (0.14) | 0.06 | (42.9)% | [Condensed Consolidated Statements of Comprehensive Loss](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This table presents the company's comprehensive loss, including net loss and other comprehensive income/loss components | Metric (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :---------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Net loss | (40,727) | (80,277) | 39,550 | (49.3)% | (89,165) | (133,748) | 44,583 | (33.3)% | | Foreign currency translation adjustments | (2,955) | 3,605 | (6,560) | (182.0)% | (4,167) | 5,147 | (9,314) | (180.9)% | | Comprehensive loss | (43,682) | (76,672) | 32,990 | (43.0)% | (93,332) | (128,601) | 35,269 | (27.4)% | [Condensed Consolidated Statements of Shareholders' Equity](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Shareholders'%20Equity) This section details changes in shareholders' equity, reflecting net loss, share-based compensation, and other adjustments - Total shareholders' equity decreased from **$840.9 million** at December 31, 2024, to **$791.7 million** at June 30, 2025, primarily due to net loss and foreign currency translation adjustments, partially offset by share-based compensation and exercise of share options[25](index=25&type=chunk) - Accumulated deficit increased from **$(2,453.1) million** at December 31, 2024, to **$(2,542.2) million** at June 30, 2025, reflecting the net loss incurred during the period[25](index=25&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) This table presents the company's cash inflows and outflows from operating, investing, and financing activities | Cash Flow Activity (in thousands $) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :---------------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Net cash used in operating activities | (92,723) | (132,279) | 39,556 | (29.9)% | | Net cash provided by investing activities | 323,211 | 2,446 | 320,765 | 13113.0% | | Net cash provided by financing activities | 51,990 | 69,870 | (17,880) | (25.6)% | | Net increase (decrease) in cash, cash equivalents and restricted cash | 282,603 | (60,100) | 342,703 | (570.2)% | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=14&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) This section provides detailed explanations for financial statement line items, accounting policies, and specific accounts [1. Organization and Principal Activities](index=14&type=section&id=Note%201.%20Organization%20and%20Principal%20Activities) This note describes Zai Lab Limited as a biopharmaceutical company and its primary geographic markets - Zai Lab Limited is a biopharmaceutical company focused on discovering, developing, and commercializing products for oncology, immunology, neuroscience, and infectious diseases[29](index=29&type=chunk) - The company's principal operations and geographic markets are in Greater China and the United States[30](index=30&type=chunk) [2. Basis of Presentation and Consolidation and Significant Accounting Policies](index=14&type=section&id=Note%202.%20Basis%20of%20Presentation%20and%20Consolidation%20and%20Significant%20Accounting%20Policies) This note outlines the basis of financial statement preparation, consolidation, and significant accounting policies - The financial statements are prepared in accordance with **U.S. GAAP** and **SEC rules** for interim financial reporting, with certain information condensed or omitted[31](index=31&type=chunk) - Management uses subjective judgment for estimates in areas such as rebates, R&D expenses, share-based compensation, deferred tax assets, and useful life of intangible assets[34](index=34&type=chunk) - The company is evaluating new **FASB ASUs (2023-09 and 2024-03)** for income tax and expense disaggregation disclosures, with expected adoption in 2025 and 2027, respectively[37](index=37&type=chunk)[38](index=38&type=chunk) [3. Cash and Cash Equivalents](index=15&type=section&id=Note%203.%20Cash%20and%20Cash%20Equivalents) This note details the composition and changes in the company's cash and cash equivalents, including currency denominations | Category (in thousands $) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Cash | 730,971 | 448,508 | | Cash equivalents | 1,188 | 1,159 | | Total | 732,159 | 449,667 | - Cash and cash equivalents increased by **$282.5 million** from December 31, 2024, to June 30, 2025[40](index=40&type=chunk) - A significant portion of cash is denominated in **US$ ($718.4 million)** and **RMB ($12.2 million)**, with RMB conversion subject to Chinese government foreign exchange controls[40](index=40&type=chunk)[41](index=41&type=chunk) [4. Inventories, Net](index=16&type=section&id=Note%204.%20Inventories,%20Net) This note provides a breakdown of inventory categories and details inventory write-downs for the period | Category (in thousands $) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Finished goods | 36,534 | 24,063 | | Raw materials | 21,232 | 13,268 | | Work in progress | 3,934 | 2,544 | | Total Inventories, net | 61,700 | 39,875 | - Inventory write-downs were **$0.3 million** for both the three and six months ended June 30, 2025, a decrease from **$0.7 million** and **$0.8 million** respectively in the prior year[42](index=42&type=chunk) [5. Property and Equipment, Net](index=16&type=section&id=Note%205.%20Property%20and%20Equipment,%20Net) This note presents the net carrying amount of property and equipment and associated depreciation expense | Category (in thousands $) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Total Gross Carrying Amount | 88,681 | 85,081 | | Less: accumulated depreciation | (38,521) | (37,120) | | Property and equipment, net | 50,160 | 47,961 | - Depreciation expense was **$2.3 million** and **$4.3 million** for the three and six months ended June 30, 2025, respectively[43](index=43&type=chunk) [6. Intangible Assets, Net](index=16&type=section&id=Note%206.%20Intangible%20Assets,%20Net) This note details the net carrying value of intangible assets, including commercial products and software | Category (in thousands $) | June 30, 2025 Net Carrying Value | December 31, 2024 Net Carrying Value | | :------------------------ | :------------------------------- | :----------------------------------- | | Commercial products | 55,265 | 54,467 | | Software | 1,254 | 1,560 | | Total | 56,519 | 56,027 | - Amortization expense for intangible assets was **$1.5 million** and **$2.9 million** for the three and six months ended June 30, 2025, respectively, an increase from the prior year[46](index=46&type=chunk) - The weighted-average remaining amortization period for intangible assets for commercial products is **9.2 years** and for software is **2.8 years**[46](index=46&type=chunk) [7. Revenues](index=17&type=section&id=Note%207.%20Revenues) This note provides a detailed breakdown of total revenues by type and commercial program | Revenue Type (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :---------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Product revenue, net | 109,085 | 100,106 | 8,979 | 9.0% | 214,735 | 187,255 | 27,480 | 14.7% | | Collaboration revenue | 892 | 398 | 494 | 124.1% | 1,729 | 398 | 1,331 | 334.4% | | Total revenues | 109,977 | 100,504 | 9,473 | 9.4% | 216,464 | 187,653 | 28,811 | 15.3% | | Commercial Program (Net Revenue in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :---------------------------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | ZEJULA | 41,042 | 44,999 | (3,957) | (8.8)% | 90,571 | 90,500 | 71 | 0.1% | | VYVGART / VYVGART Hytrulo | 26,497 | 23,190 | 3,307 | 14.3% | 44,602 | 36,352 | 8,250 | 22.7% | | NUZYRA | 14,292 | 12,295 | 1,997 | 16.2% | 29,410 | 22,208 | 7,202 | 32.4% | | OPTUNE | 12,355 | 12,584 | (229) | (1.8)% | 23,718 | 25,064 | (1,346) | (5.4)% | | QINLOCK | 8,536 | 7,038 | 1,498 | 21.3% | 17,045 | 13,131 | 3,914 | 29.8% | | XACDURO | 4,622 | — | 4,622 | NM | 5,739 | — | 5,739 | NM | | AUGTYRO | 1,399 | — | 1,399 | NM | 3,025 | — | 3,025 | NM | | Other | 342 | — | 342 | NM | 625 | — | 625 | NM | | Total product revenue, net | 109,085 | 100,106 | 8,979 | 9.0% | 214,735 | 187,255 | 27,480 | 14.7% | [8. Income Tax](index=18&type=section&id=Note%208.%20Income%20Tax) This note explains the company's income tax position, including the absence of provision and valuation allowance - No provision for income taxes was accrued due to the company being in a cumulative loss position for the periods presented[50](index=50&type=chunk) - A full valuation allowance was recorded against deferred tax assets of all consolidated entities due to their cumulative loss position[51](index=51&type=chunk) [9. Loss Per Share](index=18&type=section&id=Note%209.%20Loss%20Per%20Share) This note presents the calculation of basic and diluted loss per share and factors affecting it | Metric | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :---------------------------------------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Net loss (in thousands $) | (40,727) | (80,277) | (89,165) | (133,748) | | Weighted-average shares (basic and diluted) | 1,091,933,150 | 975,937,790 | 1,086,413,130 | 974,541,780 | | Net loss per share - basic and diluted | (0.04) | (0.08) | (0.08) | (0.14) | - Share options and non-vested restricted shares were excluded from the calculation of diluted loss per share as their inclusion would have been anti-dilutive due to the company's net loss[52](index=52&type=chunk) [10. Borrowings](index=18&type=section&id=Note%2010.%20Borrowings) This note details the company's short-term debt arrangements with Chinese financial institutions | Bank (in thousands $) | Weighted-average interest rate per annum | June 30, 2025 | | :----------------------------------- | :------------------------------------- | :------------ | | Bank of China Working Capital Loans | 2.42 % | 48,891 | | SPD Bank Working Capital Loans | 2.80 % | 41,908 | | China Merchant Bank Working Capital Loans | 2.87 % | 34,895 | | Bank of Communications Working Capital Loans | 2.75 % | 41,908 | | Ningbo Bank Discounted Bills | 1.90 % | 6,907 | | Total short-term debt | 2.66 % | 174,509 | - The company has various short-term debt arrangements with Chinese financial institutions totaling **$174.5 million** as of June 30, 2025, with a weighted-average interest rate of **2.66%**[54](index=54&type=chunk) - These facilities, including those with Bank of China, SPD Bank, CMB, BOCOM, and Ningbo Bank, support working capital needs in mainland China, typically with one-year terms and varying interest rates[56](index=56&type=chunk)[57](index=57&type=chunk)[58](index=58&type=chunk)[59](index=59&type=chunk)[60](index=60&type=chunk) [11. Other Current Liabilities](index=20&type=section&id=Note%2011.%20Other%20Current%20Liabilities) This note provides a breakdown of other current liabilities and explains the period-over-period changes | Category (in thousands $) | June 30, 2025 | December 31, 2024 | | :------------------------ | :------------ | :---------------- | | Accrued payroll | 18,004 | 30,198 | | Accrued professional service fee | 3,532 | 5,728 | | Payables for purchase of property and equipment | 2,498 | 449 | | Accrued rebate to distributors | 10,453 | 10,839 | | Tax payables | 4,762 | 5,154 | | Other | 4,802 | 6,352 | | Total | 44,051 | 58,720 | - Total other current liabilities decreased by **$14.7 million** from December 31, 2024, to June 30, 2025, primarily due to a decrease in accrued payroll[61](index=61&type=chunk) [12. Related Party Transactions](index=20&type=section&id=Note%2012.%20Related%20Party%20Transactions) This note discloses a license agreement with a related party, including upfront and potential future payments - In January 2025, the Company entered a license agreement with Zenas BioPharma (HK) Limited, a related party, for an IGF-1R antibody in Greater China, incurring a **$10.0 million** upfront fee[62](index=62&type=chunk) - Potential future payments under the Zenas agreement include up to **$117.0 million** in development and sales-based milestones, as well as tiered royalties[62](index=62&type=chunk) [13. Share-Based Compensation](index=20&type=section&id=Note%2013.%20Share-Based%20Compensation) This note details share-based compensation expense by category and unrecognized compensation expense | Expense Category (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | | :-------------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | :--------------------------- | | Selling, general and administrative | 11,244 | 10,421 | 21,470 | 21,456 | | Research and development | 5,729 | 8,217 | 11,303 | 15,162 | | Total | 16,973 | 18,638 | 32,773 | 36,618 | - As of June 30, 2025, unrecognized share-based compensation expense was **$64.7 million** for unvested share options (weighted-average period of **2.52 years**) and **$75.4 million** for unvested restricted shares (weighted-average period of **2.46 years**)[65](index=65&type=chunk) [14. License and Collaboration Agreements](index=21&type=section&id=Note%2014.%20License%20and%20Collaboration%20Agreements) This note reports on upfront fees for license agreements and the absence of new significant agreements or milestone fees - The company recorded **$20.0 million** in upfront fees for license and collaboration agreements that are not individually significant in the six months ended June 30, 2025[68](index=68&type=chunk) - No new significant license or collaboration agreements were entered into, and no milestone fees were incurred under existing significant agreements in the six months ended June 30, 2025[67](index=67&type=chunk) [15. Other Income (Expense), Net](index=21&type=section&id=Note%2015.%20Other%20Income%20(Expense),%20Net) This note details the components of other income (expense), net, and explains period-over-period changes | Category (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :------------------------ | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Government grants | 3,850 | 534 | 3,316 | 621.0% | 3,866 | 3,325 | 541 | 16.3% | | Loss on equity investments | — | (10,035) | 10,035 | (100.0)% | (1,912) | (5,147) | 3,235 | (62.9)% | | Other miscellaneous | (100) | 558 | (658) | (117.9)% | 1,599 | 2,240 | (641) | (28.6)% | | Total | 3,750 | (8,943) | 12,693 | (142.0)% | 3,553 | 418 | 3,135 | 750.0% | - Other income, net, significantly improved in Q2 2025 and H1 2025, primarily driven by higher government grants and a decreased loss on equity investments[69](index=69&type=chunk)[114](index=114&type=chunk) [16. Restricted Net Assets](index=21&type=section&id=Note%2016.%20Restricted%20Net%20Assets) This note explains restrictions on distributions from Chinese subsidiaries due to statutory reserve requirements - Chinese laws and regulations restrict the company's ability to receive distributions from its Chinese subsidiaries, requiring statutory reserves of at least **10%** of annual after-tax profit until **50%** of registered capital is reached[70](index=70&type=chunk)[71](index=71&type=chunk) - No appropriation to statutory reserves was made in the three and six months ended June 30, 2025 and 2024, due to substantial losses in the Chinese subsidiaries[72](index=72&type=chunk) - Amounts restricted, including the paid-in capital of Chinese subsidiaries, totaled **$506.0 million** as of June 30, 2025, and December 31, 2024[73](index=73&type=chunk) [17. Commitments and Contingencies](index=22&type=section&id=Note%2017.%20Commitments%20and%20Contingencies) This note discloses purchase commitments related to manufacturing and capital expenditures, and legal proceedings - As of June 30, 2025, the company had **$1.1 million** in purchase commitments related to commercial manufacturing development activities and capital expenditures, expected to be incurred within one year[74](index=74&type=chunk) - The company is not currently a party to any material legal proceedings[75](index=75&type=chunk) [18. Segment Information](index=22&type=section&id=Note%2018.%20Segment%20Information) This note clarifies that the company operates as a single segment and provides breakdowns of R&D and SG&A expenses - The company operates as a single operating segment focused on discovering, developing, and commercializing products in oncology, immunology, neuroscience, and infectious disease[77](index=77&type=chunk) | R&D Expense Category (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :------------------------------------ | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Personnel compensation and related costs | 22,447 | 31,209 | (8,762) | (28.1)% | 46,527 | 59,217 | (12,690) | (21.4)% | | Licensing fees | — | — | — | NM | 19,997 | — | 19,997 | NM | | CROs/CMOs/Investigators expenses | 19,935 | 24,305 | (4,370) | (18.0)% | 29,765 | 44,209 | (14,444) | (32.7)% | | Other costs | 8,232 | 6,111 | 2,121 | 34.7% | 15,054 | 12,844 | 2,210 | 17.2% | | Total research and development expenses | 50,614 | 61,625 | (11,011) | (17.9)% | 111,343 | 116,270 | (4,927) | (4.2)% | | SG&A Expense Category (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :------------------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Personnel compensation and related costs | 42,679 | 48,279 | (5,600) | (11.6)% | 83,322 | 94,173 | (10,851) | (11.5)% | | Other costs | 28,359 | 31,431 | (3,072) | (9.8)% | 51,138 | 54,731 | (3,593) | (6.6)% | | Total selling, general, and administrative expenses | 71,038 | 79,710 | (8,672) | (10.9)% | 134,460 | 148,904 | (14,444) | (9.7)% | [19. Subsequent Events](index=23&type=section&id=Note%2019.%20Subsequent%20Events) This note reports on a new revolving credit facility entered into after the reporting period - On August 6, 2025, the company entered into a new revolving credit facility with CMB for up to **RMB500.0 million** (approximately **$69.6 million**), replacing its previous **RMB250.0 million** facility that expired in July 2025[80](index=80&type=chunk) - The new credit facility will be available for two years and includes customary representations, warranties, and affirmative and restrictive covenants[80](index=80&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial performance, condition, and future outlook, highlighting revenue drivers and liquidity [Overview](index=24&type=section&id=Overview) This overview describes Zai Lab as a global biopharmaceutical company and its financial performance challenges - Zai Lab is a patient-focused, innovative, commercial-stage global biopharmaceutical company with a substantial presence in Greater China and the United States, focusing on oncology, immunology, neuroscience, and infectious disease[82](index=82&type=chunk) - The company has seven commercial programs and multiple late-stage product development programs, but has incurred net losses and negative cash flows from operations due to significant investments in R&D and selling, general, and administrative costs[82](index=82&type=chunk)[83](index=83&type=chunk) - Future profitability and positive cash flow depend on successfully marketing commercial products, expanding indications, and developing/commercializing pipeline candidates, with financial results expected to fluctuate[83](index=83&type=chunk)[84](index=84&type=chunk) [Recent Developments](index=24&type=section&id=Recent%20Developments) This section highlights recent product revenue growth and key advancements in the oncology and immunology pipelines - Net product revenue for the second quarter of 2025 increased by **9%** year-over-year to **$109.1 million**, primarily driven by higher sales of VYVGART, XACDURO (launched Q4 2024), and NUZYRA, partially offset by softer sales of ZEJULA due to competitive dynamics[85](index=85&type=chunk) - Oncology pipeline highlights include **FDA Fast Track designation for ZL-1310 (DLL3 ADC)** for ES-SCLC and positive Phase Ia/Ib data, positive Phase III results for bemarituzumab in 1L gastric cancer, positive Phase III PANOVA-3 trial results for Tumor Treating Fields in pancreatic cancer, **NMPA acceptance of sNDA for repotrectinib** for NTRK+ solid tumors, and new preclinical data for ZL-6201 (LRRC15 ADC) and ZL-1222 (PD-1 / IL-12)[86](index=86&type=chunk)[87](index=87&type=chunk)[89](index=89&type=chunk) - Immunology/Neuroscience pipeline highlights include **FDA approval of VYVGART Hytrulo PFS** for self-injection in gMG and CIDP, and new preclinical data for ZL-1503 (IL-13 / IL-31R) for atopic dermatitis[88](index=88&type=chunk)[90](index=90&type=chunk) [Factors Affecting Our Results of Operations](index=26&type=section&id=Factors%20Affecting%20Our%20Results%20of%20Operations) This section discusses key factors influencing financial results, including product revenue, R&D, SG&A, and license agreements - Product revenue is expected to increase through enhanced patient access (**NRDL listing, supplemental insurance**) and new product launches, while cost of product revenue will rise with increased sales volume[91](index=91&type=chunk) - The company is committed to significant and sustained investments in research and development, including internal discovery, clinical/pre-clinical trials, and business development activities, as a primary factor for long-term competitiveness[92](index=92&type=chunk) - Selling, general, and administrative expenses are expected to remain significant to support commercial product sales and preparations for future product launches[93](index=93&type=chunk) - License and collaboration agreements involve potential future payments, including up to **$211.0 million** for clinical programs, **$366.0 million** for other programs, and **$1,753.0 million** for sales-based milestones as of June 30, 2025[96](index=96&type=chunk) [Results of Operations](index=28&type=section&id=Results%20of%20Operations) This section provides a detailed analysis of the company's revenues, expenses, and net loss for the reporting periods | Metric (in thousands $) | 3 Months Ended June 30, 2025 | 3 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | 6 Months Ended June 30, 2025 | 6 Months Ended June 30, 2024 | YoY Change ($) | YoY Change (%) | | :-------------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | Total revenues | 109,977 | 100,504 | 9,473 | 9.4% | 216,464 | 187,653 | 28,811 | 15.3% | | Cost of product revenue | (43,003) | (35,148) | (7,855) | 22.3% | (81,455) | (68,767) | (12,688) | 18.4% | | Cost of collaboration revenue | (217) | (85) | (132) | 155.3% | (412) | (85) | (327) | 384.7% | | Research and development | (50,614) | (61,625) | 11,011 | (17.9)% | (111,343) | (116,270) | 4,927 | (4.2)% | | Selling, general, and administrative | (71,038) | (79,710) | 8,672 | (10.9)% | (134,460) | (148,904) | 14,444 | (9.7)% | | Loss from operations | (54,895) | (76,064) | 21,169 | (27.8)% | (111,206) | (146,373) | 35,167 | (24.0)% | | Interest income | 8,843 | 9,330 | (487) | (5.2)% | 17,449 | 18,988 | (1,539) | (8.1)% | | Interest expenses | (1,262) | (492) | (770) | 156.5% | (2,449) | (605) | (1,844) | 304.8% | | Foreign currency gains (losses) | 2,837 | (4,108) | 6,945 | (169.1)% | 3,488 | (6,176) | 9,664 | (156.5)% | | Other income (expense), net | 3,750 | (8,943) | 12,693 | (142.0)% | 3,553 | 418 | 3,135 | 750.0% | | Net loss | (40,727) | (80,277) | 39,550 | (49.3)% | (89,165) | (133,748) | 44,583 | (33.3)% | - Net product revenue increased by **$9.0 million (9%)** in Q2 2025 and **$27.5 million (15%)** in H1 2025, driven by VYVGART, XACDURO, and NUZYRA, partially offset by ZEJULA[102](index=102&type=chunk) - Research and development expenses decreased by **$11.0 million (18%)** in Q2 2025 and **$4.9 million (4%)** in H1 2025, primarily due to lower personnel and CROs/CMOs/Investigators expenses, partially offset by increased licensing fees in H1[106](index=106&type=chunk) - Selling, general, and administrative expenses decreased by **$8.7 million (11%)** in Q2 2025 and **$14.4 million (10%)** in H1 2025, mainly due to reduced personnel compensation and related costs[110](index=110&type=chunk) - Foreign currency gains of **$2.8 million** in Q2 2025 and **$3.5 million** in H1 2025, compared to losses in prior periods, were primarily driven by the appreciation of the RMB against the U.S. dollar[113](index=113&type=chunk) - Net loss significantly decreased by **$39.6 million (49%)** in Q2 2025 to **$40.7 million**, and by **$44.6 million (33%)** in H1 2025 to **$89.2 million**, reflecting improved operational efficiency and other income[116](index=116&type=chunk)[117](index=117&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=31&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) This section outlines critical accounting policies and the significant judgments and estimates involved in financial reporting - Revenue recognition involves significant judgment in estimating rebates based on contracted rates, sales volumes, and distributor inventories, with actual results potentially differing from estimates[121](index=121&type=chunk)[122](index=122&type=chunk) - Research and development expenses are accrued based on estimates of actual services performed by third parties (**CROs and CMOs**), requiring judgment on service status and contractual milestones[124](index=124&type=chunk)[125](index=125&type=chunk)[126](index=126&type=chunk) - Share-based compensation fair value is estimated using the **Black-Scholes option valuation model**, which relies on significant assumptions for volatility, expected term, dividend yield, and risk-free interest rates[127](index=127&type=chunk)[128](index=128&type=chunk) - Income tax accounting requires significant judgment in recognizing deferred tax assets and liabilities and assessing the need for valuation allowances based on future profitability forecasts and tax planning strategies[129](index=129&type=chunk)[131](index=131&type=chunk) [Liquidity and Capital Resources](index=32&type=section&id=Liquidity%20and%20Capital%20Resources) This section discusses the company's historical financing, current liquidity, and future capital requirements - The company has historically financed its activities through private placements (**$164.6 million**) and public offerings (**$2,677.8 million** net proceeds)[132](index=132&type=chunk) - Net cash used in operating activities decreased by **$39.6 million** to **$92.7 million** in the six months ended June 30, 2025, compared to **$132.3 million** in the prior year, primarily due to a decrease in net loss[133](index=133&type=chunk)[137](index=137&type=chunk) - As of June 30, 2025, the company had **$832.3 million** in cash, cash equivalents, current restricted cash, and short-term investments, which are expected to meet cash requirements for at least the next 12 months[135](index=135&type=chunk) - The company has debt arrangements with Chinese financial institutions, with **$174.5 million** in short-term debt outstanding as of June 30, 2025, providing additional capital capacity[134](index=134&type=chunk) - Net cash provided by investing activities increased significantly by **$320.8 million** in the six months ended June 30, 2025, primarily due to **$330.0 million** in proceeds from the maturity of short-term investments[138](index=138&type=chunk) [Recently Issued Accounting Standards](index=34&type=section&id=Recently%20Issued%20Accounting%20Standards) This section notes that the company has not adopted any new accounting standards during the reporting period - The company has not adopted any new accounting standards in the three and six months ended June 30, 2025[140](index=140&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) This section discusses the company's exposure to market risks, including foreign exchange, credit, and interest rate risks - The company is exposed to foreign exchange risk, particularly due to the **RMB** not being freely convertible and its value being subject to Chinese government policies and economic conditions[142](index=142&type=chunk)[144](index=144&type=chunk) - Appreciation of the **RMB** against the **U.S. dollar** or **HK dollar** would adversely affect the U.S. dollar or HK dollar amounts received from conversion, while appreciation of the U.S. dollar or HK dollar against the RMB would negatively impact conversion amounts for payments[145](index=145&type=chunk) - Credit risk is concentrated in cash and cash equivalents, restricted cash, short-term investments, accounts receivable, and notes receivable, with major financial institutions and the two largest customers accounting for significant portions[147](index=147&type=chunk)[149](index=149&type=chunk)[150](index=150&type=chunk) - Interest rate risk from short-term debt (subject to fixed and floating rates) is largely offset by exposure in cash, cash equivalents, restricted cash, and short-term investments; a hypothetical **10%** change in interest rates is not expected to materially impact financial condition[153](index=153&type=chunk)[152](index=152&type=chunk) [Item 4. Controls and Procedures](index=35&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective, with no material changes in internal control - Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025[154](index=154&type=chunk) - There were no material changes in the company's internal control over financial reporting during the fiscal quarter ended June 30, 2025[155](index=155&type=chunk) PART II. OTHER INFORMATION This part covers other required disclosures, including legal proceedings, risk factors, equity sales, and subsequent events [Item 1. Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal or administrative proceedings - The company is not currently a party to any material legal or administrative proceedings[156](index=156&type=chunk) [Item 1A. Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) There have been no material changes in the company's risk factors from those disclosed in its 2024 Annual Report - There have been no material changes in the company's risk factors from those disclosed in its 2024 Annual Report on Form 10-K[157](index=157&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=36&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities or use of proceeds are reported for the period - No unregistered sales of equity securities or use of proceeds to report[158](index=158&type=chunk) [Item 3. Defaults Upon Senior Securities](index=36&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities are reported for the period - No defaults upon senior securities to report[159](index=159&type=chunk) [Item 4. Mine Safety Disclosures](index=36&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) No mine safety disclosures are reported for the period - No mine safety disclosures to report[160](index=160&type=chunk) [Item 5. Other Information](index=36&type=section&id=Item%205.%20Other%20Information) This section reports on a new revolving credit facility with CMB and confirms no changes in Rule 10b5-1 trading arrangements - On August 6, 2025, the company secured a new two-year revolving credit facility with CMB for up to **RMB500.0 million** (approximately **$69.6 million**), replacing an expired facility[161](index=161&type=chunk) - The new credit agreement includes customary representations, warranties, and affirmative and restrictive covenants, requiring prior written consent for certain transactions[161](index=161&type=chunk) - No directors or executive officers adopted, modified, or terminated **Rule 10b5-1** or non-Rule 10b5-1 trading arrangements during the second quarter of 2025[162](index=162&type=chunk) [Item 6. Exhibits](index=37&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including employment agreements and officer certifications - Exhibits filed include an amended and restated employment agreement, CEO and CFO certifications, and Inline XBRL documents[164](index=164&type=chunk) [Signatures](index=38&type=section&id=Signatures) The report was signed by Yajing Chen, Chief Financial Officer, on August 7, 2025, as required by the Securities Exchange Act - The report was signed by Yajing Chen, Chief Financial Officer (Principal Financial and Accounting Officer), on August 7, 2025[169](index=169&type=chunk)
ZAI LAB(ZLAB) - 2025 Q2 - Quarterly Results

2025-08-07 10:18
[Executive Summary & Business Highlights](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Highlights) Zai Lab's leadership emphasized innovation, strong execution, and financial discipline, marked by Q2 2025 revenue growth and pipeline progress [CEO & COO Commentary](index=1&type=section&id=CEO%20%26%20COO%20Commentary) Dr. Samantha Du and Josh Smiley highlighted Zai Lab's pivotal period of innovation, scale, and strong execution, emphasizing patient impact, global innovation, and financial discipline - CEO emphasizes Zai Lab's pivotal period, marked by **innovation, scale, and strong execution**, with progress in patient impact, global innovation, and financial discipline[3](index=3&type=chunk) - COO highlights **VYVGART's record patient utilization** and strengthened role in MG treatment due to updated national guidelines, expecting momentum to accelerate in H2 2025[3](index=3&type=chunk) - COO projects **profitability by Q4 2025**, supported by a **28% YoY reduction in operating loss** (**37% adjusted**)[3](index=3&type=chunk) [Second Quarter 2025 Key Highlights](index=1&type=section&id=Second%20Quarter%202025%20Key%20Highlights) Zai Lab reported a 9% YoY total revenue growth to $110.0 million for Q2 2025, reaffirming full-year guidance, with VYVGART achieving record patient utilization and operating loss improving by 28% YoY Key Financial Highlights | Metric | Q2 2025 | YoY Growth | Full-Year 2025 Guidance | | :----- | :------ | :--------- | :---------------------- | | Total Revenues | $110.0 million | 9% | $560M - $590M | | Operating Loss | $54.9 million | (28)% | On track for profitability in Q4 2025 | | Adjusted Operating Loss | $34.2 million | (37)% | | - **VYVGART** reached **record patient utilization** in Q2 2025; updated national guidelines elevate its role as a treatment for both acute and maintenance gMG[4](index=4&type=chunk) - **ZL-1310 (DLL3 ADC)** data presented at ASCO 2025 showed a **67% ORR across all doses** (n=33) and **79% at 1.6mg/kg** (n=14) in 2L ES-SCLC, with a differentiated safety profile; registrational study to be initiated in H2 2025[4](index=4&type=chunk) - The global Phase 3 FORTITUDE-101 study of **bemarituzumab** met its primary endpoint of **overall survival** in first-line gastric cancer, with China regulatory submission expected in H2 2025[4](index=4&type=chunk) [Second Quarter 2025 Financial Performance](index=2&type=section&id=Second%20Quarter%202025%20Financial%20Performance) Zai Lab's Q2 2025 revenues grew 9% to $110.0 million, significantly reducing operating and net losses, supported by product sales and expense efficiencies [Financial Results Overview](index=2&type=section&id=Financial%20Results%20Overview) Zai Lab's total revenues for Q2 2025 reached $109.977 million, a 9% increase from Q2 2024, primarily driven by product revenue, significantly reducing its loss from operations and net loss Consolidated Financial Summary | Metric | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | YoY Change (%) | | :---------------------- | :---------------------- | :---------------------- | :------------- | | Total Revenues | 109,977 | 100,504 | 9% | | Product Revenue, net | 109,085 | 100,106 | 9% (10% at CER) | | Collaboration Revenue | 892 | 398 | 124% | | Loss from Operations | (54,895) | (76,064) | (28)% | | Net Loss | (40,727) | (80,277) | (49.3%) | | Loss per share (basic & diluted) | (0.04) | (0.08) | (50%) | [Product Revenue Analysis](index=2&type=section&id=Product%20Revenue%20Analysis) Product revenue, net, grew 9% YoY to $109.1 million in Q2 2025, primarily driven by strong sales of VYVGART, XACDURO, and NUZYRA, while ZEJULA sales softened due to competitive dynamics Product Sales Performance | Product | Q2 2025 Sales (USD millions) | Q1 2025 Sales (USD millions) | Q2 2024 Sales (USD millions) | QoQ Growth (%) | YoY Growth (%) | | :------ | :--------------------------- | :--------------------------- | :--------------------------- | :------------- | :------------- | | VYVGART & Hytrulo | $26.5 | $18.1 | N/A | 46% | N/A | | ZEJULA | $41.0 | N/A | $45.0 | N/A | (8.9)% | | XACDURO | $4.6 | N/A | N/A | N/A | N/A | | NUZYRA | $14.3 | N/A | $12.3 | N/A | 16.3% | - **VYVGART sales growth** was driven by extension of duration of therapy and increasing market penetration[7](index=7&type=chunk) - **ZEJULA sales were softer** due to evolving competitive dynamics within the PARPi class[7](index=7&type=chunk) [Operating Expenses and Profitability](index=2&type=section&id=Operating%20Expenses%20and%20Profitability) Operating expenses saw significant reductions in Q2 2025, with R&D decreasing by 17.9% YoY to $50.6 million and SG&A falling by 10.9% YoY to $71.0 million, leading to a 28% YoY improvement in GAAP loss from operations Operating Expenses Summary | Expense Category | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | YoY Change (%) | | :--------------- | :---------------------- | :---------------------- | :------------- | | R&D Expenses | (50,614) | (61,625) | (17.9)% | | SG&A Expenses | (71,038) | (79,710) | (10.9)% | | Loss from Operations (GAAP) | (54,895) | (76,064) | (28)% | | Adjusted Loss from Operations (Non-GAAP) | (34,187) | (54,485) | (37.2)% | - Decreases in R&D and SG&A expenses reflect reduced personnel and clinical trial costs, driven by ongoing resource prioritization and efficiency efforts[7](index=7&type=chunk) [Net Loss and Cash Position](index=2&type=section&id=Net%20Loss%20and%20Cash%20Position) Zai Lab's net loss for Q2 2025 significantly narrowed to $40.7 million, down from $80.3 million in Q2 2024, primarily due to product revenue growth outpacing net operating expenses, while maintaining a strong cash position Net Loss Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | YoY Change | | :----- | :------ | :------ | :--------- | | Net Loss | $(40.7) million | $(80.3) million | (49.3)% | | Loss per Ordinary Share | $(0.04) | $(0.08) | (50)% | | Loss per ADS | $(0.37) | $(0.82) | (54.9)% | Cash Position | Cash Position (USD millions) | June 30, 2025 | March 31, 2025 | | :--------------------------- | :------------ | :------------- | | Cash & Cash Equivalents, Short-term Investments, Current Restricted Cash | $832.3 | $857.3 | [Non-GAAP Financial Measures](index=6&type=section&id=Non-GAAP%20Financial%20Measures) Zai Lab provides non-GAAP financial measures, including growth rates adjusted for constant exchange rates (CER) and adjusted loss from operations, to offer additional perspective on operational trends and greater transparency - Non-GAAP financial measures are used to provide an additional perspective on operational trends and greater transparency into historical and projected operating performance[26](index=26&type=chunk) Product Revenue and Loss from Operations (Non-GAAP) | Metric | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | As reported YoY Growth | At CER YoY Growth | | :---------------------- | :------ | :------ | :--------------------- | :---------------- | | Product revenue, net | $109,085 | $100,106 | 9% | 10% | | Loss from operations | $(54,895) | $(76,064) | (28)% | (28)% | Reconciliation of GAAP to Non-GAAP Loss from Operations | Metric | Q2 2025 (USD thousands) | Q2 2024 (USD thousands) | | :---------------------------------- | :---------------------- | :---------------------- | | GAAP loss from operations | (54,895) | (76,064) | | Plus: Depreciation and amortization expenses | 3,735 | 2,941 | | Plus: Share-based compensation | 16,973 | 18,638 | | Adjusted loss from operations (Non-GAAP) | (34,187) | (54,485) | [Condensed Consolidated Financial Statements](index=8&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Zai Lab Limited, including the Balance Sheets, Statements of Operations, and Statements of Comprehensive Loss for the specified periods - The unaudited condensed consolidated balance sheets provide a snapshot of assets, liabilities, and shareholders' equity as of June 30, 2025, and December 31, 2024[32](index=32&type=chunk) - The unaudited condensed consolidated statements of operations detail revenues, expenses, and net loss for the three and six months ended June 30, 2025, and 2024[33](index=33&type=chunk) - The unaudited condensed consolidated statements of comprehensive loss present the net loss and other comprehensive income/loss, primarily foreign currency translation adjustments, for the three and six months ended June 30, 2025, and 2024[34](index=34&type=chunk) [Unaudited Condensed Consolidated Balance Sheets](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Balance%20Sheets) This section presents Zai Lab's unaudited balance sheets, detailing assets, liabilities, and equity for June 30, 2025, and December 31, 2024 Balance Sheet Highlights | Metric (USD thousands) | June 30, 2025 | December 31, 2024 | Change | | :--------------------- | :------------ | :---------------- | :----- | | Total Assets | 1,164,101 | 1,185,753 | (21,652) | | Total Liabilities | 372,366 | 344,855 | 27,511 | | Total Shareholders' Equity | 791,735 | 840,898 | (49,163) | | Cash and cash equivalents | 732,159 | 449,667 | 282,492 | | Short-term investments | — | 330,000 | (330,000) | | Short-term debt | 174,509 | 131,711 | 42,798 | [Unaudited Condensed Consolidated Statements of Operations](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Operations) This section outlines Zai Lab's unaudited statements of operations, detailing revenues, expenses, and net loss for the three and six months ended June 30, 2025 and 2024 Statements of Operations Summary | Metric (USD thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------- | :------ | :------ | :------ | :------ | | Total Revenues | 109,977 | 100,504 | 216,464 | 187,653 | | Loss from operations | (54,895) | (76,064) | (111,206) | (146,373) | | Net loss | (40,727) | (80,277) | (89,165) | (133,748) | | Loss per share - basic and diluted | (0.04) | (0.08) | (0.08) | (0.14) | [Unaudited Condensed Consolidated Statements of Comprehensive Loss](index=10&type=section&id=Unaudited%20Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) This section details Zai Lab's unaudited statements of comprehensive loss, presenting net loss and other comprehensive income/loss, including foreign currency adjustments, for the specified periods Statements of Comprehensive Loss Summary | Metric (USD thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------- | :------ | :------ | :------ | :------ | | Net loss | (40,727) | (80,277) | (89,165) | (133,748) | | Foreign currency translation adjustments | (2,955) | 3,605 | (4,167) | 5,147 | | Comprehensive loss | (43,682) | (76,672) | (93,332) | (128,601) | [Recent Pipeline Updates](index=2&type=section&id=Recent%20Pipeline%20Updates) Zai Lab reported significant advancements across its oncology, immunology, and neuroscience pipelines, with positive clinical data and new registrational study plans [Oncology Pipeline](index=2&type=section&id=Oncology%20Pipeline) Zai Lab reported significant advancements in its oncology pipeline, with ZL-1310 showing strong efficacy in SCLC, bemarituzumab meeting its primary OS endpoint in gastric cancer, and TTFields demonstrating OS benefit in pancreatic cancer [ZL-1310 (DLL3 ADC)](index=2&type=section&id=ZL-1310%20%28DLL3%20ADC%29) ZL-1310 (DLL3 ADC) showed strong efficacy (67% ORR) and a well-tolerated safety profile in 2L ES-SCLC, receiving U.S. FDA Fast Track designation - **ZL-1310** demonstrated an objective response rate (**ORR**) of **67% across all dose levels** (n=33) and **79% at 1.6 mg/kg** (n=14) in second-line extensive-stage small cell lung cancer (ES-SCLC)[8](index=8&type=chunk) - **ZL-1310** exhibited a **well-tolerated safety profile** with **6% Grade ≥3 treatment-related adverse events (TRAEs)** and no drug discontinuations[8](index=8&type=chunk) - The U.S. FDA granted **Fast Track designation** to ZL-1310 for treatment of ES-SCLC in May 2025[8](index=8&type=chunk) [Bemarituzumab (FGFR2b)](index=3&type=section&id=Bemarituzumab%20%28FGFR2b%29) Bemarituzumab (FGFR2b) plus chemotherapy met its primary OS endpoint in Phase 3 FORTITUDE-101 for first-line gastric cancer, with China submission planned for H2 2025 - The Phase 3 FORTITUDE-101 clinical trial evaluating first-line **bemarituzumab plus chemotherapy** met its primary endpoint of **overall survival (OS)** at a pre-specified interim analysis[11](index=11&type=chunk) - **Bemarituzumab plus chemotherapy significantly improved OS** in patients with FGFR2b overexpression compared to chemotherapy alone[11](index=11&type=chunk) - Zai Lab plans to move rapidly toward **regulatory submission in China in the second half of 2025** for bemarituzumab[11](index=11&type=chunk) [Tumor Treating Fields (TTFields)](index=3&type=section&id=Tumor%20Treating%20Fields%20%28TTFields%29) Tumor Treating Fields (TTFields) therapy showed OS benefit and improved quality of life in pancreatic cancer, with China regulatory filing planned for H2 2025 - Phase 3 PANOVA-3 trial data demonstrated that **TTFields therapy**, when added to standard of care, achieved an **OS benefit** supported by significantly improved quality of life and extended pain-free survival in pancreatic cancer[11](index=11&type=chunk) - Zai Lab plans to file for **regulatory approval in China in the second half of 2025** for TTFields in first-line pancreatic cancer[11](index=11&type=chunk) [ZL-6201 (LRRC15 ADC)](index=4&type=section&id=ZL-6201%20%28LRRC15%20ADC%29) ZL-6201 (LRRC15 ADC) is advancing into global Phase 1 development, targeting sarcoma and other LRRC15-positive solid tumors - Zai Lab is advancing **ZL-6201 (LRRC15 ADC)** into **global Phase 1 development**[13](index=13&type=chunk) - **ZL-6201** targets patients with sarcoma and potentially other LRRC15-positive solid tumors, such as breast cancer and other malignancies[13](index=13&type=chunk) [Immunology Pipeline](index=3&type=section&id=Immunology%20Pipeline) The immunology pipeline saw updates for Efgartigimod, with new China MG guidelines emphasizing its role, ZL-1503 showing promising preclinical data, and Povetacicept and VRDN-003 advancing to pivotal/registrational studies [Efgartigimod (FcRn)](index=3&type=section&id=Efgartigimod%20%28FcRn%29) China MG guidelines (2025) recommend VYVGART (efgartigimod) for early and sustained long-term treatment in myasthenia gravis, targeting Minimal Symptom Expression - The China Guidelines for the Diagnosis and Treatment of Myasthenia Gravis (MG) (2025) were published in July 2025, emphasizing **Minimal Symptom Expression (MSE)** as the primary treatment goal[11](index=11&type=chunk) - **VYVGART (efgartigimod)** is now recommended for **early use in mild-to-moderate and highly active MG patients** and for sustained long-term treatment[11](index=11&type=chunk) [ZL-1503 (IL-13/IL-31R)](index=3&type=section&id=ZL-1503%20%28IL-13%2FIL-31R%29) ZL-1503 showed promising preclinical data for moderate-to-severe atopic dermatitis, supporting global Phase 1 advancement in H2 2025 with favorable safety - New preclinical data for **ZL-1503** highlights its potential as a promising treatment for **moderate-to-severe atopic dermatitis** and other IL-13 and IL-31-driven diseases[11](index=11&type=chunk) - **ZL-1503's favorable preclinical safety profile**, prolonged half-life, and durable suppression of inflammatory and pruritogenic pathways support its continued advancement[11](index=11&type=chunk) - Zai Lab plans to advance **ZL-1503 into a global Phase 1 study** in moderate-to-severe atopic dermatitis in the second half of 2025[12](index=12&type=chunk) [Povetacicept (APRIL/BAFF)](index=4&type=section&id=Povetacicept%20%28APRIL%2FBAFF%29) Zai Lab will partner with Vertex to initiate a global pivotal Phase 2/3 study of povetacicept in pMN in Greater China in H2 2025 - Zai Lab plans to partner with Vertex to execute the **global pivotal Phase 2/3 study of povetacicept in Primary Membranous Nephropathy (pMN)** in Greater China[17](index=17&type=chunk) - The **povetacicept study in pMN** is expected to start in the second half of 2025[17](index=17&type=chunk) [VRDN-003 (IGF-1R, subcutaneous)](index=5&type=section&id=VRDN-003%20%28IGF-1R%2C%20subcutaneous%29) Zai Lab will initiate a registrational study for VRDN-003 in thyroid eye disease in Greater China in H2 2025, with global results expected in H1 2026 - Zai Lab will initiate a **registrational study for VRDN-003 in thyroid eye disease** in Greater China in the second half of 2025[21](index=21&type=chunk) - Partner Viridian is expected to provide **topline results from the global registrational REVEAL-1 and REVEAL-2 studies in the first half of 2026**[21](index=21&type=chunk) [Neuroscience Pipeline](index=4&type=section&id=Neuroscience%20Pipeline) In the neuroscience pipeline, Zai Lab's partner Bristol Myers Squibb is expected to provide data readout from the Phase 3 ADEPT-2 study of Xanomeline-Trospium (KarXT) in Alzheimer's Disease Psychosis in H2 2025 [Xanomeline-Trospium (KarXT)](index=4&type=section&id=Xanomeline-Trospium%20%28KarXT%29) Zai Lab's partner Bristol Myers Squibb expects data readout from the Phase 3 ADEPT-2 study of KarXT in Alzheimer's Disease Psychosis in H2 2025 - Zai Lab partner Bristol Myers Squibb to provide **data readout from the Phase 3 ADEPT-2 study of KarXT in Alzheimer's Disease Psychosis** in the second half of 2025[15](index=15&type=chunk) [Anticipated Major Milestones (2025 & H1 2026)](index=3&type=section&id=Anticipated%20Major%20Milestones%20%282025%20%26%20H1%202026%29) Zai Lab anticipates multiple NMPA submissions and approvals, alongside key clinical developments and data readouts across its pipelines through H1 2026 [Upcoming Potential NMPA Submissions](index=3&type=section&id=Upcoming%20Potential%20NMPA%20Submissions) Zai Lab plans to submit for NMPA approval in H2 2025 for bemarituzumab in first-line gastric cancer, Tumor Treating Fields in first-line pancreatic cancer, and efgartigimod (prefilled syringe) for gMG and CIDP - **NMPA submission for Bemarituzumab (FGFR2b)** in first-line gastric cancer in H2 2025[11](index=11&type=chunk) - **NMPA submission for Tumor Treating Fields (TTFields)** in first-line pancreatic cancer in H2 2025[11](index=11&type=chunk) - **NMPA submission for Efgartigimod (FcRn)** for prefilled syringe in gMG and CIDP in H2 2025[11](index=11&type=chunk) [Upcoming Potential NMPA Approvals](index=3&type=section&id=Upcoming%20Potential%20NMPA%20Approvals) Zai Lab expects potential NMPA approvals for Xanomeline-Trospium (KarXT) in schizophrenia, Tisotumab Vedotin (Tissue Factor ADC) in recurrent or metastatic cervical cancer, and Repotrectinib (ROS1/TRK) in NTRK+ solid tumors - Potential **NMPA approval for Xanomeline-Trospium (KarXT)** in schizophrenia[11](index=11&type=chunk) - Potential **NMPA approval for Tisotumab Vedotin (Tissue Factor ADC)** in recurrent or metastatic cervical cancer following progression on or after chemotherapy[11](index=11&type=chunk) - Potential **NMPA approval for Repotrectinib (ROS1/TRK)** in NTRK+ solid tumors[11](index=11&type=chunk) [Expected Clinical Developments and Data Readouts](index=4&type=section&id=Expected%20Clinical%20Developments%20and%20Data%20Readouts) Key clinical developments include initiating a global registrational study for ZL-1310 in 2L ES-SCLC and a global Phase 1 study for ZL-1503 in atopic dermatitis in H2 2025, with various data readouts expected across the pipeline - **ZL-1310**: Global registrational study of monotherapy in 2L ES-SCLC to be initiated in H2 2025; data readout for dose escalation of doublet in combination with atezolizumab in 1L ES-SCLC[18](index=18&type=chunk) - **ZL-1503**: Global Phase 1 study in moderate-to-severe atopic dermatitis to advance in H2 2025[12](index=12&type=chunk) - **Bemarituzumab**: Detailed results from Phase 3 FORTITUDE-101 study and potential data readout from Phase 1b/3 FORTITUDE-102 study in first-line gastric cancer[19](index=19&type=chunk) - **Efgartigimod**: Topline results from Phase 2 study in Lupus Nephritis (Q4 2025), Phase 3 ADAPT-SERON study in seronegative gMG (H2 2025), and Phase 3 ADAPT-OCULUS study in ocular myasthenia gravis (H1 2026)[19](index=19&type=chunk) - **Povetacicept**: Global pivotal Phase 2/3 study in Primary Membranous Nephropathy (pMN) in Greater China expected to start in H2 2025[17](index=17&type=chunk) - **VRDN-003**: Registrational study in thyroid eye disease in Greater China to be initiated in H2 2025; topline results from global registrational REVEAL-1 and REVEAL-2 studies in H1 2026[21](index=21&type=chunk) - **KarXT**: Data readout from Phase 3 ADEPT-2 study in Alzheimer's Disease Psychosis in H2 2025[15](index=15&type=chunk) - **IgA Nephropathy (IgAN)**: Interim analysis of global Phase 3 RAINIER study following 36 weeks of treatment with potential for U.S. accelerated approval filing in H1 2026[20](index=20&type=chunk) [Additional Company Information](index=6&type=section&id=Additional%20Company%20Information) This section provides details on Zai Lab's conference call, company overview, non-GAAP measures, forward-looking statements, and investor/media contacts [Conference Call and Webcast](index=6&type=section&id=Conference%20Call%20and%20Webcast) Zai Lab hosted a live conference call and webcast on August 7, 2025, to discuss financial results and corporate updates, with a replay available on the company's website - Conference call and webcast held on **August 7, 2025, at 8:00 a.m. ET (8:00 p.m. HKT)**[2](index=2&type=chunk) - Access to live webcast via http://ir.zailaboratory.com; registration required for dial-in[22](index=22&type=chunk)[28](index=28&type=chunk) [About Zai Lab](index=6&type=section&id=About%20Zai%20Lab) Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company operating in China and the United States, focused on developing and commercializing innovative products for unmet medical needs - Zai Lab is an **innovative, research-based, commercial-stage biopharmaceutical company** based in China and the United States[24](index=24&type=chunk) - Focus areas include **oncology, immunology, neuroscience, and infectious disease**, addressing significant unmet medical needs[24](index=24&type=chunk) [Non-GAAP Measures Definition](index=6&type=section&id=Non-GAAP%20Measures%20Definition) Zai Lab uses non-GAAP financial measures, such as constant exchange rate (CER) adjusted growth rates and adjusted loss from operations, to provide a clearer understanding of business performance and operational trends - Non-GAAP measures include **growth rates adjusted for constant exchange rates (CER)** and **adjusted loss from operations**[26](index=26&type=chunk) - **Adjusted loss from operations excludes depreciation, amortization, and share-based compensation**[26](index=26&type=chunk) - These measures provide additional perspective on operational trends and greater transparency but should not be considered an exclusive alternative to GAAP[26](index=26&type=chunk) [Forward-Looking Statements & Disclaimers](index=6&type=section&id=Forward-Looking%20Statements%20%26%20Disclaimers) The press release contains forward-looking statements regarding Zai Lab's strategy, pipeline potential, commercialization, financial guidance, and future results, which are subject to inherent uncertainties and risks - The press release contains **forward-looking statements** relating to Zai Lab's strategy, plans, potential of its business, commercial products, and pipeline programs, including revenue growth and profitability[27](index=27&type=chunk) - Forward-looking statements are subject to **inherent uncertainties, risks, and changes in circumstances** that may differ materially from those contemplated[27](index=27&type=chunk)[29](index=29&type=chunk) - Investors should not place undue reliance on these statements, and the company undertakes no obligation to update or revise them, except as may be required by law[29](index=29&type=chunk) [Investor & Media Contacts](index=7&type=section&id=Investor%20%26%20Media%20Contacts) Contact information for Zai Lab's Investor Relations and Media teams is provided for further inquiries - Investor Relations contacts: Christine Chiou / Lina Zhang[31](index=31&type=chunk) - Media contacts: Shaun Maccoun / Xiaoyu Chen[31](index=31&type=chunk)
再鼎医药(09688) - 截至二零二五年七月三十一日止之股份发行人的证券变动月报表

2025-08-06 12:01
股份發行人及根據《上市規則》第十九B章上市的香港預託證券發行人的證券變動月報表 | | | 致:香港交易及結算所有限公司 公司名稱: 再鼎醫藥有限公司 呈交日期: 2025年8月6日 I. 法定/註冊股本變動 | 1. 股份分類 | 普通股 | 股份類別 | 不適用 | | 於香港聯交所上市 (註1) | | | 是 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 證券代號 (如上市) | 09688 | 說明 | 普通股 | | | | | | | | | | 法定/註冊股份數目 | | | 面值 | | | 法定/註冊股本 | | | 上月底結存 | | | 5,000,000,000 | USD | | 0.000006 | USD | | 30,000 | | 增加 / 減少 (-) | | | | | | | USD | | | | 本月底結存 | | | 5,000,000,000 | USD | | 0.000006 | USD | | 30,000 | 本月底法定/註冊股本總額: USD 30,000 FF ...
山西证券研究早观点-20250806
Shanxi Securities· 2025-08-06 00:35
Core Insights - Adidas reported a 7% year-on-year revenue growth for FY2025H1, reaching €12.105 billion, with a net profit increase of 121% to €798 million [4] - The brand's revenue growth was 14% on a currency-neutral basis, with all regional markets achieving double-digit growth [4] - The company maintains its full-year guidance, expecting high single-digit revenue growth on a currency-neutral basis for FY2025, with double-digit growth for the Adidas brand [4] Market Trends - The domestic market indices showed positive performance, with the Shanghai Composite Index closing at 3,617.60, up 0.96% [3] - The textile and apparel sector experienced a decline of 2.14% this week, underperforming the broader market [5] - Retail sales of sports and entertainment products grew significantly, with a 22.2% year-on-year increase in the first half of 2025 [5] Industry Dynamics - The Chinese gold consumption in the first half of 2025 was 505.205 tons, a decrease of 3.54% year-on-year, with jewelry consumption dropping by 26% [5] - The pharmaceutical industry is seeing advancements in innovative drugs, particularly in obesity treatments with GLP-1 and Amylin therapies showing promising results in clinical trials [8][11] - In the biopharmaceutical sector, ADC drugs for lung cancer are demonstrating significant efficacy, with several products showing improved outcomes in clinical trials [10][12]