今日港股回调，创新药再度逆市上涨！港股通创新药ETF（159570）强势大涨近3%，成交额继续爆量，盘中成交近5亿元！上周五成交额再度刷新历史，天 量成交16.49亿元！资金持续乐观，上周累计获资金净流入近2亿元，今日盘中再获净申购4300万份！ 港股通创新药ETF（159570）成分股多数飘红：乐普生物涨超12%，百济神州涨超5%，信达生物涨超3%，晶泰控股涨超2%，康方生物、药明生物、科伦博 泰生物涨超1%。 资金狂涌创新药，港股通创新药ETF（159570）近60日"吸金"近10亿元，融资余额保持历史高位，反映杠杆资金布局意愿！最新规模19.27亿元创上市新 高，1个月实现规模翻倍！ 【机构：医药见底回暖，创新药主线强化】 光大证券认为，医药行情见底回暖，优化集采政策有望稳定资产盈利能力。近期，医药行情整体已显现见底回暖迹象，从2025.1.2~2025.3.27期间，港股创 新药指数上涨26.28%，跑赢恒生科技1.20pp。2025年工作报告提出"优化药品集采政策"，有望优化产业竞争环境，仿制药利润压缩接近尾声，竞争格局趋于 稳定，龙头白马企业凭借技术壁垒与产能优势，盈利能力有望企稳。后集采时代，行 ...

Revenue Growth - Product revenue increased by $130.9 million (or 49%) to $397.6 million, driven by the sales growth of Weiwei Jia® since its launch in September 2023 and its inclusion in the national medical insurance catalog in January 2024 [4] - Total revenue for the year ended December 31, 2024, was $398.988 million, a significant increase of 49.5% compared to $266.719 million in 2023 [20] - Product revenue, net, reached $397.614 million, up from $266.719 million in the previous year, indicating strong growth in product sales [20] - Total product revenue for 2024 reached $423.855 million, a 42% increase from $298.911 million in 2023 [81] - The net revenue from the product "卫偉迦╱衛力迦" surged by 835% to $93.6 million in 2024 from $10.0 million in 2023 [180] Expenses and Losses - R&D expenses decreased by $31.4 million (or 12%) to $234.5 million, primarily due to the progress of existing research projects, partially offset by increased licensing fees [4] - Selling, general and administrative expenses increased by $17.1 million (or 6%) to $298.7 million, mainly due to increased general sales expenses from the launch of Weiwei Jia® and the sales growth of Nuo Zai Le® [4] - Net loss decreased by $77.5 million (or 23%) to $257.1 million, primarily due to product revenue growth outpacing net operating expenses, offset by decreased interest income and increased foreign exchange losses [4] - The net loss for 2024 was $257,103,000, a decrease from the net loss of $334,620,000 in 2023, representing a 23.2% improvement [21] - The comprehensive loss for 2024 was $244,214,000, compared to $322,679,000 in 2023, indicating a 24.4% reduction [21] Cash and Liquidity - Cash and cash equivalents as of December 31, 2024, were $449.667 million, down from $790.151 million in 2023, indicating a reduction in liquidity [19] - The company reported a total cash and cash equivalents of $550,781,000 at the end of 2024, down from $791,264,000 at the end of 2023 [23] - Cash flow from operating activities showed a net cash outflow of $214,869,000 in 2024, compared to $198,178,000 in 2023, reflecting a 8.4% increase in cash outflow [23] - Cash, cash equivalents, and restricted cash amounted to $550.8 million as of December 31, 2024, including $531.0 million in USD [194] Assets and Liabilities - Total assets increased to $1.185753 billion in 2024 from $1.036295 billion in 2023, showing overall growth in the company's asset base [19] - Total liabilities rose to $344.855 million in 2024, compared to $240.177 million in 2023, indicating increased financial obligations [19] - Shareholders' equity increased to $840.898 million in 2024 from $796.118 million in 2023, reflecting a positive trend in equity position [19] - The company reported a decrease in accumulated deficit to $2,453,083,000 in 2024 from $2,195,980,000 in 2023, reflecting ongoing financial challenges [22] Research and Development - Research and development expenses totaled $234.504 million, a decrease from $265.868 million in the prior year, suggesting a focus on efficiency [20] - Clinical project expenses were $86,126, down from $112,158, indicating a reduction of approximately 23.2% year-over-year [138] - The investment in R&D and operational expenses continues to drive significant losses, with a focus on long-term development of quality candidates [165] - The company has multiple candidates in late-stage clinical development, with the ability to generate revenue dependent on obtaining regulatory approvals [174] Stock and Equity - Basic and diluted loss per share was $0.26, a decrease of 25% from $0.35 [4] - The weighted average number of shares outstanding increased to 989,477,730 in 2024 from 966,394,130 in 2023, reflecting potential dilution effects [20] - The company granted 20,947,480 stock options in 2024, with an average exercise price of $1.69 [108] - The total intrinsic value of stock options exercised in 2024 was approximately $9.4 million, compared to $20.3 million in 2023 [108] Collaborations and Agreements - The company has entered into a licensing agreement with Seagen for the development and commercialization of Tisotumab Vedotin (TIVDAK) in Greater China, with potential milestone payments up to $258 million [122] - A collaboration and licensing agreement with Yilian Biopharmaceuticals was established for the global exclusive rights to develop and commercialize DLL3-targeted ADC compounds, with potential milestone payments up to $592 million [124] - The company recorded a milestone expense of $12.0 million related to sales for the collaboration agreement with GSK for Niraparib in 2023 [113] Financial Instruments and Accounting - The company operates under US GAAP for its consolidated financial statements, ensuring compliance with important accounting policies [27] - The company applies ASC 606 for revenue recognition, confirming revenue when control of goods or services is transferred to customers [49] - The company recognizes lease liabilities and right-of-use assets at the commencement date of the lease, measuring lease liabilities at the present value of future fixed lease payments [39] Market and Future Outlook - The company expects revenue growth from existing and recently launched commercialized products to continue into 2025 [167] - The company plans to continue its market expansion efforts and explore new product development opportunities [139] - Strategic collaborations have been established with Yilian Bio and Vertex to enhance the product pipeline and leverage new therapeutic developments [168]

Group 1 - Zai Lab Limited (NASDAQ: ZLAB) has seen its share price increase by over 105% on a 12-month basis and nearly 50% year-to-date [2] - The company markets and sells seven drugs developed by US and European pharmaceutical companies [2] - The investing group Haggerston BioHealth provides insights for both novice and experienced biotech investors, including catalysts, buy and sell ratings, product sales forecasts, and integrated financial statements [2] Group 2 - Edmund Ingham, a biotech consultant with over 5 years of experience, has created detailed reports on more than 1,000 companies in the biotech, healthcare, and pharma sectors [2]

Zai Lab Limited (NASDAQ: ZLAB ) continues to develop treatments for oncology, autoimmune disorders, infectious diseases, and neurological conditions. In my view, their most important value driver today is Vyvgart for generalized myasthenia gravis [gMG], which showed significant revenue growth in 2024. Also, the recent approval in ChinaMy name is Myriam Hernandez Alvarez. I received the Electronics and Telecommunication Engineering degree from the Escuela Politecnica Nacional, Quito, Ecuador, the M.Sc. degre ...

Investment Rating - The report assigns a "Buy" rating to Zai Lab (ZLAB US) with a target price of US$62.32, indicating an upside potential of 80% from the current price of US$34.64 [1]. Core Insights - The company is expected to experience significant revenue growth, with a projected revenue of US$5.60-5.90 billion for 2025, following a strong performance in 2024 where revenue reached US$399 million, a 50% year-over-year increase [3][8]. - The inclusion of key products in the National Reimbursement Drug List (NRDL) has driven rapid revenue growth, particularly for Weiqijia and Weilian, which achieved sales of US$93.6 million in 2024 [4]. - The company has effectively controlled expenses, with R&D spending decreasing by 11.6% to US$235 million in 2024, contributing to improved operational efficiency [5][8]. Financial Summary - The financial projections for Zai Lab are as follows: - Revenue (US$ million): 2022A: 215, 2023A: 267, 2024E: 398, 2025E: 562, 2026E: 920 [7]. - Gross Profit (US$ million): 2022A: 141, 2023A: 171, 2024E: 259, 2025E: 364, 2026E: 593 [7]. - Net Profit (US$ million): 2022A: (443), 2023A: (334), 2024E: (307), 2025E: (205), 2026E: 22 [7]. - Earnings per Share (US$): 2022A: (4.63), 2023A: (3.42), 2024E: (3.13), 2025E: (2.10), 2026E: 0.22 [7].

Core Viewpoint - Zai Lab Limited (ZLAB) has seen a 15.9% increase in share price over the past four weeks, closing at $31.73, with a potential upside of 64.4% based on Wall Street analysts' mean price target of $52.17 [1] Price Targets - The average price target consists of six estimates ranging from a low of $25 to a high of $74, with a standard deviation of $17.94, indicating variability among analysts [2] - The lowest estimate suggests a decline of 21.2% from the current price, while the highest indicates a potential upside of 133.2% [2] - A low standard deviation signifies a higher agreement among analysts regarding price movement direction [7] Analyst Sentiment - Analysts are optimistic about ZLAB's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [9] - Over the last 30 days, the Zacks Consensus Estimate for the current year has increased by 29.6%, with two estimates moving higher and no negative revisions [10] - ZLAB holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimates [11] Caution on Price Targets - While price targets are often sought after, they can mislead investors, as empirical research shows they rarely indicate actual stock price movements [5] - Analysts may set overly optimistic price targets due to business incentives, which can inflate expectations [6] - Investors should treat price targets with skepticism and not rely solely on them for investment decisions [8][12]

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

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

Financial Performance - Total revenue for Q4 2024 reached $109.1 million, representing a 66% year-over-year growth[7] - Total revenue for the full year 2024 was $399 million, reflecting a 50% increase compared to the previous year[7] - The company projects full-year revenue for 2025 to be between $560 million and $590 million[7] - In Q4 2024, product revenue reached $108.5 million, a 65% increase from $65.8 million in Q4 2023; for the full year 2024, product revenue was $397.6 million, up 49% from $266.7 million in 2023[2] - The revenue from Weiwei Jia in Q4 2024 was $30 million, significantly up from $5.1 million in Q4 2023; for the full year, revenue was $93.6 million, compared to $10 million in 2023[2] - The revenue from Zele in Q4 2024 was $48.4 million, a 16% increase from $41.6 million in Q4 2023; for the full year, revenue was $187.1 million, up 11% from $168.8 million in 2023[2] - The revenue from Niuzainuo in Q4 2024 was $11 million, an 81% increase from $6.1 million in Q4 2023; for the full year, revenue was $43.2 million, up 99% from $21.7 million in 2023[2] - Product revenue from Efgartigimod (艾加莫德) for Q4 2024 was $30 million, with full-year sales reaching $93.6 million[7] - Total revenue for 2025 is projected to be between $560 million and $590 million[15] Operating Loss and Expenses - Operating loss for Q4 2024 was $67.9 million, a 45% decrease year-over-year, while the full-year operating loss was $282.1 million, down 23%[7] - The adjusted operating loss for Q4 2024 was $47.6 million, compared to $124 million in Q4 2023; for the full year 2024, the adjusted operating loss was $199.6 million, down from $366.6 million in 2023[13] - R&D expenses in Q4 2024 were $52.3 million, down from $81.9 million in Q4 2023; for the full year, R&D expenses were $234.5 million, compared to $265.9 million in 2023[2] - SG&A expenses in Q4 2024 were $82.6 million, consistent with Q4 2023; for the full year, SG&A expenses were $298.7 million, up from $281.6 million in 2023[2] Cash and Financial Position - Cash and cash equivalents totaled $879.7 million as of December 31, 2024, compared to $806.5 million as of December 31, 2023[13] - Cash and cash equivalents decreased to $449.67 million in 2024 from $790.15 million in 2023[39] - Total assets increased to $1.19 billion in 2024, compared to $1.04 billion in 2023[39] - The company has significantly improved its financial position, reducing operating losses and targeting non-GAAP operating profit by Q4 2025[8] - The company has a strong cash reserve, enabling continued investment in high-impact growth opportunities[8] - The company’s total liabilities rose to $344.86 million in 2024, up from $240.18 million in 2023[39] - The company’s capital surplus increased to $3.26 billion in 2024 from $2.98 billion in 2023[39] Clinical Development and Product Pipeline - Early clinical data for ZL-1310 (DLL3 ADC) in a global Phase 1 study showed an overall response rate (ORR) of 74%, indicating its potential as a first-in-class and best-in-class therapy for small cell lung cancer (SCLC)[7] - The company aims to accelerate clinical development of its pipeline, including ZL-1310 for SCLC and other ADCs, with global Phase 1 studies underway[14] - The NDA for KarXT, a treatment for schizophrenia, has been accepted by the National Medical Products Administration (NMPA) in China[7] - The company plans to commercialize potential blockbuster products such as Bemarituzumab for gastric cancer and KarXT for schizophrenia[14] - ZL-1310 received orphan drug designation from the FDA for SCLC treatment, with potential for a 7-year market exclusivity upon approval[19] - The PANOVA-3 trial for TTFields in pancreatic cancer achieved significant median overall survival improvement, with plans to submit a marketing application in China in H2 2025[19] - The company plans to submit a New Drug Application (NDA) for Vtama in Q1 2025, targeting recurrent or metastatic cervical cancer[19] - The company is preparing to submit supplemental NDAs for Repotrectinib in H1 2025 for NTRK-positive solid tumors[19] - The company will announce updated clinical data for ZL-1310 in SCLC at major medical conferences in 2025[26] Strategic Collaborations and Partnerships - Strategic collaborations include a partnership with Ilyang Biopharma for the development of ZL-6201, a novel LRRC15 ADC for specific solid tumors[15] - The company has secured licensing agreements for povetacicept and ZL-1108 in Greater China and Singapore, targeting IgAN and thyroid eye disease respectively[15] - Amgen, a partner of Zai Lab, will announce Phase 3 study data for FORTITUDE-101 in the first half of 2025, focusing on bemarituzumab combined with chemotherapy for first-line treatment of gastric cancer[27] - Amgen will also announce Phase 3 study data for FORTITUDE-102 in the second half of 2025, exploring bemarituzumab combined with chemotherapy and nivolumab versus chemotherapy combined with nivolumab for gastric cancer[27] - Zai Lab is participating in the Phase 3 study ADAPT-SERON for seronegative gMG, with results expected to be announced by partner Argenx[27] - Zai Lab will announce key results from a Phase 2 study for lupus nephritis (LN)[27] Company Vision and Market Position - The company aims to achieve $2 billion in revenue by 2028, driven by Efgartigimod and other potential blockbuster products[8] - The company is focused on addressing unmet medical needs in oncology, immunology, neuroscience, and infectious diseases through innovative product discovery and commercialization[31] - Zai Lab is listed on NASDAQ under the ticker ZLAB and on the Hong Kong Stock Exchange under stock code 9688[31] - The company emphasizes the importance of non-GAAP financial metrics to provide a clearer view of operational performance and financial results[33] - Forward-looking statements include expectations regarding commercialization, clinical development, and potential product benefits, but actual results may differ significantly due to various factors[35]

Financial Performance - In 2024, the company reported a total revenue of $399.0 million, representing a 50% increase compared to $266.7 million in 2023[445]. - The net loss decreased by 23% to $257.1 million in 2024 from $334.6 million in 2023[445]. - Product revenue increased by $130.9 million to $397.6 million, driven primarily by VYVGART, which saw an 835% increase in sales since its launch[458][460]. - ZEJULA maintained its position as the leading PARP inhibitor for ovarian cancer, with sales of $187.1 million, an 11% increase from the previous year[458][460]. - Net loss for 2024 was $257.1 million, a reduction from the $334.6 million loss in 2023, resulting in a loss per ordinary share of $0.26[471]. Research and Development - Research and development expenses decreased by 12% to $234.5 million in 2024, down from $265.9 million in 2023[461]. - Research and development expenses decreased by $31.4 million (12%) in 2024, totaling $234.5 million, primarily due to a $26.0 million decrease in clinical program expenses[462]. - The company has multiple late-stage product candidates and ongoing pivotal trials, indicating a strong pipeline for future growth[442][446]. - The company aims to achieve profitability by the end of 2025 while continuing to invest in research and development[448]. Cash Flow and Investments - Net cash used in operating activities increased by $16.7 million in 2024, totaling $214.9 million, influenced by a decrease in net loss and adjustments to reconcile net loss[490]. - Net cash used in investing activities surged by $364.4 million in 2024, primarily due to increased purchases of short-term investments and acquisition of intangible assets[491]. - Net cash provided by financing activities was $349.9 million in 2024, a significant increase from a net cash used of $6.4 million in 2023, mainly due to proceeds from public offerings[492]. - As of December 31, 2024, the company had cash and cash equivalents of $879.7 million, expected to meet cash requirements for at least the next 12 months[486]. Expenses - Selling, general, and administrative expenses increased by $17.1 million (6%) in 2024, reaching $298.7 million, driven by higher costs associated with the launch of VYVGART and NUZYRA[464]. Interest and Currency Risks - Interest income decreased by $2.7 million in 2024, primarily due to reduced cash and cash equivalents[466]. - Interest expense increased by $2.3 million in 2024, attributed to new short-term debt incurred during the year[467]. - Foreign currency losses increased by $0.3 million in 2024, mainly due to the depreciation of the RMB against the U.S. dollar[468]. - The company is exposed to interest rate risks on its short-term debt, which amounted to $131.7 million as of December 31, 2024[507]. - A hypothetical 10% relative change in interest rates would not have a material impact on future interest income due to the short-term nature of the company's deposits and investments[506]. - The value of the company's ADSs and ordinary shares is affected by foreign exchange rates between U.S. dollars, HK dollars, and RMB[499]. - The HK dollar has been pegged to the U.S. dollar at approximately HK$7.80 to US$1.00 since 1983, but there is no assurance this will continue[500]. - The company has not used derivative financial instruments to hedge foreign exchange risk, as it believes its exposure is limited[497]. - The conversion of RMB into foreign currencies is based on rates set by the PBOC, which can fluctuate due to political and economic conditions in Greater China[498]. Customer and Credit Risk - The company's two largest customers accounted for approximately 23% of total accounts receivable as of December 31, 2024[503]. - The company has not incurred significant credit losses historically, managing credit risk through ongoing monitoring of outstanding balances[503]. - The company manages its investment portfolio to preserve principal, provide liquidity, and maximize income without significantly increasing risk[506].