研究报告Research Report 10 May 2024 再鼎医药 Zai Lab (9688 HK) 艾加莫德 Q1 放量顺利，全年指引销售超过 7000 万美元 VYVGART 24Q1 Revenue of 13 Million USD with Full Year Guidance Over 70 Million USD [观Ta点bl聚e_焦yem Inevie1s] tment Focus [Tab维le_持Inf优o] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$15.90 再鼎医药 2024Q1 产品收入 8715 万美元（+38.8%），其中艾加莫 目标价 HK$67.51 德1316万美元。毛利率61.4%（-4.6pct）；R&D费用5465万美元 HTI ESG 2.9-1.5-3.5 （+12.7%），R&D 费用率 62.7%（-14.5pct）；SG&A 费用 6919 万 E-S-G: 0-5, (Please refer to ...

Hello, ladies and gentlemen. Thank you for standing by and welcome to the i-Labs first quarter 2024 financial results conference call. At this time, all participants are in listen-only mode. Later, we will conduct a question and answer session and instructions will follow at that time. As a reminder, today's call is being recorded. It is my pleasure to turn the floor over to Christine Chiao, Senior Vice President of Investor Relations. Please go ahead. Thank you, operator. Good morning, good evening, and we ...

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2024年3月31日止三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2024年3月31日止三個月的未經審計簡明合併業績（「2024年第一季度業績」） 以及近期產品亮點及公司進展和2024年的預期重要里程碑事件。2024年第一季度業績乃根據有別 於國際財務報告準則的美國公認會計準則編製。 承董事會命 再鼎醫藥有限公司 董事、董事長兼首席執行官 杜瑩 中國上海和美國馬薩諸塞州劍橋市，2024年5月8日 — 再鼎醫藥有限公司（納斯達克股票 代碼：ZLAB；香港聯交所股份代號：9688）今天公佈了2024年第一季度的財務業績，以 及近期的產品亮點和公司進展。 再鼎醫藥創始人、董事長兼首席執行官杜瑩博士表示：「 ...

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

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 2023 年 1 2 月 3 1 日止年度 年度業績公告 再鼎醫藥有限公司連同其附屬公司（統稱「本公司」或「我們」）謹此公佈本公司截至2023年 12月31日止年度（「報告期」）的合併業績，連同截至2022年12月31日止年度的比較數字， 該等業績乃根據美國公認會計準則（「美國公認會計準則」）編製並由本公司董事會（「董 事會」）審核委員會（「審核委員會」）審閱。 財務摘要 截至2023年12月31日止年度與截至2022年12月31日止年度比較（以美元（「美元」）計） 1 • 產品收入增加54.0百萬美元或25%至266.7百萬美元，主要是由於銷量增加、衛偉迦® （艾加莫德α注射液）的上市以及COVID-19疫情負面影響的降低，但也部分被向經 銷商提供的銷售返利增加和中國2023年下半 ...

研究报告Research Report 21 Mar 2024 再鼎医药 Zai Lab (9688 HK) 艾加莫德顺利纳入医保， 2024 年目标销售超过 7000 万美元 With the Inclusion of NRDL, Egfartigimod Targets 70+ mnUSD sales in 2024 [观Ta点ble聚_y焦em Ieniv1e]s tment Focus [Tab维le_持Info优] 于大市Maintain OUTPERFORM (Please see APPENDIX 1 for English summary) 事件 评级 优于大市OUTPERFORM 现价 HK$13.84 再鼎医药 2023 年产品收入 2.7 亿美元，同比+25%，按固定汇率计 目标价 HK$66.82 算同比+31%。其中，尼拉帕尼 1.7 亿美元（+16%），艾加莫德 HTI ESG 2.9-1.5-3.5 1000万美元，肿瘤电场治疗4700 万美元（基本持平），瑞派替尼 E-S-G: 0-5, (Please refer to the Appendix for ESG comment ...

Investment Rating - Maintains a "Buy" rating with a target price of $60 for US shares and HK$47 for Hong Kong shares [1][3][4] Core Views - Zai Lab's 4Q23 revenue of $65.83 million met expectations, with net loss of $95.43 million slightly exceeding forecasts due to higher R&D and SG&A expenses [1] - A major driver for future growth is the strong performance of Efgartigimod, which achieved $5.07 million in sales in 4Q23, a 3.7% QoQ increase, despite reimbursement impacts [1] - The company expects Efgartigimod sales to exceed $70 million in 2024, a 40% increase from previous estimates, driven by expanded hospital coverage and new indications [1] - Zai Lab anticipates a revenue CAGR of over 50% from 2023 to 2028, supported by the approval of subcutaneous formulations for Efgartigimod in 2024 and 2025 [1] Financial Performance and Forecasts - 4Q23 gross margin was 61.7%, down 1.5 percentage points QoQ, primarily due to higher production costs for Efgartigimod [1] - Revenue forecasts for 2024E and 2025E were raised by 7.5% and 3.1%, respectively, driven by higher expectations for Efgartigimod and upcoming drug approvals [1] - Net loss for 2024E and 2025E increased by 29% and 15%, respectively, due to updated financial assumptions [1] - Revenue is projected to grow from $390 million in 2024E to $983 million in 2026E, with a CAGR of 52.5% from 2024E to 2026E [6] Key Catalysts for 2024 - Three drugs expected to gain approval: SUL-DUR, Efgartigimod subcutaneous (gMG indication), and Rotrectinib (ROS1+NSCLC) [1] - Four drugs to submit China NDA applications: Efgartigimod subcutaneous (CIDP indication), Adagrasib (second-line NSCLC), TIVDAK (second-line cervical cancer), and Optune (second-line NSCLC) [1] - Partner-related FDA reviews include tumor-treating fields for NSCLC (2H24), KarXT for schizophrenia (Sep 2024), and Efgartigimod for CIDP (Jun 2024) [1] - Key clinical data readouts include Optune for NSCLC brain metastasis (1Q24) and pancreatic cancer (4Q24), as well as Adagrasib for NSCLC (2H24) [1] Valuation and Market Data - Zai Lab's US shares currently trade at $20.8, with a 52-week range of $17.7-$41.8 and a market cap of $2.06 billion [3] - Hong Kong shares trade at HK$17.4, with a 52-week range of HK$14.1-HK$32.8 and a market cap of HK$17.22 billion [4] - The target price implies a potential upside of 188% for US shares and 170% for Hong Kong shares [3][4] Industry Context - Zai Lab is part of the biotech sector, with peers such as Hutchmed, BeiGene, and Innovent Biologics also receiving "Buy" ratings from SPDB International [12]

2024年02月29日 公司研究●证券研究报告 再鼎医药（ ） 公司快报 09688.HK 艾加莫德放量可期，后期管线密集收获 买入-A(维持) 投资评级 股价(2024-02-28) 17.36港元 投资要点 商业化稳步推进，亏损同比缩窄。公司公布2023年财务业绩及近期公司进展。公 交易数据 司2023年产品总收入2.67亿美元（+25%，同增，下同），其中则乐销售收入1.69 总市值（百万港元） 17,222.64 亿美元（+16%），艾加莫德销售收入1000万美元，爱普盾销售收入4700万美元 流通市值（百万港元） 17,222.64 （-1%），擎乐销售收入1920万美元（+29%），纽再乐销售收入2170万美元 总股本（百万股） 992.09 （+316%）。随着更多产品新纳入或成功续约医保，2023年公司向经销商提供销 流通股本（百万股） 992.09 售返利1300万美元（+145%）。2023年研发开支2.66亿美元（-7%），主要系 12个月价格区间 31.150/14.960 预付款及里程碑付款减少；销售、一般及行政开支2.82亿美元（+9%），主要系 一年股价表现 艾加莫德上市销售费 ...

Financial Performance - Total product revenue for 2023 was $266.7 million, representing a 25% year-over-year increase, and a 31% increase when adjusted for constant currency[6]. - Total revenue for 2023 was $266.72 million, an increase of 24.9% compared to $215.04 million in 2022[48]. - Product revenue reached $266.72 million, up from $212.67 million in the previous year, reflecting a growth of 25.4%[48]. - 2023 sales revenue reached $19.2 million, a 29% increase from $15 million in the same period of 2022[14]. - Sales revenue for another product in 2023 was $21.7 million, up 316% from $5.2 million in 2022[14]. - The company recorded a gross profit of $170.90 million in 2023, compared to $138.02 million in 2022, reflecting a gross margin improvement[48]. - The net loss for 2023 was $334.6 million, with a loss per share of $0.35, compared to a net loss of $443.3 million and a loss per share of $0.46 in 2022[14]. - The company reported a net loss of $334.62 million for 2023, an improvement from a net loss of $443.29 million in 2022, representing a reduction of 24.6%[50]. - Operating loss improved to $(366,573) thousand in 2023, a 9% reduction from $(404,357) thousand in 2022[52]. Cash and Assets - The company’s cash reserves as of December 31, 2023, were $80.76 million, down from $100 million at the end of 2022[6]. - As of December 31, 2023, cash and cash equivalents totaled $807.6 million, down from $1 billion as of December 31, 2022[14]. - Cash and cash equivalents as of December 31, 2023, were $790.15 million, down from $1.01 billion at the end of 2022, a decrease of 21.6%[47]. - The total assets decreased to $1.04 billion in 2023 from $1.22 billion in 2022, a decline of 14.9%[47]. - The company’s total liabilities increased to $240.18 million in 2023 from $174.55 million in 2022, an increase of 37.5%[47]. - The number of issued shares increased to 977.15 million as of December 31, 2023, compared to 962.46 million in 2022, an increase of 1.5%[47]. Research and Development - R&D expenses in 2023 were $265.9 million, down from $286.4 million in 2022, primarily due to reduced prepayments and milestone payments related to licensing and collaboration agreements[14]. - Research and development expenses decreased to $265.87 million in 2023 from $286.41 million in 2022, a decline of 7.1%[48]. - The company plans to submit up to four new drug applications in 2024, including for Durobatin and Reptin[6]. - The company plans to submit several new drug applications in China, including for Adagrasib and Tisotumab Vedotin[18]. - The FDA has accepted the premarket approval application for tumor treating fields therapy for NSCLC, with a target submission to the NMPA in 2024[20]. - The company is actively recruiting patients for global clinical studies involving multiple new therapies, including ZL-1310 for small cell lung cancer[20]. - Zai Lab plans to submit an NDA for tisotumab vedotin for second-line and above cervical cancer to the NMPA[27]. - Zai Lab will participate in the global Phase 3 study KRYSTAL-7 evaluating adagrasib for first-line treatment of KRASG12C mutation NSCLC, expected to start in the second half of 2024[31]. - Zai Lab plans to submit an sBLA for subcutaneous efgartigimod for gMG, which is expected to receive NMPA approval[32]. - Zai Lab is set to initiate a global Phase 2 study for ZL-1102 targeting moderate chronic plaque psoriasis in mid-2024[31]. - Zai Lab is actively involved in multiple clinical studies across various therapeutic areas, including oncology and autoimmune diseases, to address unmet medical needs[37]. Market and Product Developments - The launch of Weiwei Jia in September 2023 in China has treated nearly 1,000 patients by the end of Q4 2023, with an estimated sales forecast of over $70 million for 2024[6]. - Weiwei Jia was included in the NRDL effective January 1, 2024, enhancing patient accessibility and treatment uptake[11]. - Sales rebates to distributors increased from $5.3 million in 2022 to $13 million in 2023 due to more products being included in the National Reimbursement Drug List (NRDL)[11]. - The inclusion of new products in the NRDL is expected to enhance patient accessibility starting January 1, 2024[14]. - The company aims to achieve profitability by the end of 2025 through revenue growth and efficiency improvements[5]. - The strategic focus for 2024 includes commercial execution to drive innovation in China and other regions[13]. - The company aims to maintain its leadership position in the ovarian cancer market in China[15]. - Zai Lab's partner Novocure will announce key data from the Phase 3 METIS study for non-small cell lung cancer brain metastases in Q1 2024[25]. - Karuna announced that the FDA has accepted the new drug application for KarXT for the treatment of adult schizophrenia, with a PDUFA target action date of September 26, 2024[6]. - Argenx announced that the FDA has accepted the sBLA for subcutaneous efgartigimod for CIDP, with a PDUFA target action date of June 21, 2024[6].

浦银国际研究 公司研究 | 医药行业 再鼎医药（ZLAB.US/9688.HK）：加速商业 化进程推动盈利前景，维持“买入”评级 阳景 浦 首席医药分析师 银 首席医药分析师阳景恢复覆盖再鼎医药（ZLAB.US/9688.HK），维持“买 Jing_yang@spdbi.com 国 (852) 2808 6434 入”评级，目标价为 60 美元/47 港元。基于再鼎医药（再鼎）过往强 际 大的商业化能力、强劲高效的执行力，我们有信心公司能够完成管理层 4Q25 开始实现盈利和 2023-2028 年收入年复合增速超过 50%的指引。 胡泽宇 CFA 我们认为，公司目前 20 亿美元的市值明显低估了其一系列具有差异化 医药分析师 的重磅创新药的长期价值及众多短期催化剂对股价的提振作用。 ryan_hu@spdbi.com  未来 5 年商业化大幅提速，有望带来超过 50%的收入年均复合增长率： (852) 2808 6446 根据管理层指引，未来 3 年（2024-2026 年）预计将有超过 7 款新产品 或新适应症上市，至 2028 年底之前，再鼎医药预计有超过 15 款商业 2024年2月23日 公 化产 ...