浦银国际研究 公司研究 | 医药行业 再鼎医药（ZLAB.US/9688.HK）：1Q24 业绩 超预期，艾加莫德增长势头愈发强劲 阳景 浦 首席医药分析师 银 再鼎医药 1Q24 业绩显著超预期，主要受益于各药品收入均好于预期， Jing_yang@spdbi.com 国 (852) 2808 6434 尤其是新纳入医保重磅药品艾加莫德单季销售强于预期。在目前好转 际 的医药板块行情下，公司凭借出色的业绩表现，叠加短中期值得期待的 艾加莫德强劲收入增长，吸引了投资者对公司股票的关注与买入，使得 胡泽宇 CFA 公司美股港股在业绩公布后均大涨 20%+。我们重申对再鼎医药的“买 医药分析师 入”评级和目标价 60 美元/47 港元，基于再鼎过往强大的商业化能力 ryan_hu@spdbi.com 和高效的执行力，我们相信艾加莫德能为公司实现 2023-2028 年收入 (852) 2808 6446 CAGR超 50%的战略目标提供强有力驱动。  1Q24收入好于预期，净亏损远好于预期：1Q24 产品收入为 8714.9万 2024年5月10日 公 美元(+38.8% YoY, +32.4% QoQ)，显著 ...

[Table_Main] 证券研究报告 | 公司点评 再鼎医药(09688.HK) 2024年05月10日 再鼎医药(09688.HK)：新品放量 买入（维持） 所属行业：医疗保健业/药品及生物科技 超预期，公司迈入发展新阶段 当前价格(港币)：16.20元 证券分析师 投资要点 李霁阳 资格编号：S0120523080003 业绩。2024年 5月 9日，再鼎医药发布第一季度财务业绩，2024年 Q1净产品  邮箱：lijy7＠tebon.com.cn 收入 8,710 万美元, 同比增长 39%, 按固定汇率计算同比增长 43%。研发费用和 SG&A占收入比例均有显著的下降，R&D: 63% (Q1'24) vs. 100% (2023)；SG&A: 79% (Q1'24) vs. 106% (2023)；截至24年第一季度, 公司拥有超7.5亿美元的现 金储备, 市场表现 收入端增长强劲，新老产品均表现优异：1）艾加莫德（卫伟迦®）收入1320 万  再鼎医药 恒生指数 美元，进医保后第一个季度销售放量迅速；2）则乐收入为 4550万美元，同比增 20% 长7%；3）擎乐和纽再乐纳入医保后均实现强劲 ...

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 ...

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

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

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

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]

Investment Rating - The investment rating for the company is "Buy - A (Maintain)" [1] Core Views - The company is experiencing steady commercialization with a narrowing loss year-on-year. In 2023, total product revenue reached $267 million, a 25% increase year-on-year, with significant contributions from various products [1] - The company is expected to see strong growth in the sales of its product, Efgartigimod, which was included in medical insurance in December 2023, leading to an estimated revenue of $70 million in 2024 [1] - The pipeline is entering a concentrated harvest period with multiple innovative products expected to be approved or submitted for approval in 2024, indicating robust growth potential [1] Financial Performance - In 2023, the company reported total revenue of $267 million, with a year-on-year growth of 25%. The revenue breakdown includes $169 million from Zelek, $10 million from Efgartigimod, and $47 million from Apatinib [1][2] - The net loss for 2023 was $335 million, a 25% reduction compared to the previous year. Research and development expenses were $266 million, a decrease of 7% [1][2] - The company forecasts revenue growth of 24%, 57%, and 65% for the years 2023, 2024, and 2025, respectively, with projected revenues of $267 million, $419 million, and $692 million [2][4] Pipeline and Product Development - Efgartigimod is expected to see significant sales growth following its inclusion in medical insurance, with nearly 1,000 patients treated by the end of January 2024 [1] - The company has several products in its pipeline, including Efgartigimod for CIDP, which is expected to submit for approval in the first half of 2024, and other innovative therapies targeting various conditions [1][4] - The company is actively participating in global clinical trials for its products, indicating a strong commitment to expanding its market presence [1][4]