Investment Rating - The report maintains a "Buy" rating for Zai Lab (ZLAB.US/9688.HK) and slightly lowers the target price to $55 for US shares and HK$43 for Hong Kong shares [1][4]. Core Insights - In Q3 2024, Zai Lab's net loss significantly narrowed to $41.67 million, a decrease of 39.7% year-over-year and 48.1% quarter-over-quarter, primarily due to lower-than-expected selling and administrative expenses [1]. - Product revenue for Q3 2024 reached $101.8 million, representing a 47% year-over-year increase and a 1.7% quarter-over-quarter increase, aligning with consensus expectations [1]. - The gross margin for product sales was stable at 64.1%, with a slight decrease of 0.8 percentage points quarter-over-quarter [1]. - The company continues to see strong growth in Efgartigimod, with Q3 2024 revenue of $27.3 million, a remarkable increase of 458% year-over-year and 17.6% quarter-over-quarter [1]. - Zai Lab has achieved approximately 65% market potential coverage for Efgartigimod, with around 10,000 myasthenia gravis patients having used the drug, and a stable monthly addition of about 1,000 new patients [1]. Financial Summary - The report projects a narrowing of net loss to $260 million for 2024, with slight adjustments to the 2025 and 2026 net loss and profit forecasts based on updated financial information [1][4]. - Revenue forecasts for 2024, 2025, and 2026 are $402 million, $651 million, and $995 million respectively, with year-over-year growth rates of 50.6%, 62.2%, and 52.8% [4][5]. - The report anticipates that Zai Lab will continue to expand its product pipeline, with several key drugs expected to be commercialized in China by the end of 2024 and early 2025 [1][4]. Market Expectations - The current stock price for Zai Lab is $29.0, with a potential upside of 90% to the target price of $55.0 [2]. - The stock has a 52-week price range of $13.4 to $36.6, and the total market capitalization is approximately $2.885 billion [2]. - For the Hong Kong shares, the current price is HK$23.4, with a potential upside of 84% to the target price of HK$43.0 [3].

Summary of the Conference Call Company and Industry Overview - The conference call was focused on the performance of a biopharmaceutical company, specifically discussing its Q3 2024 results and future outlook. The company operates in the biopharmaceutical industry, with a focus on oncology and immunotherapy products. Key Points and Arguments 1. **Q3 Performance Highlights** - The company achieved total product revenue of $100 million, representing a year-over-year growth of 47% [1][3][12]. - Operating losses narrowed by 19% year-over-year, while net losses decreased by 40% [1][5][12]. - Sales of the product "Aigamod" reached $27.3 million in Q3, marking a significant achievement [1][15]. 2. **Product Pipeline and R&D Progress** - The company plans to submit at least four new product applications domestically within the next six months [2][4]. - Recent clinical trials for the drug "DL1310" showed an overall response rate (ORR) of 74% in small cell lung cancer patients, with a 100% ORR in patients with brain metastases [6][32]. - The company is advancing multiple candidates, including "GL3010" and "CL-1503," into clinical stages, with expectations for significant breakthroughs [4][28]. 3. **Market Strategy and Future Outlook** - The company aims for annual revenue growth of approximately 50% and targets $2 billion in revenue by 2025 [5][12]. - The management expressed confidence in the commercialization of "Aigamod" and other products, anticipating a strong market presence [10][11]. - The company is also focusing on expanding its global pipeline and optimizing operational efficiency [3][12]. 4. **Regulatory and Market Access** - The company participated in national health insurance negotiations, with expectations for favorable outcomes [15][19]. - The management highlighted the importance of market access for new products, particularly in the context of competitive pricing and reimbursement strategies [19][35]. 5. **Sales and Marketing Efforts** - The company has successfully established a presence in key hospitals, covering approximately 60% of the potential market for "Aigamod" [15][16]. - There is a growing trend of repeat prescriptions among physicians, indicating strong acceptance of the product [9][15]. Other Important but Possibly Overlooked Content - The company has a robust cash reserve of $716 million, which supports its strategic goals and ongoing development efforts [12]. - The management emphasized the need for continuous education and support for healthcare providers to enhance the adoption of their therapies [9][10]. - The competitive landscape is evolving, with potential challenges from generic products and market dynamics, particularly in the oncology sector [21][22]. - The company is exploring partnerships for certain products to enhance market access and distribution capabilities [37]. This summary encapsulates the key insights from the conference call, highlighting the company's performance, strategic direction, and market positioning within the biopharmaceutical industry.

Financial Performance - For Q3 2024, product revenue net amounted to $101.8 million, a 47% increase year-over-year from $69.2 million in Q3 2023[2] - Total revenue for the three months ended September 30, 2024, was $102.265 million, a 47% increase compared to $69.228 million in the same period of 2023[26] - Product revenue for the nine months ended September 30, 2024, reached $289.102 million, up 44% from $200.889 million in the same period of 2023[29] - The net loss for Q3 2024 was $41.7 million, with a loss per share of $0.04, compared to a net loss of $69.2 million and a loss per share of $0.07 in Q3 2023[5] - Net loss for the nine months ended September 30, 2024, was $(175.419) million, a decrease of 26% compared to $(239.191) million in the same period of 2023[28] - Operating loss for the three months ended September 30, 2024, improved to $(67.853) million from $(83.570) million in the same period of 2023, representing a 19% reduction[30] - The adjusted operating loss for Q3 2024, excluding non-cash expenses, was $48.2 million[5] - The adjusted operating loss for the three months ended September 30, 2024, was $(48.187) million, compared to $(59.660) million in the same period of 2023[30] Product Revenue and Growth - The revenue from the product Weiwei Jia was $27.3 million in Q3 2024, up from $4.9 million in Q3 2023, attributed to sales growth since its launch in September 2023 and its inclusion in the NRDL from January 1, 2024[4] - The revenue from the product Zele was $48.2 million in Q3 2024, a 16% increase from $41.6 million in Q3 2023[4] - The company expects to commercialize three products in mainland China by the end of 2024 and plans to submit up to four new drug applications to the National Medical Products Administration within the next six months[2] - The company expects to commercialize SUL-DUR for treating HABP/VABP in adults by the end of 2024[12] - The company plans to submit a new drug application for KarXT for schizophrenia treatment in early 2025[13] Research and Development - R&D expenses for Q3 2024 were $66 million, compared to $58.8 million in Q3 2023, primarily due to increased upfront and milestone payments[5] - The global Phase 1 data for ZL-1310 (DLL3 ADC) indicates best-in-class potential in treating extensive-stage small cell lung cancer[2] - ZL-1310 (DLL3 ADC) achieved an objective response rate (ORR) of 74% across multiple dosing levels in a Phase 1 clinical trial for ES-SCLC, with good tolerability observed[8] - The Phase 3 clinical trial FORTITUDE-102 for Bemarituzumab (FGFR2b) has completed patient recruitment, exploring its use in first-line treatment for gastric cancer[8] - KarXT demonstrated a statistically significant reduction of 9.2 points in the PANSS total score compared to placebo in a Phase 3 study for schizophrenia, with a p-value of 0.0014[10] - ZL-1503 (IL-13/IL-31) is being explored as a new therapy for moderate to severe atopic dermatitis, with preclinical data presented at the EADV conference[10] - The company will initiate a global Phase 1 study for ZL-6301 (ROR1 ADC) in solid tumors in 2025[17] - The company is collaborating with argenx to explore Efgartigimod's potential in other IgG-mediated autoimmune diseases, with several global registration studies planned[14] - The company is participating in the Phase 3 clinical trial PANOVA-3 for local advanced pancreatic cancer, with data expected in Q4 2024[15] Financial Position - As of September 30, 2024, total cash and cash equivalents, short-term investments, and restricted cash amounted to $716.1 million, down from $730 million as of June 30, 2024[6] - As of September 30, 2024, cash and cash equivalents totaled $616.1 million, down from $790.2 million as of December 31, 2023, representing a decrease of approximately 22%[23] - Total assets decreased from $1,036.3 million on December 31, 2023, to $985.3 million on September 30, 2024, a decline of about 5%[23] - The total equity of the company decreased from $796.1 million as of December 31, 2023, to $667.7 million as of September 30, 2024, reflecting a reduction of approximately 16%[25] - The company reported an accumulated loss of $2.37 billion as of September 30, 2024, compared to $2.20 billion as of December 31, 2023, indicating an increase in losses of about 8%[25] - The company had a total current asset of $860.5 million as of September 30, 2024, down from $939.6 million at the end of 2023, a decrease of approximately 8%[23] - The accounts receivable decreased from $59.2 million as of December 31, 2023, to $50.0 million as of September 30, 2024, a decline of about 16%[23] - The company’s inventory net decreased from $44.8 million to $39.5 million, representing a reduction of approximately 12%[23] - The company’s long-term investments decreased from $9.2 million to $3.2 million, a decline of about 65%[23] - The company’s total liabilities amounted to $240.2 million as of September 30, 2024, compared to the previous figure of $286.3 million, indicating a decrease of approximately 16%[24] - The company’s total current liabilities decreased from $317.7 million to $240.2 million, reflecting a reduction of about 24%[24] Other Financial Metrics - The company reported a foreign exchange gain of $14.457 million for the three months ended September 30, 2024, compared to a gain of $4.852 million in the same period of 2023[26] - Research and development expenses for the three months ended September 30, 2024, were $65.982 million, an increase from $58.767 million in the same period of 2023[26] - The weighted average shares outstanding for basic and diluted loss per share was 981,687,390 for the three months ended September 30, 2024[26] - The company did not report any income tax expense for the periods ended September 30, 2024, and 2023[28]

Investment Rating - The report maintains a "Buy" rating for the company with a target price of $60 for the US stock and HK$47 for the Hong Kong stock [1][3]. Core Insights - The initial efficacy and safety data for ZL-1310 (DLL3 ADC) in the 2L+ ES-SCLC indication are excellent, significantly boosting investor confidence in the company's R&D pipeline [1]. - ZL-1310 demonstrated a 74% overall response rate (ORR) in the global Phase 1 trial, with a 100% ORR in patients with brain metastases [1]. - The company plans to accelerate the development of ZL-1310 for 2L+ ES-SCLC and aims to communicate with the FDA regarding the accelerated approval pathway [1]. Financial Performance - The projected revenue for 2023 is $267 million, with a year-on-year growth of 24% [2][9]. - The company is expected to incur a net loss of $335 million in 2023, improving to a loss of $137 million by 2025 [2][9]. - The revenue is forecasted to grow significantly, reaching $995 million by 2026, with a compound annual growth rate (CAGR) of 53.3% from 2023 to 2026 [2][9]. Market Expectations - The current stock price is $28.9, with a potential upside of 107% to the target price of $60 [3][5]. - The stock has a 52-week price range of $13.4 to $31.2, indicating volatility and potential for growth [3][5]. Clinical Data Comparison - ZL-1310's ORR of 74% is higher than that of competitors like YL201 (68% ORR) and ZG006 (67% ORR), showcasing its competitive edge in the market [1][8]. - The safety profile of ZL-1310 is superior, with lower rates of ≥3 grade treatment-related adverse events (TRAEs) compared to YL201 [1][8].

zajடəb 2024 中期報告 於開曼群島註冊成立的有限公司 香港聯交所：9688 納斯達克：ZLAB | --- | --- | |------------------------------|-------| | 目錄 | | | | | | 公司資料 | 2 | | 前瞻性陳述 | 4 | | 管理層討論及分析 | 7 | | 其他資料 | 26 | | 未經審計簡明合併資產負債表 | 49 | | 未經審計簡明合併經營表 | 51 | | 未經審計簡明合併綜合虧損表 | 52 | | 未經審計簡明合併股東權益表 | 53 | | 未經審計簡明合併現金流量表 | 54 | | 未經審計簡明合併財務報表附註 | 56 | | 釋義 | 71 | | 技術詞彙表 | 74 | 公司資料 董事會 執行董事 杜瑩博士（董事長兼首席執行官） 獨立董事 John Diekman博士（首席獨立董事） 陳凱先教授 Richard Gaynor博士 梁頴宇女士 William Lis先生 Scott W. Morrison先生 Leon O. Moulder, Jr.先生 Michel Vounatsos先生 Pete ...

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 6 月 3 0 日止六個月 中期業績公告 本公司謹此公佈本公司於報告期的未經審計簡明合併業績，連同2023年同期的比較數 字，該等資料乃根據美國公認會計準則編製並由審核委員會審閱。本公告列載本公司 2024年中期報告全文，並符合香港上市規則中有關中期業績初步公告附載的資料之相關 要求。 財務摘要 截至2024年6月30日止六個月與截至2023年6月30日止六個月比較（以美元計） • 產品收入淨額增加55.6百萬美元（或42%）至187.3百萬美元，主要受衛偉迦® （艾加 莫德α注射液）自2023年9月上市及於2024年1月被納入國家醫保目錄以來銷售額增 加以及則樂®、紐再樂® 及擎樂® 的銷售額增加所推動。 • 研發開支減少8.9百萬美元（或7%）至116.3百萬美元， ...

Investment Rating - The report initiates coverage with a "Buy" rating for the company [3]. Core Views - The company is transitioning from a license-in model to an innovation-driven approach, establishing a strong product pipeline and commercializing five products by the end of 2023, generating revenue of $267 million [1][11]. - The company aims for a compound annual growth rate (CAGR) of approximately 50% in revenue from 2023 to 2028, targeting $2 billion in revenue by 2028 and profitability by the end of 2025 [1][21]. Financial Projections - Revenue projections for 2024, 2025, and 2026 are $390 million, $583 million, and $866 million, respectively, with year-over-year growth rates of 46.11%, 49.51%, and 48.66% [2][6]. - The net profit for the same years is projected to be -$312 million, -$184 million, and $34 million, indicating a path towards profitability by 2026 [2][6]. Product Pipeline and Market Position - The company has established over 50 clinical-stage or planned clinical-stage pipelines across oncology, infectious diseases, central nervous system disorders, and autoimmune diseases, with eight products approved in China [16][19]. - Key products include Niraparib, a PARP inhibitor for ovarian cancer, and the first approved tumor-treating fields therapy for glioblastoma, showcasing the company's competitive advantages in innovative therapies [1][22][23]. Strategic Development - The company is focusing on a dual strategy of external licensing and internal research and development, with several products entering clinical research phases [1][14]. - The management team has extensive experience in the biopharmaceutical industry, enhancing the company's capability to navigate the complex drug development landscape [12][13].

Investment Rating - The report maintains an "Outperform" rating for Zai Lab (9688 HK) with a target price of 65.76 HKD per share, adjusted from a previous value of 67.51 HKD per share [14][19]. Core Insights - Zai Lab's product revenue for Q2 2024 reached $100 million, a 45% increase year-over-year, with VYVGART contributing $23.2 million. The gross margin was 64.9%, and the net loss was $80.28 million, improved from $120 million in the same period last year [9][18]. - The company raised its full-year guidance for VYVGART sales to $80 million, up from $70 million, due to strong sales performance and increased hospital coverage [10][19]. - Zai Lab is expanding the indications for VYVGART, with submissions for new indications expected to enhance its commercialization potential [10][19]. - The company anticipates significant growth from potential blockbuster products, projecting a CAGR of approximately 50% in revenue from 2023 to 2028 [10][19]. Financial Performance - In Q2 2024, R&D expenses were $61.63 million, accounting for 61.6% of product revenue, while SG&A expenses were $79.71 million, representing 79.6% of product revenue [9][18]. - The company had $730 million in cash and equivalents as of June 30, 2024, indicating a strong liquidity position [9][18]. - Revenue forecasts for 2024 and 2025 have been adjusted to $387 million and $518 million, respectively, reflecting a year-over-year growth of 45% and 34% [14][19]. Pipeline and Future Growth - Zai Lab has obtained global rights for a new ADC, expanding its pipeline, and aims to submit at least one new drug application annually [10][19]. - The company is advancing multiple clinical trials, including studies for IL-17A and DLL3 ADC, with expected data releases in late 2024 to early 2025 [10][19]. - The anticipated peak sales potential for several products, including SUL-DUR and KarXT, is projected to exceed $1 billion each [10][19].

Investment Rating - The report maintains a "Buy" rating for Zai Lab with a target price of $60 per share or HKD 47 per share, indicating a potential upside of +231% from the current price of $18.1 and +201% from HKD 15.6 [3][4][6]. Core Insights - Zai Lab's 2Q24 revenue exceeded expectations, primarily driven by strong growth in Efgartigimod, with a 76% quarter-over-quarter increase. The company raised its full-year sales guidance for Efgartigimod to over $80 million, up from the previous estimate of over $70 million [1][6]. - The company reported 2Q24 product revenue of $100.1 million, a 45.4% year-over-year increase, and a net loss of $80.28 million, which was higher than expected due to increased sales and administrative expenses [1][6]. - Efgartigimod's growth momentum is strong, with approximately 3,300 new patients added in 2Q24, and the company is on track to meet its annual target of 1,000 hospitals [1][6]. Financial Summary - The projected revenue for Zai Lab is expected to grow from $215 million in 2022 to $995 million by 2026, with a compound annual growth rate (CAGR) of 53.3% from 2024 to 2026 [7][11]. - The company anticipates a reduction in net losses from $443 million in 2022 to a projected profit of $37 million by 2026 [7][11]. - The gross margin for the company is projected to stabilize around 64.8% by 2026, reflecting improvements in operational efficiency [11]. Upcoming Catalysts - Key upcoming catalysts include the approval of new indications for Efgartigimod, submissions for four drug applications in China, and important clinical data readouts expected in 2H24 and 1H25 [1][8]. - The company plans to launch the subcutaneous formulation of Efgartigimod in 4Q24 and expand its indications to include CIDP and thyroid eye disease [1][8].

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2024年6月30日止三個月及六個月的未經審計簡明合併業績（「2024年第二季度 業績」）以及近期產品亮點和公司進展與2024年和2025年上半年的預期重要里程碑事件。 2024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2024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2024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。 承 ...