SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that it will present findings from preclinical studies highlighting the therapeutic potential of ZL-1310, the company’s global next-generation antibody-drug conjugate (ADC) program. The preclinical profile of ZL-1310 will be the focus of a poster presentation at the European Lung Cancer Congress 2024 (ELCC 2024), scheduled for March 20-23, 2024 in Prague, Czech Republic. ZL-1310 is a novel and promisi ...

SHANGHAI & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that the final overall survival (OS) data from the Phase 3 randomized, double-blind, placebo-controlled NORA study evaluating ZEJULA® (niraparib) in Chinese patients with platinum-sensitive recurrent ovarian cancer (PSROC) will be shared in oral presentations at the 2024 Congress of the European Society of Gynaecological Oncology (ESGO), March 7-10, 2024, in Barcelona, Spain, and the 2024 Society for Gyn ...

Zai Lab Limited (NASDAQ:ZLAB) Q4 2023 Earnings Conference Call February 28, 2024 8:00 AM ET Company Participants Christine Chiou - Senior Vice President-Investor Relations Samantha Du - Founder, Chairperson & Chief Executive Officer Josh Smiley - President & Chief Operating Officer Rafael Amado - President and Head-Global Oncology Research & Development Harald Reinhart - President and Head-Global Development, Neuroscience, Autoimmune & Infectious Diseases Yajing Chen - Chief Financial Officer Jonathan Wang ...

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].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 __________________________ FORM 10-K __________________________ (Mark One) x Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the fiscal year ended: December 31, 2023 Or o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the transition period from [ ] to [ ] | --- | --- | |---------------------------------------------------------------------------------- ...

Revenue Growth and Performance - Total product revenue for 2023 was $266.7 million, representing 25% year-over-year growth (31% at constant exchange rate)[1] - Zai Lab's product revenue increased by 25% YoY to $266.719 million in 2023[39] - VYVGART generated $10.0 million in revenue in 2023, with nearly 1,000 patients treated in Q4 2023 and an additional 1,000 patients treated in January 2024 alone[5] - ZEJULA revenue increased 16% year-over-year to $168.8 million in 2023, maintaining its position as the leading PARP inhibitor in China[4] - NUZYRA revenue surged 316% year-over-year to $21.7 million in 2023, driven by its inclusion in the NRDL[8] - VYVGART sales are expected to exceed $70.0 million in 2024[5] Financial Position and Expenses - Cash position decreased to $807.6 million as of December 31, 2023, compared to $1.0 billion in 2022[9] - Zai Lab's cash and cash equivalents decreased to $790.151 million in December 2023 from $1,008.470 million in December 2022[36] - Zai Lab's total assets decreased to $1,036.295 million in 2023 from $1,220.140 million in 2022[36] - R&D expenses decreased to $265.9 million in 2023 from $286.4 million in 2022, primarily due to reduced upfront and milestone payments[8] - Zai Lab's R&D expenses decreased to $265.868 million in 2023 from $286.408 million in 2022[39] Net Loss and Operational Improvement - Net loss improved to $334.6 million in 2023 from $443.3 million in 2022, driven by faster revenue growth and increased interest income[9] - Zai Lab's net loss decreased to $334.620 million in 2023 from $443.286 million in 2022[39] - Zai Lab's loss from operations improved to $366.573 million in 2023 from $404.357 million in 2022[44] Regulatory Submissions and Approvals - Up to four new regulatory submissions are expected in 2024, including sulbactam-durlobactam, efgartigimod SC, and repotrectinib[1] - Zai Lab plans to submit a Marketing Authorization Application (MAA) for Tumor Treating Fields in second-line+ NSCLC in 2024[15] - Zai Lab plans to submit an NDA for Tisotumab Vedotin in second-line+ cervical cancer to the NMPA[25] - Potential NMPA approval of efgartigimod SC for gMG and submission of sBLA for CIDP in H1 2024[25] Clinical Trials and Studies - Zai Lab to complete patient enrollment in the China bridging study for Xanomeline-Trospium in schizophrenia by Q4 2024[27] - Zai Lab to initiate a global Phase 2 study for ZL-1102 in mild-to-moderate chronic plaque psoriasis in mid-2024[28]

Core Insights - Zai Lab Limited announced the publication of data from the Phase 1/2 TRIDENT-1 study in the New England Journal of Medicine, evaluating repotrectinib in patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC) [1][4] - Repotrectinib demonstrated high response rates and durable activity in both treatment-naïve and treatment-resistant patients, including those with brain metastases [1][3] - The drug has been granted Breakthrough Therapy Designations in China for various patient categories, indicating its potential significance in treating ROS1-positive metastatic NSCLC [6] Company Overview - Zai Lab is a biopharmaceutical company focused on developing innovative products for oncology, autoimmune disorders, infectious diseases, and neuroscience [7] - The company has an exclusive license agreement with Turning Point Therapeutics to develop and commercialize repotrectinib in Greater China [6][7] Study Details - The TRIDENT-1 study involved 519 patients, with primary endpoints including maximum tolerated dose and confirmed objective response rate [3] - The study's results support the efficacy of repotrectinib in addressing limitations of first-generation TKIs for ROS1+ NSCLC [3] Market Context - In China, over 800,000 new lung cancer cases are diagnosed annually, with NSCLC accounting for approximately 85% of these cases [2] - ROS1 rearrangements occur in ≤2% of NSCLC patients, highlighting a niche but critical market for targeted therapies like repotrectinib [2]

Zai Lab Limited (NASDAQ:ZLAB) Q3 2023 Earnings Conference Call November 8, 2023 8:00 AM ET Company Participants Christine Chiou - Senior Vice President-Investor Relations Samantha Du - Founder, Chairperson & Chief Executive Officer Josh Smiley - President & Chief Operating Officer Rafael Amado - President & Head of Global Oncology and Research & Development Harald Reinhart - President & Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases Yajing Chen - Chief Financial Officer Confere ...

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9月30 日止三個月及九個月的未經審核業績 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2023年9月30日止三個月及九個月的未經審核簡明合併業績（「2023年第三季度 業績」）以及近期產品亮點及公司進展和2023/2024年的預期重要里程碑事件。2023年第三季度 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 香港，2023年11月8日 於本公告日期，本公司董事會包括董事杜瑩博士；以及獨立董事陳凱先博士、John Diekman博士、Richard Gaynor醫學博士、梁頴宇女士、William Lis先生、Scott W. Mo ...

[PART I. FINANCIAL INFORMATION](index=8&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=8&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Zai Lab Limited as of September 30, 2023, and for the three and nine months then ended, including balance sheets, statements of operations, comprehensive loss, shareholders' equity, and cash flows, along with accompanying notes [Condensed Consolidated Balance Sheets](index=8&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of September 30, 2023, total assets decreased to $1.04 billion from $1.22 billion at year-end 2022, primarily due to a reduction in cash and cash equivalents, while total liabilities and shareholders' equity also saw slight declines Condensed Consolidated Balance Sheet Highlights (in thousands of U.S. dollars) | Account | September 30, 2023 | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $788,806 | $1,008,470 | | Total current assets | $959,731 | $1,124,336 | | **Total assets** | **$1,043,694** | **$1,220,140** | | **Liabilities & Equity** | | | | Total current liabilities | $124,896 | $139,842 | | **Total liabilities** | **$162,715** | **$174,545** | | **Total shareholders' equity** | **$880,979** | **$1,045,595** | [Condensed Consolidated Statements of Operations](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For Q3 2023, total revenues increased to $69.2 million, and the net loss significantly narrowed to $69.2 million from $161.2 million year-over-year, driven by higher product revenue, lower R&D expenses, and a foreign currency gain Statement of Operations Summary (in thousands of U.S. dollars) | Metric | Q3 2023 | Q3 2022 | Nine Months 2023 | Nine Months 2022 | | :--- | :--- | :--- | :--- | :--- | | **Product revenue, net** | **$69,228** | **$56,963** | **$200,889** | **$150,633** | | Total revenues | $69,228 | $57,540 | $200,889 | $152,439 | | Research and development | $(58,767) | $(99,524) | $(183,920) | $(219,462) | | Loss from operations | $(83,570) | $(128,583) | $(242,592) | $(307,064) | | Foreign currency gain (loss) | $4,852 | $(40,442) | $(26,315) | $(73,052) | | **Net loss** | **$(69,152)** | **$(161,190)** | **$(239,191)** | **$(381,517)** | | Loss per share - basic | $(0.07) | $(0.17) | $(0.25) | $(0.40) | [Condensed Consolidated Statements of Cash Flows](index=13&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the nine months ended September 30, 2023, net cash used in operating activities improved to $183.3 million, while net cash used in investing activities shifted to $25.2 million, resulting in an overall decrease of $218.7 million in cash, cash equivalents, and restricted cash Cash Flow Summary (in thousands of U.S. dollars) | Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | $(183,261) | $(258,350) | | Net cash (used in) provided by investing activities | $(25,233) | $424,389 | | Net cash used in financing activities | $(6,826) | $(1,531) | | **Net (decrease) increase in cash** | **$(218,675)** | **$155,376** | [Notes to Financial Statements](index=15&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies and financial items, highlighting ZEJULA as the top product revenue contributor, share-based compensation expenses, and milestone payments for SUL-DUR and repotrectinib Net Revenue by Product (Nine Months Ended Sep 30, in thousands of U.S. dollars) | Product | 2023 | 2022 | | :--- | :--- | :--- | | ZEJULA | $127,230 | $102,863 | | Optune | $38,596 | $35,051 | | QINLOCK | $14,535 | $9,123 | | NUZYRA | $15,588 | $3,596 | | VYVGART | $4,940 | — | | **Total** | **$200,889** | **$150,633** | - Share-based compensation expense totaled **$59.2 million** for the nine months ended September 30, 2023, up from $45.7 million in the prior-year period[76](index=76&type=chunk) - During Q3 2023, the company paid a **$3.0 million** development milestone for SUL-DUR and a **$5.0 million** development milestone for repotrectinib[78](index=78&type=chunk) [Management's Discussion and Analysis (MD&A)](index=22&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, noting a 33% increase in net product revenue to $200.9 million and a narrowed net loss of $239.2 million for the first nine months of 2023, supported by strong liquidity of $822.2 million in cash and investments [Recent Developments](index=22&type=section&id=Recent%20Developments) Recent developments include the commercial launch of VYVGART in China, positive final overall survival data for ZEJULA, Breakthrough Therapy Designations for repotrectinib and efgartigimod SC, and key executive appointments - Launched VYVGART in September 2023 for adult patients with generalized myasthenia gravis (gMG), making it the company's fifth commercial product[92](index=92&type=chunk) - The Center for Drug Evaluation (CDE) of the NMPA granted Breakthrough Therapy Designation (BTD) for repotrectinib for patients with advanced NTRK gene fusion solid tumors[100](index=100&type=chunk) - The CDE also granted BTD for subcutaneous efgartigimod for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP)[105](index=105&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) For Q3 2023, total revenues grew 20% year-over-year to $69.2 million, with the net loss improving by 57% to $69.2 million, driven by increased product revenue, decreased R&D expenses, and reduced foreign currency losses Financial Performance Summary (Nine Months Ended Sep 30, in thousands of U.S. dollars) | Metric | 2023 | 2022 | Change % | | :--- | :--- | :--- | :--- | | Total revenues | $200,889 | $152,439 | 32% | | Research and development | $(183,920) | $(219,462) | (16)% | | Selling, general, and administrative | $(198,982) | $(186,947) | 6% | | **Net loss** | **$(239,191)** | **$(381,517)** | **(37)%** | - The decrease in R&D expenses for the nine months ended Sep 30, 2023 was primarily due to a **$30.9 million** decrease in licensing fees and a **$11.1 million** decrease in CRO/CMO expenses[128](index=128&type=chunk) - Foreign currency loss decreased by **$46.7 million** in the nine months ended Sep 30, 2023, primarily due to decreased remeasurement loss from the depreciation of the RMB against the U.S. dollar[136](index=136&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of September 30, 2023, the company maintained a strong liquidity position with $822.2 million in cash, cash equivalents, restricted cash, and short-term investments, sufficient to fund operations for at least the next 12 months - The company held **$822.2 million** in cash, cash equivalents, restricted cash, and short-term investments as of September 30, 2023[153](index=153&type=chunk) - Net cash used in operating activities decreased by **$75.1 million** to **$183.3 million** in the nine months ended September 30, 2023, compared to the same period in 2022[155](index=155&type=chunk) - Management expects current cash reserves to be sufficient to meet cash requirements for at least the next 12 months[153](index=153&type=chunk) [Quantitative and Qualitative Disclosures about Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) The company is exposed to market risks, primarily foreign exchange risk from RMB fluctuations, credit risk concentrated in cash deposits and accounts receivable, and has not experienced a material impact from inflation to date - The company's primary market risk is foreign exchange risk due to the fluctuation of the RMB against the U.S. dollar, as most operations are in China while financial statements are in U.S. dollars[162](index=162&type=chunk) - Credit risk is concentrated in cash held at major financial institutions and accounts receivable. As of September 30, 2023, the two largest customers accounted for approximately **29%** of total accounts receivable[167](index=167&type=chunk)[168](index=168&type=chunk) - Inflation has not had a material impact on the company's results of operations[170](index=170&type=chunk) [Controls and Procedures](index=36&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the third quarter of 2023 - Management concluded that as of September 30, 2023, the company's disclosure controls and procedures were effective[172](index=172&type=chunk) - No material changes were made to the internal control over financial reporting during the fiscal quarter ended September 30, 2023[173](index=173&type=chunk) [PART II. OTHER INFORMATION](index=36&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=36&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal or administrative proceedings - As of the report date, the company is not involved in any material legal proceedings[174](index=174&type=chunk) [Risk Factors](index=36&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the risk factors previously disclosed in the company's Annual Report on Form 10-K for the year ended December 31, 2022, have been reported - No material changes in risk factors were reported compared to those disclosed in the 2022 Annual Report[175](index=175&type=chunk) [Other Information](index=37&type=section&id=Item%205.%20Other%20Information) On August 12, 2023, Joshua Smiley, the company's President and COO, adopted a Rule 10b5-1 trading plan to purchase up to 15,000 ADSs, set to terminate by May 13, 2024 - The company's President and COO, Joshua Smiley, adopted a Rule 10b5-1 trading plan on August 12, 2023, to purchase up to **15,000 ADSs**[179](index=179&type=chunk)