Revenue and Sales Performance - Net product revenue for Q1 2024 was $87.1 million, a 39% increase from $62.8 million in Q1 2023, primarily driven by increased sales volume and the launch of VYVGART[89]. - Total product revenue for the first quarter of 2024 was $87.1 million, representing a 39% increase from $62.8 million in the same period of 2023[109]. - ZEJULA sales increased by 7% to $45.5 million, while QINLOCK saw a significant increase of 367% to $6.1 million[109]. - VYVGART was commercially launched in September 2023 and included in the NRDL in Q1 2024, contributing to revenue growth[106]. - QINLOCK and NUZYRA saw increased sales due to their inclusion in the NRDL, with QINLOCK added in Q1 2023 and NUZYRA's oral formulation added in Q1 2024[106]. - ZEJULA remained the leading PARP inhibitor in hospital sales for ovarian cancer in mainland China, with continued support from NRDL listings[106]. Expenses and Losses - The cost of sales increased by 58% to $33.6 million in Q1 2024 from $21.3 million in Q1 2023, reflecting higher product sales volume[103]. - Research and development expenses rose by 13% to $54.6 million in Q1 2024 compared to $48.5 million in Q1 2023, indicating continued investment in product development[103]. - Selling, general, and administrative expenses increased by 11% to $69.2 million in Q1 2024 from $62.5 million in Q1 2023, supporting commercial operations[103]. - The net loss for Q1 2024 was $53.5 million, a 9% increase from a net loss of $49.1 million in Q1 2023[103]. - The company’s net loss increased by $4.3 million in Q1 2024, contributing to the rise in cash used in operating activities[140]. Cash Flow and Financial Position - As of March 31, 2024, the company had cash and cash equivalents of $750.8 million, expected to meet cash requirements for at least the next 12 months[136]. - The company reported a net decrease in cash, cash equivalents, and restricted cash of $39.4 million in Q1 2024, an improvement from a decrease of $128.4 million in Q1 2023[139]. - Net cash used in operating activities increased by $20.8 million to $90.1 million in Q1 2024, primarily due to a $24.7 million increase in net changes in operating assets and liabilities[140]. - Net cash provided by investing activities was $3.3 million in Q1 2024, a significant shift from net cash used of $54.0 million in Q1 2023, mainly due to a $100.0 million decrease in purchases of short-term investments[141]. - Net cash provided by financing activities was $47.5 million in Q1 2024, compared to net cash used of $3.9 million in Q1 2023, driven by $48.2 million in proceeds from short-term debts[142]. - The company had cash and cash equivalents of $650.8 million as of March 31, 2024, down from $790.2 million as of December 31, 2023[153]. Research and Development - Clinical program expenses within R&D increased by 50% to $18.8 million, driven by newly initiated studies[114]. - Research and development expenses rose by 13% to $54.6 million, primarily due to a $7.5 million increase in CROs/CMOs/Investigators expenses[112]. Debt and Obligations - As of March 31, 2024, the company may be required to pay up to $303.5 million in development and regulatory milestone payments for current clinical programs[101]. - The company entered into debt arrangements allowing subsidiaries to borrow up to approximately $164.5 million to support working capital needs[137]. Foreign Currency and Interest - Foreign currency losses amounted to $2.1 million in the first quarter of 2024, contrasting with a gain of $8.9 million in the same period of 2023[119]. - Interest income decreased by $0.6 million to $9.7 million due to reduced cash and cash equivalents[117]. Customer Concentration - As of March 31, 2024, accounts receivable from the two largest customers accounted for approximately 21% of total accounts receivable[154]. Accounting Standards - The company has not adopted any new accounting standards since December 31, 2023[144]. Foreign Exchange Risk - The company has not used derivative financial instruments to hedge foreign exchange risk, as it does not currently have significant direct exposure[147].

Exhibit 99.1 Zai Lab Announces First Quarter 2024 Financial Results and Recent Corporate Updates – Net product revenue of $87.1 million for the first quarter of 2024, representing 39% y-o-y growth; 43% y-o-y growth at constant exchange rate (CER) ® – VYVGART (efgartigimod alfa injection) sales of $13.2 million for the first quarter of 2024, driven by increased patient access; an estimated 2,700 new patients were treated with VYVGART in the first quarter of 2024 – Regulatory reviews ongoing for sulbactam-dur ...

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 ...

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 ____________________ Title of each class Trading Symbol(s) Name of each exchange on which registered American Depositary Shares, each representing 10 Ordinary Shares, par value $0.000006 per share ZLAB The Nasdaq Global Market Ordinary Shares, par value $0.000006 per share* 9688 The Stock Exchange of Hong Kong Limited FORM 10-Q ____________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHAN ACT ...