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, 2022 Or o Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 | --- | --- | |---------------------------------------------------------------------------------------------------|------------------------ ...

Zai Lab Limited (NASDAQ:ZLAB) Q3 2022 Results Conference Call November 10, 2022 8:00 AM ET Company Participants Billy Cho - Chief Financial Officer Samantha Du - Founder, Chairperson and Chief Executive Officer Josh Smiley - Chief Operating Officer Harald Reinhart - President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases Jonathan Wang - Chief Business Development Conference Call Participants Michael Yee - Jefferies Yigal Nochomovitz - Citi Anupam Rama - J.P. Morgan Ziyi Chen ...

Company Overview - The company is listed on the Hong Kong Stock Exchange under the ticker 9688 and on NASDAQ as ZLAB[1]. - The company has four commercialized products approved for sale in Greater China and twelve projects in late-stage development as of August 3, 2022[8]. - The company employed 2,063 full-time employees as of June 30, 2022, an increase from 1,951 full-time employees as of January 31, 2022[64]. Financial Performance - Total revenue for the six months ended June 30, 2022, was $94.9 million, a 66% increase from $57.0 million in the same period of 2021[41]. - Product revenue net amounted to $93.7 million, up 64% from $57.0 million year-over-year, with significant contributions from Zelek and Aipudun[44]. - The company recorded a net loss of $220.3 million for the six months ended June 30, 2022, a 44% improvement from a loss of $396.2 million in the same period of 2021[41]. - Cash used in operating activities for the six months ended June 30, 2022, and 2021 was $132.0 million and $235.3 million, respectively, showing a decrease in cash burn[33]. - The company anticipates a significant increase in R&D expenditures as it advances its twelve late-stage clinical candidates and initiates more clinical trials[34]. Research and Development - Research and development expenses amounted to $10.4 million in the second quarter of 2022, related to several development milestones achieved with partners[8]. - The company plans to continue its clinical research for other products and candidates[7]. - The company is assessing its development plans to prioritize resources on projects that are likely to have a beneficial impact on patients and enhance global competitiveness[34]. Regulatory and Compliance - The mid-term report includes forward-looking statements regarding the company's strategies, business potential, and financial performance[7]. - The report emphasizes the need for funding to support operational and business activities[7]. - The company faces various risks, including regulatory approval timelines and the impact of COVID-19 on business operations[7]. - The company announced the acceptance of the new drug application for Majigatuximab by the National Medical Products Administration in January 2022, targeting HER2-positive metastatic breast cancer patients who have received two or more prior therapies[11]. Market and Product Development - The company plans to leverage its position in Greater China to expand its revenue base and explore innovative opportunities[40]. - The company announced the completion of the first patient enrollment in the PANOVA-3 study for TTFields in pancreatic cancer in Greater China in January 2022[9]. - Adagrasib showed an objective response rate (ORR) of 43% and a disease control rate (DCR) of 80% in the KRYSTAL-1 study for NSCLC patients with KRASG12C mutations[10]. Equity and Financing - The company raised approximately $164.6 million from private equity financing and net proceeds of about $2,462.7 million from its IPO and subsequent offerings as of June 30, 2022[33]. - The company may require substantial additional funding through public or private equity sales, debt financing, or other arrangements to support ongoing operations[59]. - The company has no interest-bearing loans, resulting in a debt-to-equity ratio of zero as of June 30, 2022, and December 31, 2021[64]. Corporate Governance - The board appointed John Diekman as the Chief Independent Director to strengthen corporate governance[17]. - Joshua Smiley joined the company as Chief Operating Officer on August 1, 2022, bringing over 26 years of experience in the biopharmaceutical industry[18]. COVID-19 Impact - COVID-19 has adversely impacted the company's operations, particularly during the lockdown period from March to May 2022, which may continue to affect performance in the second half of 2022[38]. - Ongoing COVID-19 restrictions may lead to delays or disruptions in manufacturing and supply capabilities, potentially affecting the company's ability to sell products in the Greater China region[39]. Future Outlook - The company provided guidance for the next quarter, expecting revenue to grow by 20% to RMB 1.8 billion[173]. - New product launches are anticipated to contribute an additional RMB 300 million in revenue over the next six months[174]. - The company is exploring potential acquisitions to enhance its product portfolio, with a budget of up to RMB 500 million allocated for this purpose[171].

Zai Lab Limited (NASDAQ:ZLAB) Q2 2022 Earnings Conference Call August 10, 2022 8:00 AM ET Company Participants Samantha Du - Founder, Chairperson and Chief Executive Officer Josh Smiley - Chief Operating Officer Billy Cho - Chief Financial Officer Alan Sandler - President, Head of Global Development, Oncology Harald Reinhart - President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases Jonathan Wang - Chief Business Development Conference Call Participants Michael Yee - Jefferies ...

Start Time: 08:00 January 1, 0000 8:48 AM ET Zai Lab Limited (NASDAQ:ZLAB) Q1 2022 Earnings Conference Call May 11, 2022, 08:00 AM ET Company Participants Samantha Du - Founder, Chairperson and CEO Billy Cho - CFO Alan Sandler - President, Head of Global Development, Oncology Harald Reinhart - President, Head of Global Development, Neuroscience, Autoimmune and Infectious Diseases Jonathan Wang - Chief Business Development Conference Call Participants Michael Yee - Jefferies Yigal Nochomovitz - Citigroup Anu ...

Financial Performance - Total revenue for Q1 2022 was $46.7 million, up from $20.1 million in Q1 2021, with key product sales including $29.6 million from Zejula, $12.8 million from Epoetin, $3 million from Qianglian, and $700,000 from Nuplazid[28]. - Total revenue for the three months ended March 31, 2022, was $46.724 million, compared to $20.103 million for the same period in 2021, representing a 132.5% increase[38]. - Product revenue for the three months ended March 31, 2022, was $46.095 million, while collaboration revenue was $629,000[38]. - Net loss for Q1 2022 was $82.4 million, reduced from a net loss of $232.9 million in Q1 2021, with a net loss per share of $0.09 compared to $0.26 in the prior year[29]. - Operating loss for the three months ended March 31, 2022, was $79.764 million, compared to an operating loss of $227.092 million for the same period in 2021, showing a significant improvement[38]. - The net loss for the three months ended March 31, 2022, was $82,394 thousand, a significant improvement from a net loss of $232,910 thousand for the same period in 2021[39]. - The total comprehensive loss for the same period was $84,587 thousand, compared to $230,010 thousand in the prior year, indicating a reduction in overall losses[39]. Clinical Development - Zai Lab reported a solid performance in Q1 2022, with a focus on advancing its proprietary pipeline of 11 global rights candidates[2]. - The company plans to submit a new drug application for efgartigimod in mainland China by mid-2022 and initiate a registrational study for bemarituzumab in first-line gastric cancer in the Greater China region[2]. - The company is committed to advancing its clinical pipeline and expects multiple key clinical study results in 2022, enhancing its late-stage collaboration pipeline[2]. - The company plans to initiate a pivotal study for bemarituzumab in late-stage gastric cancer and GEJ cancer in Q4 2022[10]. - The company is collaborating with Amgen on a phase 1b study of bemarituzumab combined with chemotherapy for FGFR2b overexpressing gastric cancer[9]. - The company aims to start a pivotal clinical study for CLN-081 after completing food effect pharmacokinetics research in the second half of 2022[15]. - The company has initiated a phase 1 clinical study of elzovantinib in Greater China, with the first patient enrolled[16]. - Retifanlimab clinical study for MSI-H/dMMR endometrial cancer patient enrollment in Greater China has been completed and closed[17]. - The company plans to submit a new drug application for gMG to the National Medical Products Administration in mid-2022[23]. - ZL-1102, a novel fully human VH antibody fragment targeting IL-17A, is set to initiate a global Phase 2 study for chronic plaque psoriasis in the second half of 2022[23]. - The company plans to submit a new drug application for SUL-DUR to the NMPA in Q4 2022[26]. - The company is in communication with the NMPA regarding the registration of KarXT for schizophrenia in China in mid-2022[25]. Research and Development - R&D expenses for Q1 2022 were $53.9 million, a decrease from $203.9 million in Q1 2021, primarily due to the absence of new licensing upfront payments[28]. - The company expects to provide clinical data updates for the SHIELD-1 study in the second half of 2022[16]. - The company will announce preliminary clinical data from the dose escalation cohort of BLU-945 combined with osimertinib in the SYMPHONY trial in the second half of 2022[18]. - BLU-945 showed early evidence of safety and clinical activity in the SYMPHONY trial for EGFR-driven advanced NSCLC, consistent with preclinical data[18]. - In the SYMPHONY trial, a cohort has been initiated to evaluate BLU-945 in combination with osimertinib for second-line or later treatment of EGFR mutation NSCLC patients[18]. - Efgartigimod demonstrated a higher sustained response rate in ITP patients (21.8%) compared to placebo (5%) in the ADVANCE study, achieving statistical significance (p = 0.0316)[22]. - Efgartigimod's subcutaneous formulation showed non-inferiority to the intravenous formulation in gMG patients, with total IgG levels decreasing from baseline[23]. - The company aims to include Nuplazid's CABP and ABSSSI indications in the national medical insurance catalog in 2022[24]. Market and Commercialization - Zai Lab's commercial team continues to drive significant growth for four marketed products in the Greater China region despite challenges from the COVID-19 pandemic and geopolitical risks[3]. - Cash and cash equivalents, short-term investments, and restricted cash totaled $1.313 billion as of March 31, 2022, down from $1.409 billion as of December 31, 2021[29]. - Cash and cash equivalents as of March 31, 2022, were $846.957 million, down from $964.100 million as of December 31, 2021[36]. - Total assets as of March 31, 2022, were $1.500 billion, compared to $1.610 billion as of December 31, 2021[37]. - Total liabilities as of March 31, 2022, were $192.907 million, down from $230.000 million as of December 31, 2021[36]. - Shareholders' equity as of March 31, 2022, was $1.308 billion, compared to $1.380 billion as of December 31, 2021[37]. - The company appointed Josh Smiley as COO, effective August 2022, bringing over 26 years of biopharmaceutical experience[27]. - The company completed a 1-for-10 reverse stock split effective March 30, 2022, to enhance liquidity and attract more investors[27].