Financial Data and Key Metrics Changes - Total revenues for the full year of 2022 were $215 million, compared to $144.3 million in 2021, representing a 49% year-over-year growth [31] - Total revenues for the fourth quarter of 2022 were $62.6 million, compared to $44.2 million in the prior year, representing a 41.7% year-over-year growth [31] - Net loss for 2022 was $443.3 million, or a loss per share of $0.46, compared to a net loss of $704.5 million, or a loss per share of $0.76 for 2021 [34] Business Line Data and Key Metrics Changes - Product revenues for ZEJULA were $145.2 million in 2022, a 55.2% increase from $93.6 million in 2021 [32] - Optune generated $47.3 million in revenue for 2022, up 21.6% from $38.9 million in 2021 [32] - QINLOCK and NUZYRA reported revenues of $15 million and $5.2 million respectively, with NUZYRA showing significant growth from close to zero in 2021 [32] Market Data and Key Metrics Changes - ZEJULA is expected to become the leader in PARP sales for ovarian cancer in China in 2023, with a market share of 39% of total PARP hospital sales in Q4 2022 [14][30] - The COVID-19 challenges have mostly subsided, leading to expectations of strong revenue growth in 2023 [14] Company Strategy and Development Direction - Zai Lab aims to achieve commercial profitability in 2023 and overall corporate profitability by the end of 2025, with plans to launch at least 8 additional products [10] - The company is focused on advancing its product pipeline and strengthening its portfolio through transformative assets and partnerships [10] - Zai Lab is optimistic about the supportive global regulatory environment for innovative biopharmaceutical companies [10] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about returning to normalcy in China post-COVID, with expectations for a strong growth year in 2023 [38] - The company is confident in achieving corporate profitability by the end of 2025, based on careful planning and modest assumptions on sales and expenses [56] Other Important Information - Zai Lab's oncology franchise is making progress, with significant milestones expected in 2023, including BLA approvals and new drug applications [12][14] - The company has made significant advancements in its autoimmune and infectious disease therapeutic areas, with several key submissions and approvals anticipated [28][26] Q&A Session Summary Question: Update on COVID situation in China and its impact on commercial and clinical execution - Management reported a positive outlook on the COVID situation, with expectations for a strong growth year in 2023 and effective navigation of challenges faced in 2022 [38] Question: Commercial opportunity for Tumor Treating Fields and reimbursement - Management indicated that the opportunity for Tumor Treating Fields is significant, with potential formalization of NRDL expected this year [39] Question: Portion of revenues reimbursed by private pay and supplemental insurance - Approximately 70% of sales were through some NRDL mechanism, with expectations for growth in supplemental insurance coverage [43] Question: R&D and SG&A spending outlook - R&D spending is expected to remain flat with modest increases, while SG&A is anticipated to grow as the company targets commercial profitability [48][49] Question: KarXT opportunity and commercialization plans - Management highlighted the significant unmet need in schizophrenia treatment and the potential for KarXT, with plans for an efficient commercial setup [66][70]

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) Citi Biotech C-Suite Fireside Chat Series Conference Call February 14, 2023 11:00 AM ET Company Participants Josh Smiley - COO Conference Call Participants Yigal Nochomovitz - Citi Yigal Nochomovitz Okay, great. I’m Yigal Nochomovitz. I’m one of the biotech analysts here at Citi. This is a continuation of our newly introduced C-suite series where we feature management from some of our covered companies for a one-hour discussion about the pipeline and other topics. So, it’s my g ...

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 ...