Zai Lab Limited

Hello, ladies and gentlemen, thank you for standing by and welcome to XyLab's fourth quarter 2021 financial results conference call. At this time, all participants are in the listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at a time. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to Billy Cho, Chief Financial Officer of XyLab. who will make introductory comments.

Thank you, operator. Good morning, good evening, and welcome, everyone. XyLab recently issued a press release providing the details of the company's financial results for the 12-month ended and fourth quarter ended December 31, 2021, as well as product highlights and corporate updates. The press release is available in the investor relations section of the company's corporate website at ir.xylaboratory.com. Today's call will be led by Dr. Samantha Du, Dialogues founder, chairperson, and chief executive officer. She'll be joined by Dr. Alan Sandler, president and head of global development oncology, who will discuss advances with our oncology product candidates. Dr. Harold Reinhart, president and head of global development neuroscience, autoimmune, and infectious diseases, who will speak about progress we've made in those three therapeutic areas. And I will discuss the performance of our market products and conclude with comments on our financial results. Additional executives will also be available to answer questions during the Q&A portion of the call. As a reminder during today's call, Dylab will be making certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including our business plans and objectives and timing and success of our clinical trials, our sales and revenue forecast for our products and product candidates, regulatory applications, and commercial launches. The forward-looking statements are not guarantees of future performance. and therefore we should not put undue reliance upon them. These statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from what we expect. I refer you to our SEC filings for discussion of risk factors that could cause our actual results to differ materially from those discussed today. At this time, it is my pleasure to turn the call over to Zylus founder, chairperson, and chief executive officer, Dr. Samantha Du.

Thank you, Billy. Hello, everyone, and thank you all for joining us. On this call, I'll discuss highlights from our 2021 and what we expect to accomplish in 2022. 2021 marked another year of strong growth and execution for ZyLife. We significantly expanded our portfolio of potentially first-in-class and the best-in-class assets. we made meaningful advances with our global pipeline of 11 assets, including achieving proof of concept for CL1102, our internally developed anti-L17A human body for chronic plaque psoriasis for global rights. Through business development, we deepened our world-class gastric and lung cancer franchises with four additional promising drug candidates, including Adagrassip. We bolstered our autoimmune franchise with Ascotigamot, a pipeline in the product opportunity. And we expanded into neuroscience with an exciting non-crisis, CAR-XT. We achieved additional regulatory submissions and approvals, including our first non-oncology approval for Neutera. Our commercial execution continues to gain strong momentum for our four marketed products. We're also pleased to have Zuzula included in the NRDL for first-line ovarian cancer maintenance treatment, and we expect it to become the leading PARP inhibitor in ovarian cancer in China, given its unique label for ovarian cancer patients regardless of biomarker species. Last but not least, we further grew our talented global team both in the United States and China, building a solid foundation for continuing growth and execution. We have set clear strategic priorities for 2022 to position ourselves to lead the next wave for biopharma innovation. First, will expedite bringing medicines to patients by accelerating important data results and regulatory filings across our entire portfolio. We plan to file the MDA for eczema tick-moth in China in mid-2022, subject to ongoing discussion with NMPA, and to initiate a China registrational study for vimatizumab in first-line gastric cancer. in Greater China. Second, we'll continue to invest in R&D and advance our internal pipeline with global rights. We plan to move our CL1102 into full global development and submit up to two R&D for internally developed compounds with global rights in 2022. Lastly, we'll leverage our leading position in China to accelerate our growing revenue base and to source innovation internally and externally with potentially transformative assets and partnership opportunities. Our mission is to build a leading global biopharmaceutical company. Looking ahead, we plan to have at least 50 market products approved in more than 30 indications by 2025. We believe that the regulatory environment will continue to be supportive of innovative biopharma companies like Xylab. We are also confident in the long-term market potential of our differentiated world-class portfolio designed to address significant unmet medical needs and to create significant value for all of our constituents, including our shareholders. For example, we are currently forecasting that peak sales of the current assets in our lung and GI cancer franchises could generate up to a combined total of $2.5 to $3 billion through 2030. And now, I'll turn the call over to Dr. Alan Sandler. Alan? Dr. Alan Sandler Thank you, Samantha.