Zai Lab Limited

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

Thank you, operator. Good morning and welcome, everyone. XyLab recently issued a press release providing the details of the company's financial results for the third quarter ended September 30th, 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 Dewey, XyLab's founder, chairperson, and chief executive officer. She'll be joined by Jonathan Wong, head of business development, to discuss our recent collaboration for three new potentially transformative medicines. Dr. Alan Sandler, president and head of global development oncology, who will discuss advances with our oncology product candidates. Dr. Harold Reinhart, GMO, autoimmune and infectious diseases, who will speak about progress we've made in two therapeutic areas. Tao Fu, chief strategy officer, who will discuss the performance of our market products. And I will conclude with comments on our financial results in the quarter. We'll all be available to answer questions during the Q&A portion of the call. As a reminder, during today's call, XyLab 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, regulatory applications, and commercial launches. These forward-looking statements are not guarantees of future performance, and therefore you 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 a 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 Zyla's founder, chairperson, and chief executive officer, Dr. Samantha Dew.

Thank you, Billy. Hello, everyone, and thank you all for joining us. On this call, I'll discuss highlights from our third quarter, including two exciting new deals we announced yesterday, and give you the latest update for what we expect to accomplish in the fourth quarter and beyond. We continue to deliver strong growth and performance across our entire business. We made important advances across our innovative portfolio, which we continue to differentiate in terms of the steps and breath. I'm very pleased to share with you that we expanded our product portfolio both vertically and horizontally by establishing partnerships for three new potentially first-in-class or second-in-class products. Our agreement with Brooklyn Medicine for two promising lung cancer compounds, Blue 945 and Blue 701 present opportunities to further expand our world-class lung cancer franchise. Our deal with Corona Therapeutics allows us to enter a whole new therapeutic area, Neuroscience. In an exciting, unprecedented CAR-XT, Johnson & Wong will provide additional details about its products. In the third quarter of 2021, Xilab made significant progress across all fronts, R&D, BD, regulatory, and commercial. It continued to generate strong revenue growth from Zula, Aptune, and Kinglock. We had a positive meeting with an MPA on Ascot TIGMOD, which suggests the potential for an accelerated pathway for regulatory approval for GMT in China. Subject to the FDA approval and further discussion with NMPA, we expect to file the MDAs in China by the first half of 2022. We announced exciting data from the ATT&CK clinical trials for subectin, gerobectin, and we will now proceed to prepare regulatory silos. We achieved clinical approval concepts for CL1102 our L17A novel VH antibody fragment for topical treatment of mild to moderate type psoriasis. Demonstrating proof of concept for GL1102 is an important milestone for SciLab in our effort to discover and develop a pipeline of internally developed products with global rights. and to expand to as many indications as possible worldwide. Innovation, several of our innovative product candidates had exciting data updates at recent medical meetings. Alan, Harold, and Paul will elaborate on those positive developments in a few minutes. We continue to expect approval of MISERA for community-acquired bacterial pneumonia. and acute bacterial skin structure infection by the NMPA in the fourth quarter. We are making progress in preparing regulatory filings for tumor-treating fields in mesothelioma and marked tooth and mouth in breast cancer. And we expect to enroll patients in China for numerous global clinical trials over the next several quarters. We now have 28 globally innovative assets in our pipeline, and the quality, depth, and breadth of our pipeline continues to go from strength to strength. 13 products are in late phase development, of which five have already been approved in the U.S., and four have received FDA breakthrough therapy designation. In addition, Our growing pipeline includes 11 early stage programs with worldwide rights, including three in global clinical trials and one that achieves plural concepts and is advancing into full development. We have had a very productive year so far. For 2021, we expect our fourth quarter and 2022 to be reaching milestones to unlock significant value in our business With that, I'll now ask Jonathan to speak about our two collaborations. Jonathan?