Ladies and gentlemen, thank you for standing by, and welcome to the Legend Biotech Report's fourth quarter 2020 financial results. At this time, all participant lines are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one on your telephone. Please be advised that today's conference is being recorded, and if you require any further assistance, please press star zero. I would like to hand the conference to your speaker today, Jessie Yeung. Please go ahead, ma'am. Good morning, everyone. I hope everyone is safe and healthy. Welcome to Legend Biotech's fourth quarter and full year 2020 earnings conference call. This is Jessie Yeung, Head of Corporate Finance and Investor Relations for Legend Biotech. Joining me on today's call is Ying Huang, Chief Executive Officer and Chief Financial Officer for Legend Biotech. A few logistics before we get into the details. This review is being made available via webcast, accessible through the Investor Relations section of the Legend Biotech website. Please note that today's presentation includes forward-looking statements. We encourage you to review the cautionary statement regarding such statement in today's presentation, as well as the company's prospectus filed with the SEC on June 8th, which identifies certain factors that may cause the company's actual results to differ materially from those projected. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this presentation. Legend Biotech specifically disclaims any obligation to update any forward-looking statement. Moving to today's agenda, we will be starting with opening remarks followed by the financial results. We will do a quick review of the ASH 2020 data before we end today's call with a Q&A session. I would now like to turn the conference call to Ying. Thank you, Jessie, and good morning, everyone. Before I start, I would like to thank everyone and hope everyone is safe and healthy. Let me begin today's call by reminding what we do here and why we do what we do here at Legend. It is to serve the patients. Our team at Legend Biotech works tirelessly to bring innovative therapies to patients living with debilitating diseases. I am extremely proud to be a part of this team and grateful for this effort. Within the fourth quarter of 2020, we achieved critical milestones. At the recent ASH 2020 conference, our collaboration partner, J&J, and Legend, shared exciting results from the combined phase I-B and phase II CARTITUDE-1 study of cilta-cel, an investigational BCMA-targeted CAR T therapy. The data continued to show a very high overall response rate. Specifically, 97% of patients achieved a response. More importantly, 67% of the patients achieved a stringent complete response at a median follow-up of 12.4 months. Also, in December 2020, we initiated rolling submission of BLA or Biologics License Application to the U.S. FDA for cilta-cel. This submission is based on results from the pivotal p hase I-B/II CARTITUDE-1 study that evaluated the efficacy and safety of cilta-cel in the treatment of patients with relapse and/or refractory multiple myeloma. We also announced the U.S. FDA cleared the IND application for LB1901, which is Legend Biotech's investigational autologous CAR T, targeting CD4 for the treatment of T-cell lymphoma. Given that a substantial portion of patients with peripheral T-cell lymphoma and also cutaneous T-cell lymphoma experience relapse even with the current treatment options, there remains a high unmet medical need for these patients. With this IND clearance, we're planning to initiate a phase I first-in-human study for LB1901 in the U.S. Lastly, we also achieved the designation of accelerated assessment in Europe for the treatment of relapse and refractory myeloma for cilta-cel. The CHMP, or Committee for Medicinal Products for Human Use in European Medicines Agency, accepted the request from Janssen, our collaborative partner for this assessment, which means instead of the 210 evaluation days for the evaluation process by EMA, this accelerated assessment usually takes 150 evaluation days. Let's turn over to the financial results from 2020 and also fourth quarter 2020. Our net loss under IFRS accounting standards in 2020 was about $303 million. This compared to a loss of $133 million in 2019. Loss per share for 2020 was $1.28 compared to $0.66 loss per share for 2019. These results were driven mostly by larger teams and also a higher number of clinical trials, as well as a higher number of clinical trial patients in our CARTITUDE program, as well as the CAR T program in China. In terms of quarter-over-quarter comparison, in the fourth quarter of 2020, our net loss was about $58 million. That compared to a $64 million loss in the fourth quarter of 2019. Loss per share for the fourth quarter of 2020 was $0.22, compared to $0.32 loss per share in the Q4 of 2019. The next slide, as you can see, we continue to push forward with a robust pipeline of next generation cell therapies. Besides the BCMA program, for which we're conducting the CARTITUDE-1 in the U.S., the CARTITUDE-2 five -cohort phase II trial globally, and also the ongoing phase III randomized active controlled CARTITUDE-4 phase III trials. In China, we're conducting the pivotal phase II trial called CARTIFAN-1. Besides the BCMA program, we're continuing to conduct the phase I first-in-human studies, IIT studies in China. This includes a dual targeting CD19/CD22 auto CAR-T for non-Hodgkin's lymphoma, a dual targeting CD33/CLL1 auto CAR-T for acute leukemia, and also a CD4 targeting T-cell lymphoma program. In the field of allo or allogeneic CAR-T, we're conducting two active phase I studies. The first one is a CD20 targeting allogeneic CAR-T for non-Hodgkin's lymphoma. The second one is a gamma delta BCMA- targeting T-cell program for the treatment of myeloma. In the solid tumor field, we're conducting a study for Claudin 18.2 targeting auto CAR-T for gastric cancer and pancreatic cancer. In addition, we recently started a phase I study for a mesothelin targeting auto CAR-T for ovarian cancer. Now I would like to take a moment to highlight some of the clinical data from the CARTITUDE- 1 study that was presented recently at the ASH 2020 conference. As you can see from this slide, the data continues to show a very high overall response rate, specifically 94 out of the 97 patients enrolled achieved a response. More importantly, 67% of those patients achieved a stringent complete response. At the median follow-up of 12.4 months with the data cut, the median progression-free survival has not been reached yet. This study also demonstrated a manageable safety profile for cilta-cel at the recommended phase II dose, which is 0.75 million cells per kilogram body weight. Given that these patients were heavily pre-treated, in fact, the median life of prior therapy was 6, we believe these results are really excellent. As we look into the rest of 2021 and also into 2022, I would like to discuss the near-term targets for the company. In the first half of 2021, we're working with our collaboration partner, Janssen Pharmaceuticals, to potentially file the MAA application with EMA for cilta-cel. As I just previously mentioned, recently, the EMA accepted a request from Janssen on accelerated assessment for the marketing application for cilta-cel. We're also planning to file BLA in China, pending discussion with CDE for cilta-cel in the second half of this year. In the U.S., which is the most important market for cilta-cel, we're targeting FDA approval by end of 2021. Lastly, we're planning to initiate the phase I first-in-human study for LB1901 for the T-cell lymphoma in the U.S. Our collaboration partner, Janssen, is also working to file an NDA to the Japan Ministry of Health, Labour and Welfare for cilta-cel in the second half of this year. In 2022, we're expecting the EMA approval for cilta-cel in European Union. We're also expecting the CDE approval for cilta-cel in China. In terms of the data update for cilta-cel, I'm pleased to announce that Legend Biotech, in collaboration with Janssen, intends to present updated data from the CARTITUDE-1 and CARTITUDE-2 phase II studies at major medical conferences in 2021. In addition, Legend Biotech, along with Janssen, anticipates to publish the data from the LEGEND-2 phase I first-in-human studies in 2021. As a reminder, this phase I study enrolled a total of 74 patients in the phase I study, and every patient has completed the required three-year follow-up as of November 2020. In the next slide, as you can see, we have a comprehensive clinical development program for cilta-cel in patients with multiple myeloma. In 2020, we initiated a global phase III study called CARTITUDE-4. We also expanded the multi-cohort phase II study called CARTITUDE-2. The most recent Cohort E, is enrolling patients with newly diagnosed multiple myeloma or first-line myeloma. We intend to present data from CARTITUDE-1 and also CARTITUDE-2 studies at major conference in 2021. As I mentioned, we also anticipate to publish in a paper format the phase I LEGEND-2 long-term follow-up. With that, Victor, can you please open the Q&A? Of course. As a reminder, ladies and gentlemen, to ask a question, you will need to press star one on your telephone, and to withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Our first question will come to the line of Matthew Harrison from Morgan Stanley. Your line is open. Great. Good morning. Thanks for taking the questions. I guess two for me. Ying, I believe you said your plan is to have the BLA approved in the U.S. by the end of 2021. Can you maybe just comment where in the progress of the rolling submission you guys are now, and to be able to meet that timeline, I assume you're assuming an accelerated assessment. If you could comment on that would be great. Second, we haven't talked about this before, but maybe you could just comment broadly on your expectations around the commercial opportunity in China and what sort of work you're doing to prepare for that, given you're planning to submit sometime later this year. Thanks. Thank you, Matthew, for the question. Let me address your first questions about the BLA in the U.S. We did say that both J&J and Legend expect the cilta-cel to be approved by FDA by end of this year. We're expecting to ask FDA for priority review, given our breakthrough designation by the FDA. As you know, typically after a BLA package has been completed, there's a two-month acceptance period, following which there's a six-month review period. The total is eight months after we complete the BLA package. Broadly speaking, J&J and Legend have stated that we expect the drug to be approved by end of 2021. Therefore, if you do the math, that means we should expect the BLA package to be completed by end of April. We're not providing any guidance or provide any clarity on exactly when this is completed. What we can tell you today is that we're completely on track in terms of the BLA submission here. Again, we stand by the expectation that we expect cilta-cel to be approved and launched by 2021, end of this year. That's what we'll say about the BLA submission timeline. As a reminder. Before- Yeah, go ahead. Sorry. I was going to say, before you answer the second question, can I just ask a quick follow-up on that? Of course. Will you announce when you complete the submission or only when you have acceptance from the FDA? J&J and Legend are actually discussing the disclosure around the BLA submission and also the BLA acceptance. Unfortunately, I am not at liberty to tell exactly today what our plan is. Suffice to say that you will hear from the partners here about this. Probably the only thing I can say is stay tuned. You will hear something from J&J and Legend about this. To address the second question, Matthew, in terms of commercial market potential in China, I guess if you look at the current landscape in China, there's no commercial CAR-T therapy yet. If you look at the CDE process so far, two product candidates, namely Yescarta from Fosun Kite, which is JV from Fosun and Kite Pharma, has been submitted, and right now it's still being reviewed by CDE. The other one is the liso-cel product from WuXi Juno, which is a JV between WuXi and Juno Therapeutics. Again, that is in the review process. The application has been submitted to CDE. Given that there's no commercial CAR-T therapy yet in the Chinese market, it's difficult to comment on, for example, pricing and also the coverage from commercial insurance or reimbursement from the healthcare plans in China. However, if you look at the sheer number of patients who suffer from myeloma or [audio distortion] and beyond myeloma, it's actually a similar or bigger number compared to what we have in the U.S. As you know, in the U.S., every year, about 14,000 patients unfortunately die from multiple myeloma, and that's the minimal addressable market for us pending the FDA approval. We believe the size of the patient population in China is actually larger. Since there's no commercial product that's been already approved in the market yet, we have no benchmark to assess that. In our opinion, in the first launch phase, this drug is most likely going to be paid through self-pay mechanism, that is out-of-pocket from patients for this. Right now there's a ceiling for China national coverage for the drug cost, and we just don't think any CAR-T would come to the market immediately with the national health plan coverage. Great. Thanks very much. Thank you. Once again, as a reminder, that's star one for questions, star one. Our next question will come from the line of Biren Amin from Jefferies. You may begin. Yeah. Hi, guys. Thanks for taking my questions. Ying, on CARTITUDE-2, I believe you're going to have some data this year. Can you just maybe talk about which cohorts we should expect data in? I think there's about four or five cohorts in the trial that you guys are investigating. Any color you could provide there would be helpful. Sure. Thanks, Biren, for your question. As you know, we have already opened five cohorts for the CARTITUDE-2 program so far, which is a global trial. If you look at the patient population we're enrolling, because we opened the Cohort A first, I just want to remind you that in the Cohort A, we were planning to enroll 20 to 30 patients who were treated with one to three prior lines of therapy, and also refractory to Revlimid. This is essentially the same patient population we're testing in the randomized global phase III trial called CARTITUDE-4. However, this is a single-arm phase II study here. As you can imagine, if we do plan to publish or present any data from the CARTITUDE-2 trial, most likely it will start with Cohort A. That is the most likely patient population in which we will present data in 2021. Great. Maybe on some of your phase I programs, you've got several programs, the CD19, CD22, CD33/CLL1, and CD20 allogeneic. Can you just maybe talk about when we could expect data from some of the phase I studies? Should we expect it this year, or is it more likely next year? Absolutely. Happy to answer that question. Biren, we do have six active phase I ongoing studies in China for various indications, and depending on which program, we're in also different stage. In some programs, we're screening patients. In some programs, we're opening sites, getting through the ethical committee approvals. In some programs, we're actually already dosing patients by now. Given the pace of the enrollment, we're not providing any official guidance. However, I think the earliest possible time for us to report any data from these phase I programs would be second half towards the end of this year, we should be able to have some data in hand. That is, we should have a reasonable number of patients in terms of data. Would these data readout coincide with the IND filing here in the U.S. for these programs? Not necessarily, Biren. For example, we're already working on an IND for the Claudin 18.2 targeting auto-CART for gastric cancer and pancreatic cancer. Right now, at the same time, we're also conducting a phase I IIT study in China for this same program in gastric cancer patients. Although we don't have much clinical data for that program yet, but we have made a decision to move forward given our belief in the scientific rationale for targeting Claudin 18.2 as a treatment for gastric and pancreatic cancer. Also, given the preclinical data we have observed in our lab, we have made a decision to move forward. We're actually actively preparing for an IND application in the U.S. for that program later this year. Great. Thank you. Thank you. Thank you. Actually not showing any further questions in the queue. I'd like to turn the call over to Ying for any closing remarks. Okay, great. Again, I just want to thank everyone for dialing in, and thank you very much for your interest in Legend Biotech. Jessie and I will be standing by. If you have any further questions, feel free to contact us through any means. Again, thank you very much, and we look forward to a very productive year in 2021. Ladies and gentlemen, this concludes today's conference call. 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