Legend Biotech Corporation

Ladies and gentlemen, thank you for standing by. Welcome to Legend Biotech's third quarter 2025 earnings call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this session, you would need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Jessie Young, Vice President of Investor Relations and Finance. Please go ahead.

Good morning. This is Jessie Young, Vice President of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to reveal our third quarter of 2025 performance. Prior to this call, we issued a press release announcing our financing results for the quarter. You can find the press release on our IR website at legendbiotech.com. Joining me on today's call are Ying Huan, the company's chief executive officer, Alan Bash, the company's president of Kavikti, and Carlos Santos, the company's chief financial officer. Following the prepared remarks, we will open up the call for Q&A. We have our president of R&D, Guo Wei Fan, joining the Q&A session. During today's call, we will be making forward-looking statements, which are subject to risks and uncertainties that may cause our actual results to differ materially from those expressed or implied here within. These forward-looking statements are discussed in greater detail in our SEC filings, which we encourage you to read and can be found under the investor section of our company website. In addition, adjusted net income or loss is a law IFRS metric. This non-IFRS financial measures is in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with IFRS. There are a number of limitations related to the use of this non-IFRS financial measures versus their closest IFRS equivalents. However, we believe that providing information concerning adjusted net income or loss and adjusted net income or loss per share enhances an investor's understanding of our financial performance. We use adjusted net income or loss as a performance metric that guides management in its operation and planning for the future of the business. We believe that adjusted net income or loss provides a useful measure of our operating performance from period to period. Our personal list includes IFRS to non-IFRS for consideration for these measures. With that, I will now turn the call over to Ying.

Hello, everyone. Thank you for joining us today. The third quarter was marked by significant milestones that I will elaborate on momentarily. And we are looking forward to presenting new data at the annual American Society of Hematology meeting in December. During the third quarter, CARVIC-T net trade sales were approximately $524 million, which is an 84% increase year over year. We have now treated over 9,000 patients with CARVIC-T, and our launch remains the strongest CAR-T launch to date. In the U.S., the majority of our utilization is in the earlier line setting. Additionally, we continue to see a lot of excitement about our long-term survival data presented at ASCOB on CARTICTUDE1. As a reminder, one-third of patients with heavily pretreated relapsed refractory multiple myeloma remain alive and progression-free for five years or more after being treated with CARVICTI. This is especially impressive considering that today's bridging protocol did not exist at the time of the CARTICTUDE1 trial, and patients in the trial had received a median of 6.5 prior lines of therapy. Ever since our CAR T1 results were first presented in 2020, we have been setting new standards for efficacy in CAR T for multiple myeloma. We're now changing that standard to curative potential. In fact, a recent article from Nature stated that one-third of the treated individuals had no evidence of detectable myeloma after five years without further therapy, an outcome widely thought of as a prerequisite to consider using the TURB cure. This kind of efficacy for heavily pre-treating patients is unprecedented in the field of multiple myeloma. On a regulatory front, the FDA recently approved an update to include CARB-X's overall survival benefit in this label. This was based on an analysis from the Phase III CARTITUDE IV study showing a statistically significant improvement in overall survival for CARVICT-T compared to the standard of care therapy in patients with relapse refractory multiple myeloma after one to three prior lines of therapy. Importantly, CARVICT-T is the only approved CAR-T in multiple myeloma with a demonstrated overall survival benefit in its label, which represents another step forward towards educating the physician community on CARVICTI's unique profile as we work to bring CARVICTI to more second-line patients in need across the United States. We expect label updates such as these and previous RANS updates will continue to improve the patient experience and enhance access in both community and academic settings. In fact, I want to share findings from a recent survey that was presented at the International Myeloma Society meeting, where 237 patients and 267 physicians were represented across US, UK, Spain, France, Germany, Italy, Japan, and Brazil. In terms of what patients value when selecting a new line of treatment, overall survival was clearly the most important attribute for patients. Also, on the topic of survival, we are pleased that there will be two oral presentations on CARVICT at this year's upcoming ASH meeting. Before we dive deeper into this, I want to highlight that there will be an oral presentation at ASH on LUCAR-G35D, our first in-class allogeneic gamma-della-T CAR-T cell therapy targeting both CD19 and CD20 in adults with relapsed refractory B-cell non-Hodgkin's lymphoma. As you may have seen in the abstract, we are pleased that preliminary efficacy showed an encouraging response rate and sustained durability in patients. Turning to the CARVIC-T oral presentations, based on the CARVIC-T4 subgroup analysis, 80% of patients with standard risk cytogenetics were progression-free and off treatment at 2.5 years. In patients with standard risk disease, who achieved MRD-CR at one year, this rate increased to 100%. The low rate of progression events in CARVIC-D treated patients with standard risk cytogenetics shows the profound benefit of a single infusion in this population. In the second oral presentation on CARVIC-D, Based on correlated biomarker data, longer PFS is associated with better immune fitness at baseline and stronger immune responses post-carbectin infusion, as observed in peripheral blood and within the tumor microenvironment of patients with relapsed refractory multiple myeloma in CARTZ1 and CARTZ4 studies. The peripheral immune fitness was more pronounced in patients with one and prior lines of therapy versus three prior lines of therapy and beyond. where deterioration plateaued. Similarly, on this topic, on the next slide featuring data we presented at ASCO, you can see that while Carvicti has a favorable benefit-risk profile across all different subgroups and lines of therapy, its PFS improvement diminishes with each line of therapy, which is why it's important to follow the latest International Myeloma Working Group guidelines on obtaining CAR-T therapy as early as first relapse. This slide also contextualizes the significance of our efficacy data from CAR-T1, where there were 6.5 median prior lines of therapy, and CAR-VT still demonstrated a median PFS of 35 months. As we approach 10,000 annualized dose manufacturing capacity, we continue to extend our leadership in cell therapy through further advancing the field of CAR-T in multiple myeloma. We recently initiated another study called CAR-T-SU-10, which is a Phase II multi-cohort trial to further characterize the efficacy and safety of CAR-VT, which speaks to our commitment to investigating new protocols. Furthermore, A recent blood paper on effective bridging strategies across 20 centers found that among the 119 patients who proceeded to CAR-T therapy after receiving TAOVI, including 98 patients receiving CARVICT. Not only were these deep responses sustained soluble B-cell maturation antigen decline and consistent CAR-T expansion, there were also no cases of peripheral neuropathy, Parkinsonism, or colitis reported. As we focus on educating the physician community on our overall survival benefit based on the extensive CAR-VICT-D data that's been generated, we're also taking the opportunity to remind physicians about the latest research on bridging therapy and ALC monitoring, as well as the most recent IMWG guidelines on CAR-T. In a few moments, you will hear from Alan on how we and our partner, Johnson & Johnson, are bringing CARVICTI to more multiple myeloma patients in need. In light of the demand, we continue to see across the U.S. and overseas, we are moving full steam ahead on our capacity expansion plans. On a final note on CARVICTI before we turn to our pipeline, we continue to expect to complete enrollment for CARDIV-5, 6 this year. We believe the CARDIV-5 and 6 trials are key to moving CARVICTI into the frontline setting. Looking ahead at our long-term growth, in addition to looking forward to moving CAR-VICT-T into the frontline, we remain focused on solidifying our leadership in cell therapy more broadly. We are making progress in new indications, such as solid tumor and NHL programs, as you have seen with the data at recent medical conferences. Additionally, we are looking forward to the ribbon-cutting ceremony tomorrow for our new research facility in Philadelphia, where in vivo delivery will be one of its key focuses, positioning us well to pursue this area of innovation. We remain excited about the new frontier of cell therapy. To sum up, Legend is the largest standalone cell therapy company with over 9,000 cardiac patients treated as we forged the path to cure. With a cash position of nearly $1 billion, we are investing in our core differentiators in cell therapy and remain focused on delivering operational efficiency in order to ensure durable long-term growth. We continue to anticipate achieving profitability for Carvicti by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses. And with that, I'll pass it over to Alan to provide an update on Carvicti.