Legend Biotech Corporation

Legend Biotech second quarter 2025 earnings call. At this time, all participants are in the 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 the star 1-1 on your telephone, and then you will hear an automated message advising your hand is raised. And to withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would now like to turn your conference over to Caroline Paul, Associate Director of Investor Relations. Please go ahead.

Good morning. This is Caroline Paul, Associate Director of Investor Relations at Legend Biotech. Thank you for joining our conference call today to review our second quarter of 2025 performance. Prior to this call, we issued a press release announcing our financial 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 Huang, the company's chief executive officer, Alan Bash, the company's president of Carbecti, and Jesse Young, the company's interim chief financial officer. Following the prepared remarks, we will open up the call for Q&A. We have our President of R&D, Goi Fang, and Chief Medical Officer, Maithili Kaneru, 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 Investors section of our company website. In addition, adjusted net income or loss is a non-IFRS metric. This non-IFRS financial measure 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 these 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 of 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 press release includes IFRS to non-IFRS reconciliations for these measures. With that, I will now turn the call over to Yang.

Hello, everyone. Thank you for joining us today. We had quite an eventful second quarter as we made history with our long-term survival data at ASCO and achieved the most CAR-T sales ever during a single quarter. During the second quarter, CAR-VT net trade sales were approximately $439 million, which is 136% increase year over year. We have now treated over 7,500 patients with CAR-VT, and our launch remains the strongest CAR-T launch to date. In the US, more than half of our utilization is now in the earlier line setting. We continue to anticipate achieving operational break-even for CARBICTI by the end of 2025 and company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses. On a regulatory front, we're excited about the FDA's decision to remove risk evaluation and mitigation strategies, or REVs, for currently approved BCMA and CD19-directed autologous CAR-T therapies. As a result of this change, CAR-VT's FDA label was also updated to reduce monitoring requirements, such as instructing patients to remain within proximity of a healthcare facility for at least two weeks instead of four weeks. and advising patients to avoid driving for at least two weeks following product administration compared to eight weeks previously. We expect these label updates to improve the patient experience and enhance access for patients in both the community and academic settings. On another overwhelmingly positive note, we received a lot of great publicity following our presentations at ASCO and EHA in June. starting with new data presented at ASCO on our pipeline candidates. In the Phase 1 study, LB1908, our autologous Claudine 18.2-targeted CAR T-cell product, demonstrated encouraging antitumor activity with manageable safety and tolerability, and CAR T-cell expansion was observed in all patients. Additionally, in the Phase 1 dose escalating study evaluating LB2102, our DLL3-targeting CAR-T candidate, no dose-limiting toxicity were reported, and a preliminary efficacy signal was observed up to four dose levels. As a reminder, we have an exclusive global licensing agreement with Novartis to develop and commercialize LB2102 and other DLL3-targeting CAR-T therapies discovered by legend. Turning to CAR-VICT, there were two different analyses I'd like to spend some time highlighting from ASCO. First, you'll recall that in the final protocol-specified analysis of cartitude 1, the median PFS was 35 months, and median overall survival had not been reached, which had already established a new benchmark for triple-class exposed patients with relapsed refractory multiple myeloma. Subsequently, at ASCO this year, in an analysis of remission and survival from cartitude 1, 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 without further multiple myeloma treatment. Furthermore, patients with high-risk cytogenetics and those with extramedullary plasmacytomas were equally likely to be progression-free. To put this into context, At the RSCO investor event, Dr. Sondar Jagnaz noted that some of his patients were deciding between hospice and CAR T therapy. The median overall survival of five years clearly set a new benchmark in this population. As a result of this groundbreaking data, numerous media outlets publicized these results as well as patient stories. A number of clinicians indicated to us that they have noticed increased patient awareness about CARVICTI following some of these articles and TV news stories. Second, based on analysis of subgroups in intent to treat population from CARTITUDE4, CARVICTI improved progression-free survival and overall survival versus the standard of care in all subgroups, including patients with standard and high-risk phylogenetics, EMD, and one prior line of therapy and beyond. For example, the median PFS for patients with high-risk fetal genetics was 37 months compared to 10 months for the standard of care. These data continue to support a positive benefit versus risk ratio for CARVICT in patients with lenalidomide refractory multiple myeloma as early as after first relapse. Turning to further improvements in CARVICTI safety profile, we continue to leverage our learnings on extensive data that's been generated on over 7,500 patients treated with CARVICTI. We are facilitating best practice sharing on predicting, mitigating, and managing neurologic events, and we continue to highlight new safety data to patients and physicians. Importantly, we do not see a mature impact on utilization and expect continued strong performance on CARVICTI. In a few moments, you'll hear from Alan on how we and our partner, Johnson & Johnson, are trying to bring CARVICTI to more patients in need of a CAR T therapy with a demonstrated survival benefit. On a final note on CARVICTI, before we turn to our pipeline, we continue to expect to complete enrollment for CAR T6 this year. We believe CAR T5 and 6 trials are key to moving CARVICTI into the frontline setting. Looking at long-term growth for Legend, in addition to looking toward moving CARV-X into the frontline, we remain focused on solidifying our leadership in the field of cell therapy. We're making progress in new indications, such as solid tumor programs, as you have seen with the recent ASCO data. Additionally, we remain excited about the new research facility currently being built in Philadelphia, where in vivo delivery will be one of its key focuses. positioning us well to pursue this area of innovation with the right infrastructure and resources. We believe this next-generation approach to off-the-shelf therapy holds a lot of promise for incurable diseases. Our new platform, TAVEC, which is short for T-Cell Activation Vector, is being used to target oncology and autoimmune indications. It provides T-cell specificity, activation, and safety through mutations in glycoprotein to block transduction of non-T-cells. We've already dosed a few patients in an IIT study for non-Hodgkin's lymphoma, and we're planning for multiple U.S. IND-enabling studies in the future. We're excited to be embarking on this next frontier of cell therapy innovation, and we look forward to providing additional updates as we make progress on this front. To sum up, Legend is the largest standalone cell therapy company with over 7,500 CARVIC-T patients treated as we forge the path to cure. With a cash position of approximately $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. And with that, I'll pass it over to Alan to provide an update on CARVIC-T.