Legend Biotech Corporation

Good day and welcome to the Legend Biotech fourth quarter and full year 2024 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. Instructions will be given at that time. As a reminder, this call may be recorded. I would like to turn the call over to Caroline Paul, Associate Director of Investor Relations. Please go ahead.

Good morning. 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 fourth quarter of 2024 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 Kuang, the company's Chief Executive Officer, 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 Carbectie, Alan Bash, president of R&D, Goi Fang, and chief medical officer, Maithili Konaru, 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 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 loss and adjusted net loss per share enhances an investor's understanding of our financial performance. We use adjusted net 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 loss provides a useful measure of our operating performance from period to period by excluding certain items that we believe are not representative of our core business. 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. I am glad that you are able to join us and hear about our recent accomplishments as the largest standalone cell therapy company. As you can see on slide 6, we have been executing against our strategic priorities, paving the way for us to achieve blockbuster status and operational break-even for Carvicti by the end of 2025, and anticipated company-wide profitability in 2026, excluding unrealized foreign exchange gains or losses. I would like to start by expanding on CARVICTI's unique profile, which is the first and only CAR-T in multiple myeloma to clinically demonstrate a survival benefit versus standard of care. At the ASH 2024 annual meeting, we shared new results from the Phase III CARTITUDE IV study that show 89% of invaluable patients achieved minimal residual disease negativity with a single infusion of CARVICTI after a three-year follow-up compared to 38% for those treated with standard of care. As you may know, the FDA ODAC Committee recently recommended the uses of MRG negativity as discretion as a potential surrogate endpoint in multiple myeloma trials, which creates other potential opportunities for approval in the future. Additionally, we're pleased to see that CARVICT outcomes data is reaching the broader multiple myeloma community. The International Myeloma Working Group recently published a series of core recommendations on sequencing therapy for the treatment of multiple myeloma. Notably, one of these recommendations in patients who are reasonable candidates for both BCMA CAR T therapy and bispecific T cell engagers is to pursue CAR T therapy first. Our sales trajectory since our launch is no doubt due to Carvicti's unique profile, along with strong manufacturing and commercial execution. Remember, Legend and J&J are pioneering and undertaking at a scale that we believe has never been done before in the field of multiple myeloma for CAR-T. On this note, on slide seven, we'd like to highlight how the FDA has approved our CMO Novartis facility for commercial production of Carvicti in New Jersey. We are looking forward to initiating clinical production at our facility called TechLand in Ghent, Belgium in the coming weeks and initiating commercial production there later this year. This is another critical component of our plans for serving patients in Europe and beyond to meet the increasing demand. We are thrilled with our industry-leading early launch performance and we're not stopping there. We continue our commitment to bringing Carvicti to all eligible patients in the U.S. and Europe who might benefit from its differentiated efficacy. We're pleased that Carvicti recently received approval for reimbursement in Spain. Moving to slide 9, in the fourth quarter of 2024, net trade sales of Carvicti were approximately $334 million. which is a 110% increase year-over-year and a 17% increase from third quarter. This performance was aligned with our expectation for accelerating growth in the second half of last year and was driven by strong demand, continued capacity expansion, and the Carditude 4 label launch for use as early as the second line. Regarding OUS performance, sales of $31 million increased 138% year-over-year, and 15% quarter over quarter, owing to our recent increases in capacity and launches in Germany, Austria, Switzerland, and Brazil. In the United States, we continue to certify more hospitals as authorized treatment centers. The total number of US hospitals that are certified to treat with CARVICTI is now 102. We believe outpatient administration remains another key competitive advantage for us. CARVICTI is the only approved CAR T in multiple myeloma that has seen significant use in outpatient settings. Because of the delayed onset of CRS with CARVICTI, providers are able to utilize outpatient administration to support patient needs. We are pleased with the progress we have made since one year ago when outpatient treatment accounted for 30% of our overall volume. and anticipate a majority of our volume coming from outpatient use by end of this year. We're also committed to facilitating best practice sharing as we treat more and more patients. We have now treated over 5,000 patients with CAR-VT, which has created the most comprehensive CAR-T patient data set in multiple myeloma. New data is constantly being generated about CARVICTI's benefit over risk profile. For example, at the tender meeting in February, as you can see on slide 10, real-world data was presented on risk mitigation strategies for CARVICTI. On the clinical front for CARVICTI, as you may know, CARVICTI 5 is fully enrolled, and we expect to complete enrollment for CARVICTI 6 this year. We believe these trials are key to moving CARVICTI into the frontline setting. We believe these studies we have underway and our manufacturing and commercial execution will enable us to maximize Carvicti's potential. As you can see on slide 12, Carvicti is the proven leader forging the path to cure in multiple myeloma. Turning to our upcoming company milestones on slide 14, as we continue to work toward doubling Carvicti's supply in 2025, we anticipate growth to be driven by capacity expansion in Belgium and in New Jersey In addition to increasing our manufacturing capacity, we're working to include our overall survival benefit in CARVICTI's label, which is the gold standard that doctors want for their patients. Looking at long-term growth for legend, we're building out our pipeline programs, and we look to use the successful model we have pioneered with CARVICTI and take it to other therapeutic areas where options are limited. These include blood cancers and next-generation multiple myeloma therapies. solid tumor programs, and autoimmune diseases. The new research facility we're building in Philadelphia is a testament to our commitment to pipeline investments, and we are looking forward to opening it later this year. To sum up, Carvicti is the market leader in multiple myeloma CAR T therapies. We have scaled up our business and delivered on our commitment to doubling Carvicti's supply. We have continued to expand the body of evidence on CARB-X's differentiated clinical profile, and we continue to build out our pipeline to leverage our end-to-end expertise and ensure long-term growth. Now it's time to take a closer look at the financials, so I'll turn that call over to Jessie.