Legend Biotech Corporation

Ladies and gentlemen, thank you for standing by. Welcome to Legend Biotech's second quarter 2024 earnings conference 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 the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. 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 the conference over to Jessie Young, Vice President of Investor Relations and Finance. Please go ahead.

Good morning. This is Jessie Young, VP of Investor Relations and Finance at Legend Biotech. Thank you for joining our conference call today to review our second quarter of 2024 performance. The second quarter has been an eventful one. We are pleased to report 18.5% sequential growth in Cavic-T cells. More importantly, we received label expansion approvals from both FDA and EMA. Lastly, we are most excited about the survival benefits demonstrated by Cavic-T in the second analysis of Casetil-4. Nothing gives us more joy than helping patients with multiple myeloma live longer. Joining me on today's call are Ying Huang, the company's chief executive officer, and Laurie McComber, the company's chief financial officer. Following the prepared remarks, we will open up the call for a Q&A. We have Guo-Wei Fan, chief scientific officer, and Steve Gavell, head of commercial development for the US and Europe, 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. Thank you.

Hello and welcome to our second quarter earnings call. I am pleased that you could join us. Since our last earnings call, we have made progress on multiple fronts, which you can see in our earnings presentation on slide 5. First, we announced positive top-line results from CAR 2-4. In the pre-specified second interim analysis, CAR-VICTi demonstrated statistically significant and clinically meaningful improvement in overall survival. compared to standard therapies. We look forward to presenting this important data set at major medical meetings in the coming months. Additionally, at ASCO and the EHA, we provided new data from the phase two CART2 study and new and updated data from the phase three CART4 study. We would like to bring to your attention a recent paper published in Nature. As you will see on slide six, Data were reviewed from 339 multiple myeloma patients treated at Mayo Clinic with antibody drug conjugates CAR-T and T-cell engagers targeting BCMA in the period of 2018 through 2023, with a median follow-up of 21 months. The study found that CAR-T and T-cell engagers demonstrate superior efficacy in both PFS and OS to that of ADCs. The authors also concluded that, where feasible, CAR-T should be the initial BCMA-directed therapy. We're encouraged by the real-world clinical evidence of CAR-T advocacy, particularly the insight it provides into the strong efficacy of CAR-VT. As many of you know, our expansive CAR-VT dataset enables us to continue building a strong foundation for our market penetration. On this note, we recently added two regulatory approvals to the global market opportunity you see on slide 7. The United Kingdom's Medicines and Healthcare Products Regulatory Agency approved CARVICTI for second-line multiple myeloma, and Health Canada approved CARVICTI as well. Our efforts to bring CARVICTI to more patients globally translated into net trade sales for the second quarter of $186 million. which is a 60% increase year over year and 18.5% increase quarter over quarter, as you will see on slide 9. The increase in our second quarter performance versus the first quarter was a result of the ongoing launch of Carvicti and share gains from capacity expansion and manufacturing efficiencies. Importantly, We continue to see growth in patient demand and we are reiterating our expectation for pronounced growth for Curvicti in the second half of the year as we continue to add more slots and expand our capacity. We remain laser focused on making more supply available to the market and reducing van to van time. Turning to slide 11, our CMO Novartis has begun clinical production of Curvicti in the US. This frees up production capacity for commercial production at our facility in Ryerton, New Jersey. We're on track to complete physical expansion of the Ryerton site and anticipate approval of the new section of Ryerton in the second half of 2025. We continue to expect that our Obelisk facility in Ghent, Belgium, will be approved for commercial production later this year. We more than doubled our predictive production capacity in 2023 and are on track for continued expansion. The increases to our production capacity will help us keep up with growing patient demand. Our cash balance now stands at $1.3 billion, which we believe provides us the resources needed to increase production, as I just mentioned, and gives us financial runway into 2026. when we expect to begin to achieve an operating profit. In other developments, we continue to bring more hospitals online as authorized treatment centers. We now have a total of 77 US hospitals certified to treat cardiovascular patients. Outpatient treatment now comprises approximately 40% of our volume. and remains an important medium for us as we expand our marketing efforts in the community setting for the second line and beyond. Finally, turning to our pipeline on slide 13, I am pleased to share that we recently completed Carditude 5 enrollment. As you might recall, this randomized phase 3 study evaluates patients with newly diagnosed multiple myeloma for whom stem cell transplant is not planned as initial therapy. If we were to receive approvals based on CAR T5 and CAR T6, it would translate into an additional 52,000 patients annually. I'm also pleased to share that we recently broke ground on the new state-of-the-art research center in Philadelphia to advance our portfolio of next-generation cell therapies. We are excited to expand our research presence in the U.S. and attract top talent from the growing biotechnology innovation hub Philadelphia, the birthplace of gene and cell therapy. In summary, we are executing against the substantial opportunity ahead of us as we expand our manufacturing capabilities and increase our earlier line commercial activities with an eye towards investment in future transformative cell therapies. Now, I would like to turn the call over to Laurie to walk you through the financials for the second quarter. Laurie,