Legend Biotech Corporation

Good day, and welcome to the Legend Biotech Report's fourth quarter earnings call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session, and instructions will be given at that time. As a reminder, this call is being recorded. I would now like to hand the call over to Jessie Young, Head of Investor Relations and Public Relations. You may begin.

Good morning. This is Jessie Young, Head of Investor Relations and Public Relations at Legend Biotech. Thank you for joining our conference call today to review our fourth quarter and full year 2023 performance. 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 Gaffel, 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 herewithin. 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. Thank you. I will now turn the call over to Ying.

Good morning, everyone. We're glad you could join us today because a lot has happened since our last earning score. First, we're excited at the prospect of bringing our lead therapy, CARVICTI, to more multiple myeloma patients in Europe. As many of you have heard, CARVICTI received a positive opinion from the Committee for Medicinal Products for Human Use to expand into earlier lines of treatment. CARVIC-T is the first CAR-T therapy to receive a positive CHMP opinion in the second-line setting for patients with relapse and lenalidomide refractory multiple myeloma. The formal European Commission decision is expected in April. As for the approval of CARVIC-T in the United States in the second line, we are scheduled to meet with the FDA's Oncologic Drug Advisory Committee this Friday, the 15th, to answer any outstanding questions they have. We are preparing for a potential launch in this expanded indication on the particular date of April 5th. And we will, of course, keep you posted. Now, I'd like to turn to other achievements and activities since our last earnings call. Our work to bring Carvicti to more patients globally resulted in total net sales for the fourth quarter of 2023 of $159 million. For the full year, total sales for Carvicti were half a billion dollars. The increase in our fourth quarter performance versus the third quarter was the result of the ongoing launch of Carvicti and share gain from capacity expansion and manufacturing efficiencies. We have now been in the market for seven full quarters, and we are the fastest-launched CAR T therapy. We anticipate continued quarter-over-quarter growth throughout 2024 as well. We believe our cash balance of $1.3 billion provides us with financial runways through the end of 2025. In order to serve more patients and meet our revenue targets, we have expanded our supply of lentiviral vectors significantly through a large reactor in Switzerland operated by our partner Johnson & Johnson. In addition, Johnson & Johnson has another factory under construction in the Netherlands. We also continued to expand our internal manufacturing capacity in partnership with Janssen. Our cell processing site in Ghent, Belgium, called Obelisk, produced the first batches of Corvicti for clinical use in January 2024. We hope to start commercial production in the second half of the year. Construction progressed on our second manufacturing site, Techland, in Belgium, and it's expected to be complete at the end of the year. We have increased capacity at our Raritan, New Jersey facility, doubling cell processing capacity since the beginning of 2023. The increases to our production capacity will help ensure we meet our target of supplying Carvicti to 10,000 patients by the end of 2025. I am excited to announce we have a new veteran leader with more than 25 years of experience now overseeing our manufacturing sites. Our own Berk van der Wijn has been promoted to senior vice president, global manufacturing and technical operations. Our previous head of global tech ops, Liz Gosen, has stepped aside from full-time work for personal reasons and is now serving as a senior advisor for us. Berk joined us in 2021 to start our European organization and the manufacturing facilities I just mentioned. The site in Ghent that has just came online and second one under construction. Before joining Legend, he served at Janssen, Teva, and AstraZeneca. Burke has earned the trust and respect of our global manufacturing teams, and he's already made a big impact. The increase in production capacity enabling us to meet growing patient demand comes in parallel with new data we presented at the American Society of Hematology meeting in December. In an oral presentation, we unveiled data showing improvements in patient outcomes as early as second-line treatment in our pivotal phase III CARTITUDE IV study. The results demonstrated clinically meaningful improvements in health-related quality-of-life measures and reductions in symptoms following treatment with CARVICTi compared to standard care. In other news from the fourth quarter, we continue to bring more hospitals online, and we now have a total of 65 U.S. hospitals certified to treat with CARVICT patients. Additionally, about 30% of patients are now administered in the outpatient setting. Turning to the pipeline, we're investigating the potential of our cell therapies in blood cancers beyond multiple myeloma and also in solid tumors. We have started dosing patients in our DLL3 targeted program, the Phase 1 clinical trial of LB2102 in lung cancer. The armoring used in LB2102 can also be deployed in other pipeline programs if validated in the clinic. After Phase 1, Novartis will take over and conduct any further development, including manufacturing and commercial activities. To sum up 2023, we closed the year with accomplishments on several fronts. Now, I would like to turn the call over to Laurie to walk you through the financials for 2023. Laurie?