Legend Biotech Corporation

Good morning and thank you for standing by. Welcome to the Legend Biotech Report second quarter 2023 financial results. 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, Head of Investor Relations and Public Relations. Please go ahead.

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 second quarter 2023 performance. Joining me on today's call are Ying Huang, our CEO, and Lolly McComber, Legend CFO. Following the prepared remarks, we will open up the call for Q&A. We have Guo Wei Fan, Chief Scientific Officer, and Steve Gaffel, Head of Commercial Development for the U.S. and Europe, joining the Q&A session. During today's call, we will be making forward-looking statements. which are subject to risk 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 session of our company website. Thank you, and I will now turn the call over to Ying.

Good morning, everyone. Thank you for joining us today. We have had a very busy first half of the year and we're excited to be sharing our latest corporate developments with you on a quarterly basis, starting with today's call. Over the past six months, our teams have worked incredibly hard to accomplish a number of critical milestones that have set the stage for decisive growth for our company for years to come. First and foremost, as you may have seen, reported by our partner J&J on July 20th, our first approved therapy CARVICTI generated total sales of $170 million in the second quarter of 2023. amounting to $189 million in sales in the first half of 2023. The strong performance in the quarter exceeded our expectations, which was driven by continued strong demand for our product and a meaningful increase in our daily slot capacity. We were able to ramp up a lot more quickly than anticipated and we made continued improvements in our manufacturing processes. We're very pleased by the progress made in our commercial launch and remain committed to making CARVICT available and accessible to patients who are eligible for treatments through our ongoing investments to increase capacity and improve efficiency in the second half of 2023. We continue to find success in our portfolio and pipeline, including the CARTITUDE clinical development program that investigates CARVICT in additional patient populations. These results demonstrate the strength of our company in our relentless pursuit of novel therapies for patients with unmet needs. This year, at the American Society of Clinical Oncology meeting in June, we presented new data from our Phase III CARTTITUDE IV study investigating CARVICT in relapsed and lenalidomide refractory patients with one to three prior lines of treatment. In this study, CARVICTI reduced the risk of disease progression or death by 74% compared to standard of care regimens. The data were also published in the New England Journal of Medicine and presented at the European Hematology Association 2023 Congress later that month. Based on the CART2 score data, our partner Janssen submitted a type 2 variation application to the European Medicines Agency and a supplemental biologic license application to the US Food and Drug Administration to expand the indication for CARVICTI for use in earlier lines of multiple myeloma treatment as early as after first relapse. We see CARVICTI as the crux of the new myeloma landscape and have submitted regulatory applications for its expansion from 4 plus lines to 2 plus lines. We're excited by the potential to provide treatment options to patients earlier in their treatment journey and are encouraged by the results of ongoing CARDI4 study. We look forward to working closely with regulatory authorities around the world as we seek to expand the indication. As part of our efforts to expand manufacturing capacity, we signed a three-year contract with Novartis to manufacture additional clinical doses of Carvicti in April and added additional certified treatment centers this quarter as part of our ongoing efforts to improve efficiencies while expanding capacity and access to this novel therapy. In addition to our success with CARVICTI, we're also advancing our pipeline of therapies for solid tumors. This quarter, the U.S. Food and Drug Administration granted LB2101, targeting DLL3, our investigational therapy for small cell lung cancer, an orphan drug designation, in which we were able to open a trial site in the U.S. to prepare for patient recruitment. Another one of our solid tumor programs, LB1908, targeting Claudine 18.2 in gastric cancer, is also progressing on track. We recently opened two clinical trial sites in the U.S. for this program in the second quarter, and we anticipate dosing our first patient soon. We look forward to reporting on the progress across both of these solid tumor programs in the future. And finally, our financial outlook is equally promising and positions us to execute our plans through 2025. On the heels of our strong Caritude4 data, we were able to raise approximately $785 million in gross proceeds in a quarter through a registered direct offering, private placement, and the exercise of a warrant. bringing our cash, cash equivalents, deposits, and investments to $1.5 billion at quarter end. Further, as part of our collaboration with Janssen for Curvicti and the Carditude Clinical Development Program, we received a $15 million milestone payment this quarter at the acceptance of the Type 2 application for Curvicti and achieved another milestone for $20 million at the US FDA acceptance of the SPLA of Carditude 4. We continue to see additional revenue from Curvicti as we reach additional key data and regulatory milestones. Turning to the next slide, slide six, a final analysis of data from the pivotal phase 1B2, Partitude 1 study was presented at the ASCO and EHA annual meetings this year that showed sustained, deep, and durable responses in heavily pretreated patients with relapsed or refractory multiple myeloma. This data shows that CARVICTi continues to demonstrate both efficacy and safety years after treatment, which has made our therapy a leading option for adult patients with relapsed or refractory myeloma. In addition, five-year follow-up data from LEGEN2 were presented. It is the longest follow-up by any BCMA-target CAR-T cell therapy. At the five-year follow-up, these data are encouraging and bolster our belief that siltacel or Carvicti is a paradigm-shifting therapy. Moving on to slide seven, as I mentioned earlier, we recently announced the submission of the supplemental biologics license application to the U.S. Food and Drug Administration to expand the label for Carvicti. The application for expansion includes the treatment of adult patients with relapse and lanolidomide refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor and an immunomodulatory agent. With this finding, we hope to move Carvicti into the two to four prior lines of therapy setting in multiple myeloma subject to FDA approval. FDA has now accepted this SBLA filing and assigned a PDUPA date of April 5, 2024. In the clinic, we plan to complete enrollment of the ongoing Phase III CARTITUDE V trial, which evaluates psilocybin in newly diagnosed patients for whom transplant is not intended by end of this year. Furthermore, we're planning to initiate enrollment of our first-line CARTITUDE 6 study in fourth quarter of 2023. Next slide, slide eight. We're pleased to report that Carvicti continues market penetration with net sales of $170 million in second quarter of 2023, consisting of $140 million in the US and $3 million in EU. The 63% quarter-over-quarter sequential growth in the US was primarily driven by high demand from physicians and patients, higher slot availability, and lower out-of-spec rate. As of June 30th, the number of activated US treatment sites was 54. On slide 9, you will see our R&D team continues to advance our proprietary pipeline in the second quarter. In last quarter, we opened our first clinical trial site for our DLL3 program in the US. our second ongoing clinical trial in the U.S. In addition, a number of patients are being enrolled and dosed in a number of phase one IIT programs in China. I'll now turn the call over to our CFO, Laurie Makenberg, to go over our second quarter financial performance in more detail.