Legend Biotech Corporation

Good day, ladies and gentlemen. Thank you for standing by. Welcome to Legend Biotech First Quarter 2024 Financial Results Conference Call. At this time, all participants are on 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 automatic message advising your hand is raised. Please note that today's conference may be recorded. I will now hand the conference over to your speaker host, Jessie Young, Head of Investor Relations and Public Relations. Please go ahead.

Good morning. This is Jessie Yang, Head of Investor Relations and Public Relations at Legend Biotech. Thank you for joining our conference call today to review our first quarter 2024 performance. Joining me on today's call are Ying Huang, the company's Chief Executive Officer, and Laurie McCumber, 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 Investors section of our company website. Thank you.

Hello, everyone, and welcome to our first quarter earnings call. I am pleased that you could join us. As many of you on this call know, 2024 has been an eventful year for us. Obviously, our major news was the approval of Corvicti by the FDA and European Commission for second-line relapse or refractory multiple myeloma. These approvals have the potential to change the treatment paradigm for tens of thousands of patients in the United States and Europe. The feedback from key opinion leaders, oncologists, advocates, patients, and caregivers has been tremendous. On March 15th, we received international media attention when the FDA's Oncologic Drug Advisory Committee, or ODAC, meeting raised awareness about multiple myeloma and the positive benefit risk profile of CARVICTi. ODAC's unanimous 11-0 recommendation in favor of CARVICTi was independent and objective validation of its value proposition. We also added another noteworthy approval to our growing list. The Brazilian Health Regulatory Agency has approved CARVICTI for second-line multiple myeloma. I am pleased to report that CARVICTI is now available by prescription in Brazil. Our patient-facing colleagues and those who work in manufacturing are energized and eager to share our transformative therapy with more patients around the world. As you will see on our addressable market slide, our second-line indication translates to an addressable patient population of 80,000 across three major markets. Turning to financial developments, Kavikti net trade sales for the first quarter were $157 million, which is a 100% increase year over year. Sequentially, net sales decreased by $2 million from $159 million in the fourth quarter of last year. This was the result of phasing due to the timing of orders and when they were delivered and billed for, as well as manufacturing testing needed for the upcoming expansion. Importantly, there was growth in patient demand, and obviously that was before the recent second-line approvals. So we do anticipate continued growth for Curvicti, particularly in the second half of the year as we continue to add more slots and expand our capacity. Right now, there's no higher priority in the company than making more supply available to the market and reducing the van to van time. We're working to expand production from every angle. We're continually increasing production at our Raritan, New Jersey facility, where we have doubled cell processing capacity since the beginning of 2023. We're laser focused on completing physical expansion of our Raritan site this year. We plan to double Corvicti capacity by the end of 2024 compared to the end of 2023. Our production capacity will be augmented later in the year when our Obelisk facility in Ghent, Belgium is approved for commercial production. Clinical production already started back in January. With the second line FDA approval, the specifications for manufacturing Corvicti were widened, which should give us greater yield going forward. Finally, Legend and J&J expanded a previous agreement with Novartis to perform commercial manufacturing for Carvictis throughout the end of 2029. The increases to our production capacity will help ensure we meet our target of annualized capacity of 10,000 patient slots by the end of 2025. Our cash balance now stands at $1.3 billion, which we believe provides us the resources needed to increase production 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 have now a total of 72 US hospitals certified to treat COVID patients. So our reach in the community is growing in parallel with the increase in eligible patients. outpatient treatment comprises approximately one-third of our volume and remains an important differentiator for us. Due to the longer onset of CRS for CARVIC-T patients, this side effect can potentially be managed in the outpatient setting, which allows those hospital beds to be utilized for other patients who need them. Finally, since our last earnings call in March, we published our first ESG report. Not only does it summarize our achievements as responsible corporate citizens, the report provides a great overview of the company and transparency into how we conduct our business. To sum up, so far in 2024, we have achieved our significant regulatory goals and are working to execute with excellence to meet the growing demand for Carvacti. Now, I would like to turn the call over to Laurie to walk you through the financials for the first quarter. Laurie?