Legend Biotech Corporation

Good day, ladies and gentlemen. Thank you for standing by. Welcome to Legend Biotech Report's third quarter 2023 financial results conference call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during this 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 Yang, Head of Investor Relations and Public Relations, you may begin.

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 third quarter 2023 performance. Joining me on today's call are Ying Huang, the company's Chief Executive Officer, and Laurie McComber, the Communist Chief Financial Officer. Following the prepared remarks, we will open up the call for a Q&A. We will be joined by Guo Wei Fan, Chief Scientific Officer, and Steve Scaffold, Head of Commercial Development for the US and Europe. 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 investment section of our company website. Thank you. I will now turn the call over to Ying.

Good morning, and thank you for joining us today to discuss the third quarter financial and corporate accomplishments of Legend Biotech. We are pleased with the progress we have made over the last quarter to advance our portfolio and pipeline of innovative therapies that are focused on addressing the serious and intractable disease patients face. Last week, we announced that we have entered into an exclusive global licensing agreement with Novartis, which grants Novartis the rights to develop, manufacture, and commercialize LB2102 and other potential CAR T therapies, selectively targeting DLL3. LB2102 is an investigational autologous chimeric antigen receptor T cell therapy for the treatment of adult patients with extensive stage small cell lung cancer. As part of this agreement, we will receive an upfront payment of $100 million and are eligible to receive up to $1.01 billion in milestone payments, as well as tiered royalties on net sales. will also be reimbursed for development costs for the ongoing phase one clinical trial, which will evaluate the safety and efficacy in patients with small cell lung cancer and patients with large cell neuroendocrine carcinoma and to determine the recommended dose for phase two study. We're excited by this transaction and we look forward to seeing how this therapy performs in a clinic. Carvicti, or Siltacel, continues to drive our revenue and direct our priorities. We have worked tirelessly to bring Carvicti to patients who are eligible for treatment, and our efforts are reflected in the total net sales of $152 million in third quarter, bringing total net sales for 2023 to $341 million so far this year. Our third quarter performance was driven by ongoing market launches, expanding market share and capacity improvements, as well as the commercial launch of CARVICTI in Germany, which contributed to quarter-over-quarter ex-U.S. growth of 300%. In the U.S., we have experienced growth of 23% quarter-over-quarter. We remain steadfast in our goal to make CARVICTI available and accessible to patients worldwide, and we look forward to sharing highlights of that journey with you today. We have progressively met strong demand for CARVICTI in collaboration with Janssen. First, Janssen has scaled the in-house production of lentivirus at its factories in Switzerland and has another factory in the Netherlands under construction to complement and support LV supply, which should be online by 2025. LV expansion is crucial because it is often the rate limiting factor in any car team manufacturing and growing LV supply is an important front in our ramp up. Second, we're still on track with our pre-planned capacity increase at our Ryerson site and production from our CDMO is supporting that expansion next year. Third, The first of our state-of-the-art manufacturing facilities in Ghent has received a license from the Federal Agency for Medicines and Health Products in Belgium. This was an important hurdle to clear, and once the Investigational Medicinal Product Dossier is approved by local authorities, we'll begin manufacturing supercells at Ghent for clinical use by end of this year. The Ghent facility will be an important part of the CARVICTI supply chain network. We're committed to bring CARVICTI to more patients who are eligible for this important therapy. Our manufacturing ramp-up supports commercial delivery as well as our ongoing CARTITUDE clinical development program with Janssen. Of the five clinical trials evaluating silted cells, three are ongoing, and CARTITUDE 6, our phase 3 study for frontline patients, enrolled its first patient. The activation of one of our GAND facilities will enable us to continue the commercial ramp we began in the U.S. while onboarding new clinical patients. In addition to making capacity enhancements, we work with roughly 60 certified treatment centers across the U.S. and are expanding access to CARVICTI in select European countries, including Germany. Our teams are working hard on multiple fronts to bring this efficacious one-time treatment to patients in need. We are pleased to share that since trials began in 2018, we have treated more than 2,000 people with Cilta-Cell. Our pipeline is also robust, and we're exploring the potential of cell therapies in both hematologic malignancies and solid tumors. The funds from our transaction with Novartis will primarily be used to develop other promising pipeline assets such as our allogeneic cell therapies. The armoring used in LG2102 can also be deployed in other pipeline programs if validated in a clinic. We continue to explore innovation in our pipeline and are excited about their progression. Now I want to turn this to Laurie.